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Bundesinstitut für Arzneimittel und Medizinprodukte 560. Bekanntmachung über die Zulassung von Arzneimitteln sowie andere Amtshandlungen Vom 19. Mai 2026 Gemäß § 34 Absatz 1 Satz 2 des Arzneimittelgesetzes (AMG) in der Fassung der Bekanntmachung vom 12. Dezember 2005 (BGBl. I S. 3394), das zuletzt durch Artikel 2 Absatz 4 des Gesetzes vom 12. Mai 2026 (BGBl. 2026 I Nr. 143) geändert worden ist, wird Folgendes bekannt gemacht: I. Erteilung einer Zulassung Bezeichnung des Arzneimittels Zul.-Nr. Datum der Zulassung Zulassungsinhaber Arzneimittel zur Anwendung am Menschen Abavalex 10 mg/ml Lösung zum Einnehmen 7016631.00.00 10.11.2025 G.L. Pharma GmbH Abirateron Zentiva 500 mg Filmtabletten (Es handelt sich um ein parallel importiertes Arzneimittel) 7021473.00.00 04.11.2025 B2B Medical GmbH Amlodipin/Valsartan - 1 A Pharma 5 mg/160 mg Filmtabletten (Es handelt sich um ein parallel importiertes Arzneimittel) 7021319.00.00 10.11.2025 CC - Pharma GmbH Amlodipin/Valsartan/HCT - 1 A Pharma 5 mg/160 mg/12,5 mg Filmtabletten (Es handelt sich um ein parallel importiertes Arzneimittel) 7020727.00.00 05.11.2025 BB Farma s.r.l. Anagrelid Heumann 1 mg Hartkapseln 7015770.00.00 08.11.2025 Torrent Pharma (Malta) Limited Apixaban Abdi 2,5 mg Filmtabletten 7011293.00.00 10.11.2025 Abdi Farma GmbH Apixaban Abdi 5 mg Filmtabletten 7011294.00.00 10.11.2025 Abdi Farma GmbH Apixaban Devatis 2,5 mg Filmtabletten 7013177.00.00 03.11.2025 Devatis GmbH Apixaban Devatis 5 mg Filmtabletten 7013178.00.00 03.11.2025 Devatis GmbH Apixaban Olpha 2,5 mg Filmtabletten 7014338.00.00 05.11.2025 Akciju sabiedrība „Olpha“ Apixaban Olpha 5 mg Filmtabletten 7014339.00.00 05.11.2025 Akciju sabiedrība „Olpha“ Apixaban PharmConsul 2,5 mg Filmtabletten 7020521.00.00 12.11.2025 PharmConsul s.r.o. Apixaban PharmConsul 5 mg Filmtabletten 7020522.00.00 12.11.2025 PharmConsul s.r.o. Apixaban Viatris Pharma 7015041.00.00 15.11.2025 Viatris Limited Apixaban Viatris Pharma 5 mg Filmtabletten 7015042.00.00 15.11.2025 Viatris Limited Apremilast Heumann 10 mg + 20 mg + 30 mg Filmtabletten 7018124.00.00 24.11.2025 Torrent Pharma (Malta) Limited Apremilast Heumann 30 mg Filmtabletten 7018125.00.00 24.11.2025 Torrent Pharma (Malta) Limited Aripiprazol – 1 A Pharma 300 mg Pulver und Lösungsmittel zur Herstellung einer Depot-Injektionssuspension 7017327.00.00 17.11.2025 1 A Pharma GmbH Aripiprazol – 1 A Pharma 400 mg Pulver und Lösungsmittel zur Herstellung einer Depot-Injektionssuspension 7017328.00.00 17.11.2025 1 A Pharma GmbH Aristelle 0,03 mg/2 mg Filmtabletten 7015369.00.00 10.11.2025 Aristo Pharma GmbH Atovaquon Glenmark 750 mg/5 ml Suspension (Es handelt sich um ein parallel importiertes Arzneimittel) 7021570.00.00 19.11.2025 kohlpharma GmbH Bekanntmachung Veröffentlicht am Freitag, 28. August 2026 BAnz AT 28.08.2026 B9 Seite 1 von 18 Bezeichnung des Arzneimittels Zul.-Nr. Datum der Zulassung Zulassungsinhaber Azelastin/Fluticason STADA Nasenspray 137 Mikrogramm/50 Mikrogramm pro Sprühstoß Nasenspray, Suspension 7020767.00.00 06.11.2025 STADAPHARM GmbH Brivaracetam biomo 100 mg Filmtabletten 7016605.00.00 12.11.2025 biomo pharma GmbH Brivaracetam biomo 10 mg Filmtabletten 7016601.00.00 12.11.2025 biomo pharma GmbH Brivaracetam biomo 25 mg Filmtabletten 7016602.00.00 12.11.2025 biomo pharma GmbH Brivaracetam biomo 50 mg Filmtabletten 7016603.00.00 12.11.2025 biomo pharma GmbH Brivaracetam biomo 75 mg Filmtabletten 7016604.00.00 12.11.2025 biomo pharma GmbH Budesonide Farmak 0,125 mg/ml Suspension für einen Vernebler 7012126.00.00 10.11.2025 Farmak International Spolka Z Ograniczona Odpowiedzialnoscia Budesonide Farmak 0,25 mg/ml Suspension für einen Vernebler 7012127.00.00 10.11.2025 Farmak International Spolka Z Ograniczona Odpowiedzialnoscia Budesonide Farmak 0,5 mg/ml Suspension für einen Vernebler 7012128.00.00 10.11.2025 Farmak International Spolka Z Ograniczona Odpowiedzialnoscia Budo-San Uno 9 mg magensaftresistentes Granulat (Es handelt sich um ein parallel importiertes Arzneimittel) 7021336.00.00 03.11.2025 EMRA-MED Arzneimittel GmbH Calciumfolinat Carefarm 15 mg Tabletten (Es handelt sich um ein parallel importiertes Arzneimittel) 7020238.00.00 27.11.2025 Orifarm GmbH Candesartan Mylan 4 mg Tabletten 7014827.00.00 08.11.2025 Mylan Germany GmbH Carmustin STADA 100 mg Pulver und Lösungsmittel für ein Konzentrat zur Herstellung einer Infusionslösung 7008671.00.00 06.11.2025 STADAPHARM GmbH Cystohipp 1 g Tabletten 7016239.00.00 14.11.2025 Dr. Pfleger Arzneimittel GmbH Dabigatranetexilat Galenicum Axium 110 mg Hartkapseln 7007914.00.00 03.11.2025 Galenicum Health S.L.U. Dabigatranetexilat Galenicum Axium 150 mg Hartkapseln 7007915.00.00 03.11.2025 Galenicum Health S.L.U. Dabigatranetexilat Galenicum Axium 75 mg Hartkapseln 7007913.00.00 03.11.2025 Galenicum Health S.L.U. Dagraduo 100 mg/10 mg Filmtabletten 7016044.00.00 22.11.2025 KRKA, d.d., Novo mesto Dantrolen Carefarm 25 mg Hartkapseln (Es handelt sich um ein parallel importiertes Arzneimittel) 7021571.00.00 20.11.2025 Orifarm GmbH Dapagliflozin Adalvo 10 mg Filmtabletten 7020232.00.00 08.11.2025 Adalvo Limited Dapagliflozin Adalvo 5 mg Filmtabletten 7020231.00.00 08.11.2025 Adalvo Limited Dapagliflozin beta 10 mg Filmtabletten 7016851.00.00 22.11.2025 betapharm Arzneimittel GmbH Dapagliflozin beta 5 mg Filmtabletten 7016686.00.00 22.11.2025 betapharm Arzneimittel GmbH Dapagliflozin ELPEN 10 mg Filmtabletten 7017995.00.00 21.11.2025 Elpen Pharmaceutical Co. Inc. Dapagliflozin ELPEN 5 mg Filmtabletten 7017994.00.00 21.11.2025 Elpen Pharmaceutical Co. Inc. Dapagliflozin/Metformin 123 Acurae Pharma 5 mg/1000 mg Filmtabletten 7017625.00.00 15.11.2025 123 Acurae Pharma GmbH Dapagliflozin/Metformin 123 Acurae Pharma 5 mg/850 mg Filmtabletten 7017624.00.00 14.11.2025 123 Acurae Pharma GmbH Dapagliflozin/Metforminhydrochlorid Juta 5 mg/1000 mg Filmtabletten 7012954.00.00 11.11.2025 „JUTA“ Pharma GmbH Dapagliflozin/Metforminhydrochlorid Juta 5 mg/850 mg Filmtabletten 7012953.00.00 11.11.2025 „JUTA“ Pharma GmbH Dapagliflozin/Metformin-TAD 5 mg/1000 mg Filmtabletten 7017953.00.00 15.11.2025 TAD Pharma GmbH Dapagliflozin/Metformin-TAD 5 mg/850 mg Filmtabletten 7017952.00.00 13.11.2025 TAD Pharma GmbH Bekanntmachung Veröffentlicht am Freitag, 28. August 2026 BAnz AT 28.08.2026 B9 Seite 2 von 18 Bezeichnung des Arzneimittels Zul.-Nr. Datum der Zulassung Zulassungsinhaber Dapasitazin 100 mg/10 mg Filmtabletten 7016132.00.00 21.11.2025 KRKA, d.d., Novo mesto Daptomycin Eugia 350 mg Pulver zur Herstellung einer Injektions-/Infusionslösung 7015857.00.00 15.11.2025 Eugia Pharma (Malta) Limited Daptomycin Eugia 500 mg Pulver zur Herstellung einer Injektions-/Infusionslösung 7015858.00.00 15.11.2025 Eugia Pharma (Malta) Limited Deplanda 11,25 mg Fertigspritze mit Implantat (Es handelt sich um ein parallel importiertes Arzneimittel) 7021544.00.00 25.11.2025 Orifarm GmbH Dicloreum 20 mg/g Gel 7008313.00.00 19.11.2025 Alfasigma S.p.A. Dimethylfumarat Basics 120 mg magensaftresistente Hartkapseln 7015078.00.00 18.11.2025 Basics GmbH Dimethylfumarat Basics 240 mg magensaftresistente Hartkapseln 7015079.00.00 18.11.2025 Basics GmbH Dimethylfumarat-ratiopharm 120 mg magensaftresistente Hartkapseln 7016252.00.00 22.11.2025 ratiopharm GmbH Dimethylfumarat-ratiopharm 240 mg magensaftresistente Hartkapseln 7016253.00.00 22.11.2025 ratiopharm GmbH Dolomorphon akut 1,3 mg Filmtabletten 7017138.00.00 25.11.2025 G.L. Pharma GmbH Dolomorphon akut 2,6 mg Filmtabletten 7017139.00.00 25.11.2025 G.L. Pharma GmbH Dronedaron Aristo 400 mg Filmtabletten (Es handelt sich um ein parallel importiertes Arzneimittel) 7021384.00.00 03.11.2025 BB Farma s.r.l. Dronedaron Pliva 400 mg Filmtabletten (Es handelt sich um ein parallel importiertes Arzneimittel) 7021112.00.00 03.11.2025 BB Farma s.r.l. Duloxetin STADA 20 mg magensaftresistente Hartkapseln 7013000.00.00 14.11.2025 STADAPHARM GmbH Duloxetin STADA 40 mg magensaftresistente Hartkapseln 7013001.00.00 14.11.2025 STADAPHARM GmbH Dydrogesteron Adalvo 10 mg Filmtabletten 7013571.00.00 24.11.2025 Adalvo Limited Dydroxel 10 mg Filmtabletten 7011312.00.00 06.11.2025 Exeltis Germany GmbH Edoxaban 123 Acurae Pharma 15 mg Filmtabletten 7013954.00.00 25.11.2025 123 Acurae Pharma GmbH Edoxaban 123 Acurae Pharma 30 mg Filmtabletten 7013955.00.00 25.11.2025 123 Acurae Pharma GmbH Edoxaban 123 Acurae Pharma 60 mg Filmtabletten 7013956.00.00 25.11.2025 123 Acurae Pharma GmbH Eltrombopag onkovis 25 mg Filmtabletten 7020801.00.00 03.11.2025 Onkovis GmbH Eltrombopag onkovis 50 mg Filmtabletten 7020802.00.00 03.11.2025 Onkovis GmbH Eltrombopag onkovis 75 mg Filmtabletten 7020803.00.00 03.11.2025 Onkovis GmbH Ephedrinhydrochlorid Aguettant 30 mg/ml Injektionslösung 7010174.00.00 22.11.2025 Laboratoire Aguettant Ephedrinhydrochlorid Aguettant 3 mg/ml Injektionslösung 7010173.00.00 22.11.2025 Laboratoire Aguettant Epirubicin Hikma 2 mg/ml Lösung zur intravesikalen Anwendung/Injektionslösung 7015654.00.00 05.11.2025 Hikma Farmaceutica (Portugal), S.A. Eplerenon AbZ 25 mg Filmtabletten (Es handelt sich um ein parallel importiertes Arzneimittel) 7021543.00.00 04.11.2025 B2B Medical GmbH Eplerenon AbZ 50 mg Filmtabletten (Es handelt sich um ein parallel importiertes Arzneimittel) 7021382.00.00 04.11.2025 B2B Medical GmbH Eplerenon-ratiopharm 25 mg Filmtabletten (Es handelt sich um ein parallel importiertes Arzneimittel) 7022043.00.00 19.11.2025 B2B Medical GmbH Bekanntmachung Veröffentlicht am Freitag, 28. August 2026 BAnz AT 28.08.2026 B9 Seite 3 von 18 Bezeichnung des Arzneimittels Zul.-Nr. Datum der Zulassung Zulassungsinhaber Eplerenon Teva 25 mg Filmtabletten (Es handelt sich um ein parallel importiertes Arzneimittel) 7021491.00.00 07.11.2025 Abacus Medicine A/S Eplerenon Teva 50 mg Filmtabletten (Es handelt sich um ein parallel importiertes Arzneimittel) 7022066.00.00 07.11.2025 Abacus Medicine A/S Exemestan PUREN 25 mg Filmtabletten 7011705.00.00 27.11.2025 Eugia Pharma (Malta) Limited Ezetimib/Atorvastatin-ratiopharm 10 mg/40 mg Filmtabletten (Es handelt sich um ein parallel importiertes Arzneimittel) 7020730.00.00 03.11.2025 BB Farma s.r.l. FOSTER NEXThaler 100 Mikrogramm/ 6 Mikrogramm pro Inhalation (Es handelt sich um ein parallel importiertes Arzneimittel) 7021033.00.00 19.11.2025 2CARE4 ApS Hydrocortison Hualan 10 mg Tabletten 7017602.00.00 01.11.2025 Hualan Pharmaceuticals Limited Hydrocortison Hualan 15 mg Tabletten 7017603.00.00 01.11.2025 Hualan Pharmaceuticals Limited Hydrocortison Hualan 20 mg Tabletten 7017604.00.00 01.11.2025 Hualan Pharmaceuticals Limited Hydrocortison Hualan 2,5 mg Tabletten 7017600.00.00 01.11.2025 Hualan Pharmaceuticals Limited Hydrocortison Hualan 5 mg Tabletten 7017601.00.00 01.11.2025 Hualan Pharmaceuticals Limited Hydrocortison Inresa 100 mg Pulver zur Herstellung einer Injektions-/Infusionslösung 7020129.00.00 28.11.2025 Inresa Arzneimittel GmbH Hydromorphon G.L. akut 1,3 mg Filmtabletten 7020626.00.00 25.11.2025 G.L. Pharma GmbH Hydromorphon G.L. akut 2,6 mg Filmtabletten 7020627.00.00 25.11.2025 G.L. Pharma GmbH Hydromorphon Glenmark 1,3 mg Filmtabletten 7020607.00.00 14.11.2025 Glenmark Arzneimittel GmbH Hydromorphon Glenmark 2,6 mg Filmtabletten 7020608.00.00 14.11.2025 Glenmark Arzneimittel GmbH Iloprost Waymade 100 Mikrogramm/ml Konzentrat zur Herstellung einer Infusionslösung 7016447.00.00 16.11.2025 Waymade B.V. Iloprost Waymade 20 Mikrogramm/ml Konzentrat zur Herstellung einer Infusionslösung 7016446.00.00 16.11.2025 Waymade B.V. Imigran Nasal 20 mg (Es handelt sich um ein parallel importiertes Arzneimittel) 7021510.00.00 29.11.2025 B2B Medical GmbH LABIGAT 375 mg Retardtabletten 7013832.00.00 25.11.2025 Pharmathen S.A. LABIGAT 500 mg Retardtabletten 7013833.00.00 25.11.2025 Pharmathen S.A. LABIGAT 750 mg Retardtabletten 7013834.00.00 25.11.2025 Pharmathen S.A. Lacosamid Olpha 100 mg Filmtabletten 7017609.00.00 24.11.2025 Akciju sabiedrība „Olpha“ Lacosamid Olpha 150 mg Filmtabletten 7017610.00.00 24.11.2025 Akciju sabiedrība „Olpha“ Lacosamid Olpha 200 mg Filmtabletten 7017611.00.00 24.11.2025 Akciju sabiedrība „Olpha“ Lacosamid Olpha 50 mg Filmtabletten 7017608.00.00 24.11.2025 Akciju sabiedrība „Olpha“ Ladiazyl 6 mg/ml Injektionslösung im Fertigpen 7011689.00.00 03.11.2025 Biocon Pharma Malta I Limited Latanoprost Stulln 50 Mikrogramm/ml Augentropfen, Lösung im Einzeldosisbehältnis 7014622.00.00 10.11.2025 Pharma Stulln GmbH Linezolid Teva 600 mg Filmtabletten (Es handelt sich um ein parallel importiertes Arzneimittel) 7022169.00.00 28.11.2025 B2B Medical GmbH Lobezyl 6 mg/ml Injektionslösung im Fertigpen 7011688.00.00 03.11.2025 Biocon Pharma Malta I Limited Lutrate Depot 22,5 mg Pulver und Lösungsmittel zur Herstellung einer Depot-Injektionssuspension (Es handelt sich um ein parallel importiertes Arzneimittel) 7020662.00.00 04.11.2025 B2B Medical GmbH MENOGON HP 1200 I.E. Injektionslösung im Fertigpen (Es handelt sich um ein parallel importiertes Arzneimittel) 7020298.00.00 21.11.2025 PB Pharma GmbH Bekanntmachung Veröffentlicht am Freitag, 28. August 2026 BAnz AT 28.08.2026 B9 Seite 4 von 18 Bezeichnung des Arzneimittels Zul.-Nr. Datum der Zulassung Zulassungsinhaber MENOGON HP 600 I.E. Injektionslösung im Fertigpen (Es handelt sich um ein parallel importiertes Arzneimittel) 7020297.00.00 21.11.2025 PB Pharma GmbH Mesalazin B2B Medical 500 mg Zäpfchen (Es handelt sich um ein parallel importiertes Arzneimittel) 7021297.00.00 28.11.2025 B2B Medical GmbH metex 50 mg/ml Injektionslösung, Fertigspritze (Es handelt sich um ein parallel importiertes Arzneimittel) 7021472.00.00 27.11.2025 B2B Medical GmbH Methylphenidat Humantis 10 mg Hartkapseln mit veränderter Wirkstofffreisetzung 7013048.00.00 24.11.2025 Humantis GmbH Methylphenidat Humantis 20 mg Hartkapseln mit veränderter Wirkstofffreisetzung 7013049.00.00 24.11.2025 Humantis GmbH Methylphenidat Humantis 30 mg Hartkapseln mit veränderter Wirkstofffreisetzung 7013050.00.00 24.11.2025 Humantis GmbH Methylphenidat Humantis 40 mg Hartkapseln mit veränderter Wirkstofffreisetzung 7013051.00.00 24.11.2025 Humantis GmbH Methylphenidat Humantis 50 mg Hartkapseln mit veränderter Wirkstofffreisetzung 7013052,00.00 24.11.2025 Humantis GmbH Methylphenidat Humantis 5 mg Hartkapseln mit veränderter Wirkstofffreisetzung 7013047.00.00 24.11.2025 Humantis GmbH Methylphenidat Humantis 60 mg Hartkapseln mit veränderter Wirkstofffreisetzung 7013053.00.00 24.11.2025 Humantis GmbH Methylprednisolon mibe 16 mg Tabletten 7010918.00.00 22.11.2025 mibe GmbH Arzneimittel Methylprednisolon mibe 4 mg Tabletten 7010916.00.00 22.11.2025 mibe GmbH Arzneimittel Methylprednisolon mibe 8 mg Tabletten 7010917.00.00 22.11.2025 mibe GmbH Arzneimittel Midazolam QbD Group Austria 1 mg/ml Injektions-/Infusionslösung 7015300.00.00 26.11.2025 QbD Group Austria GmbH Midazolam QbD Group Austria 5 mg/ml Injektions-/Infusionslösung 7015301.00.00 22.11.2025 QbD Group Austria GmbH Minoxidil Redcare 20 mg/ml Lösung zur Anwendung auf der Haut (Kopfhaut) 7014556.00.00 21.11.2025 RC Pharma B.V. Minoxidil Redcare 50 mg/ml Lösung zur Anwendung auf der Haut (Kopfhaut) 7014555.00.00 21.11.2025 RC Pharma B.V. Monmibi 1,0 mg Kit für ein radioaktives Arzneimittel 7008975.00.00 22.11.2025 Curium Romania S.R.L. Morphin Basi 20 mg/ml Injektionslösung 7014027.00.00 18.11.2025 Laboratórios Basi - Indústria Farmaceutica, S.A. Nintedanib - 1 A Pharma 100 mg Weichkapseln 7012077.00.00 24.11.2025 1 A Pharma GmbH Nintedanib - 1 A Pharma 150 mg Weichkapseln 7012078.00.00 24.11.2025 1 A Pharma GmbH Nintedanib beta 100 mg Weichkapseln 7016568.00.00 03.11.2025 betapharm Arzneimittel GmbH Nintedanib beta 150 mg Weichkapseln 7016569.00.00 03.11.2025 betapharm Arzneimittel GmbH Nintedanib HEXAL 100 mg Weichkapseln 7012072.00.00 24.11.2025 H e x a l Aktiengesellschaft Nintedanib HEXAL 150 mg Weichkapseln 7012073.00.00 24.11.2025 H e x a l Aktiengesellschaft Norepinephrin Aguettant 1 mg/ml Konzentrat zur Herstellung einer Infusionslösung 7016267.00.00 22.11.2025 Laboratoire Aguettant Oxaliplatin actrevo 5 mg/ml Konzentrat zur Herstellung einer Infusionslösung 7010767.00.00 03.11.2025 actrevo GmbH Oxycodon Medipha Sante 10 mg Retardtabletten 7015149.00.00 22.11.2025 MEDIPHA SANTE Oxycodon Medipha Sante 15 mg Retardtabletten 7015150.00.00 22.11.2025 MEDIPHA SANTE Oxycodon Medipha Sante 20 mg Retardtabletten 7015151.00.00 22.11.2025 MEDIPHA SANTE Oxycodon Medipha Sante 30 mg Retardtabletten 7015152.00.00 22.11.2025 MEDIPHA SANTE Bekanntmachung Veröffentlicht am Freitag, 28. August 2026 BAnz AT 28.08.2026 B9 Seite 5 von 18 Bezeichnung des Arzneimittels Zul.-Nr. Datum der Zulassung Zulassungsinhaber Oxycodon Medipha Sante 40 mg Retardtabletten 7015153.00.00 22.11.2025 MEDIPHA SANTE Oxycodon Medipha Sante 5 mg Retardtabletten 7015148.00.00 22.11.2025 MEDIPHA SANTE Oxycodon Medipha Sante 60 mg Retardtabletten 7015154.00.00 22.11.2025 MEDIPHA SANTE Oxycodon Medipha Sante 80 mg Retardtabletten 7015155.00.00 22.11.2025 MEDIPHA SANTE Paclitaxel albumin beta 5 mg/ml Pulver zur Herstellung einer Infusionsdispersion 7018640.00.00 14.11.2025 betapharm Arzneimittel GmbH Pilesia 10 mg Filmtabletten 7016842.00.00 22.11.2025 FARMITALIA INDUSTRIA CHIMICO FARMACEUTICA S.R.L. IN FORMA ABBREVIATA FARMITALIA S.R.L. Pilesia 12 mg Filmtabletten 7016843.00.00 22.11.2025 FARMITALIA INDUSTRIA CHIMICO FARMACEUTICA S.R.L. IN FORMA ABBREVIATA FARMITALIA S.R.L. Pilesia 2 mg Filmtabletten 7016838.00.00 22.11.2025 FARMITALIA INDUSTRIA CHIMICO FARMACEUTICA S.R.L. IN FORMA ABBREVIATA FARMITALIA S.R.L. Pilesia 4 mg Filmtabletten 7016839.00.00 22.11.2025 FARMITALIA INDUSTRIA CHIMICO FARMACEUTICA S.R.L. IN FORMA ABBREVIATA FARMITALIA S.R.L. Pilesia 6 mg Filmtabletten 7016840.00.00 22.11.2025 FARMITALIA INDUSTRIA CHIMICO FARMACEUTICA S.R.L. IN FORMA ABBREVIATA FARMITALIA S.R.L. Pilesia 8 mg Filmtabletten 7016841.00.00 22.11.2025 FARMITALIA INDUSTRIA CHIMICO FARMACEUTICA S.R.L. IN FORMA ABBREVIATA FARMITALIA S.R.L. Pirfenidon Zentiva 267 mg Filmtabletten (Es handelt sich um ein parallel importiertes Arzneimittel) 7024517.00.00 03.11.2025 BB Farma s.r.l. Pirfenidon Zentiva 801 mg Filmtabletten (Es handelt sich um ein parallel importiertes Arzneimittel) 7020995.00.00 03.11.2025 BB Farma s.r.l. Raltegravir Viatris 600 mg Filmtabletten 7016398.00.00 14.11.2025 Mylan Germany GmbH Raltegravir Zentiva 600 mg Filmtabletten 7020911.00.00 08.11.2025 Zentiva Pharma GmbH Ramipril/Amlodipin 089PHARM 10 mg/10 mg Hartkapseln 7018896.00.00 05.11.2025 089PHARM GmbH Ramipril/Amlodipin 089PHARM 10 mg/5 mg Hartkapseln 7018895.00.00 05.11.2025 089PHARM GmbH Ramipril/Amlodipin 089PHARM 5 mg/10 mg Hartkapseln 7018894.00.00 05.11.2025 089PHARM GmbH Ramipril/Amlodipin 089PHARM 5 mg/5 mg Hartkapseln 7018893.00.00 05.11.2025 089PHARM GmbH Ramipril/bisoprolol Egis 10 mg/10 mg Hartkapseln 7007931.00.00 25.11.2025 Egis Gyógyszergyár Zrt. Ramipril/bisoprolol Egis 10 mg/5 mg Hartkapseln 7007930.00.00 25.11.2025 Egis Gyógyszergyár Zrt. Ramipril/bisoprolol Egis 5 mg/10 mg Hartkapseln 7007929.00.00 25.11.2025 Egis Gyógyszergyár Zrt. Ramipril/bisoprolol Egis 5 mg/5 mg Hartkapseln 7007928.00.00 25.11.2025 Egis Gyógyszergyár Zrt. Ranolazin ELPEN 375 mg Retardtabletten 7006102.00.00 08.11.2025 Elpen Pharmaceutical Co. Inc. Ranolazin ELPEN 500 mg Retardtabletten 7006103.00.00 08.11.2025 Elpen Pharmaceutical Co. Inc. Ranolazin ELPEN 750 mg Retardtabletten 7006104.00.00 08.11.2025 Elpen Pharmaceutical Co. Inc. Bekanntmachung Veröffentlicht am Freitag, 28. August 2026 BAnz AT 28.08.2026 B9 Seite 6 von 18 Bezeichnung des Arzneimittels Zul.-Nr. Datum der Zulassung Zulassungsinhaber Recigar 1,5 mg/Dosis, Lösung zum Einnehmen 7015361.00.00 03.11.2025 APC Instytut Spolka z ograniczona odpowiedzialnoscia Rectogesic 4 mg/g (Es handelt sich um ein parallel importiertes Arzneimittel) 7021704.00.00 19.11.2025 2CARE4 ApS Rivaroxaban Juta 10 mg Filmtabletten 7007245.00.00 22.11.2025 „JUTA“ Pharma GmbH Rivaroxaban Juta 15 mg Filmtabletten 7007246.00.00 22.11.2025 „JUTA“ Pharma GmbH Rivaroxaban Juta 15 mg Filmtabletten, Rivaroxaban Juta 20 mg Filmtabletten 7007751.00.00 22.11.2025 „JUTA“ Pharma GmbH Rivaroxaban Juta 20 mg Filmtabletten 7007247.00.00 22.11.2025 „JUTA“ Pharma GmbH Rivaroxaban Juta 2,5 mg Filmtabletten 7007244.00.00 22.11.2025 „JUTA“ Pharma GmbH Rivaroxaban Olpha 10 mg Filmtabletten 7016079.00.00 24.11.2025 Akciju sabiedrība „Olpha“ Rivaroxaban Olpha 15 mg Filmtabletten 7016080.00.00 24.11.2025 Akciju sabiedrība „Olpha“ Rivaroxaban Olpha 20 mg Filmtabletten 7016081.00.00 24.11.2025 Akciju sabiedrība „Olpha“ Rivaroxaban Olpha 2,5 mg Filmtabletten 7016078.00.00 24.11.2025 Akciju sabiedrība „Olpha“ Rivaroxaban Zentiva 2,5 mg Filmtabletten (Es handelt sich um ein parallel importiertes Arzneimittel) 7021490.00.00 12.11.2025 Orifarm GmbH Ropinirol AbZ 2 mg Retardtabletten (Es handelt sich um ein parallel importiertes Arzneimittel) 7020725.00.00 07.11.2025 BB Farma s.r.l. Roxaza 375 mg Retardtabletten 7006099.00.00 08.11.2025 Elpen Pharmaceutical Co. Inc. Roxaza 500 mg Retardtabletten 7006100.00.00 08.11.2025 Elpen Pharmaceutical Co. Inc. Roxaza 750 mg Retardtabletten 7006101.00.00 08.11.2025 Elpen Pharmaceutical Co. Inc. Ryaltris 25 Mikrogramm/600 Mikrogramm pro Sprühstoß Nasenspray, Suspension (Es handelt sich um ein parallel importiertes Arzneimittel) 7020481.00.00 27.11.2025 European Pharma B.V. Sabril Beutel 500 mg Granulat zur Herstellung einer Lösung zum Einnehmen (Es handelt sich um ein parallel importiertes Arzneimittel) 7021848.00.00 29.11.2025 Orifarm GmbH Seroquel 25 mg Filmtabletten (Es handelt sich um ein parallel importiertes Arzneimittel) 7021014.00.00 04.11.2025 B2B Medical GmbH Sitagliptin AshCure 100 mg Filmtabletten 7013696.00.00 16.11.2025 AshCure Pharma B.V. Sitagliptin AshCure 25 mg Filmtabletten 7013694.00.00 16.11.2025 AshCure Pharma B.V. Sitagliptin AshCure 50 mg Filmtabletten 7013695.00.00 16.11.2025 AshCure Pharma B.V. Sitagliptin/Metformin GeneriNobel 50 mg/1000 mg Filmtabletten 7006995.00.00 14.11.2025 GeneriNobel GmbH Sitagliptin/Metformin GeneriNobel 50 mg/850 mg Filmtabletten 7006994.00.00 14.11.2025 GeneriNobel GmbH Testogel 50 mg transdermales Gel im Beutel (Es handelt sich um ein parallel importiertes Arzneimittel) 7022470.00.00 20.11.2025 kohlpharma GmbH TESTOGEL 50 mg transdermales Gel im Beutel (Es handelt sich um ein parallel importiertes Arzneimittel) 7021958.00.00 21.11.2025 EurimPharm Arzneimittel GmbH Tevanate 70 mg Tabletten (Es handelt sich um ein parallel importiertes Arzneimittel) 7020710.00.00 24.11.2025 BB Farma s.r.l. ThyroTop 38 - 7400 MBq Hartkapseln 7020638.00.00 15.11.2025 Izotóp Intézet Kft. Ticagrelor PUREN 60 mg Filmtabletten 7016250.00.00 08.11.2025 PUREN Pharma GmbH & Co. KG Ticagrelor PUREN 90 mg Filmtabletten 7016251.00.00 08.11.2025 PUREN Pharma GmbH & Co. KG Bekanntmachung Veröffentlicht am Freitag, 28. August 2026 BAnz AT 28.08.2026 B9 Seite 7 von 18 Bezeichnung des Arzneimittels Zul.-Nr. Datum der Zulassung Zulassungsinhaber Tolvaptan-ratiopharm 30 mg + 90 mg Tabletten (Es handelt sich um ein parallel importiertes Arzneimittel) 7023587.00.00 06.11.2025 CC - Pharma GmbH Tolvaptan-ratiopharm SIADH 15 mg Tabletten (Es handelt sich um ein parallel importiertes Arzneimittel) 7021508.00.00 20.11.2025 B2B Medical GmbH Tolvaptan Teva 30 mg + 90 mg Tabletten (Es handelt sich um ein parallel importiertes Arzneimittel) 7021487.00.00 06.11.2025 EMRA-MED Arzneimittel GmbH Tostran 20 mg/g Gel (Es handelt sich um ein parallel importiertes Arzneimittel) 7021634.00.00 27.11.2025 EMRA-MED Arzneimittel GmbH Valganciclovir PUREN 450 mg Filmtabletten (Es handelt sich um ein parallel importiertes Arzneimittel) 7021509.00.00 04.11.2025 B2B Medical GmbH Vancomycin Carefarm 125 mg Hartkapseln (Es handelt sich um ein parallel importiertes Arzneimittel) 7021916.00.00 28.11.2025 Orifarm GmbH Vareniclin Medichem 0,5 mg + 1 mg Filmtabletten 7018632.00.00 01.11.2025 MEDICHEM S.A. Viacoram 3,5 mg/2,5 mg Tabletten (Es handelt sich um ein parallel importiertes Arzneimittel) 7020299.00.00 25.11.2025 ACA Müller ADAG Pharma Aktiengesellschaft Viacoram 7 mg/5 mg Tabletten (Es handelt sich um ein parallel importiertes Arzneimittel) 7020300.00.00 25.11.2025 ACA Müller ADAG Pharma Aktiengesellschaft Vidisic 2 mg/g Augengel (Es handelt sich um ein parallel importiertes Arzneimittel) 7021446.00.00 25.11.2025 EurimPharm Arzneimittel GmbH Vitamin D3 Aristo 1000 I.E. Tabletten 7016676.00.00 05.11.2025 Aristo Pharma GmbH Vitamin D3 Devatis 1000 I.E. Weichkapseln 7013507.00.00 21.11.2025 Devatis GmbH Vitamin D3 Devatis 20.000 I.E. Weichkapseln 7013509.00.00 21.11.2025 Devatis GmbH Vitamin D3 Devatis 2000 I.E. Weichkapseln 7013508.00.00 21.11.2025 Devatis GmbH Voxsio 7013489.00.00 24.11.2025 INFECTOPHARM Arzneimittel und Consilium GmbH Wynzora 50 Mikrogramm/g + 0,5 mg/g Creme (Es handelt sich um ein parallel importiertes Arzneimittel) 7020480.00.00 03.11.2025 axicorp Pharma B.V. II. Erteilung einer Registrierung für ein traditionelles pflanzliches Arzneimittel gemäß § 39a AMG Bezeichnung des traditionellen pflanzlichen Arzneimittels Reg.-Nr. Datum der Reg. Zulassungsinhaber Arzneimittel zur Anwendung am Menschen Kyolic Tabletten 7013181.00.00 11.11.2025 Wakunaga of Europe GmbH III. Verlängerung einer Zulassung gemäß § 31 Absatz 3 AMG Bezeichnung des Arzneimittels Zul.-Nr. Datum der Zulassung Zulassungsinhaber Arzneimittel zur Anwendung am Menschen Ticagrelor AL 60 mg Filmtabletten 2203398.00.00 22.01.2022 ALIUD PHARMA GmbH Ticagrelor AL 90 mg Filmtabletten 2203399.00.00 22.01.2022 ALIUD PHARMA GmbH Levosimendan Altan 2,5 mg/ml Konzentrat zur Herstellung einer Infusionslösung 2206256.00.00 19.11.2021 Altan Pharmaceuticals SA Bekanntmachung Veröffentlicht am Freitag, 28. August 2026 BAnz AT 28.08.2026 B9 Seite 8 von 18 Bezeichnung des Arzneimittels Zul.-Nr. Datum der Zulassung Zulassungsinhaber Duloxetin Amarox 20 mg magensaftresistente Hartkapseln 7005190.00.00 29.03.2022 AMAROX PHARMA GmbH Duloxetin Amarox 30 mg magensaftresistente Hartkapseln 7005191.00.00 29.03.2022 AMAROX PHARMA GmbH Duloxetin Amarox 40 mg magensaftresistente Hartkapseln 7005192.00.00 29.03.2022 AMAROX PHARMA GmbH Duloxetin Amarox 60 mg magensaftresistente Hartkapseln 7005193.00.00 29.03.2022 AMAROX PHARMA GmbH Levetiracetam AMETAS 250 mg Filmtabletten 2204671.00.00 25.11.2021 AMETAS medical GmbH Levetiracetam AMETAS 500 mg Filmtabletten 2204672.00.00 25.11.2021 AMETAS medical GmbH Levetiracetam AMETAS 750 mg Filmtabletten 2204673.00.00 25.11.2021 AMETAS medical GmbH Levetiracetam AMETAS 1000 mg Filmtabletten 2204674.00.00 25.11.2021 AMETAS medical GmbH Prucaloprid Aristo 1 mg Filmtabletten 2206014.00.00 09.12.2021 Aristo Pharma GmbH Prucaloprid Aristo 2 mg Filmtabletten 2206015.00.00 09.12.2021 Aristo Pharma GmbH Clindamycin/Benzoylperoxid AL 10 mg/g + 50 mg/g Gel 7000607.00.00 26.04.2022 Aspire Pharma (Malta) Limited Posaconazol axunio 100 mg magensaftresistente Tabletten 7003163.00.00 30.06.2021 axunio Pharma GmbH Cefazolin Dali Pharma 1 g Pulver zur Herstellung einer Injektions-/Infusionslösung 2206018.00.00 07.12.2021 DALI Pharma GmbH Cefazolin Dali Pharma 2 g Pulver zur Herstellung einer Infusionslösung 2206019.00.00 07.12.2021 DALI Pharma GmbH Gentamicutan comp 0,64 mg/g + 1,67 mg/g Creme 2201414.00.00 22.10.2021 Dermapharm Aktiengesellschaft Gentamicutan comp 0,64 mg/g + 1,67 mg/g Salbe 2201415.00.00 22.10.2021 Dermapharm Aktiengesellschaft Ezetimib/Atorvastatin ELPEN 10 mg/10 mg Filmtabletten 2205680.00.00 29.10.2021 Elpen Pharmaceutical Co. Inc. Ezetimib/Atorvastatin ELPEN 10 mg/20 mg Filmtabletten 2205681.00.00 29.10.2021 Elpen Pharmaceutical Co. Inc. Ezetimib/Atorvastatin ELPEN 10 mg/40 mg Filmtabletten 2205682.00.00 29.10.2021 Elpen Pharmaceutical Co. Inc. Ezetimib/Atorvastatin ELPEN 10 mg/80 mg Filmtabletten 2205683.00.00 29.10.2021 Elpen Pharmaceutical Co. Inc. Clormilla 0,03 mg/2 mg Filmtabletten 2206010.00.00 22.12.2021 Exeltis Germany GmbH ASS Fairmed Healthcare Protect 100 mg magensaftresistente Tabletten 2200544.00.00 03.04.2018 Fairmed Healthcare GmbH Prednison 10 mg GALEN 90895.00.00 11.08.2015 GALENpharma GmbH Artirem 0,0025 mmol/ml Injektionslösung 7001364.00.00 16.02.2023 Guerbet DopaRos 87703.00.00 12.06.2017 Helmholtz-Zentrum Dresden - Rossendorf e.V. Clopidogrel Heumann 75 mg Filmtabletten 93600.00.00 20.06.2017 Heumann Pharma GmbH & Co. Generica KG Methaddict 80 mg Tabletten 2202744.00.00 08.02.2021 H e x a l Aktiengesellschaft Tamsulosinhydrochlorid HEXAL 0,4 mg Retardtabletten 99552.00.00 27.10.2017 H e x a l Aktiengesellschaft Lenalidomid AXiromed 2,5 mg Hartkapseln 2205670.00.00 15.04.2021 Medical Valley Invest AB Lenalidomid AXiromed 5 mg Hartkapseln 2205671.00.00 15.04.2021 Medical Valley Invest AB Lenalidomid AXiromed 7,5 mg Hartkapseln 2205672.00.00 15.04.2021 Medical Valley Invest AB Lenalidomid AXiromed 10 mg Hartkapseln 2205673.00.00 15.04.2021 Medical Valley Invest AB Lenalidomid AXiromed 15 mg Hartkapseln 2205674.00.00 14.04.2021 Medical Valley Invest AB Lenalidomid AXiromed 20 mg Hartkapseln 2205675.00.00 14.04.2021 Medical Valley Invest AB Bekanntmachung Veröffentlicht am Freitag, 28. August 2026 BAnz AT 28.08.2026 B9 Seite 9 von 18 Bezeichnung des Arzneimittels Zul.-Nr. Datum der Zulassung Zulassungsinhaber Lenalidomid AXiromed 25 mg Hartkapseln 2205676.00.00 14.04.2021 Medical Valley Invest AB Clobazam Micro Labs 10 mg Tabletten 2204872.00.00 12.07.2021 Micro Labs GmbH Clobazam Micro Labs 20 mg Tabletten 2204873.00.00 12.07.2021 Micro Labs GmbH Bimatoprost/Timolol Micro Labs 0,3 mg/ml + 5 mg/ml Augentropfen, Lösung im Einzeldosisbehältnis 7000002.00.00 22.11.2021 Micro Labs GmbH Bilastin Viatris 20mg Tabletten 7000201.00.00 20.09.2021 Mylan Germany GmbH Folinsäure PhaRes 10 mg/ml Injektionslösung 97478.00.00 01.04.2017 Pharma Resources GmbH Paclitaxel PhaRes 6 mg/ml Konzentrat zur Herstellung einer Infusionslösung 97753.00.00 27.10.2016 Pharma Resources GmbH Perocur 250 mg 97538.00.00 20.01.2017 Pharma-Zentrale GmbH Iloprost RAFARM 10 Mikrogramm/ml Lösung für einen Vernebler 2204458.00.00 26.02.2022 RAFARM ANONYMOS EMPORIKI KAI VIOMICHANIKI ETAIREIA FARMAKEUTIKON PROIONTON Iloprost RAFARM 20 Mikrogramm/ml Lösung für einen Vernebler 2204579.00.00 26.02.2022 RAFARM ANONYMOS EMPORIKI KAI VIOMICHANIKI ETAIREIA FARMAKEUTIKON PROIONTON ASS-ratiopharm PROTECT 100 mg magensaftresistente Tabletten 2200543.00.00 03.04.2018 ratiopharm GmbH Ezetimib/Atorvastatin-ratiopharm 10 mg/10 mg Filmtabletten 2206106.00.00 09.11.2021 ratiopharm GmbH Ezetimib/Atorvastatin-ratiopharm 10 mg/20 mg Filmtabletten 2206107.00.00 09.11.2021 ratiopharm GmbH Ezetimib/Atorvastatin-ratiopharm 10 mg/40 mg Filmtabletten 2206108.00.00 09.11.2021 ratiopharm GmbH Ezetimib/Atorvastatin-ratiopharm 10 mg/80 mg Filmtabletten 2206109.00.00 09.11.2021 ratiopharm GmbH Icatibant-ratiopharm 30 mg Injektionslösung in einer Fertigspritze 7000735.00.00 28.09.2021 ratiopharm GmbH octenident antiseptic 1 mg/ml Lösung zur Anwendung in der Mundhöhle 2204730.00.00 05.10.2021 Schülke & Mayr GmbH Asacol 800 mg magensaftresistente Tabletten 89227.00.00 28.01.2015 Tillotts Pharma GmbH Carbamazepin Umedica 100 mg Tabletten 2204641.00.00 27.08.2021 Umedica Netherlands B.V. Carbamazepin Umedica 200 mg Tabletten 2204642.00.00 27.08.2021 Umedica Netherlands B.V. Carbamazepin Umedica 400 mg Tabletten 2204643.00.00 27.08.2021 Umedica Netherlands B.V. Visublend 0,3 mg/ml + 5 mg/ml Augentropfen, Lösung 7000711.00.00 19.11.2021 Visufarma - Societa' per Azioni, in Forma Abbreviata Visufarma S.P.A. Iloprost Zentiva 20 Mikrogramm/ml Konzentrat zur Herstellung einer Infusionslösung 2205437.00.00 02.10.2021 Zentiva Pharma GmbH IV. Verlängerung einer Registrierung gemäß § 39c Absatz 3 AMG Bezeichnung des traditionellen pflanzlichen Arzneimittels Reg.-Nr. Datum der Reg. Zulassungsinhaber Arzneimittel zur Anwendung am Menschen Passidon 2201382.00.00 28.12.2020 Ardeypharm GmbH Pharmazeutische Fabrik Kneipp Erkältungsbad Eucalyptus 31 g/100 ml 2201841.00.00 24.10.2020 Kneipp GmbH Kneipp Erkältungsbad Eucalyptus 21 g/100 ml 2201842.00.00 24.10.2020 Kneipp GmbH Nomon mono Kapseln 71773.00.00 07.01.2011 MaxMedic Pharma GmbH Bekanntmachung Veröffentlicht am Freitag, 28. August 2026 BAnz AT 28.08.2026 B9 Seite 10 von 18 V. Erlöschen einer Zulassung gemäß § 31 Absatz 1 Nummer 1 AMG – ohne Abverkauf – Bezeichnung des Arzneimittels Zul.-Nr. Zulassungsinhaber Arzneimittel zur Anwendung am Menschen Dimethylfumarat - 1 A Pharma 120 mg magensaftresistente Hartkapseln 7005669.00.00 1 A Pharma GmbH Dimethylfumarat - 1 A Pharma 240 mg magensaftresistente Hartkapseln 7005670.00.00 1 A Pharma GmbH Meloxicam - 1 A Pharma 7,5 mg Tabletten 63072.00.00 1 A Pharma GmbH Oxycodon - 1 A Pharma 10 mg Retardtabletten 87960.00.00 1 A Pharma GmbH Oxycodon - 1 A Pharma 20 mg Retardtabletten 87962.00.00 1 A Pharma GmbH Oxycodon - 1 A Pharma 40 mg Retardtabletten 87964.00.00 1 A Pharma GmbH Oxycodon - 1 A Pharma 5 mg Retardtabletten 87959.00.00 1 A Pharma GmbH Oxycodon - 1 A Pharma 60 mg Retardtabletten 87965.00.00 1 A Pharma GmbH Oxycodon - 1 A Pharma 80 mg Retardtabletten 87966.00.00 1 A Pharma GmbH Tolterodin - 1 A Pharma 1 mg Filmtabletten 69944.00.00 1 A Pharma GmbH Pertussin Hustentropfen 6166775.00.00 Abanta Pharma GmbH Imurel 50 mg Filmtabletten 67350.00.00 ACA Müller ADAG Pharma Aktiengesellschaft Cisatracurium Accord 2 mg/ml Injektionslösung/Infusionslösung 91266.00.00 Accord Healthcare B.V. Cyclophosphamid Accord 1000 mg Pulver zur Herstellung einer Injektions-/Infusionslösung 2206031.00.00 Accord Healthcare B.V. Cyclophosphamid Accord 500 mg Pulver zur Herstellung einer Injektions-/Infusionslösung 2206030.00.00 Accord Healthcare B.V. Efavirenz Accord 600 mg Filmtabletten 91130.00.00 Accord Healthcare B.V. Telmisartan/Hydrochlorothiazid Accord 80 mg/12,5 mg Tabletten 94520.00.00 Accord Healthcare B.V. aerALin 100% (V/V) 83579.00.00 AIR LIQUIDE Medical GmbH Terbutalin AL retard 10874.00.00 ALIUD PHARMA GmbH Theophyllin AL 300 retard 29619.01.00 ALIUD PHARMA GmbH Xipamid AL 10mg Tabletten 55019.00.00 ALIUD PHARMA GmbH Dexmedetomidin Altan 4 Mikrogramm/ml Infusionslösung 2202432.00.00 Altan Pharma Limited Posaconazol Altan 300 mg Konzentrat zur Herstellung einer Infusionslösung 7000116.00.00 Altan Pharma Limited Ropivacain Altan 2 mg/ml Infusionslösung 2202819.00.00 Altan Pharma Limited Palmeux 100 mg Depot-Injektionssuspension in einer Fertigspritze 2204391.00.00 Amdipharm Limited Palmeux 150 mg Depot-Injektionssuspension in einer Fertigspritze 2204392.00.00 Amdipharm Limited Palmeux 25 mg Depot-Injektionssuspension in einer Fertigspritze 2204388.00.00 Amdipharm Limited Palmeux 50 mg Depot-Injektionssuspension in einer Fertigspritze 2204389.00.00 Amdipharm Limited Palmeux 75 mg Depot-Injektionssuspension in einer Fertigspritze 2204390.00.00 Amdipharm Limited Androcal 50 mg Filmtabletten 70352.00.00 Apogepha Arzneimittel GmbH Urol methin 41163.00.00 Apogepha Arzneimittel GmbH Cabazitaxel AqVida 20 mg/ml Konzentrat zur Herstellung einer Infusionslösung 7004680.00.00 AqVida GmbH Cabazitaxel AqVida 20 mg/ml Konzentrat zur Herstellung einer Infusionslösung 7004681.00.00 AqVida GmbH Tapentadol Aristo retard 100 mg Retardtabletten 7006599.00.00 Aristo Pharma GmbH Tapentadol Aristo retard 150 mg Retardtabletten 7006600.00.00 Aristo Pharma GmbH Tapentadol Aristo retard 200 mg Retardtabletten 7006601.00.00 Aristo Pharma GmbH Tapentadol Aristo retard 25 mg Retardtabletten 7006597.00.00 Aristo Pharma GmbH Tapentadol Aristo retard 250 mg Retardtabletten 7006608.00.00 Aristo Pharma GmbH Tapentadol Aristo retard 50 mg Retardtabletten 7006598.00.00 Aristo Pharma GmbH Genotropin MiniQuick 0,8 mg 97019.00.00 axicorp Pharma B.V. Bekanntmachung Veröffentlicht am Freitag, 28. August 2026 BAnz AT 28.08.2026 B9 Seite 11 von 18 Bezeichnung des Arzneimittels Zul.-Nr. Zulassungsinhaber Intestifalk 3 mg 7008111.00.00 axicorp Pharma B.V. Mezavant 1200 mg 7010019.00.00 axicorp Pharma B.V. Rispolept Consta 37,5 mg 81711.00.00 axicorp Pharma B.V. Sandostatin 100 µg 97674.00.00 axicorp Pharma B.V. Celebrex 100 mg 89886.00.00 AxiCorp Pharma GmbH Daptomycin Baxter 500 mg Pulver zur Herstellung einer Injektions-/Infusionslösung 2205765.00.00 Baxter Holding B.V. ASPIRIN COMPLEX HEISSGETRÄNK 500 mg / 30 mg Granulat zur Herstellung einer Suspension zum Einnehmen 87846.00.00 Bayer Vital GmbH Pirfenidon beta 534 mg Filmtabletten 7004389.00.00 betapharm Arzneimittel GmbH Desfluran Cadiasun 100 % Flüssigkeit zur Herstellung eines Dampfs zur Inhalation 96486.00.00 Cadiasun Pharma GmbH Frisium 10 mg 7008412.00.00 Candoro ethics GmbH Pantoprazol Carinopharm 40 mg Pulver zur Herstellung einer Injektionslösung 80491.00.00 Carinopharm GmbH Minirin Nasenspray 80587.00.00 CC - Pharma GmbH Norditropin SimpleXx 15 mg/1,5 ml 68466.00.00 CC - Pharma GmbH Targin 5 mg/2,5 mg Retardtabletten 7009778.00.00 CC - Pharma GmbH Tobi 300 mg/5 ml Lösung für einen Vernebler 62152.00.00 CC - Pharma GmbH Wellvone Suspension 97648.00.00 CC - Pharma GmbH Zomacton 4 mg 78481.00.00 CC - Pharma GmbH Cefakliman N 6751315.00.00 Cefak KG Cefamadar 32497.00.00 Cefak KG Abirateron Day Zero 500 mg Filmtabletten 7002966.00.00 Day Zero ehf. Pirfenidon Day Zero ehf. 267 mg Filmtabletten 7004242.00.00 Day Zero ehf. Pirfenidon Day Zero ehf. 801 mg Filmtabletten 7004243.00.00 Day Zero ehf. Tecraveno 30 mg Injektionslösung in einer Fertigspritze 7003680.00.00 Day Zero ehf. Carba retard 300 mg Desitin 7354.00.00 Desitin Arzneimittel GmbH Neurocil 100 mg 6244794.01.00 Desitin Arzneimittel GmbH Salofalk 250 mg 82300.00.00 Docpharm GmbH toxiLoges Tropfen 6331354.00.00 Dr. Loges + Co. GmbH Dolo Visano Methocarbamol 750 mg Tabletten 77978.00.00 Dr.Kade Pharmazeutische Fabrik GmbH Luvased Nacht zum Einschlafen 6953007.00.00 Dr.Kade Pharmazeutische Fabrik GmbH Makatussin Tropfen 3001734.00.00 Dr.Kade Pharmazeutische Fabrik GmbH Vitaferro Brause 4128.00.00 Dr.Kade Pharmazeutische Fabrik GmbH Muxan 100 mg/g Creme 67648.00.00 Engelhard Arzneimittel GmbH & CoKG PAS-FATOL N 6192614.00.00 Esteve Pharmaceuticals GmbH Rheotromb 500.000 I.E. Pulver zur Herstellung einer Injektions- bzw. Infusionslösung 1863.05.00 EUMEDICA S.A. AmoxiPLUS ratiopharm comp. 875/125mg Filmtabletten 56164.00.00 EurimPharm Arzneimittel GmbH Brivudin Aristo 125 mg Tabletten 7009373.00.00 EurimPharm Arzneimittel GmbH Fenistil Tropfen 7005701.00.00 EurimPharm Arzneimittel GmbH Fraxiparina 0,3ml 38924.00.00 EurimPharm Arzneimittel GmbH Fraxiparina 0,4ml 50243.00.00 EurimPharm Arzneimittel GmbH Fraxiparina 0,8ml 50243.02.00 EurimPharm Arzneimittel GmbH Liptruzet 10 mg/10 mg Filmtabletten 2202013.00.00 EurimPharm Arzneimittel GmbH Bekanntmachung Veröffentlicht am Freitag, 28. August 2026 BAnz AT 28.08.2026 B9 Seite 12 von 18 Bezeichnung des Arzneimittels Zul.-Nr. Zulassungsinhaber Maxalt lingua 10 mg Schmelztabletten 7010431.00.00 EurimPharm Arzneimittel GmbH Minirin Rhinyle 47515.00.00 EurimPharm Arzneimittel GmbH Minrin 10 µg Nasenspray, Lösung 49287.00.00 EurimPharm Arzneimittel GmbH Norditropin simplexx 10mg/1,5ml 53198.01.00 EurimPharm Arzneimittel GmbH Resochina Tabletten 48643.00.00 EurimPharm Arzneimittel GmbH Zostex 125 mg Tabletten 7008938.00.00 EurimPharm Arzneimittel GmbH Tapentadol EVER Pharma 25 mg Retardtabletten 7006615.00.00 EVER Valinject GmbH Testosteron GALEN 25 mg transdermales Gel im Beutel 7001566.00.00 GALENpharma GmbH Cinacalcet Glenmark 30 mg Filmtabletten 7003739.00.00 Glenmark Arzneimittel GmbH Cinacalcet Glenmark 60 mg Filmtabletten 7003740.00.00 Glenmark Arzneimittel GmbH Cinacalcet Glenmark 90 mg Filmtabletten 7003741.00.00 Glenmark Arzneimittel GmbH Pirfenidon Glenmark 534 mg Filmtabletten 7004831.00.00 Glenmark Arzneimittel GmbH Glimepirid HEXAL 4 mg Tabletten 63817.03.00 H e x a l Aktiengesellschaft Isotret-Hexal 10 mg Kapseln 54100.00.00 H e x a l Aktiengesellschaft Isotret-Hexal 20 mg Kapseln 54100.01.00 H e x a l Aktiengesellschaft Olanzapin HEXAL 20 mg Schmelztabletten 79715.00.00 H e x a l Aktiengesellschaft PregabaHEXAL 200 mg Hartkapseln 93036.00.00 H e x a l Aktiengesellschaft Roxihexal 50mg Filmtabletten 45123.00.00 H e x a l Aktiengesellschaft Timohexal 0.5% 28696.02.00 H e x a l Aktiengesellschaft Ramiclair 10 mg Tabletten 58563.02.00 Hennig Arzneimittel GmbH & Co KG Ramiclair 5 mg/25 mg Plus Tabletten 58299.01.00 Hennig Arzneimittel GmbH & Co KG Sitagliptin Metforminhydrochlorid Hennig 50 mg/1000 mg Filmtabletten 7004444.00.00 Hennig Arzneimittel GmbH & Co KG Sitagliptin Metforminhydrochlorid Hennig 50 mg/850 mg Filmtabletten 7004443.00.00 Hennig Arzneimittel GmbH & Co KG Tadalafil Hennig 10 mg Filmtabletten 97958.00.00 Hennig Arzneimittel GmbH & Co KG Naproherm 250 mg Brausetabletten 82218.00.00 Hermes Pharma GmbH Naproxen Hermes 250 mg Brausetabletten 82219.00.00 Hermes Pharma GmbH Ramipril Heumann 10 mg Tabletten 58540.02.00 Heumann Pharma GmbH & Co. Generica KG Ramipril Heumann 2,5 mg Tabletten 58540.00.00 Heumann Pharma GmbH & Co. Generica KG Ramipril Heumann 5 mg Tabletten 58540.01.00 Heumann Pharma GmbH & Co. Generica KG Lisinopril Holsten 10 mg Tabletten 44944.02.00 Holsten Pharma GmbH Pflügerplex Leptandra 157 H 6459098.00.00 Homöopathisches Laboratorium Alexander Pflüger GmbH & Co. KG Ibu-Lysin - 1 A Pharma 200 mg Filmtabletten 2203112.00.00 INN-FARM d.o.o. Uvalysat Bürger 6027171.00.00 Johannes Bürger Ysatfabrik Gesellschaft mit beschränkter Haftung Tadalafil Jubilant 10 mg Filmtabletten 7000241.00.00 Jubilant Pharmaceuticals NV Tadalafil Jubilant 20 mg Filmtabletten 7000242.00.00 Jubilant Pharmaceuticals NV Tadalafil Jubilant 2,5 mg Filmtabletten 7000239.00.00 Jubilant Pharmaceuticals NV Tadalafil Jubilant 5 mg Filmtabletten 7000240.00.00 Jubilant Pharmaceuticals NV Candesartancilexetil Q-Pharm 16 mg Tabletten 77108.00.00 „JUTA“ Pharma GmbH Candesartancilexetil Q-Pharm 8 mg Tabletten 77107.00.00 „JUTA“ Pharma GmbH Candesartan-comp. Q-Pharm 16 mg/12,5 mg Tabletten 77119.00.00 „JUTA“ Pharma GmbH Candesartan-comp. Q-Pharm 8 mg/12,5 mg Tabletten 77118.00.00 „JUTA“ Pharma GmbH Juformin 1000mg Filmtabletten 60308.00.00 „JUTA“ Pharma GmbH Jutabis 10 mg Tabletten 49842.01.00 „JUTA“ Pharma GmbH Bekanntmachung Veröffentlicht am Freitag, 28. August 2026 BAnz AT 28.08.2026 B9 Seite 13 von 18 Bezeichnung des Arzneimittels Zul.-Nr. Zulassungsinhaber Losar-Q 50 mg Filmtabletten 75373.00.00 „JUTA“ Pharma GmbH Lariam 34108.00.00 kohlpharma GmbH Valocordin-Diazepam 6270981.00.00 Krewel Meuselbach GmbH Pantoprazol Lannacher 20 mg magensaftresistente Tabletten 68069.00.00 Lannacher Heilmittel Ges.m.b.H. Pantoprazol Lannacher 40 mg magensaftresistente Tabletten 68070.00.00 Lannacher Heilmittel Ges.m.b.H. CONTROCAR 6030277.00.00 lege artis Pharma GmbH & CoKG Tramadol LIBRAPHARM Zäpfchen 13144.00.00 Libra-Pharm GmbH Levocetirizin Fairmed 5 mg Filmtabletten 87223.00.00 Masuu Pharma Europe Limited Methylphenidat-HCl MEDICE 50 mg Hartkapseln mit veränderter Wirkstofffreisetzung 97387.00.00 MEDICE Arzneimittel Pütter GmbH & Co. KG Nicorette Mint Spray 1 mg/Sprühstoß Spray zur Anwendung in der Mundhöhle, Lösung 7007616.00.00 MEDICOPHARM AG Arzneimittel & Medikal Produkte Dociteren 541.00.00 Mibe GmbH Arzneimittel Wasser zur Injektion JENAPHARM 3000359.00.00 Mibe GmbH Arzneimittel Latanoprost + Timolol TRB 50 Mikrogramm/ml + 5 mg/ml Augentropfen 84611.00.00 N R Pharma Limited Benperidol-neuraxpharm 6198841.00.00 neuraxpharm Arzneimittel GmbH Duloxetin-neuraxpharm 30 mg magensaftresistente Hartkapseln 93573.00.00 neuraxpharm Arzneimittel GmbH Duloxetin-neuraxpharm 60 mg magensaftresistente Hartkapseln 93574.00.00 neuraxpharm Arzneimittel GmbH Naratriptan-neuraxpharm 2,5 mg Filmtabletten 86879.00.00 neuraxpharm Arzneimittel GmbH Risperidon-neuraxpharm 1 mg/ml Lösung zum Einnehmen 66810.00.00 neuraxpharm Arzneimittel GmbH Abtei Kieselerde Pulver für Haut, Haare und Nägel 6451777.00.00 Omega Pharma Deutschland GmbH ACOXXEL 120 mg Filmtabletten 77702.00.00 Organon Healthcare GmbH Diprosone Lösung 6451205.00.00 Organon Healthcare GmbH Loniten 2,5 mg Tabletten 84409.00.00 Orifarm GmbH Sevorane 95093.00.00 Orifarm GmbH Zeldox 20mg Hartkapseln 73608.00.00 Orifarm GmbH Actiq 600 Mikrogramm Lutschtabletten, gepresst, mit integriertem Applikator zur Anwendung in der Mundhöhle 97136.00.00 Orifarm GmbH Bortezomib Carefarm 2,5 mg Pulver zur Herstellung einer Injektionslösung 7009966.00.00 Orifarm GmbH Budiair 200 Mikrogramm Druckgasinhalation, Lösung 7008150.00.00 Orifarm GmbH Fentanyl-ratiopharm 12 Mikrogramm/h Matrixpflaster 7009209.00.00 Orifarm GmbH Fentanyl-ratiopharm 25 Mikrogramm/h Matrixpflaster 7009210.00.00 Orifarm GmbH Gingium 120 mg Filmtabletten 7007204.00.00 Orifarm GmbH Irinotecan Accord 20 mg/ml Konzentrat zur Herstellung einer Infusionslösung 7004361.00.00 Orifarm GmbH Marvelon 21830.00.00 Orifarm GmbH Sunitinib Zentiva 12,5 mg Hartkapseln 7009874.00.00 Orifarm GmbH Sunitinib Zentiva 25 mg Hartkapseln 7009875.00.00 Orifarm GmbH Sunitinib Zentiva 50 mg Hartkapseln 7009876.00.00 Orifarm GmbH Sunitinib-ratiopharm 12,5 mg Hartkapseln 7009772.00.00 Orifarm GmbH Sunitinib-ratiopharm 25 mg Hartkapseln 7009773.00.00 Orifarm GmbH Sunitinib-ratiopharm 50 mg Hartkapseln 7009774.00.00 Orifarm GmbH Ziprasidon Mylan 60 mg Hartkapseln 7010477.00.00 Orifarm GmbH Cambiola 6153376.00.00 PharmaSGP GmbH Telmisartan Fair-Med Healthcare 20mg Tabletten 92254.00.00 PharmSol Europe Limited Telmisartan Fair-Med Healthcare 40mg Tabletten 92255.00.00 PharmSol Europe Limited Telmisartan Fair-Med Healthcare 80mg Tabletten 92256.00.00 PharmSol Europe Limited Cinacalcet PUREN 30 mg Filmtabletten 2201633.00.00 PUREN Pharma GmbH & Co. KG Bekanntmachung Veröffentlicht am Freitag, 28. August 2026 BAnz AT 28.08.2026 B9 Seite 14 von 18 Bezeichnung des Arzneimittels Zul.-Nr. Zulassungsinhaber Abirateron Qilu 250 mg Tabletten 7000003.00.00 Qilu Pharma Spain S.L. Ramend Abführ-Tabletten 20mg 8727.00.00 Queisser Pharma GmbH & Co. KG Hepacyn Frischpflanzen-Artischocke 45823.00.00 QUIRIS Healthcare GmbH & Co. KG ROTOP - Neurospect 3003669.00.00 ROTOP Pharmaka GmbH Sorafenib Sigillata 200mg Filmtabletten 2201844.00.00 Sigillata Limited Bronchostad Hustenlöser Sirup 6232414.00.00 STADA Consumer Health Deutschland GmbH DOXO-cell 10mg Injektionslösung 44925.00.00 STADAPHARM GmbH Xipamid STADA 10mg Tabletten 53818.00.00 STADAPHARM GmbH Xipamid STADA 20mg Tabletten 53818.01.00 STADAPHARM GmbH Xipamid STADA 40mg Tabletten 53818.02.00 STADAPHARM GmbH Epogam 1000 mg 29644.00.00 Strathmann GmbH & Co. KG tetesept Erkältungs Bad 6422468.00.00 tetesept Pharma GmbH Venlafaxin Fair-Med 150 mg Hartkapseln, retardiert 83134.00.00 THRIVE PHARMA LTD. Venlafaxin Fair-Med 37,5 mg Hartkapseln, retardiert 83132.00.00 THRIVE PHARMA LTD. Venlafaxin Fair-Med 75 mg Hartkapseln, retardiert 83133.00.00 THRIVE PHARMA LTD. Caspofungin Tillomed 50 mg Pulver für ein Konzentrat zur Herstellung einer Infusionslösung 96109.00.00 TILLOMED PHARMA GmbH Caspofungin Tillomed 70 mg Pulver für ein Konzentrat zur Herstellung einer Infusionslösung 96110.00.00 TILLOMED PHARMA GmbH Sugammadex Tillomed 100 mg/ml Injektionslösung 7008837.00.00 TILLOMED PHARMA GmbH Xusal akut Tropfen 49904.00.01 UCB Pharma GmbH Xusal Saft 56570.00.00 UCB Pharma GmbH donasan 1500 mg Pulver zur Herstellung einer Lösung zum Einnehmen 83367.00.00 VEMEDIA Manufacturing B.V. Bifiteral mit Pflaumenaroma 667 mg/ml Lösung zum Einnehmen 99807.00.00 Viatris Healthcare GmbH Metamucil kalorienarm Orange 6238109.00.00 Wick Pharma - Zweigniederlassung der Procter & Gamble GmbH WICK Husten-Pastillen gegen Reizhusten mit Honig 7,33 mg/Lutschpastille 6080683.00.00 Wick Pharma - Zweigniederlassung der Procter & Gamble GmbH Finalgon 4 mg/g + 25 mg/g Salbe 84844.00.00 Zentiva Pharma GmbH Linagliptin Zentiva 5 mg Filmtabletten 7001906.00.00 Zentiva Pharma GmbH Pantoprazol Zentiva 40 mg Pulver zur Herstellung einer Injektionslösung 7005381.00.00 Zentiva Pharma GmbH Tapentadol Zentiva 25 mg Retardtabletten 7006627.00.00 Zentiva Pharma GmbH VI. Erlöschen einer Registrierung gemäß § 31 Absatz 1 Nummer 1 AMG – ohne Abverkauf – Bezeichnung des Arzneimittels Reg.-Nr. Zulassungsinhaber Arzneimittel zur Anwendung am Menschen Bioplasgen 7002973.00.00 Deutsche Homöopathie-Union DHU-Arzneimittel GmbH & Co. KG. Crataegus STADA 450 mg Filmtabletten 7001266.00.00 STADA Arzneimittel Aktiengesellschaft NeyDIL Nr.53 D7 2521577.00.00 vitOrgan Arzneimittel GmbH Revitolan Nr. 22 D7 2521512.00.00 vitOrgan Arzneimittel GmbH Bekanntmachung Veröffentlicht am Freitag, 28. August 2026 BAnz AT 28.08.2026 B9 Seite 15 von 18 VII. Erlöschen einer Zulassung gemäß § 31 Absatz 1 Nummer 3 AMG Bezeichnung des Arzneimittels Zul.-Nr. Zulassungsinhaber Arzneimittel zur Anwendung am Menschen KANTOS NEXThaler 200 Mikrogramm/12 Mikrogramm pro Inhalation Pulver zur Inhalation 2203581.00.00 Chiesi Farmaceutici S.p.A. FOSTER NEXThaler 200 Mikrogramm/12 Mikrogramm pro Inhalation Pulver zur Inhalation 2203582.00.00 Chiesi Farmaceutici S.p.A. KANTOS MASTER NEXThaler 200 Mikrogramm/12 Mikrogramm pro Inhalation Pulver zur Inhalation 2203583.00.00 Chiesi Farmaceutici S.p.A. INUVAIR NEXThaler 200 Mikrogramm/12 Mikrogramm pro Inhalation Pulver zur Inhalation 2203584.00.00 Chiesi Farmaceutici S.p.A. Tacrolimus SANDOZ 1 mg Hartkapseln 2203553.00.00 EMRA-MED Arzneimittel GmbH Pronoran 50 mg Retardtabletten 2203797.00.00 INOPHA GmbH Ibuprofen Pharmadev 200 mg Filmtabletten 2204881.00.00 Pharmadev Healthcare Limited Ibuprofen Pharmadev 400 mg Filmtabletten 2204882.00.00 Pharmadev Healthcare Limited Sunitinib Piramal 12,5 mg Hartkapseln 2204507.00.00 Piramal Critical Care B.V. Sunitinib Piramal 25 mg Hartkapseln 2204508.00.00 Piramal Critical Care B.V. Sunitinib Piramal 37,5 mg Hartkapseln 2204509.00.00 Piramal Critical Care B.V. Sunitinib Piramal 50 mg Hartkapseln 2204510.00.00 Piramal Critical Care B.V. VIII. Änderung einer Bezeichnung gemäß § 29 Absatz 2 AMG Eine Beurteilung der Zulässigkeit der angezeigten Änderung und eine Entscheidung über die Verkehrsfähigkeit des betreffenden Arzneimittels ist mit dieser Veröffentlichung nicht verbunden. Bisherige Bezeichnung des Arzneimittels Neue Bezeichnung des Arzneimittels Zul.-/Reg.-Nr. Apremilast Eignapharma 10 mg + 20 mg + 30 mg Filmtabletten Apremilast Dermapharm 10 mg + 20 mg + 30 mg Filmtabletten 7014001.00.00 Apremilast Eignapharma 30 mg Filmtabletten Apremilast Dermapharm 30 mg Filmtabletten 7014002.00.00 Azedil Kombi-Packung mit 0,5 mg/ml Augentropfen, Lösung und 1 mg/ml Nasenpray, Lösung Azelastin axicur Kombi-Packung mit 0,5 mg/ml Augentropfen, Lösung und 1 mg/ml Nasenspray, Lösung 90151.00.00 Azedil 0,5 mg/ml Augentropfen, Lösung Azelastin axicur 0,5 mg/ml Augentropfen, Lösung 90149.00.00 Azedil 1 mg/ml Nasenspray, Lösung Azelastin axicur 1 mg/ml Nasenspray, Lösung 90150.00.00 Carbo animalis C10 Carbo animalis C12 6564429.00.00 Cefuroxim Qilu 1,5 g Pulver zur Herstellung einer Injektions-/Infusionslösung Cefuroxim Eberth 1,5 g Pulver zur Herstellung einer Injektions-/Infusionslösung 7009747.00.00 Cefuroxim Qilu 250 mg Pulver zur Herstellung einer Injektions-/Infusionslösung Cefuroxim Eberth 250 mg Pulver zur Herstellung einer Injektions-/Infusionslösung 7009745.00.00 Cefuroxim Qilu 750 mg Pulver zur Herstellung einer Injektions-/Infusionslösung Cefuroxim Eberth 750 mg Pulver zur Herstellung einer Injektions-/Infusionslösung 7009746.00.00 Cholesterinum C2 Cholesterinum C6 2502476.00.00 Dimethylfumarat Shelterpharma 120 mg magensaftresistente Hartkapseln Dimethylfumarate Intas 120 mg magensaftresistente Hartkapseln 7013459.00.00 Dimethylfumarat Shelterpharma 240 mg magensaftresistente Hartkapseln Dimethylfumarate Intas 240 mg magensaftresistente Hartkapseln 7013460.00.00 dormiLoges Schlaftropfen Dormoysat Schlaftropfen 6856847.00.00 Echinacea C2 Echinacea C6 2502605.00.00 Etoricoxib NIO 120 mg Filmtabletten Etoricoxib nio 120 mg Filmtabletten 2201704.00.00 Bekanntmachung Veröffentlicht am Freitag, 28. August 2026 BAnz AT 28.08.2026 B9 Seite 16 von 18 Bisherige Bezeichnung des Arzneimittels Neue Bezeichnung des Arzneimittels Zul.-/Reg.-Nr. Etoricoxib NIO 30 mg Filmtabletten Etoricoxib nio 30 mg Filmtabletten 2201701.00.00 Etoricoxib NIO 60 mg Filmtabletten Etoricoxib nio 60 mg Filmtabletten 2201702.00.00 Etoricoxib NIO 90 mg Filmtabletten Etoricoxib nio 90 mg Filmtabletten 2201703.00.00 Hydroxycarbamid HEXAL 100 mg Filmtabletten Ardjaq 100 mg Filmtabletten 7002900.00.00 Hydroxycarbamid HEXAL 1000 mg Filmtabletten Ardjaq 1000 mg Filmtabletten 7002901.00.00 Hydroxycarbamid HEXAL 500 mg Ardjaq 500 mg Hartkapseln 71991.00.00 Kalium phosphoricum C2 Kalium phosphoricum C6 2516005.00.00 Lycopodium D2 Lycopodium D3 2500468.00.00 Metoprololsuccinat Pharmaclan 190 mg Retardtabletten Metoprololsuccinat Heumann 190 mg Retardtabletten 7012041.00.00 Metoprololsuccinat Pharmaclan 23,75 mg Retardtabletten Metoprololsuccinat Heumann 23,75 mg Retardtabletten 7012038.00.00 Metoprololsuccinat Pharmaclan 47,5 mg Retardtabletten Metoprololsuccinat Heumann 47,5 mg Retardtabletten 7012039.00.00 Metoprololsuccinat Pharmaclan 95 mg Retardtabletten Metoprololsuccinat Heumann 95 mg Retardtabletten 7012040.00.00 Mg 10% Inresa Magnesium Inresa 0,4 mmol/ml 6914674.00.00 Momekort 50 Mikrogramm/Sprühstoß Nasenspray, Suspension Mometason axicur Heuschnupfenspray 50 Mikrogramm/Sprühstoß Nasenspray, Suspension 87696.00.00 Natrium sulfuricum C2 Natrium sulfuricum C6 6572765.00.00 Opium C2 Opium C6 2505125.00.00 Oxybugamma 2,5 Oxybutynin AAA-Pharma 2,5 mg Tabletten 42978.00.00 Oxybugamma 5 Oxybutynin AAA-Pharma 5 mg Tabletten 42554.00.00 Oxycodon/Naloxon PAINBREAK 10 mg/5 mg Retardtabletten Oxycodon/Naloxon Hormosan 10 mg/5 mg Retardtabletten 99081.00.00 Oxycodon/Naloxon PAINBREAK 20 mg/10 mg Retardtabletten Oxycodon/Naloxon Hormosan 20 mg/10 mg Retardtabletten 99082.00.00 Oxycodon/Naloxon PAINBREAK 30 mg/15 mg Retardtabletten Oxycodon/Naloxon Hormosan 30 mg/15 mg Retardtabletten 99083.00.00 Oxycodon/Naloxon PAINBREAK 40 mg/20 mg Retardtabletten Oxycodon/Naloxon Hormosan 40 mg/20 mg Retardtabletten 99084.00.00 Oxycodon/Naloxon PAINBREAK 5 mg/2,5 mg Retardtabletten Oxycodon/Naloxon Hormosan 5 mg/2,5 mg Retardtabletten 99080.00.00 Pantoprazol Holsten 20 mg magensaftresistente Tabletten Pantoprazol Macleods 20mg magensaftresistente Tabletten 88283.00.00 Pantoprazol Holsten 40 mg magensaftresistente Tabletten Pantoprazol Macleods 40mg magensaftresistente Tabletten 81864.00.00 Quetiapin Fair.Med Healthcare 100 mg Filmtabletten Quetiapin Thrive Pharma 100 mg Filmtabletten 84613.00.00 Quetiapin Fair-Med Healthcare 150 mg Filmtabletten Quetiapin Thrive Pharma 150 mg Filmtabletten 84614.00.00 Quetiapin Fair-Med Healthcare 200 mg Filmtabletten Quetiapin Thrive Pharma 200 mg Filmtabletten 84615.00.00 Quetiapin Fair-Med Healthcare 25 mg Filmtabletten Quetiapin Thrive Pharma 25 mg Filmtabletten 84612.00.00 Quetiapin Fair-Med Healthcare 300 mg Filmtabletten Quetiapin Thrive Pharma 300 mg Filmtabletten 84616.00.00 Bekanntmachung Veröffentlicht am Freitag, 28. August 2026 BAnz AT 28.08.2026 B9 Seite 17 von 18 Bisherige Bezeichnung des Arzneimittels Neue Bezeichnung des Arzneimittels Zul.-/Reg.-Nr. Safinamid Vivanta Generics 100 mg Filmtabletten Safinamid AL 100 mg Filmtabletten 7018608.00.00 Safinamid Vivanta Generics 50 mg Filmtabletten Safinamid AL 50 mg Filmtabletten 7018607.00.00 Salofalk 1 g Suppositorien Salofalk 1000 mg Zäpfchen 2202358.00.00 Salofalk 1 g Suppositorien Salofalk 1000 mg Zäpfchen 97406.00.00 Salofalk 250 mg Suppositorien Salofalk 250 mg Zäpfchen 55774.00.00 Salofalk 500 mg Suppositorien Salofalk 500 mg Zäpfchen 55774.01.00 Salofalk 500 mg Suppositorien Salofalk 500 mg Zäpfchen 2202338.00.00 Sandostatin LAR-Monatsdepot 20 mg Sandostatina LAR-Monatsdepot 20 mg 46381.02.00 Secale cornutum C2 Secale cornutum C6 2505087.00.01 VERINTEX spag. Peka, innerlich VERINTEX spag. Peka N, innerlich 2522512.00.00 Zincum metallicum C10 Zincum metallicum C12 2516100.00.00 Weitere Informationen zu den Arzneimitteln erhalten Sie unter: www.dimdi.de Bonn, den 19. Mai 2026 13.21-3533-00 Bundesinstitut für Arzneimittel und Medizinprodukte Im Auftrag Dr. M. Horn Bekanntmachung Veröffentlicht am Freitag, 28. August 2026 BAnz AT 28.08.2026 B9 Seite 18 von 18 Bundesanzeiger Verlag GmbH 2026-08-26T13:11:44+0200 Bundesanzeiger Verlag GmbH

BERLIN Friedrichstraße 134 10117 Berlin BONN Ubierstraße 71–73 53173 Bonn Pharma Deutschland e. V. info@pharmadeutschland.de www.pharmadeutschland.de BRÜSSEL Rue Marie de Bourgogne 58 1000 Brüssel Ihre Ansprechpartner in der Pharma Deutschland-Pressestelle: Hannes Hönemann Leiter Abteilung Presse- und Öffentlichkeitsarbeit M: +49-171-5618203 hoenemann@pharmadeutschland.de Anna Frederike Gutzeit CvD Presse- und Öffentlichkeitsarbeit M: +49-170-4548014 gutzeit@pharmadeutschland.de Pressemitteilung Blut und Plasma sind Teil der Versorgungssicherheit Sommermonate stellen Blutversorgung vor besondere Herausforderungen. Berlin (28. August 2026) – Blut wird täglich für die medizinische Versorgung benötigt. Gleichzeitig können die Bestände insbesondere in den Sommermonaten schnell zurückgehen. Urlaubszeit und hohe Temperaturen wirken sich ungünstig auf die Bereitschaft zur Blutspende aus, während der Bedarf an Blutpräparaten in den Kliniken fortbesteht, an einem Tag werden ca. 15.000 Spenden verbraucht. Da Blutskonserven nur begrenzt haltbar sind, lässt sich die Versorgung nicht langfristig aus Vorräten sicherstellen. Regelmäßige Spenden sind daher entscheidend für eine stabile Versorgung. Dabei geht es nicht nur um die unmittelbare Versorgung von Patientinnen und Patienten mit Blutpräparaten. Auch Blutplasma ist für die Gesundheitsversorgung von zentraler Bedeutung: Es dient als Ausgangsstoff für die Herstellung zahlreicher Arzneimittel. Dazu gehören unter anderem Immunglobuline und Präparate mit Gerinnungsfaktoren. Für Patientinnen und Patienten mit bestimmten Immundefekten oder Gerinnungsstörungen sind diese Arzneimittel teils lebensnotwendig. „Blut und Plasma sind wichtige Ressourcen für die medizinische Versorgung. Anders als viele Arzneimittel lässt sich Blut nicht industriell herstellen. Was in der medizinischen Versorgung benötigt wird, kann nur durch Blutspenden bereitgestellt werden. Bei Blutpräparaten geht es um eine unmittelbare Versorgung, bei Plasma zusätzlich um einen zentralen Ausgangsstoff für die Herstellung von Arzneimitteln. Beides setzt voraus, dass ausreichend Spenden zur Verfügung stehen“, sagt Dorothee Brakmann von Pharma Deutschland. Die Gewinnung von Plasma und die Herstellung plasmabasierter Arzneimittel kann zudem nicht kurzfristig erfolgen. Zwischen der Plasmaspende und dem fertigen Arzneimittel liegen zahlreiche 2 komplexe Verarbeitungsschritte und ein entsprechend langer Produktionszeitraum, der mehrere Monate dauern kann. Eine kontinuierliche Versorgung mit Plasma ist deshalb eine wichtige Voraussetzung für eine verlässliche Arzneimittelversorgung. Pharma Deutschland unterstützt daher die kontinuierliche Aufmerksamkeit für Blut- und Plasmaspenden. Gerade in Zeiten, in denen die Spendenbereitschaft saisonbedingt zurückgehen kann, ist es wichtig, die Versorgung mit Blut und Plasma stabil zu halten. _______________ Der Pharma Deutschland e.V. ist der mitgliederstärkste Branchenverband der Pharmaindustrie in Deutschland. Er vertritt die Interessen von rund 400 Mitgliedsunternehmen, die in Deutschland ca. 80.000 Mitarbeiterinnen und Mitarbeiter beschäftigen. Die in Pharma Deutschland e.V. organisierten Unternehmen tragen maßgeblich dazu bei, die Arzneimittelversorgung in Deutschland zu sichern. So stellen sie fast 80 Prozent der in Apotheken verkauften rezeptfreien und fast zwei Drittel der rezeptpflichtigen Arzneimittel sowie einen Großteil der stofflichen und dentalen Medizinprodukte für die Patientinnen und Patienten bereit. Unter www.pharmadeutschland.de gibt es mehr Informationen zu Pharma Deutschland.

BERLIN Friedrichstraße 134 10117 Berlin BONN Ubierstraße 71–73 53173 Bonn Pharma Deutschland e. V. info@pharmadeutschland.de www.pharmadeutschland.de BRÜSSEL Rue Marie de Bourgogne 58 1000 Brüssel Ihre Ansprechpartner in der Pharma Deutschland-Pressestelle: Hannes Hönemann Leiter Abteilung Presse- und Öffentlichkeitsarbeit M. +49-171-5618203 hoenemann@pharmadeutschland.de Anna Frederike Gutzeit CvD Presse- und Öffentlichkeitsarbeit M: +49-170-4548014 gutzeit@pharmadeutschland.de Pressemitteilung Gesundheitsversorgung bewegt Sachsen-Anhalt vor der Landtagswahl Bevölkerung und Parteien geht es um erreichbare Versorgungsangebote in der Stadt und auf dem Land. Berlin (27. August 2026) – Kurz vor der Landtagswahl in Sachsen- Anhalt am 6. September rückt die Gesundheitsversorgung in den Mittelpunkt. Für die Menschen im Land ist entscheidend, dass medizinische Angebote gut erreichbar bleiben – von der Apotheke über die Arztpraxis bis zum Krankenhaus. „Gesundheitsversorgung ist Daseinsvorsorge und damit eine zentrale Zukunftsfrage für Sachsen-Anhalt“, sagt Dorothee Brakmann, Hauptgeschäftsführerin von Pharma Deutschland. „Die Menschen wollen sich darauf verlassen können, dass sie im Alltag schnell und persönlich Hilfe erhalten: in der Apotheke, in der Arztpraxis und im Krankenhaus.“ Die Gesundheitsversorgung ist zentrales Thema im laufenden Wahlkampf. Parteiübergreifend besteht der Anspruch, eine erreichbare und verlässliche Versorgung im ganzen Land zu sichern. Die Parteien greifen die Sicherung ambulanter Versorgung auf, einschließlich der haus- und fachärztlichen Versorgung sowie der Gewinnung von Nachwuchs. Sie befassen sich außerdem mit der Zukunft der Krankenhäuser, ihrer Finanzierung, ihrer Struktur und ihrer Rolle für die regionale Versorgung. Zugleich betonen sie, dass medizinische Angebote auch im ländlichen Raum erreichbar bleiben müssen. Die Menschen in Sachsen-Anhalt bewerten die Versorgung durch Apotheken besonders positiv. 83,3 Prozent der Befragten geben laut dem Pharma Deutschland Gesundheitsmonitor an, mit der Apothekenversorgung zufrieden zu sein. Nur 3,6 Prozent sehen in diesem Bereich Probleme. Apotheken sind für viele Menschen der mailto:hoenemann@pharmadeutschland.de 2 am einfachsten erreichbare Zugang zum Gesundheitssystem. Sie beraten persönlich zu Arzneimitteln, helfen bei akuten Beschwerden, unterstützen bei der sicheren Anwendung von Medikamenten und vermitteln bei Bedarf in die weitere medizinische Versorgung. Insbesondere vor dem Hintergrund des demografischen Wandels und des in den kommenden Jahren bevorstehenden Ruhestands vieler Ärztinnen und Ärzte gewinnt die Frage einer ausreichenden medizinischen Versorgung an Bedeutung. Aktuell nehmen jedoch nur 31 Prozent der Befragten in Sachsen-Anhalt ein ausreichendes Angebot an Ärztinnen und Ärzten wahr. Damit liegt der Wert deutlich unter dem Bundesdurchschnitt von 52 Prozent. Sachsen-Anhalt hat in den vergangenen Jahren bereits wichtige Maßnahmen zur Sicherung und Weiterentwicklung der Gesundheitsversorgung auf den Weg gebracht. Das Gesundheitskabinett des Landes beschloss Anfang 2025 ein Maßnahmenpaket gegen den Ärzte- und Zahnärztemangel sowie einen Fahrplan für die Weiterentwicklung der Krankenhausplanung. Vorgesehen sind unter anderem die Ausweitung der Landarztquote, Stipendien und Unterstützungsangebote für die Niederlassung in ländlichen Regionen. Seit dem Start der Landarztquote im Jahr 2020 konnten nach Angaben des Gesundheitsministeriums mehr als 130 angehende Ärztinnen und Ärzte für ländliche Regionen gewonnen werden. Auch die Krankenhausplanung wird weiterentwickelt. Ziel ist es, Kliniken stärker zu spezialisieren, Qualität zu sichern und die ambulante und stationäre Versorgung besser miteinander zu verzahnen. Die Krankenhausplanung des Landes verfolgt ausdrücklich das Ziel einer bedarfsgerechten Versorgung. _______________ Im Auftrag von Pharma Deutschland führt das Meinungsforschungsinstitut Civey seit Januar 2025 ein kontinuierliches Live-Monitoring zur individuellen medizinischen Versorgungssituation sowie zu Erfahrungen im Kontext pharmazeutischer Themen durch. Die Anzahl der Antworten, die stellvertretend für die Grundgesamtheit in der Stichprobe zur Berechnung des repräsentativen Ergebnisses berücksichtigt werden, liegt bei 5.000 Befragten. Die erhobenen Daten werden nach den sechs Landesverbänden von Pharma Deutschland differenziert analysiert. Die Ergebnisse sind repräsentativ für die angegebene Grundgesamtheit. Für die Berechnung regionaler Ergebnisse nutzt Civey Small-Area-Methoden mit einem Echtzeit- Modell. Dazu werden die Ergebnisse auf Basis einer modellbasierten, statistischen Methode für kleine Datenräume erhoben. Weitere Informationen und Ergebnisse finden Sie auf unserer Webseite. https://www.pharmadeutschland.de/pharmawissen-fuer-alle/gesundheitsmonitor/ 3 Der Pharma Deutschland e.V. ist der mitgliederstärkste Branchenverband der Pharmaindustrie in Deutschland. Er vertritt die Interessen von rund 400 Mitgliedsunternehmen, die in Deutschland ca. 80.000 Mitarbeiterinnen und Mitarbeiter beschäftigen. Die in Pharma Deutschland e.V. organisierten Unternehmen tragen maßgeblich dazu bei, die Arzneimittelversorgung in Deutschland zu sichern. So stellen sie fast 80 Prozent der in Apotheken verkauften rezeptfreien und fast zwei Drittel der rezeptpflichtigen Arzneimittel sowie einen Großteil der stofflichen und dentalen Medizinprodukte für die Patientinnen und Patienten bereit. Unter www.pharmadeutschland.de gibt es mehr Informationen zu Pharma Deutschland. http://www.pharmadeutschland.de/

AM\1348825EN.docx PE791.123v02-00 EN United in diversity EN European Parliament 2024-2029 Committee on the Environment, Climate and Food Safety 2025/0394(COD) 28.7.2026 AMENDMENTS 264 - 465 Draft report Susana Solís Pérez (PE787.998v01-00) Amending Directives 2008/98/EC, 2010/75/EU, (EU) 2015/2193 and (EU) 2024/1785 of the European Parliament and of the Council as regards simplification of some requirements and reduction of administrative burden Proposal for a directive (COM(2025)0986 – 2025/0394(COD)) PE791.123v02-00 2/158 AM\1348825EN.docx EN AM_Com_LegReport AM\1348825EN.docx 3/158 PE791.123v02-00 EN Amendment 264 Anna Zalewska Proposal for a directive Article 2 – paragraph 1 – point 1 a (new) Directive 2010/75/EU Article 15 – paragraph 3 Present text Amendment (1a) In Article 15, paragraph 3 is replaced by the following: 3. The competent authority shall set the strictest achievable emission limit values by applying BAT in the installation, considering the entire range of the emission levels associated with the best available techniques (“BAT-AELs”) to ensure that, under normal operating conditions, emissions do not exceed the BAT-AELs as laid down in the decisions on BAT conclusions referred to in Article 13(5). The emission limit values shall be based on an assessment by the operator of the entire BAT-AEL range, analysing the feasibility of meeting the strictest end of the BAT-AEL range and demonstrating the best overall performance that the installation can achieve by applying BAT as described in BAT conclusions, having regard to possible cross-media effects. The emission limit values shall be set through either of the following:(a)setting emission limit values expressed for the same or shorter periods of time and under the same reference conditions as the BAT-AELs; or(b)setting emission limit values different from those referred to in point (a) in terms of values, periods of time and reference conditions.Where the emission limit values are set in accordance with point (b), the competent authority shall, at least annually, assess the results of emission monitoring in order to ensure that emissions under normal operating conditions have not exceeded the BAT-AELs.General binding rules referred to in Article 6 may be applied while setting relevant emission limit values in accordance with this ‘3. The competent authority shall set appropriate, technically achievable emission limit values by applying BAT in the installation, considering the applicable best available techniques (“BAT-AELs”) to ensure that, under normal operating conditions, emissions do not exceed the BAT-AELs as laid down in the decisions on BAT conclusions referred to in Article 13(5). The emission limit values shall be based on an assessment by the operator of the entire BAT-AEL range and demonstrating the best overall performance that the installation can achieve by applying BAT as described in BAT conclusions, having regard to possible cross-media effects. The emission limit values shall be set through either of the following:(a)setting emission limit values expressed for the same or shorter periods of time and under the same reference conditions as the BAT-AELs; or(b)setting emission limit values different from those referred to in point (a) in terms of values, periods of time and reference conditions.Where the emission limit values are set in accordance with point (b), the competent authority shall, at least annually, assess the results of emission monitoring in order to ensure that emissions under normal operating conditions have not exceeded the BAT-AELs.General binding rules referred to in Article 6 may be applied while setting relevant emission limit values in accordance with this Article. The general binding rules shall be established by the Member State, based on PE791.123v02-00 4/158 AM\1348825EN.docx EN Article.If general binding rules are adopted, the strictest achievable emission limit values by applying BAT shall be set for categories of installations having similar characteristics that are relevant in determining the lowest emission levels achievable, considering the entire range of the BAT-AELs. The general binding rules shall be established by the Member State, based on the information in the BAT conclusions, analysing the feasibility of meeting the strictest end of the BAT-AEL range and demonstrating the best performance that those categories of installations can achieve by applying BAT as described in BAT conclusions. the information in the BAT conclusions and demonstrating the best performance that those categories of installations can reasonably achieve by applying BAT as described in BAT conclusions.’ Or. en ((https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A02010L0075-20240804)) Amendment 265 Alexander Bernhuber Proposal for a directive Article 2 – paragraph 1 – point 1 b (new) Directive 2010/75/EU Article 15 – paragraph 3 – subparagraph 1 – first sentence Present text Amendment (1b) in Article 15(3), first subparagraph, the first sentence is replaced by the following: 3. The competent authority shall set the strictest achievable emission limit values by applying BAT in the installation, considering the entire range of the emission levels associated with the best available techniques (“BAT-AELs”) to ensure that, under normal operating conditions, emissions do not exceed the BAT-AELs as laid down in the decisions on BAT conclusions referred to in Article 13(5). ‘3. The competent authority shall set emission limit values based on the relevant BAT, considering the entire range of the emission levels associated with the best available techniques (“BAT-AELs”) to ensure that, under normal operating conditions, emissions do not exceed the BAT-AELs as laid down in the decisions on BAT conclusions referred to in Article 13(5).’ AM\1348825EN.docx 5/158 PE791.123v02-00 EN Or. en (EU/2010/75/EU) Justification Article 15 (3) of Directive 2010/75/EU should only require competent authorities to set emission limit values (ELVs) within the relevant BAT AEL range in permits to better reflect the local and site-specific conditions of each installation. Amendment 266 François-Xavier Bellamy, Céline Imart Proposal for a directive Article 2 – paragraph 1 – point 1 b (new) Directive 2010/75/EU Article 15 – paragraph 4 Text proposed by the Commission Amendment (1b) In Article 15, paragraph 4 is deleted. Or. fr Amendment 267 Andrea Wechsler, Christian Ehler, Jens Gieseke, Angelika Niebler, Oliver Schenk, Norbert Lins, Zala Černilec Tomašič, Peter Liese, Wouter Beke Proposal for a directive Article 2 - paragraph 1 – point 1 a (new) Directive 2010/75/EU Article 15 – paragraph 4 Present text Amendment (1a) in Article 15, paragraph 4 is deleted Or. en (https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A02010L0075-20240804) Justification The amendment removes binding environmental performance ranges which would add complexity beyond the core BAT-based emission limit framework. This ensures that PE791.123v02-00 6/158 AM\1348825EN.docx EN permitting remains focused on measurable emission control, reduces administrative burden and avoids disproportionate requirements. Amendment 268 Daniel Buda Proposal for a directive Article 2– paragraph 1 – point 1 a (new) Directive 2010/75 Article 15 – paragraph 4 Present text Amendment (1a) in Article 15, paragraph 4 is deleted. Or. en Justification Requiring competent authorities to set water, waste and resource performance values for all installations, regardless of their relevance to the sector, would undermine this process, create inconsistent requirements across Member States and impose unnecessary administrative burdens without delivering additional environmental benefits. Amendment 269 Alexander Bernhuber Proposal for a directive Article 2 – paragraph 1 – point 1a (new) Directive 2010/75/EC Article 15 – paragraph 4 Present text Amendment (1a) in Article 15, paragraph 4 is deleted: Or. en (2010/75/EU) Justification AEPLs are obsolete because of several provisions in the special legislative acts such as Water Framework Directive, Ambient Air Quality Directive, Waste Framework Directive. AM\1348825EN.docx 7/158 PE791.123v02-00 EN Amendment 270 Elżbieta Katarzyna Łukacijewska, Krzysztof Hetman Proposal for a directive Article 2 – paragraph 1 – point 1 b (new) Directive 2010/75/EC Article 15 – paragraph 4 – point a Text proposed by the Commission Amendment (1b) in Article 15(4), point (a) is deleted Or. en Justification Environmental performance limit values should be deleted as they create an additional layer of binding permitting and compliance obligations for operators, including operators of large combustion plants. Consumption levels, resource efficiency concerning materials, water and energy, and waste generation are already addressed through other EU and national legal frameworks, including energy efficiency, water, waste and resource-efficiency legislation. Introducing binding environmental performance limit values under the IED would therefore risk duplicating existing requirements and increasing administrative complexity, contrary to the simplification objective of the Omnibus package. Removing this obligation would preserve the focus of the IED on emissions control and integrated pollution prevention, while avoiding disproportionate administrative and operational burdens in areas already regulated elsewhere. Amendment 271 Pietro Fiocchi Proposal for a directive Article 2 – paragraph 1 – point 1 b (new) Directive 2010/75/EU Article 15 – paragraph 4 – point a Present text Amendment (1b) in Article 15(4), point (a) is deleted; Or. en (https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A02010L0075- 20240804&qid=1783407411429) PE791.123v02-00 8/158 AM\1348825EN.docx EN Amendment 272 Jeannette Baljeu, Andreas Glück, Ilhan Kyuchyuk, Ana Vasconcelos Proposal for a directive Article 2 – paragraph 1 – point 1 a (new) Directive 2010/75/EU Article 15 – paragraph 4 – subparagraph 3 Text proposed by the Commission Amendment (1a) in Article 15(4) , the following subparagraph is added: For installations forming part of European semiconductor technology initiatives and strategic projects recognised under Regulation (EU) XXX/XXX [Chips Act 2], as well as integrated production facilities and open EU foundries recognised under Regulation (EU) 2023/1781, competent authorities shall take into account the specific technical characteristics of semiconductor manufacturing when applying this paragraph, including process stability, product quality requirements and the limited availability of technically feasible abatement or substitution alternatives. Or. en Justification Semiconductor manufacturing is essential for Europe’s technological sovereignty and resilience. This amendment ensures that the existing IED derogation mechanism can take account of the specific technical constraints of semiconductor production. Amendment 273 Pietro Fiocchi Proposal for a directive Article 2 – paragraph 1 – point 1 c (new) Directive 2010/75/EU Article 15 – paragraph 4 – point b AM\1348825EN.docx 9/158 PE791.123v02-00 EN Present text Amendment (1c) in Article 15(4), point (b) is replaced by the following: (b) set, for normal operating conditions, indicative environmental performance levels concerning waste and resources other than water, which are not less strict than the binding ranges referred to in the first subparagraph. ‘(b) set, for normal operating conditions, indicative environmental performance levels concerning water, waste and resources, which are consistent with the indicative ranges referred to in the first subparagraph.’ Or. en (https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A02010L0075- 20240804&qid=1783407411429) Justification Indicative values would provide the necessary flexibility to adapt resource consumption or waste generation to site-specific constraints. This would ensure that environmental efforts are focused where they have a real impact, rather than meeting disproportionate and rigid targets. Amendment 274 François-Xavier Bellamy Proposal for a directive Article 2 – paragraph 1 – point 1 b (new) Directive 2010/75/EU Article 15 – paragraph 4 Present text Amendment (1b) In Article 15, paragraph 4 is replaced by the following: 4. Without prejudice to Article 9(2), the competent authority shall set, for normal operating conditions, binding ranges for environmental performance that are not to be exceeded during one or more periods, as laid down in the decisions on BAT conclusions referred to in Article 13(5). 4. Without prejudice to Article 9(2), the competent authority shall set, for normal operating conditions, indicative ranges for environmental performance that are not to be exceeded during one or more periods, as laid down in the decisions on BAT conclusions referred to in Article 13(5). In addition, the competent authority shall: In addition, the competent authority shall: (a) set, for normal operating conditions, environmental performance limit values (a) set, for normal operating conditions, environmental performance limit values PE791.123v02-00 10/158 AM\1348825EN.docx EN concerning water, having regard to possible cross-media effects, that are not to be exceeded during one or more periods, and which are not less strict than the binding ranges referred to in the first subparagraph; concerning water, having regard to possible cross-media effects, that are not to be exceeded during one or more periods, and which are not less strict than the indicative ranges referred to in the first subparagraph; (b) set, for normal operating conditions, indicative environmental performance levels concerning waste and resources other than water, which are not less strict than the binding ranges referred to in the first subparagraph. (b) set, for normal operating conditions, indicative environmental performance levels concerning waste and resources other than water, which are not less strict than the indicative ranges referred to in the first subparagraph. Or. fr Amendment 275 Sergio Berlato, Michele Picaro, Pietro Fiocchi, Stefano Cavedagna, Nicola Procaccini, Antonella Sberna, Paolo Inselvini Proposal for a directive Article 1 - paragraph 1 – point 1 a (new) Directive 2010/75/EU Article 15 – paragraph 5 – subparagraph 2 Present text Amendment The competent authority shall document in an annex to the permit conditions the reasons for derogating from paragraph 3, and the result of the assessment referred to in the first subparagraph of this paragraph and the justification for the conditions imposed. The competent authority may grant temporary derogations from the requirements of paragraphs 2 and 3 of this Article and from Article 11, points (a) and (b), for the testing and use of emerging techniques for a total period of time not exceeding 9 months, pro vided that after the period specified, either the technique is stopped or the activity achieves at least the emission levels asso ciated with the best available techniques. Or. en (https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32010L0075) Amendment 276 Anna Zalewska AM\1348825EN.docx 11/158 PE791.123v02-00 EN Proposal for a directive Article 2 – paragraph 1 – point 1 b (new) Directive 2010/75/EU Article 15 – paragraph 5 Present text Amendment (1b) Article 15, paragraph 5 is replaced by the following: 5. By way of derogation from paragraph 3, and without prejudice to Article 18, the competent authority may, in specific cases, set emission limit values higher than the BAT-AELs. Such a derogation may apply only where an assessment shows that the achievement of BAT-AELs as described in BAT conclusions would lead to disproportionately higher costs compared to the environmental benefits due to:(a)the geographical location or the local environmental conditions of the installation concerned; or(b)the technical characteristics of the installation concerned. The competent authority shall document in an annex to the permit conditions the reasons for derogating from paragraph 3, and the result of the assessment referred to in the first subparagraph of this paragraph and the justification for the conditions imposed.The emission limit values set in accordance with the first subparagraph shall, however, not exceed the emission limit values set out in the Annexes to this Directive, where applicable.Derogations granted in accordance with this paragraph shall respect the principles set out in Annex II. The competent authority shall ensure that the operator provides an assessment of the impact of the derogation on the concentration of the pollutants concerned in the receiving environment and in any case ensure that no significant pollution is caused and that a high level of protection of the environment as a whole is achieved. Derogations shall not be granted where they could put at risk compliance with environmental quality standards referred to in Article 18.The competent authority shall ‘5. By way of derogation from paragraph 3, and without prejudice to Article 18, the competent authority may set emission limit values higher than the BAT-AELs. Such a derogation may apply where an assessment reasonably demonstrates that the achievement of BAT-AELs as described in BAT conclusions would result in disproportionately higher costs compared to the environmental benefits due to:(a)the geographical location or the local environmental conditions of the installation concerned; (b)the technical characteristics of the installation concerned; c) the economic viability, strategic importance or security of supply of the installation concerned. The competent authority shall document in an annex to the permit conditions the reasons for derogating from paragraph 3, and the result of the assessment referred to in the first subparagraph of this paragraph and the justification for the conditions imposed.The emission limit values set in accordance with the first subparagraph shall, however, not exceed the emission limit values set out in the Annexes to this Directive, where applicable.Derogations granted in accordance with this paragraph shall respect the principles set out in Annex II. The competent authority shall ensure that the operator provides an assessment of the impact of the derogation on the concentration of the pollutants concerned in the receiving environment and in any case ensure that no significant pollution is caused and that a high level of protection of the environment as a whole is achieved. Derogations shall not be granted where they could put at risk compliance with PE791.123v02-00 12/158 AM\1348825EN.docx EN re-assess whether derogations granted in accordance with this paragraph are justified, every four years or as part of each reconsideration of the permit conditions pursuant to Article 21, where such reconsideration occurs earlier than four years after the derogation was granted.The Commission shall adopt an implementing act to establish a standardised methodology for assessing the disproportionality between the costs of implementation of the BAT conclusions and the potential environmental benefits referred to in the first subparagraph. That implementing act shall be adopted in accordance with the examination procedure referred to in Article 75(2). environmental quality standards referred to in Article 18.The competent authority shall re-assess whether derogations granted in accordance with this paragraph are justified, every eight years or as part of each reconsideration of the permit conditions pursuant to Article 21, where such reconsideration occurs earlier than four years after the derogation was granted.The Commission shall adopt an implementing act to establish a standardised methodology for assessing the disproportionality between the costs of implementation of the BAT conclusions and the potential environmental benefits referred to in the first subparagraph. That implementing act shall be adopted in accordance with the examination procedure referred to in Article 75(2).’ Or. en ((https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A02010L0075-20240804)) Amendment 277 Alexander Bernhuber Proposal for a directive Article 2 – paragraph 1 – point 1 b (new) Directive 2010/75/EC Article 15 – paragraph 5 Present text Amendment (1b) in Article 15, paragraph 5 is replaced by the following: By way of derogation from paragraph 3, and without prejudice to Article 18, the competent authority may, in specific cases, set emission limit values higher than the BAT-AELs. Such a derogation may apply only where an assessment shows that the achievement of BAT-AELs as described in BAT conclusions would lead to disproportionately higher costs compared to the environmental benefits due to: ‘By way of derogation from paragraph 3, and without prejudice to Article 18, the competent authority may, in specific cases, set emission limit values higher than the BAT-AELs. Such a derogation may apply only where an assessment shows that the achievement of BAT-AELs as described in BAT conclusions would lead to disproportionately higher costs compared to the environmental benefits due to: AM\1348825EN.docx 13/158 PE791.123v02-00 EN (a) the geographical location or the local environmental conditions of the installation concerned; or (a) the geographical location or the local environmental conditions of the installation concerned; or (b) the technical characteristics of the installation concerned. (b) the technical characteristics of the installation concerned. The competent authority shall document in an annex to the permit conditions the rea- sons for derogating from paragraph 3, and the result of the assessment referred to in the first subparagraph of this paragraph and the justification for the conditions imposed. The competent authority shall document in an annex to the permit conditions the rea- sons for derogating from paragraph 3, and the result of the assessment referred to in the first subparagraph of this paragraph and the justification for the conditions imposed. The emission limit values set in accordance with the first subparagraph shall, however, not exceed the emission limit values set out in the Annexes to this Directive, where applicable. The emission limit values set in accordance with the first subparagraph shall, however, not exceed the emission limit values set out in the Annexes to this Directive, where applicable. Derogations granted in accordance with this paragraph shall respect the principles set out in Annex II. The competent authority shall ensure that the operator provides an assessment of the impact of the derogation on the concentration of the pollutants concerned in the receiving environment and in any case ensure that no significant pollution is caused and that a high level of protection of the environment as a whole is achieved. Derogations shall not be granted where they could put at risk compliance with environmental quality standards referred to in Article 18. The competent authority shall in any case ensure that no significant pollution is caused and that a high level of protection of the environment as a whole is achieved. The competent authority shall re-assess whether derogations granted in accordance with this paragraph are justified, every four years or as part of each reconsideration of the permit conditions pursuant to Article 21, where such reconsideration occurs earlier than four years after the derogation was granted. The competent authority shall re-assess whether derogations granted in accordance with this paragraph are justified, every four years or as part of each reconsideration of the permit conditions pursuant to Article 21, where such reconsideration occurs earlier than four years after the derogation was granted. On the basis of information provided by Member States in accordance with Article 72(1), in particular concerning the application of this paragraph, the Commission may, where necessary, assess and further clarify, through guidance, the criteria to be taken into account for the application of this paragraph.’ PE791.123v02-00 14/158 AM\1348825EN.docx EN The Commission shall adopt an implementing act to establish a standardised methodology for assessing the disproportionality between the costs of implementation of the BAT conclusions and the potential environmental benefits referred to in the first subparagraph. That implementing act shall be adopted in accordance with the examination procedure referred to in Article 75(2). The Commission shall adopt an implementing act to establish a standardised methodology for assessing the disproportionality between the costs of implementation of the BAT conclusions and the potential environmental benefits referred to in the first subparagraph. That implementing act shall be adopted in accordance with the examination procedure referred to in Article 75(2). Or. en (2010/75/EU) Justification This proposal intends to change the new requirements of Annex II, which authorities must consider when granting exemptions and which are overly ambitious and burdensome. Furthermore, the implementing act – introduced in 2024 - which in turn creates additional bureaucracy, is unnecessary when a guideline can serve the same purpose. Amendment 278 Andrea Wechsler, Christian Ehler, Jens Gieseke, Angelika Niebler, Oliver Schenk, Norbert Lins, Zala Černilec Tomašič, Peter Liese, Wouter Beke Proposal for a directive Article 2 – paragraph 1 – point 1 b (new) Directive 2010/75/EU Article 15 – paragraph 6 Text proposed by the Commission Amendment (1b) in Article 15, paragraph 6 is deleted; Or. en (https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A02010L0075-20240804) Justification The amendment is consequential to the deletion of binding environmental performance ranges. Removing the related derogation mechanism avoids redundant procedures, simplifies the legal framework and ensures that competent authorities and operators are not subject to unnecessary administrative steps. AM\1348825EN.docx 15/158 PE791.123v02-00 EN Amendment 279 Alexander Bernhuber Proposal for a directive Article 2 – paragraph 1 – point 1 c (new) Directive 2010/75/EU Article 15 – paragraph 6 Present text Amendment (1c) in Article 15, paragraph 6 is deleted; Or. en (2010/75/EU) Justification AEPLs are obsolete because of several provisions in the special legislative acts such as Water Framework Directive, Ambient Air Quality Directive, Waste Framework Directive. Amendment 280 Andrea Wechsler, Christian Ehler, Jens Gieseke, Angelika Niebler, Oliver Schenk, Norbert Lins, Zala Černilec Tomašič, Peter Liese, Wouter Beke Proposal for a directive Article 2 – paragraph 1 – point 1 c (new) Directive 2010/75/EU Article 15 – paragraph 7 Present text Amendment (1c) in Article 15, paragraph 7 is replaced by the following: 7. By way of derogation from paragraphs 3 and 4, and provided that no significant pollution is caused and all measures resulting in less pollution have been exhausted, the competent authority may set less strict emission limit values or environmental performance limit values in the event of a crisis due to extraordinary circumstances beyond the control of the operator and Member States, leading to a severe disruption or shortage of: (a) energy supplies, provided that there is an overriding public interest in security of ‘7. By way of derogation from paragraphs 3 and 4, the competent authority may set less strict emission limit values in the event of a crisis due to extraordinary circumstances beyond the control of the operator and Member States, leading to a severe disruption or shortage of: (a) energy supplies, provided that there is an overriding public interest in security of energy supply; (b) resources, materials or equipment essential for the operator to perform activities of public interest, in compliance with the applicable emission PE791.123v02-00 16/158 AM\1348825EN.docx EN energy supply; (b) resources, materials or equipment essential for the operator to perform activities of public interest, in compliance with the applicable emission limit values or environmental performance limit values; or (c) essential resources, materials or equipment where the production output compensates for such shortage or disruption, for reasons of public health or public safety or for other imperative reasons of overriding public interest. The derogation shall not be granted for more than three months. If the reasons justifying the granting of a derogation persist, the derogation may be prolonged for a maximum period of three months. As soon as the supply conditions are restored or where there is an alternative to the energy supplies, resources, materials or equipment, the Member State shall ensure that the decision to set less strict emission limit values and environmental performance limit values ceases to have effect, and the installation shall comply with permit conditions set in accordance with paragraphs 3 and 4. The Member States shall take measures to ensure that emissions resulting from the derogation referred to in the first subparagraph are monitored. The competent authority shall make information on the derogation and the conditions imposed publicly available in accordance with Article 24 (2). The Commission may, where necessary, assess and further clarify, through guidance, the criteria to be taken into account for the appli cation of this paragraph. Member States shall notify the Commission of any derogation granted under this paragraph, including the reasons justifying the granting of the derogation and the conditions imposed. The Commission shall assess whether the derogation granted is justified having due regard to the criteria set in this paragraph. If the Commission raises objections within 2 months of the notification by the Member limit values; or (c) essential resources, materials or equipment where the production output compensates for such shortage or disruption, for reasons of public health or public safety or for other imperative reasons of overriding public interest. The derogation shall not be granted for more than six months. If the reasons justifying the granting of a derogation persist, the derogation may be prolonged for a maximum period of six months. As soon as the supply conditions are restored or where there is an alternative to the energy supplies, resources, materials or equipment, the Member State shall ensure that the decision to set less strict emission limit values ceases to have effect, and the installation shall comply with permit conditions set in accordance with paragraphs 3 and 4. The Member States shall take measures to ensure that emissions resulting from the derogation referred to in the first subparagraph are monitored. The competent authority shall make information on the derogation and the conditions imposed publicly available in accordance with Article 24 (2). The Commission may, where necessary, assess and further clarify, through guidance, the criteria to be taken into account for the appli cation of this paragraph. Member States shall notify the Commission of any derogation granted under this paragraph, including the reasons justifying the granting of the derogation and the conditions imposed. ’; AM\1348825EN.docx 17/158 PE791.123v02-00 EN State, the Member States shall without delay revise the derogation accordingly. Or. en (https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A02010L0075-20240804) Justification The amendment ensures that crisis derogations are workable in extraordinary circumstances affecting energy supply, critical resources or activities of public interest. Extending the time limits provides greater operational realism, while maintaining monitoring, transparency and notification requirements and ensuring that derogations cease once supply conditions are restored. Amendment 281 Alexander Bernhuber Proposal for a directive Article 2 – paragraph 1 – point 1 d (new) Directive 2010/75/EU Article 15 – paragraph 7 Present text Amendment (1d) in Article 15, paragraph 7 is replaced by the following: 7. By way of derogation from paragraphs 3 and 4, and provided that no significant pollution is caused and all measures resulting in less pollution have been exhausted, the competent authority may set less strict emission limit values or environmental performance limit values in the event of a crisis due to extraordinary circumstances beyond the control of the operator and Member States, leading to a severe disruption or shortage of: ‘7. By way of derogation from paragraph 3, and provided that no significant pollution is caused and all measures resulting in less pollution have been exhausted, the competent authority may set less strict emission limit values in the event of a crisis due to extraordinary circumstances beyond the control of the operator and Member States, leading to a severe disruption or shortage of: (a) energy supplies, provided that there is an overriding public interest in security of energy supply; (a) energy supplies, provided that there is an overriding public interest in security of energy supply; (b) resources, materials or equipment essential for the operator to perform activities of public interest, in compliance with the applicable emission limit values or (b) resources, materials or equipment essential for the operator to perform activities of public interest, in compliance with the applicable emission limit values or PE791.123v02-00 18/158 AM\1348825EN.docx EN environmental performance limit values; or (c) essential resources, materials or equipment where the production output compensates for such shortage or disruption, for reasons of public health or public safety or for other imperative reasons of overriding public interest. (c) essential resources, materials or equipment where the production output compensates for such shortage or disruption, for reasons of public health or public safety or for other imperative reasons of overriding public interest. The derogation shall not be granted for more than three months. If the reasons justifying the granting of a derogation persist, the derogation may be prolonged for a maximum period of three months. The derogation shall not be granted for more than three months. If the reasons justifying the granting of a derogation persist, the derogation may be prolonged for a maximum period of three months. As soon as the supply conditions are restored or where there is an alternative to the energy supplies, resources, materials or equipment, the Member State shall ensure that the decision to set less strict emission limit values and environmental performance limit values ceases to have effect, and the installation shall comply with permit conditions set in accordance with paragraphs 3 and 4. As soon as the supply conditions are restored or where there is an alternative to the energy supplies, resources, materials or equipment, the Member State shall ensure that the decision to set less strict emission limit values ceases to have effect, and the installation shall comply with permit conditions set in accordance with paragraph 3. The Member States shall take measures to ensure that emissions resulting from the derogation referred to in the first subparagraph are monitored. The Member States shall take measures to ensure that emissions resulting from the derogation referred to in the first subparagraph are monitored. The competent authority shall make information on the derogation and the conditions imposed publicly available in accordance with Article 24 (2). The competent authority shall make information on the derogation and the conditions imposed publicly available in accordance with Article 24 (2). The Commission may, where necessary, assess and further clarify, through guidance, the criteria to be taken into account for the application of this paragraph. The Commission may, where necessary, assess and further clarify, through guidance, the criteria to be taken into account for the application of this paragraph. Member States shall notify the Commission of any derogation granted under this paragraph, including the reasons justifying the granting of the derogation and the conditions imposed.’; Member States shall notify the Commission of any derogation granted under this paragraph, including the reasons justifying the granting of the derogation and the conditions imposed. AM\1348825EN.docx 19/158 PE791.123v02-00 EN Or. en (2010/75/EU) Justification AEPLs are obsolete because of several provisions in the special legislative acts such as Water Framework Directive, Ambient Air Quality Directive, Waste Framework Directive. Amendment 282 Jeannette Baljeu, Andreas Glück, Ilhan Kyuchyuk Proposal for a directive Article 2 – paragraph 1 – point 1 a (new) Directive 2010/75/EU Article 15 – paragraph 7 a (new) Text proposed by the Commission Amendment (1a) in Article 15, the following paragraph is inserted: ‘7a. For the purposes of paragraph 7, activities, investments or production outputs necessary for defence readiness, defence-critical production, the secure supply of ammunition, munitions, military equipment, or other defence-critical materials, or the protection of national security may be considered to serve public safety or imperative reasons of overriding public interest, where the conditions set out in that paragraph are fulfilled.’; Or. en Justification Derogations already exist in Union environmental legislation on grounds such as overriding public interest, public safety or crisis situations. In the current security environment, it should be clear that such grounds may also cover defence readiness activities and investments, including the continuity of defence-critical production and the secure supply of ammunition, munitions, military equipment and other essential materials. This amendment clarifies the application of the existing IED crisis derogation to defence-related situations, without creating a general exemption from the Directive and while maintaining the existing safeguards on pollution prevention, proportionality and time limitation. PE791.123v02-00 20/158 AM\1348825EN.docx EN Amendment 283 Daniel Buda Proposal for a directive Article 2 – paragraph 1 – point 1 b (new) Directive 2010/75/EU Article 16 – paragraph 2 Present text Amendment (1b) In Article 16, paragraph 2 is replaced by the following: 2. The frequency of the periodic monitoring referred to in Article 14(1), point (e), shall be determined by the competent authority in a permit for each individual installation or in general binding rules. 2. The frequency of the periodic monitoring referred to in Article 14(1), point (e), shall be determined by the competent authority in general binding rules. Monitoring requirements may be replaced by equivalent monitoring or technical measures ensuring an equivalent level of environmental protection. The monitoring frequency may be reduced if the emission levels are proven to be sufficiently stable. Without prejudice to the first subparagraph, periodic monitoring shall be carried out as set out in the BAT conclusions, where applicable, and at least once every 4 years for groundwater and 9 years for soil, unless such monitoring is based on a systematic appraisal of the risk of contamination. Without prejudice to the first subparagraph, periodic monitoring shall be carried out as set out in the BAT conclusions, where applicable, and at least once every 4 years for groundwater and 9 years for soil, unless such monitoring is based on a systematic appraisal of the risk of contamination.’; Or. en Justification Installations experience huge increases in monitoring requirements being introduced in the BAT conclusions, which result in large administrative burdens with no real environmental effect. The environmental authorities do not have possibilities to alter the frequency of the monitoring or approve alternative methods for measurements and monitoring. Amendment 284 Jessica Polfjärd AM\1348825EN.docx 21/158 PE791.123v02-00 EN Proposal for a directive Article 2 – paragraph 1 – point 1 a (new) Directive (EU) 2010/75/EU Article 16 – paragraph 2 Present text Amendment (1a) in Article 16, paragraph 2 is replaced by the following: 2. The frequency of the periodic monitoring referred to in Article 14(1), point (e), shall be determined by the competent authority in a permit for each individual installation or in general binding rules. ‘2. The frequency of the periodic monitoring referred to in Article 14(1), point (e), shall be determined by the competent authority in general binding rules. Monitoring requirements may be replaced by equivalent monitoring or technical measures ensuring an equivalent level of environmental protection. The monitoring frequency may be reduced if the emission levels are proven to be sufficiently stable. Without prejudice to the first subparagraph, periodic monitoring shall be carried out as set out in the BAT conclusions, where applicable, and at least once every 4 years for groundwater and 9 years for soil, unless such monitoring is based on a systematic appraisal of the risk of contamination. Without prejudice to the first subparagraph, periodic monitoring shall be carried out as set out in the BAT conclusions, where applicable, and at least once every 4 years for groundwater and 9 years for soil, unless such monitoring is based on a systematic appraisal of the risk of contamination.’; Or. en (02010L0075-20240804) Amendment 285 François-Xavier Bellamy, Céline Imart Proposal for a directive Article 2 – paragraph 1 – point 1 c (new) Directive 2010/75/EU Article 16 – paragraph 2 PE791.123v02-00 22/158 AM\1348825EN.docx EN Present text Amendment (1c) In Article 16, paragraph 2 is replaced by the following: 2. The frequency of the periodic monitoring referred to in Article 14(1), point (e), shall be determined by the competent authority in a permit for each individual installation or in general binding rules. ‘2. The frequency of the periodic monitoring referred to in Article 14(1), point (e), shall be determined by the competent authority in general binding rules. Monitoring requirements may be replaced by equivalent monitoring measures or technical measures ensuring an equivalent level of environmental protection. The monitoring frequency may be reduced if the emission levels are proven to be sufficiently stable. Without prejudice to the first subparagraph, periodic monitoring shall be carried out as set out in the BAT conclusions, where applicable, and at least once every 4 years for groundwater and 9 years for soil, unless such monitoring is based on a systematic appraisal of the risk of contamination. Without prejudice to the first subparagraph, periodic monitoring shall be carried out as set out in the BAT conclusions, where applicable, and at least once every 4 years for groundwater and 9 years for soil, unless such monitoring is based on a systematic appraisal of the risk of contamination.’ Or. fr Amendment 286 Ondřej Knotek, Jana Nagyová, Antonín Staněk, Anne-Sophie Frigout Proposal for a directive Article 2 – paragraph 1 – point 1 b (new) Directive 2010/75/EU Article 16 – paragraph 4 Present text Amendment (1b) in Article 16, paragraph 4 is replaced by the following: 4. Where the assessment referred to in Article 15(5) demonstrates that the derogation will have a quantifiable or measurable effect on the environment, ‘4. Where the assessment referred to in Article 15(5) demonstrates that the derogation will have a measurable and significant effect on the environment, AM\1348825EN.docx 23/158 PE791.123v02-00 EN Member States shall ensure that the concentration of the pollutants concerned is monitored in the receiving environment. Where relevant, monitoring and measuring methods for each pollutant concerned which are set out in other relevant Union legislation shall be used for the purpose of the monitoring referred to in this paragraph. Member States shall ensure that the concentration of the pollutants concerned is monitored in the receiving environment. Where relevant, monitoring and measuring methods for each pollutant concerned which are set out in other relevant Union legislation shall be used for the purpose of the monitoring referred to in this paragraph.’; Or. en (Directive (EU) 2024/1785, amending Directive 2010/75/EU) Justification If a technical study identifies only a negligible contribution, for example to the existing background pollution, there is no need to introduce monitoring of the pollutant concerned in the receiving environment. Amendment 287 Andrea Wechsler, Christian Ehler, Jens Gieseke, Angelika Niebler, Oliver Schenk, Norbert Lins, Zala Černilec Tomašič, Peter Liese, Wouter Beke Proposal for a directive Article 2 – paragraph 1 – point 1 d (new) Directive 2010/75/EU Article 18 Present text Amendment (1d) Article 18 is replaced by the following: Environmental quality standards Where an environmental quality standard requires stricter conditions than those achievable by the use of the best available techniques, additional measures shall be included in the permit, with a view to reducing the specific contribution of the installation to the pollution occurring in the relevant area, without prejudice to other measures which may be taken to comply with environmental quality standards. Where stricter conditions have been included in the permit in accordance with the first paragraph, the competent authority shall ‘Environmental quality standards Where an environmental quality standard requires stricter conditions than those achievable by the use of the best available techniques, additional measures may be included in the permit, without prejudice to other measures which may be taken to comply with environmental quality standards.’ PE791.123v02-00 24/158 AM\1348825EN.docx EN assess the impact of the stricter conditions on the concentration of the pollutants concerned in the receiving environment. Where the load of pollutants emitted by the installation has a quan tifiable or measurable effect on the environment, Member States shall ensure that the concentration of the pollutants concerned in the receiving environment is monitored. The results of such monitoring shall be transmitted to the competent authority. Where monitoring and measurement methods for the pollutants concerned are set out in other relevant Union legislation, such methods, including effect-based methods as appropriate, shall be used for the purpose of the monitoring referred to in the third paragraph. Or. en (https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A02010L0075-20240804) Justification The amendment ensures a more proportionate application of additional permit conditions where environmental quality standards require stricter measures than those achievable through BAT. It avoids automatic additional burdens where other measures may be more effective. Amendment 288 Ondřej Knotek, Jana Nagyová, Antonín Staněk, Anne-Sophie Frigout Proposal for a directive Article 2 – paragraph 1 – point 1 c (new) Directive 2010/75/EU Article 18 Present text Amendment (1c). Article 18 is replaced by the following: Article 18 ‘Article 18 Environmental quality standards Environmental quality standards AM\1348825EN.docx 25/158 PE791.123v02-00 EN Where an environmental quality standard requires stricter conditions than those achievable by the use of the best available techniques, additional measures shall be included in the permit, with a view to reducing the specific contribution of the installation to the pollution occurring in the relevant area, without prejudice to other measures which may be taken to comply with environmental quality standards. Where an environmental quality standard requires stricter conditions than those achievable by the use of the best available techniques, additional measures may be included in the permit, without prejudice to other measures which may be taken to comply with environmental quality standards.’; Where stricter conditions have been included in the permit in accordance with the first paragraph, the competent authority shall assess the impact of the stricter conditions on the concentration of the pollutants concerned in the receiving environment. Where the load of pollutants emitted by the installation has a quantifiable or measurable effect on the environment, Member States shall ensure that the concentration of the pollutants concerned in the receiving environment is monitored. The results of such monitoring shall be transmitted to the competent authority. Or. en (Directive (EU) 2024/1785, amending Directive 2010/75/EU) Amendment 289 Sergio Berlato, Michele Picaro, Pietro Fiocchi, Stefano Cavedagna, Nicola Procaccini, Antonella Sberna, Paolo Inselvini Proposal for a directive Article 2 – paragraph 1- point 1 b (new) Directive 2010/75/EU Article 18 Present text Amendment (1b) Article 18 is replaced by the following: PE791.123v02-00 26/158 AM\1348825EN.docx EN Where an environmental quality standard requires stricter condi tions than those achievable by the use of the best available tech niques, additional measures shall be included in the permit, without prejudice to other measures which may be taken to com ply with environmental quality standards. ‘Following the failure to achieve an environmental quality standard, the competent authority shall consider including additional conditions in the authorisation to reduce the specific contribution of the installation to pollution occurring in the relevant area, without prejudice to other measures that may be taken to comply with environmental quality standards and taking into account the technical- economic feasibility of such additional conditions. Where stricter conditions have been included in the permit in accordance with the first paragraph, the competent authority shall assess the impact of the stricter conditions on the concentration of the pollutants concerned in the receiving environment. Where the load of pollutants emitted by the installation has a quantifiable or measurable effect on the environment, Member States shall ensure that the concentration of the pollutants concerned in the receiving environment is monitored. The results of such monitoring shall be transmitted to the competent authority. Where monitoring and measurement methods for the pollutants concerned are set out in other relevant Union legislation, such methods, including effect-based methods as appropriate, shall be used for the purpose of the monitoring referred to in the third paragraph.’; Or. en (https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32010L0075) Amendment 290 Carmen Crespo Díaz, Dolors Montserrat Proposal for a directive Article 2 – paragraph 1 – point 1 a (new) AM\1348825EN.docx 27/158 PE791.123v02-00 EN Directive 2010/75/EU Article 20 – paragraph 2 – subparagraph 3 (new) Text proposed by the Commission Amendment (1a) In Article 20(2), the following subparagraph is added: ‘Member States shall establish shortened procedures for updating permits in the case of substantial changes to installations that have positive environmental impacts.’ Or. es Justification Member States should provide for fast-track procedures for installations that provide for substantial changes with the aim of improving their environmental performance. Amendment 291 Elżbieta Katarzyna Łukacijewska, Krzysztof Hetman Proposal for a directive Article 2 – paragraph 1 – point 1 c (new) Directive 2010/75/EU Article 21 – paragraph 3 a (new) Text proposed by the Commission Amendment (1c) in Article 21, the following paragraph is inserted: 3a. For installations for which a decommissioning date has been set by law, the obligation to update the permit referred to in paragraph 3 shall not apply, provided that the remaining operating period is limited and that the competent authority considers that such update would be disproportionate in view of the remaining lifetime of the installation and the expected environmental benefits. Or. en PE791.123v02-00 28/158 AM\1348825EN.docx EN Justification For installations with a statutory closure date, full permit updates and related retrofits may be disproportionate where they would deliver only limited environmental benefits during the remaining operating period. A targeted clause would reduce unnecessary burden while preserving the competent authority’s assessment role. Amendment 292 François-Xavier Bellamy Proposal for a directive Article 2 – paragraph 1 – point 1 c (new) Directive 2010/75/EU Article 21 – paragraph 3 – introductory part Text proposed by the Commission Amendment (1c) In Article 21(3), the introductory part is replaced by the following: 3. Within 4 years of publication of decisions on BAT conclusions in accordance with Article 13(5) relating to the main activity of an installation, the competent authority shall ensure that: ‘3. Within 8 years of publication of decisions on BAT conclusions in accordance with Article 13(5) relating to the main activity of an installation, the competent authority shall ensure that:’ Or. fr Amendment 293 Sergio Berlato, Michele Picaro, Pietro Fiocchi, Stefano Cavedagna, Nicola Procaccini, Antonella Sberna, Paolo Inselvini Proposal for a directive Article 2 – paragraph 1 – point 1 c (new) Directive 2010/75/EU Article 21 – paragraph 3 Present text Amendment (1c) in Article 21, paragraph 3 is replaced by the following: 3. Within 4 years of publication of decisions on BAT conclusions in accordance with Article 13(5) relating to ‘3. Within 8 years of publication of decisions on BAT conclusions in accordance with Article 13(5) relating to AM\1348825EN.docx 29/158 PE791.123v02-00 EN the main activity of an installation, the competent authority shall ensure that: the main activity of an installation, the competent authority shall ensure that:’ (a) all the permit conditions for the installation concerned are reconsidered and, if necessary, updated to ensure compliance with this Directive, in particular, with Article 15(3), (4) and (5), where applicable; (a) all the permit conditions for the installation concerned are reconsidered and, if necessary, updated to ensure compliance with this Directive, in particular, with Article 15(3) and (4), where applicable; (b) the installation complies with those permit conditions. (b) the installation complies with those permit conditions. The reconsideration shall take into account all the new or updated BAT conclusions applicable to the installation and adopted in accordance with Article 13(5) since the permit was granted or last reconsidered. The reconsideration shall take into account all the new or updated BAT conclusions applicable to the installation and adopted in accordance with Article 13(5) since the permit was granted or last reconsidered." Or. en (https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32010L0075) Amendment 294 Ondřej Knotek, Jana Nagyová, Antonín Staněk, Anne-Sophie Frigout, Viktória Ferenc Proposal for a directive Article 2 – paragraph 1 – point 1a (new) Directive 2010/75/EU Article 21 – paragraph 3 Present text Amendment (1a) in Article 21, paragraph 3 is replaced by the following: 3. Within 4 years of publication of decisions on BAT conclusions in accordance with Article 13(5) relating to the main activity of an installation, the competent authority shall ensure that: ‘3. Within 8 years of publication of decisions on BAT conclusions in accordance with Article 13(5) relating to the main activity of an installation, the competent authority shall ensure that: (a) all the permit conditions for the installation concerned are reconsidered and, if necessary, updated to ensure compliance with this Directive, in particular, with Article 15(3), (4) and (5), where applicable; (a) all the permit conditions for the installation concerned are reconsidered and, if necessary, updated to ensure compliance with this Directive, in particular, with Article 15(3) and (5), where applicable; PE791.123v02-00 30/158 AM\1348825EN.docx EN (b) the installation complies with those permit conditions. (b) the installation complies with those permit conditions. The reconsideration shall take into account all the new or updated BAT conclusions applicable to the installation and adopted in accordance with Article 13(5) since the permit was granted or last reconsidered. The reconsideration shall take into account all the new or updated BAT conclusions applicable to the installation and adopted in accordance with Article 13(5) since the permit was granted or last reconsidered.’ Or. en (Directive (EU) 2024/1785, amending Directive 2010/75/EU) Amendment 295 Sergio Berlato, Michele Picaro, Pietro Fiocchi, Stefano Cavedagna, Nicola Procaccini, Antonella Sberna, Paolo Inselvini Proposal for a directive Article 2 – paragraph 1 – point 1 d (new) Directive 2010/75/EU Article 21 – paragraph 5 Present text Amendment (1d) In Article 21, paragraph 5 is replaced by the following: 5. The permit conditions shall be reconsidered and, where necessary, updated at least in the following cases: ‘"5. The permit conditions shall be reconsidered and, where necessary, updated at least in the following cases : (a) the pollution caused by the installation is of such significance that the existing emission limit values of the permit need to be revised or new such values need to be included in the permit; (a) the pollution caused by the installation is of such significance that the existing emission limit values of the permit need to be revised or new such values need to be included in the permit; (b) the operational safety requires other techniques to be use; (b) the operational safety requires other techniques to be use ; (c) where it is necessary to comply with an environmental quality standard referred to in Article 18, including in the case of a new or revised quality standard or where the status of the receiving environment requires a revision of the permit, in the context of the procedure referred to in Article 20 and Article 21, paragraph 3, in order to achieve compliance with plans (c) where it is necessary to comply with a new or revised environmental quality standard in accordance with Article 18.’ AM\1348825EN.docx 31/158 PE791.123v02-00 EN and programmes set under Union legislation; (d) in the case of a request from the operator to extend the duration of the operation of an installation undertaking the activity referred to in Annex I, point 5.4." Or. en (https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32010L0075) Amendment 296 Pietro Fiocchi Proposal for a directive Article 2 – paragraph 1 – point 1 d(new) Directive 2010/75/EU Article 24 – paragraph 1 – point d Present text Amendment (1d) in Article 24(1), point (d) is deleted; Or. en (https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A02010L0075- 20240804&qid=1783407411429) Justification Extending public participation to all procedures for adapting installations to the state of the art (BAT) is disproportionate. Existing permitting procedures already adequately incorporate public consultation for substantial changes. Generalising this obligation to all new permits resulting from IED reviews would significantly prolong permit delivery times. Amendment 297 Pietro Fiocchi Proposal for a directive Article 2 – paragraph 1 – point 1 e(new) Directive 2010/75/EU Article 24 – paragraph 1 – point e PE791.123v02-00 32/158 AM\1348825EN.docx EN Present text Amendment (1e) in Article 24(1), point (e) is deleted; Or. en (https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A02010L0075- 20240804&qid=1783407411429) Justification Extending public participation to all procedures for adapting installations to the state of the art (BAT) is disproportionate. Existing permitting procedures already adequately incorporate public consultation for substantial changes. Generalising this obligation to all new permits resulting from IED reviews would significantly prolong permit delivery times. Amendment 298 Elżbieta Katarzyna Łukacijewska, Krzysztof Hetman Proposal for a directive Article 2 – paragraph 1 – point 1d (new) Directive 2010/75/EU Article 24 – paragraph 2 – point a Present text Amendment 1 d. in Article 24(2), point (a) is replaced by the following: (a) the content of the decision, including a copy of the permit and any subsequent updates, including consolidated permit conditions where relevant; ‘(a) the content of the decision, including a copy of the permit and any subsequent updates;’; Or. en Justification The wording “including consolidated permit conditions where relevant” is unclear and may create additional administrative burden for competent authorities and operators. It should remain for competent authorities to decide whether consolidation is appropriate in a given case. Amendment 299 Anna Zalewska AM\1348825EN.docx 33/158 PE791.123v02-00 EN Proposal for a directive Article 2 – paragraph 1 – point 1 c (new) Directive 2010/75/EU Article 24 – paragraph 3 Present text Amendment (1c) in Article 24, paragraph 3 is replaced by the following: ‘3. The competent authority shall also make available to the public, including systematically via the internet, on a webpage which is easy to find, free of charge and without restricting access to registered users, the following:(a)relevant information on the measures taken by the operator upon definitive cessation of activities in accordance with Article 22;(b)the results of emission monitoring as required under the permit conditions and held by the competent authority;(c)the results of the monitoring referred to in Article 16(4) and in Article 18.’ ‘3. The competent authority shall ensure access to the following information, based on aggregated data:(a)relevant information on the measures taken by the operator upon definitive cessation of activities in accordance with Article 22;(b)the summary of emission monitoring as required under the permit conditions and held by the competent authority, excluding commercially confidential information;(c)the summary of the monitoring referred to in Article 16(4) and in Article 18.’ Or. en ((https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A02010L0075-20240804)) Amendment 300 Andrea Wechsler, Christian Ehler, Jens Gieseke, Angelika Niebler, Oliver Schenk, Norbert Lins, Zala Černilec Tomašič, Peter Liese, Wouter Beke Proposal for a directive Article 2 – paragraph 1 – point 1 e (new) Directive 2010/75/EU Article 27a – paragraph 3 – point g Present text Amendment (1e) in Article 27a(3), point (g) is deleted; Or. en (https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A02010L0075-20240804) PE791.123v02-00 34/158 AM\1348825EN.docx EN Justification The amendment streamlines the composition of the centre by focusing its assistance on public institutions, research bodies, industry, farmers, technology providers, Member States and the Commission. This strengthens technical and implementation-oriented expertise, reduces procedural complexity and supports the deployment of innovative and emerging techniques. Amendment 301 Ondřej Knotek, Jana Nagyová, Antonín Staněk, Anne-Sophie Frigout, Roman Haider, Viktória Ferenc Proposal for a directive Article 2 c– paragraph 1 – point 1b (new) Directive 2010/75/EU Article 27a – paragraph 3 – point g Present text Amendment " (1b) in Article 27a(3), point (g) is deleted; Or. en (Directive (EU) 2024/1785, amending Directive 2010/75/EU) Amendment 302 François-Xavier Bellamy, Céline Imart Proposal for a directive Article 2 – paragraph 1 – point 1 d (new) Directive 2010/75/EU Article 27a – paragraph 3 – point e Present text Amendment (1d) In Article 27a(3), point (e) is replaced by the following: (e) representatives of the industries and farmers concerned; ‘(e) representatives of the industries concerned;’ Or. fr Amendment 303 Ondřej Knotek, Jana Nagyová, Antonín Staněk, Anne-Sophie Frigout AM\1348825EN.docx 35/158 PE791.123v02-00 EN Proposal for a directive Article 2 d – paragraph 1 – point 1 d (new) Directive 2010/75/EU Article 27c Present text Amendment (1d) Article 27c is replaced by the following: Article 27c ‘Article 27c Emission levels and indicative environmental performance values associated with emerging techniques Emission levels and indicative environmental performance values associated with emerging techniques By way of derogation from Article 21(3), the competent authority may set: By way of derogation from Article 21(3), the competent authority may set: (a) emission limit values that ensure that, within 6 years of publication of a decision on BAT conclusions in accordance with Article 13(5) relating to the main activity of an installation, emissions do not, under normal operating conditions, exceed emission levels associated with emerging techniques as laid down in the decisions on BAT conclusions; (a) indicative emission limit values that ensure that, within 6 years of publication of a decision on BAT conclusions in accordance with Article 13(5) relating to the main activity of an installation, emissions do not, under normal operating conditions, exceed emission levels associated with emerging techniques as laid down in the decisions on BAT conclusions.’ (b) indicative environmental performance values consistent with the decisions on BAT conclusions. (b) indicative environmental performance values consistent with the decisions on BAT conclusions. Or. en (Directive (EU) 2024/1785, amending Directive 2010/75/EU) Amendment 304 Andrea Wechsler, Christian Ehler, Jens Gieseke, Angelika Niebler, Oliver Schenk, Norbert Lins, Zala Černilec Tomašič, Peter Liese, Wouter Beke Proposal for a directive Article 2 – paragraph 1 – point 1a (new) Directive 2010/75/EU Article 27c Present text Amendment PE791.123v02-00 36/158 AM\1348825EN.docx EN (1a) Article 27c is replaced by the following: Emission levels and indicative environmental performance values associated with emerging techniques By way of derogation from Article 21(3), the competent authority may set: ‘Emission levels and indicative environmental performance values associated with emerging techniques By way of derogation from Article 21(3), the competent authority may set: (a) emission limit values that ensure that, within 6 years of publication of a decision on BAT conclusions in accordance with Article 13(5) relating to the main activity of an installation, emissions do not, under normal operating conditions, exceed emission levels associ ated with emerging techniques as laid down in the decisions on BAT conclusions; (a) indicative emission limit values that ensure that, within 6 years of publication of a decision on BAT conclusions in accordance with Article 13(5) relating to the main activity of an installation, emissions do not, under normal operating conditions, exceed emission levels associ ated with emerging techniques as laid down in the decisions on BAT conclusions.’ (b) indicative environmental performance values consistent with the decisions on BAT conclusions. Or. en (https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A02010L0075-20240804) Justification The amendment ensures that emerging techniques are promoted as innovation pathways rather than converted prematurely into binding benchmarks. Indicative emission limit values provide flexibility for first-of-a-kind technologies, reduce investment risk and support industrial transformation. Amendment 305 Martin Günther, Sebastian Everding, Per Clausen Proposal for a directive Article 2 – paragraph 1 – point 2 Directive 2010/75/EU Article 27d Text proposed by the Commission Amendment (2) Article 27d is deleted; deleted Or. en AM\1348825EN.docx 37/158 PE791.123v02-00 EN Amendment 306 Jutta Paulus Proposal for a directive Article 2 – paragraph 1 – point 2 Directive 2010/75/EU Article 27d Text proposed by the Commission Amendment (2) Article 27d is deleted; (2) In Article 27d(3), the second subparagraph is replaced by the following: ‘Where elements of the transformation plans have already been developed in accordance with other Union legislation and are compliant with this Article, a reference may be made in the transformation plan to the relevant documents. By 1 July 2028, the Commission shall adopt an implementing act specifying the circumstances in which operators may consider that elements of the transformation plans are developed in accordance with other Union legislation and may therefore only include a reference in transformation plans to the relevant documents. That implementing act shall be adopted in accordance with the examination procedure referred to in Article 75(2).’; Or. en Amendment 307 Martin Günther, Sebastian Everding, Per Clausen Proposal for a directive Article 2 – paragraph 1 – point 3 Directive 2010/75/EU Article 27e Text proposed by the Commission Amendment PE791.123v02-00 38/158 AM\1348825EN.docx EN (3) Article 27e is amended as follows: deleted (a) in paragraph 1, first subparagraph, the introductory sentence is replaced by the following: ‘Without prejudice to Article 18, in the event of deep industrial transformation of the installation, the competent authority may extend the period for the installation to comply with the updated permit conditions referred to in Article 21(3) up to a total of eight years maximum, provided that:;’ ‘Without prejudice to Articles 18 and 22, in the event of deep industrial transformation consisting of the closure of an installation and its replacement by a new installation to be completed within eight years of publication of decisions on BAT conclusions, in accordance with Article 13(5), relating to the main activity of the existing installation, the competent authority may waive the obligation of updating the permit in accordance with Article 21(3), provided that all the following conditions are met:;’ Or. en Amendment 308 Jutta Paulus Proposal for a directive Article 2 – paragraph 1 – point 3 Directive 2010/75/EU Article 27e Text proposed by the Commission Amendment (3) Article 27e is amended as follows: deleted (a) in paragraph 1, first subparagraph, the introductory sentence is replaced by the following: ‘Without prejudice to Article 18, in the event of deep industrial transformation of the installation, the competent authority AM\1348825EN.docx 39/158 PE791.123v02-00 EN may extend the period for the installation to comply with the updated permit conditions referred to in Article 21(3) up to a total of eight years maximum, provided that:;’ ‘Without prejudice to Articles 18 and 22, in the event of deep industrial transformation consisting of the closure of an installation and its replacement by a new installation to be completed within eight years of publication of decisions on BAT conclusions, in accordance with Article 13(5), relating to the main activity of the existing installation, the competent authority may waive the obligation of updating the permit in accordance with Article 21(3), provided that all the following conditions are met:;’ Or. en Amendment 309 Ondřej Knotek, Jana Nagyová, Antonín Staněk, Anne-Sophie Frigout, Viktória Ferenc Proposal for a directive Article 2 – paragraph 1 – point 3 – point a Directive 2010/75/EU Article 27e – paragraph 1 – subparagraph 1 – introductory part Text proposed by the Commission Amendment Without prejudice to Article 18, in the event of deep industrial transformation of the installation, the competent authority may extend the period for the installation to comply with the updated permit conditions referred to in Article 21(3) up to a total of eight years maximum, provided that: Without prejudice to Article 18, in the event of deep industrial transformation of the installation, the competent authority may extend the period for the installation to comply with the updated permit conditions referred to in Article 21(3) up to a total of ten years maximum, provided that: Or. en Amendment 310 Anna Zalewska PE791.123v02-00 40/158 AM\1348825EN.docx EN Proposal for a directive Article 2 – paragraph 1 – point 3 – point a a (new) Directive 2010/75/EU Article 27e – paragraph 1 – subparagraph 3 (new) Text proposed by the Commission Amendment (aa) in paragraph 1, the following subparagraph is added: ‘The period referred to in the first subparagraph may be extended for such period as is strictly necessary, where compliance within eight years cannot reasonably be achieved due to the scale, technical complexity, investment cycle, construction schedule, permitting requirements, or dependency on enabling infrastructure of the deep industrial transformation provided that the delay is not attributable to circumstances within the operators control.’ Or. en Amendment 311 Ondřej Knotek, Jana Nagyová, Antonín Staněk, Anne-Sophie Frigout, Viktória Ferenc Proposal for a directive Article 2 – paragraph 1 – point 3 – point b Directive 2010/75/EU Article 27e – paragraph 2 – subparagraph 1 – introductory part Text proposed by the Commission Amendment Without prejudice to Articles 18 and 22, in the event of deep industrial transformation consisting of the closure of an installation and its replacement by a new installation to be completed within eight years of publication of decisions on BAT conclusions, in accordance with Article 13(5), relating to the main activity of the existing installation, the competent authority may waive the obligation of updating the permit in accordance with Without prejudice to Articles 18 and 22, in the event of deep industrial transformation consisting of the closure of an installation and its replacement by a new installation to be completed within ten years of publication of decisions on BAT conclusions, in accordance with Article 13(5), relating to the main activity of the existing installation, the competent authority may waive the obligation of updating the permit in accordance with AM\1348825EN.docx 41/158 PE791.123v02-00 EN Article 21(3), provided that all the following conditions are met: Article 21(3), provided that all the following conditions are met: Or. en Amendment 312 Jeannette Baljeu, Andreas Glück, Ilhan Kyuchyuk, Ana Vasconcelos, Katri Kulmuni Proposal for a directive Article 2 – paragraph 1 – point 3 – point b a (new) Directive 2010/75/EU Article 27e – paragraph 2a (new) Text proposed by the Commission Amendment (ba) the following paragraph is added: ‘2a. Where a deep industrial transformation referred to in paragraphs 1 or 2 is materially dependent on the timely availability of external enabling infrastructure that is outside the control of the operator, including hydrogen infrastructure, carbon dioxide transport or storage infrastructure, low-carbon electricity supply or electricity grid capacity, the competent authority may extend the period referred to in paragraph 1 up to a total of ten years. Such an extension may be granted only where the operator demonstrates that the transformation remains technically and economically credible, that the delay is primarily caused by the lack of such external enabling infrastructure, and that the installation will apply interim measures to prevent or, where that is not practicable, minimise emissions and other environmental impacts. The competent authority shall include appropriate milestones, monitoring requirements and review clauses in the permit. This paragraph shall be without prejudice to Articles 14, 15, 18 and 22 and shall not allow a deterioration of local environmental quality or compliance with PE791.123v02-00 42/158 AM\1348825EN.docx EN applicable environmental quality standards.’; Or. en Justification Deep decarbonisation of energy-intensive industry often depends on external infrastructure that operators cannot deliver alone, such as hydrogen networks, CO₂ infrastructure or sufficient electricity grid capacity. Operators should not be penalised for infrastructure delays outside their control, provided the transformation remains credible and interim safeguards are applied. Amendment 313 Jeannette Baljeu, Andreas Glück, Ilhan Kyuchyuk Proposal for a directive Article 2 – paragraph 1 – point 3 – point b b (new) Directive 2010/75/EU Article 27e – paragraph 2b (new) Text proposed by the Commission Amendment (bb) the following paragraph is inserted: ‘2b. For installations, or clearly separable parts of installations, whose purpose is linked to defence or national security, the competent authority may set emission limit values derogating from BAT- associated emission levels where strict application of those levels would demonstrably and directly affect essential security interests, operational defence readiness, or the continuity of defence- critical production. Any such derogation shall be limited to the specific pollutant, process and period for which it is strictly necessary, shall be reviewed regularly and shall be accompanied by proportionate alternative measures to prevent or, where that is not practicable, minimise emissions and other environmental impacts. Member States shall document the reasons for such AM\1348825EN.docx 43/158 PE791.123v02-00 EN derogation, without requiring the disclosure of classified information.’; Or. en Justification Certain defence-critical installations may face exceptional operational or security constraints. A narrowly framed possibility to derogate from BAT-associated emission levels is justified where strict application would directly affect essential security interests or operational defence readiness. This does not create a general exemption from the IED, but ensures that environmental requirements are applied in a way that remains compatible with national security, while maintaining safeguards for human health and the environment. Amendment 314 François-Xavier Bellamy, Céline Imart Proposal for a directive Article 2 – paragraph 1 – point 3 a (new) Directive 2010/75/EU Articles 70a, 70b, 70c, 70d, 70e, 70f, 70g, 70h, 70i Text proposed by the Commission Amendment (3a) Articles 70a, 70b, 70c, 70d, 70e, 70f, 70g, 70h and 70i are deleted. Or. fr Amendment 315 Daniel Buda Proposal for a directive Article 2 – paragraph 1 – point 3 a (new) Directive 2010/75/EU Articles 70a Text proposed by the Commission Amendment (3a) Article 70a is deleted Or. en PE791.123v02-00 44/158 AM\1348825EN.docx EN Justification Livestock farms should not be treated in the same way as industrial installations. Aggregating separate farms solely because they are geographically close or linked through economic or legal relationships risks bringing family farms and cooperative structures within the scope of the IED, even where individual holdings remain below the established thresholds. This approach does not reflect the actual environmental impact of each farm, creates legal uncertainty, discourages cooperation between farmers and imposes disproportionate administrative and compliance burdens without delivering corresponding environmental benefits. Therefore, livestock farming should be excluded from the scope of the IED. Amendment 316 François-Xavier Bellamy, Céline Imart Proposal for a directive Article 2 – paragraph 1 – point 3 a (new) Directive 2010/75/EU Article 70a Present text Amendment Article 70a (3a) Article 70a is deleted Or. en Amendment 317 Alexander Bernhuber Proposal for a directive Article 2 – paragraph 1 – point 3 a (new) Directive 2010/75/EU Article 70aa (new) Text proposed by the Commission Amendment (3a) the following article is inserted: ‘Article 70aa Overriding public interest Member States shall ensure that, in permitting procedures, as well as in the planning, construction and operation of livestock installations pursuant to Chapter VIa, including related infrastructures and installations, these activities are presumed AM\1348825EN.docx 45/158 PE791.123v02-00 EN to be in the overriding public interest, in particular serving food production, security of supply and sustainable agricultural management. Member States shall ensure that permitting procedures for such activities are conducted efficiently and without undue delay. Member States may, in duly justified individual cases, restrict the application of this paragraph to specific parts of their territory, specific categories of livestock installations or installations with specific technical characteristics. Member States shall inform the Commission of such restrictions and provide justification therefore.’; Or. en Justification Livestock farming makes an essential contribution to food production and security of supply in the Union. In a context of growing uncertainty and increasing requirements, maintaining a viable and sustainable production capacity is of particular importance.Classifying such activities as being in the overriding public interest strengthens legal certainty and enables more efficient procedures without undermining the objectives of Directive 2010/75/EU. It ensures an appropriate balance between environmental protection and food security. Amendment 318 Anne-Sophie Frigout, Valérie Deloge, Gilles Pennelle, Mathilde Androuët, Ondřej Knotek, Jana Nagyová, Antonín Staněk Proposal for a directive Article 2 – paragraph 1 – point 3 a (new) Directive 2010/75/EU Article 70b Text proposed by the Commission Amendment (3a) Article 70b is deleted. Or. fr PE791.123v02-00 46/158 AM\1348825EN.docx EN Justification Precise details on the aggregation rule introduced by the revision of the directive are not given at this stage and the rule is not suitable for livestock activities that are not industrial, when a company or group has numerous sites. The rule is a potential source of additional administrative complexity. Amendment 319 Anna Zalewska Proposal for a directive Article 2 – paragraph 1 – point 3 a (new) Directive 2010/75/EU Article 70b Present text Amendment (3a) Article 70b is deleted Or. en (https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A02010L0075-20240804) Amendment 320 Daniel Buda Proposal for a directive Article 2 – paragraph 1 – point 3 b (new) Directive 2010/75/EU Articles 70b Text proposed by the Commission Amendment (3b) Article 70b is deleted Or. en Justification Livestock farms should not be treated in the same way as industrial installations. Aggregating separate farms solely because they are geographically close or linked through economic or legal relationships risks bringing family farms and cooperative structures within the scope of the IED, even where individual holdings remain below the established thresholds. This approach does not reflect the actual environmental impact of each farm, creates legal uncertainty, discourages cooperation between farmers and imposes disproportionate AM\1348825EN.docx 47/158 PE791.123v02-00 EN administrative and compliance burdens without delivering corresponding environmental benefits. Therefore, livestock farming should be excluded from the scope of the IED. Amendment 321 Sergio Berlato, Michele Picaro, Pietro Fiocchi, Stefano Cavedagna, Nicola Procaccini, Antonella Sberna, Paolo Inselvini Proposal for a directive Article 2 – paragraph 1 – point 3 a (new) Directive 2010/75/EU Article 70 b Present text Amendment (3a) Article 70b is deleted; Or. it (https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=OJ:L_202401785) Amendment 322 Carmen Crespo Díaz, Dolors Montserrat Proposal for a directive Article 2 – paragraph 1 – point 3 a (new) Directive 2010/75/EU Article 70b – paragraph 1 Text proposed by the Commission Amendment (3a) In Article 70b, paragraph 1 is replaced by the following: Member States shall adopt measures to ensure that if two or more installations engaged in livestock rearing activities are located close to each other and if their operator is the same or if the installations are under the control of operators who are engaged in an economic or legal relationship, the competent authority may consider those installations to be a single unit for the purpose of calculating the capacity threshold referred to in Article 70a. Member States shall adopt measures to ensure that if two or more installations are engaged in livestock rearing activities, they are located very close to each other and if their operator is the same or they are under the control of operators who are engaged in an economic or legal relationship, the competent authority may consider those installations to be a single unit for the purpose of calculating the capacity threshold referred to in Article 70a. PE791.123v02-00 48/158 AM\1348825EN.docx EN Member States shall ensure that the rule referred to in the first subparagraph is not used to circumvent the obligations set out in this Directive. Member States shall ensure that the rule referred to in the first subparagraph is not used to circumvent the obligations set out in this Directive. Or. es Justification This amendment aims to make the wording of the Directive more precise and to give legal certainty to operators by clearly setting out the conditions for the application of the installation aggregation rule. It is also specified that installations must be ‘very’ close, which is a prerequisite for counting several installations as one. Otherwise, the distance between two pollution points would not justify the aggregation of installations from an environmental point of view. Amendment 323 Jessica Polfjärd Proposal for a directive Article 2 – paragraph 1 – point 3 a (new) Directive (EU) 2010/75/EU Article 70b – paragraph 1 – subparagraph 1 Present text Amendment (3a) in Article 70b(1), the first subparagraph is deleted; Or. en (02010L0075-20240804) Amendment 324 Michal Wiezik, Martin Hojsík Proposal for a directive Article 2 – paragraph 1 – point 3 a (new) Directive (EU) 2024/1785 Article 70b – paragraph 1 – subparagraph 1 Present text Amendment AM\1348825EN.docx 49/158 PE791.123v02-00 EN (3a) in Article 70(b)(1), the first subparagraph is replaced with the following: Member States shall adopt measures to ensure that if two or more installations engaged in livestock rearing activities are located close to each other and if their operator is the same or if the installations are under the control of operators who are engaged in an economic or legal relationship, the competent authority may consider those installations to be a single unit for the purpose of calculating the capacity threshold referred to in Article 70a. ‘Member States shall adopt measures to ensure that if two or more installations engaged in livestock rearing activities are located close to each other or at any part of the area of land which drains into waters of the respective catchment and contributes to its pollution, and if their operator is the same or if the installations are under the control of operators who are engaged in an economic or legal relationship, or are under the control of different operators but belong to the same company, the competent authority may consider those installations to be a single unit for the purpose of calculating the capacity threshold referred to in Article 70a.’ Or. en (Directive (EU) 2024/1785) Justification While the EC will prepare guidance in 2028 for MS on the criteria to consider, the basic act can still use more precision- in particular the term used in other part of the Directive is inserted ''or are under the control of different operators but belong to the same company''. In the EU region where citizens won a court case related to livestock pollution in 2025, large number of installations pertain to the same company. Company is having more control over the thresholds and redistribution of installations than individual operators and in order to prevent circumvention of this rule, and to target all the subjects which are relevant for an application of this rule, this wording might better encompass the existing realities. Amendment 325 Daniel Buda Proposal for a directive Article 2 – paragraph 1 – point 3 c (new) Directive 2010/75/EU Articles 70c Text proposed by the Commission Amendment PE791.123v02-00 50/158 AM\1348825EN.docx EN (3c) Article 70c is deleted; Or. en Justification Livestock farms should not be treated in the same way as industrial installations. Aggregating separate farms solely because they are geographically close or linked through economic or legal relationships risks bringing family farms and cooperative structures within the scope of the IED, even where individual holdings remain below the established thresholds. This approach does not reflect the actual environmental impact of each farm, creates legal uncertainty, discourages cooperation between farmers and imposes disproportionate administrative and compliance burdens without delivering corresponding environmental benefits. Therefore, livestock farming should be excluded from the scope of the IED. Amendment 326 François-Xavier Bellamy, Céline Imart Proposal for a directive Article 2 – paragraph 1 – point 3 b (new) Directive 2010/75/EU Article 70 c – paragraph 1 Present text Amendment (3b) In Article 70c, paragraph 1 is replaced by the following: Member States shall take the necessary measures to ensure that no installation falling within the scope of this Chapter operates without a permit or without being registered and that the operation of all installations within the scope of this Chapter complies with the uniform conditions for operating rules referred to in Article 70i. Member States shall take the necessary measures to ensure that no installation falling within the scope of this Chapter operates without a permit or without being registered and that the operation of all such installations complies with the uniform rules for operating conditions referred to in Article 70i. Member States may use any similar pre- existing procedure for the registration of installations in order to avoid creating an administrative burden. Member States may apply a permitting procedure to the intensive rearing of poultry and pigs: Member States may apply a permitting procedure to the rearing of poultry and pigs: (a) with more than 40 000 places for poultry; (a) with more than 40 000 places for poultry; AM\1348825EN.docx 51/158 PE791.123v02-00 EN (b) with more than 2 000 places for production pigs over 30 kg; or (b) with more than 2 000 places for production pigs (over 30 kg); (c) with more than 750 places for sows. (c) with more than 750 places for sows. Member States may include requirements for certain categories of installations falling within the scope of this Chapter in the general binding rules referred to in Article 6. Member States may include requirements for certain categories of installations falling within this Chapter in the general binding rules referred to in Article 6. Member States shall specify the procedure for registration or granting a permit in respect of installations falling within the scope of this Chapter. Those procedures shall include at least the information listed in paragraph 2. Member States shall specify the procedure for registration or permitting applicable to installations falling within this Chapter. Those procedures shall include, at a minimum, the information listed in paragraph 2. Or. fr Amendment 327 Anne-Sophie Frigout, Valérie Deloge, Gilles Pennelle, Mathilde Androuët, Ondřej Knotek, Jana Nagyová Proposal for a directive Article 2 – paragraph 1 – point 3 b (new) Directive 2010/75/EU Article 70c – paragraph 2 – point c Text proposed by the Commission Amendment (3b) In article 70c(2), point (c) is deleted; Or. fr Amendment 328 Alexander Bernhuber Proposal for a directive Article 2 – paragraph 1 – point 3 b (new) Directive 2010/75/EU Article 70c – paragraph 1 – subparagraph 1 Present text Amendment PE791.123v02-00 52/158 AM\1348825EN.docx EN (3b) in Article 70c(1), the first subparagraph is replaced by the following Member States shall take the necessary measures to ensure that no installation falling within the scope of this Chapter operates without a permit or without being registered and that the operation of all installations within the scope of this Chapter complies with the uniform conditions for operating rules referred to in Article 70i. ‘Member States shall take the necessary measures to ensure that no installation falling within the scope of this Chapter operates without a permit or without being registered and that the operation of all installations within the scope of this Chapter complies with the uniform conditions for operating rules referred to in Article 70i. This obligation shall apply only to installations newly constructed after the entry into force of this Chapter.’; Or. en (Directive 2010/75/EU) Amendment 329 Alexander Bernhuber Proposal for a directive Article 2 – paragraph 1 – point 3 c (new) Directive 2010/75/EU Article 70c – paragraph 1 – subparagraph 3 Present text Amendment (3c) in Article 70c(1), the third subparagraph is deleted; Or. en (Directive 2010/75/EU) Amendment 330 Daniel Buda Proposal for a directive Article 2 – paragraph 1 – point 3 d (new) Directive 2010/75/EU Article 70d Text proposed by the Commission Amendment AM\1348825EN.docx 53/158 PE791.123v02-00 EN (3d) Article 70d is deleted; Or. en Justification Livestock farms should not be treated in the same way as industrial installations. Aggregating separate farms solely because they are geographically close or linked through economic or legal relationships risks bringing family farms and cooperative structures within the scope of the IED, even where individual holdings remain below the established thresholds. This approach does not reflect the actual environmental impact of each farm, creates legal uncertainty, discourages cooperation between farmers and imposes disproportionate administrative and compliance burdens without delivering corresponding environmental benefits. Therefore, livestock farming should be excluded from the scope of the IED. Amendment 331 Anne-Sophie Frigout, Valérie Deloge, Gilles Pennelle, Mathilde Androuët, Ondřej Knotek, Jana Nagyová, Antonín Staněk Proposal for a directive Article 2 – paragraph 1 – point 3 c (new) Directive 2010/75/EU Article 70d Text proposed by the Commission Amendment (3c) Article 70d is deleted; Or. fr Justification Given the reporting obligations already introduced by the Emissions Portal Regulation, this obligation seems redundant. Amendment 332 François-Xavier Bellamy, Céline Imart Proposal for a directive Article 2 – paragraph 1 – point 3 c (new) PE791.123v02-00 54/158 AM\1348825EN.docx EN Directive 2010/75/EU Article 70d Present text Amendment (3b) In Directive (EU) 2010/75, Article 70d is amended as follows: 1. Member States shall ensure that the operator carries out monitoring of emissions and of associated environmental performance levels in accordance with the uniform conditions for operating rules referred to in Article 70i. Member States shall ensure that the operator monitors emissions and associated environmental performance levels in accordance with the uniform operating rules referred to in Article 70i. Monitoring data shall be obtained by means of measurement methods or, where not practicable, by calculation methods such as the use of emission factors. The methods used for obtaining the monitoring data shall be described in the operating rules. Monitoring data shall be obtained by means of measurement methods or by calculation methods, including the use of emission factors. The methods used for obtaining the monitoring data shall be described in the operating rules. 2. In the event of non-compliance with the emission limit values and environmental performance limit values set out in the uniform conditions for operating rules referred to in Article 70i, Member States shall require the operator to take the measures necessary to ensure that compliance is restored within the shortest possible time. In the event of non-compliance with the emission limit values and environmental performance limit values set out in the uniform operating rules, Member States shall require the operator to take the measures necessary to ensure that compliance is restored within a compatible timeframe, taking account of the specificities of the agricultural sector. Or. fr Amendment 333 Michal Wiezik, Martin Hojsík Proposal for a directive Article 2 – paragraph 1 – point 3 b (new) Directive 2010/75/EU Article 70d – paragraph 3 a (new) Text proposed by the Commission Amendment (3b) in Article 70(d), the following paragraph is added: ‘3a. Member States may use the data on the use of veterinary antimicrobial medicinal products for which data on use AM\1348825EN.docx 55/158 PE791.123v02-00 EN shall be collected from data providers in accordance with Commission Delegated Regulation (EU) 2021/578 supplementing Regulation (EU) 2019/6, including from farmers, when selecting representative monitoring stations for the purpose of monitoring indicators of antimicrobial resistance on groundwater and surface water watch list in accordance with Directive (EU) 2026 /805. Where a monitoring station for indicators of antimicrobial resistance is located in the vicinity of a livestock installation covered by this Directive where this has a potential to affect the quality of water relevant for the monitoring in question, the respective operator of the livestock installation shall be given prior notice. The respective monitoring of indicators present on the surface and groundwater watch list comes at a no cost to the operator.’; Or. en Amendment 334 Anne-Sophie Frigout, Valérie Deloge, Gilles Pennelle, Mathilde Androuët, Ondřej Knotek, Jana Nagyová Proposal for a directive Article 2 – paragraph 1 – point 3 d (new) Directive 2010/75/EU Article 70d Text proposed by the Commission Amendment (3d) Article 70d is amended as follows: (a) the third subparagraph of paragraph 1 is deleted; (b) paragraph 2 is replaced by the following: ‘2. In the event of non-compliance with the emission values and environmental performance limit values set out in the uniform conditions for operating rules PE791.123v02-00 56/158 AM\1348825EN.docx EN referred to in Article 70i, Member States shall require the operator to take the measures necessary to ensure that compliance is restored within deadlines compatible with the specificities of the agricultural sector.’ Or. fr Justification Livestock farming is based on biological cycles. Unlike the industrial sector, adjustments are constrained by unavoidable time factors. If limit values are exceeded as a result of production factors that are already in place (genetic type, working methods, production system, etc.), lowering those values may require an adaptation time that is considerably different from ‘simple’ technological adjustments. Amendment 335 Daniel Buda Proposal for a directive Article 2 – paragraph 1 – point 3 e (new) Directive 2010/75/EU Articles 70e Text proposed by the Commission Amendment Article 70e (3e) Article 70e is deleted Or. en Justification Livestock farms should not be treated in the same way as industrial installations. Aggregating separate farms solely because they are geographically close or linked through economic or legal relationships risks bringing family farms and cooperative structures within the scope of the IED, even where individual holdings remain below the established thresholds. This approach does not reflect the actual environmental impact of each farm, creates legal uncertainty, discourages cooperation between farmers and imposes disproportionate administrative and compliance burdens without delivering corresponding environmental benefits. Therefore, livestock farming should be excluded from the scope of the IED. Amendment 336 François-Xavier Bellamy, Céline Imart AM\1348825EN.docx 57/158 PE791.123v02-00 EN Proposal for a directive Article 2 – paragraph 1 – point 3 d (new) Directive 2010/75/EU Article 70e Present text Amendment (3d) Article 70e is replaced by the following: 1.Member States shall ensure that suitable monitoring is carried out in accordance with the uniform conditions for operating rules referred to in Article 70i. 1. Member States shall ensure that suitable monitoring is carried out in accordance with the uniform operating rules referred to in Article 70i. 2.All monitoring results shall be recorded, processed and presented in such a way as to enable the competent authority to verify compliance with the operating conditions, emission limit values and environmental performance limit values which are included in the general binding rules referred to in Article 6 or in the permit. 2. All monitoring results shall be recorded, processed and presented in such a way as to enable the competent authority to verify compliance with the operating conditions, emission limit value ranges and environmental performance limit values which are set in the general binding rules referred to in Article 6 or in the permit. 3.The operator shall, without delay, make available the data and information listed in paragraph 2 to the competent authority upon request. The competent authority may make such a request in order to verify compliance with the uniform conditions for operating rules. The competent authority shall make that request if a member of the public requests access to the data or information listed in paragraph 2. 3. The operator shall make available the data and information referred to in paragraph 2 to the competent authority upon request. Or. fr Amendment 337 Anne-Sophie Frigout, Valérie Deloge, Gilles Pennelle, Mathilde Androuët, Ondřej Knotek, Jana Nagyová Proposal for a directive Article 2 – paragraph 1 – point 3 e (new) Directive 2010/75/EU Article 70e – paragraph 2 Present text Amendment PE791.123v02-00 58/158 AM\1348825EN.docx EN (3e) In Article 70e, paragraph 2 is replaced by the following: 2. All monitoring results shall be recorded, processed and presented in such a way as to enable the competent authority to verify compliance with the operating conditions, emission limit values and environmental performance limit values which are included in the general binding rules referred to in Article 6 or in the permit. ‘2. All monitoring results shall be recorded, processed, and presented in such a way as to enable the competent authority to verify compliance with the operating conditions, emission limit values and environmental performance limit value ranges which are included in the general binding rules referred to in Article 6 or in the permit.’ Or. fr (DIRECTIVE 2010/75/EU) Justification Disclosing sensitive data on operations at each facility can leave farmers seriously exposed. Only the competent authority responsible for controls should have access to this information. Allowing anyone, even without any standing, to request such disclosure appears to be wholly disproportionate. Amendment 338 Anne-Sophie Frigout, Valérie Deloge, Gilles Pennelle, Mathilde Androuët, Ondřej Knotek, Jana Nagyová Proposal for a directive Article 2 – paragraph 1 – point 3 f (new) Directive 2010/75/EU Article 70e – paragraph 3 Present text Amendment (3f) In Article 70e, paragraph 3 is replaced by the following: 3. The operator shall, without delay, make available the data and information listed in paragraph 2 to the competent authority upon request. The competent authority may make such a request in order to verify compliance with the uniform conditions for operating rules. The competent authority shall make that request if a member of the public requests access to the data or information listed in paragraph 2. ‘3. The operator shall make available the data and information listed in paragraph 2 to the competent authority upon request. The competent authority may make such a request in order to verify compliance with the uniform conditions for operating rules.’ AM\1348825EN.docx 59/158 PE791.123v02-00 EN Or. fr (DIRECTIVE 2010/75/EU) Justification Disclosing sensitive data on operations at each facility can leave farmers seriously exposed. Only the competent authority responsible for controls should have access to this information. Allowing anyone, even without any standing, to request such disclosure appears wholly disproportionate. Amendment 339 Daniel Buda Proposal for a directive Article 2 – paragraph 1 – point 3 f(new) Directive 2010/75/EU Articles 70f Text proposed by the Commission Amendment (3f) Article 70f is deleted Or. en Justification Livestock farms should not be treated in the same way as industrial installations. Aggregating separate farms solely because they are geographically close or linked through economic or legal relationships risks bringing family farms and cooperative structures within the scope of the IED, even where individual holdings remain below the established thresholds. This approach does not reflect the actual environmental impact of each farm, creates legal uncertainty, discourages cooperation between farmers and imposes disproportionate administrative and compliance burdens without delivering corresponding environmental benefits. Therefore, livestock farming should be excluded from the scope of the IED. Amendment 340 François-Xavier Bellamy, Céline Imart Proposal for a directive Article 2 – paragraph 1 – point 3 e (new) Directive 2010/75/EU Article 70f – paragraph 3 – subparagraph 1 Present text Amendment PE791.123v02-00 60/158 AM\1348825EN.docx EN (3e) In Article 70f(3), the first subparagraph is replaced by the following: 3. In the event of non-compliance with the requirements set out in this Chapter, Member States shall ensure that the competent authority requires the operator to take any measures, in addition to the measures taken by the operator under Article 70d, that are necessary to ensure that compliance is restored without delay. ‘3. In the event of non-compliance with the requirements set out in this Chapter, Member States shall ensure that the competent authority requires the operator to take any measures, in addition to the measures taken by the operator under Article 70d, that are necessary to ensure that compliance is restored within a reasonable deadline which takes account of the specificities of the sector.’ Or. fr Amendment 341 Anne-Sophie Frigout, Valérie Deloge, Gilles Pennelle, Mathilde Androuët, Ondřej Knotek, Jana Nagyová, Antonín Staněk Proposal for a directive Article 2 – paragraph 1 – point 3 g (new) Directive 2010/75/EU Article 70f – paragraph 3 – subparagraph 1 Present text Amendment (3g) In Article 70f, paragraph 3, the first subparagraph is replaced by the following: 3. In the event of non-compliance with the requirements set out in this Chapter, Member States shall ensure that the competent authority requires the operator to take any measures, in addition to the measures taken by the operator under Article 70d, that are necessary to ensure that compliance is restored without delay. ‘3. In the event of non-compliance with the requirements set out in this Chapter, Member States shall ensure that the competent authority requires the operator to take any measures, in addition to the measures taken by the operator under Article 70d, that are necessary to ensure that compliance is restored within a reasonable deadline which takes account of the specificities of the sector.’ Or. fr (DIRECTIVE 2010/75/EU) AM\1348825EN.docx 61/158 PE791.123v02-00 EN Amendment 342 Carmen Crespo Díaz, Dolors Montserrat Proposal for a directive Article 2 – paragraph 1 – point 3 b (new) Directive 2010/75/EU Article 70f – paragraph 3 – subparagraph 2 Present text Amendment (3b) In Article 70f, the second subparagraph of paragraph 3 is replaced by the following: Where non-compliance causes a significant degradation of local air, water or soil conditions, or where it poses, or risks posing, a significant danger to human health, the operation of the installation shall be suspended by the competent authority until compliance is restored. Where non-compliance causes a significant degradation of local air, water or soil conditions, or where it poses, or risks posing, a significant danger to human health, the competent authority may adopt relevant measures to ensure compliance, including suspending the operation of the installation until compliance is restored. Or. es Justification The Directive should provide for the possibility of not applying the suspension of activity directly in case of non-compliance. The avenues for cooperation between the administration and the company responsible should be exhausted before resorting to drastic measures. Amendment 343 François-Xavier Bellamy, Céline Imart Proposal for a directive Article 2 – paragraph 1 – point 3 f (new) Directive 2010/75/EU Article 70g Text proposed by the Commission Amendment (3f) Article 70g is replaced by the following: 1. Member States shall ensure that the public concerned are given early and effective opportunities to participate in the following procedures: ‘1. Member States shall ensure that the public directly concerned are given, at an early and effective stage, the opportunity to participate in the following procedures: PE791.123v02-00 62/158 AM\1348825EN.docx EN (a) preparation of general binding rules as referred to in Article 6 on permits for installations falling within the scope of this Chapter; (a) preparation of general binding rules as referred to in Article 6 on permits for installations falling within this Chapter; (b) the granting of a permit for a new installation falling within the scope of this Chapter; (b) the granting of a permit for a new installation; (c) the granting of an updated permit in accordance with Article 70c(4) for any substantial change to an existing installation falling within the scope of this Chapter; or (c) the granting of an updated permit in accordance with Article 70c(4) for any substantial change to an existing installation; (d) the procedure for registration, in the event that general binding rules are not adopted, and the Member States allow the installation only to be registered. (d) the procedure for registration, in the event that general binding rules are not adopted, and the Member State allows only registration. 2. The competent authority shall make available to the public, including systematically via the internet, free of charge and without restricting access to registered users, the following documents and information: 2. The competent authority shall make available to the public directly concerned, including via the internet, free of charge and without restricting access to registered users, the following documents and information: (a) the permit or the registration; (a) the permit or the registration; (b) the results of the consultations held in accordance with paragraph 1; (b) the results of the consultations held in accordance with paragraph 1; (c) the general binding rules referred to in Article 6 which are applicable to installations falling within the scope of this Chapter; and (c) the general binding rules referred to in Article 6.’ (d) the reports of inspections of the installations falling within the scope of this Chapter. Or. fr Amendment 344 Jessica Polfjärd Proposal for a directive Article 2 – paragraph 1 – point 3 b (new) Directive (EU) 2010/75/EU Article 70g – paragraph 1 – introductory part AM\1348825EN.docx 63/158 PE791.123v02-00 EN Present text Amendment (3b) in Article 70g(1), the introductory part is replaced by the following: 1. Member States shall ensure that the public concerned are given early and effective opportunities to participate in the following procedures: ‘1. Member States shall ensure that the public directly affected are given early and effective opportunities to participate in the following procedures:’ Or. en (02010L0075-20240804) Amendment 345 Jessica Polfjärd Proposal for a directive Article 2 – paragraph 1 – point 3 c (new) Directive (EU) 2010/75/EU Article 70g – paragraph 2 – introductory part Present text Amendment (3c) in Article 70g(2), the introductory part is replaced by the following: 2. The competent authority shall make available to the public, including systematically via the internet, free of charge and without restricting access to registered users, the following documents and information: ‘2. The competent authority shall make available to the public directly affected, including via the internet, free of charge and without restricting access to registered users, the following documents and information:’ Or. en (02010L0075-20240804) Amendment 346 Anne-Sophie Frigout, Valérie Deloge, Gilles Pennelle, Mathilde Androuët, Ondřej Knotek, Jana Nagyová Proposal for a directive Article 2 – paragraph 1 – point 3 h (new) Directive 2010/75/EU Article 70g – paragraph 2 – point d PE791.123v02-00 64/158 AM\1348825EN.docx EN Text proposed by the Commission Amendment (3h) In article 70g(2), point (d) is deleted; Or. fr Justification Checks are the state’s responsibility, and it will take any measures needed to ensure installations operate properly. There is no reason to give open access to these reports. Amendment 347 Daniel Buda Proposal for a directive Article 2 – paragraph 1 – point 3 g (new) Directive 2010/75/EU Article 70g Text proposed by the Commission Amendment (3g) Article 70g is amended as follows: (a) in paragraph 1, the introductory part is replaced by the following: ‘Member States shall ensure that the public directly affected are given early and effective opportunities to participate in the following procedures:’ (b) paragrah 2 is replaced by the following: ‘2. The competent authority shall make available to the public directly affected, including via the internet, free of charge and without restricting access to registered users, the following documents and information: (a) the permit; (b) the results of the consultations held in accordance with paragraph 1; (c) the general binding rules referred to in Article 6 applicable to installations falling within the scope of this Chapter.’; AM\1348825EN.docx 65/158 PE791.123v02-00 EN Or. en Justification Only persons with a direct interest in the case should have standing to take part in the permit‑granting or permit‑updating process. Amendment 348 Daniel Buda Proposal for a directive Article 2 – paragraph 1 – point 3 h (new) Directive 2010/75/EU Article 70h Text proposed by the Commission Amendment (3h) Article 70h is deleted Or. en Justification Livestock farms should not be treated in the same way as industrial installations. Aggregating separate farms solely because they are geographically close or linked through economic or legal relationships risks bringing family farms and cooperative structures within the scope of the IED, even where individual holdings remain below the established thresholds. This approach does not reflect the actual environmental impact of each farm, creates legal uncertainty, discourages cooperation between farmers and imposes disproportionate administrative and compliance burdens without delivering corresponding environmental benefits. Therefore, livestock farming should be excluded from the scope of the IED. Amendment 349 François-Xavier Bellamy, Céline Imart Proposal for a directive Article 2 – paragraph 1 – point 3 g (new) Directive 2010/75/EU Article 70h – paragraph 1 Text proposed by the Commission Amendment (3g) In Article 70h, paragraph 1 is replaced by the following: Member States shall ensure that, in accordance with the relevant national legal Member States shall ensure that, in accordance with the relevant national legal PE791.123v02-00 66/158 AM\1348825EN.docx EN system, members of the public concerned have access to a review procedure before a court of law or another independent and impartial body established by law to challenge the substantive or procedural legality of decisions, acts or omissions subject to this Chapter when one of the following conditions is met: system, members of the public directly concerned have access to a review procedure before a court of law, or another independent and impartial body established by law, in order to challenge the substantive or procedural legality of decisions, acts or omissions subject to this Chapter when one of the following conditions is met: (a) they have a sufficient interest; (a) they have a direct interest; (b) they maintain the impairment of a right, where administrative procedural law of a Member State requires this as a precondition. (b) they cite the impairment of a right, where administrative procedural law of a Member State requires this as a precondition. Standing in the review procedure shall not be conditional on the role that the member of the public concerned played during a participatory phase of the decision- making procedures under this Directive. The admissibility of the review procedure shall not be made conditional on the role that the member of the public concerned played during a participatory phase of the decision-making procedures under this Directive. The review procedure shall be fair, equitable, timely and not prohibitively expensive, and shall provide for adequate and effective remedies, including injunctive relief as appropriate. The review procedure shall be equitable, impartial, timely and not prohibitively expensive, and shall provide for adequate and effective redress mechanisms, including injunctive relief as appropriate. Or. fr Amendment 350 Jessica Polfjärd Proposal for a directive Article 2 – paragraph 1 – point 3 d (new) Directive 2010/75/EU Article 70h – paragraph 1 – introductory part Present text Amendment (3d) in Article 70h(1), the introductory part is replaced by the following: Member States shall ensure that, in accordance with the relevant national legal system, members of the public concerned ‘Member States shall ensure that, in accordance with the relevant national legal system, members of the public directly AM\1348825EN.docx 67/158 PE791.123v02-00 EN have access to a review procedure before a court of law, or another independent and impartial body established by law to challenge the substantive or procedural legality of decisions, acts or omissions subject to this Chapter when one of the following conditions is met: affected have access to a review procedure before a court of law, or another independent and impartial body established by law to challenge the substantive or procedural legality of decisions, acts or omissions subject to this Chapter when one of the following conditions is met:’ Or. en (02010L0075-20240804) Amendment 351 Jessica Polfjärd Proposal for a directive Article 2 – paragraph 1 – point 3 e (new) Directive 2010/75/EU Article 70h – paragraph 1 – point a Present text Amendment (3e) in Article 70h(1), point a is replaced by the following: (a) they have a sufficient interest; ‘(a) they have a direct interest;’; Or. en (02010L0075-20240804) Amendment 352 Alexander Bernhuber Proposal for a directive Article 2 – paragraph 1 – point 3 d (new) Directive 2010/75/EU Article 70h – paragraph 2 a (new) Text proposed by the Commission Amendment (3d) in Article 70h, the following paragraph is added: PE791.123v02-00 68/158 AM\1348825EN.docx EN ‘2a. In the context of judicial proceedings relating to permitting decisions under this Directive, Member States may preclude arguments from being raised before a court of law where they were not raised during the administrative stage, as long as the competent authority made available the necessary information in due time so that those arguments were known or could have been known and reviewed during the administrative stage leading to the authorisation of the project, without prejudice to the right of access to justice.’; Or. en (Directive 2010/75/EU) Amendment 353 François-Xavier Bellamy, Céline Imart Proposal for a directive Article 2 – paragraph 1 – point 3 h (new) Directive 2010/75/EU Article 70i Text proposed by the Commission Amendment (3h) Article 70i is replaced by the following: 1. The Commission shall organise an exchange of information between Member States, the sectors concerned, non- governmental organisations promoting environmental protection and the Commission before establishing uniform conditions for operating rules in accordance with paragraph 2. The exchange of information shall, in particular, address the following: ‘1. The Commission shall organise an exchange of information between Member States, the sectors concerned, non- governmental organisations promoting environmental protection and the Commission before establishing uniform conditions for operating rules in accordance with paragraph 2. The exchange of information shall, in particular, address the following: (a) the emission and environmental performance levels of installations and techniques, and other measures consistent with Annex III; (a) the emission and environmental performance levels of installations and techniques, and other measures consistent with Annex III; AM\1348825EN.docx 69/158 PE791.123v02-00 EN (b) the techniques used, associated monitoring, cross-media effects, economic and technical viability and developments in that regard; (b) the techniques used, associated monitoring, cross-media effects, economic and technical viability and developments in that regard; (c) best available techniques identified after considering the issues mentioned in points (a) and (b); (c) best available techniques identified after considering the issues mentioned in points (a) and (b); (d) emerging techniques. (d) emerging techniques. 1a. The limit values provided for in the uniform conditions for operating rules may be assessed by physiological stage or on an overall holding basis. 2. Before adopting the implementing act establishing uniform rules for operating conditions, the Commission shall carry out an assessment of the economic, financial, social and environmental impacts of the proposed measures. That assessment shall be made public before the draft implementing act is submitted for consultation. 2. The Commission shall adopt by 1 September 2026 an implementing act to establish uniform conditions for operating rules for each of the activities referred to in Annex Ia. 2. The Commission shall adopt by 1 September 2027 an implementing act establishing uniform rules on operating conditions for each of the activities referred to in Annex Ia. The uniform conditions for operating rules shall be consistent with the use of best available techniques for the activities listed in Annex Ia and shall take into account the nature, type, size and stocking density of those installations, the size of herds of single animal types in mixed farms, and the specificities of pasture-based rearing systems, where animals are only seasonally reared in indoor installations. They shall also include indicative information on emerging techniques, where available. The uniform rules on operating conditions shall be consistent with the use of best available techniques for the activities listed in Annex Ia and shall take into account the nature, type, size and stocking density of those installations, the size of herds by animal type in mixed farms, and the specificities of outdoor rearing systems, where animals are only seasonally reared indoors. They shall also include, where appropriate, indicative information on emerging techniques. Member States may supplement or replace the emission levels and environmental performance of installations and techniques referred to in point (a) of paragraph 1 with parameters or technical measures that ensure a high level of environmental protection, while taking into account the specific structural, PE791.123v02-00 70/158 AM\1348825EN.docx EN climate and economic features of livestock systems. That implementing act shall be adopted in accordance with the examination procedure referred to in Article 75(2). That implementing act shall be adopted in accordance with the examination procedure referred to in Article 75(2). 3. Member States shall ensure that the competent authority follows or is informed of developments in best available techniques and of the publication of any new or updated uniform conditions for operating rules. Member States shall ensure that the competent authority follows or is informed of developments in best available techniques and of the publication of any new uniform rules for operating conditions or updates thereof. 4. The uniform rules on operating conditions adopted under this Article shall constitute fully harmonised requirements for the activities falling under Annex Ia, and Member States shall not adopt or maintain additional or more stringent national measures concerning emission reduction, nutrient and manure management, housing systems, environmental performance obligations or other operational environmental requirements for those activities, unless such derogation is explicitly provided for under Union law. By way of derogation from the first sentence and Article 70c, the competent authority may, in duly justified exceptional cases, set less stringent emission limit values or environmental performance standards where a documented assessment demonstrates that achieving the levels resulting from application of the uniform rules would entail costs that are manifestly disproportionate to the environmental benefits, provided that no significant pollution is caused and that all Union environmental quality standards are followed. The competent authority shall set out, in an annex to the permit conditions, the reasons justifying such a derogation, including the results of the assessment and the justification for the conditions imposed.’ Or. fr AM\1348825EN.docx 71/158 PE791.123v02-00 EN Amendment 354 Carmen Crespo Díaz, Dolors Montserrat Proposal for a directive Article 2 – paragraph 1 – point 3 c (new) Directive 2010/75/EU Article 70i – paragraph 2 – subparagraph 1 Text proposed by the Commission Amendment (3c) In Article 70i, paragraph 2, subparagraph 1 is replaced by the following: The Commission shall adopt by 1 September 2026 an implementing act to establish uniform conditions for operating rules for each of the activities referred to in Annex Ia. ‘The Commission shall adopt by 1 September 2028 an implementing act to establish uniform conditions for operating rules for each of the activities referred to in Annex Ia.’ Or. es Justification It is necessary to provide for reasonable time frames for establishing uniform conditions for the operation of livestock rearing activities. In line with the approach taken in terms of implementation deadlines, a longer deadline can be envisaged for the adoption of the implementing act, which should be done in dialogue and consultation with the sectors concerned, who will be responsible for making the required investments. Amendment 355 Anne-Sophie Frigout, Valérie Deloge, Gilles Pennelle, Mathilde Androuët, Ondřej Knotek, Jana Nagyová Proposal for a directive Article 2 – paragraph 1 – point 3 i (new) Directive 2010/75/EU Article 70i Text proposed by the Commission Amendment (3i) Article 70i is amended as follows: (a) In paragraph 1, the following points are added: PE791.123v02-00 72/158 AM\1348825EN.docx EN ‘(da) Prior to the adoption of the implementing act to establish uniform conditions for operating rules, the Commission shall carry out an assessment of the economic, financial, social and environmental impacts of the planned measure; (db) The assessment shall be published before the consultation phase for the draft implementing act.’; (b) The following paragraph is inserted: ‘1a. The limit values provided for in the uniform conditions for operating rules may be assessed by physiological stage or on an overall holding basis.’ (c) In paragraph 2, the second subparagraph is replaced by the following: ‘The uniform conditions for operating rules shall be consistent with the use of best available techniques for the activities listed in Annex Ia and shall take into account the nature, type, size and stocking density of those installations, the size of herds of single animal types in mixed farms, and the specificities of pasture- based rearing systems, where animals are only seasonally reared in indoor installations. They shall also include indicative information on emerging techniques, where available. Member States may supplement or replace the emission levels and environmental performance of installations and techniques referred to in point (a) of paragraph 1 with parameters or technical measures that ensure a high level of environmental protection, while taking into account the specific structural, climate and economic features of livestock systems.’; (d) The following paragraph is added: ‘4. By way of derogation from Article 70c, the competent authority may, in specific cases, set less strict environmental performance or emission limits. Such a AM\1348825EN.docx 73/158 PE791.123v02-00 EN derogation may apply only where an assessment shows that the achievement of emission levels and environmental performance as described in the operating rules referred to in paragraph 1 would lead to disproportionately higher costs compared to the environmental benefits. The competent authority shall document in an annex to the permit conditions the reasons for which the first subparagraph applies, including the result of the assessment and the justification for the conditions imposed, and shall ensure that no significant pollution is caused.’; Or. fr Amendment 356 Carmen Crespo Díaz, Dolors Montserrat Proposal for a directive Article 2 – paragraph 1 – point 3 d (new) Directive 2010/75/EU Article 70i – paragraph 1 – point b Present text Amendment (3d) In Article 70i, paragraph 1, point (b) is replaced by the following: the techniques used, associated monitoring, cross-media effects, economic and technical viability and developments in that regard; ‘the techniques used, associated monitoring, cross-media effects, economic and technical viability, the value for money of their use in relation to the size of the farm, the climatic and regional conditions, and the availability of sufficiently representative and comparable data;’ Or. es ((02010L0075-20240804)) Amendment 357 Carmen Crespo Díaz, Dolors Montserrat PE791.123v02-00 74/158 AM\1348825EN.docx EN Proposal for a directive Article 2 – paragraph 1 – point 3 e (new) Directive 2010/75/EU Article 70i – paragraph 2 – subparagraph 2 Present text Amendment (3e) In Article 70i, paragraph 2, the second subparagraph is replaced by the following: The uniform conditions for operating rules shall be consistent with the use of best available techniques for the activities listed in Annex Ia and shall take into account the nature, type, size and stocking density of those installations, the size of herds of single animal types in mixed farms, and the specificities of pasture-based rearing systems, where animals are only seasonally reared in indoor installations. ‘The uniform operating conditions shall be consistent with the use of best available techniques for the activities listed in Annex Ia and shall take into account the nature, type, size and stocking density of the installations, the size of the farms, the various production systems, the climatic and regional conditions, including Mediterranean climates, and the technical and financial viability of the techniques required. Such conditions shall not impose any emission limit values or environmental performance levels that cannot be achieved using techniques that are available, proportionate and economically viable for the category of farm in question.’ Or. es ((02010L0075-20240804)) Amendment 358 Carmen Crespo Díaz, Dolors Montserrat Proposal for a directive Article 2 – paragraph 1 – point 3 f (new) Directive 2010/75/EU Article 70i – paragraph 2 – subparagraph 2 a (new) Present text Amendment (02010L0075-20240804) (3f) In Article 70i, paragraph 2, the following subparagraph is added: ‘Prior to the adoption of the implementing act mentioned in this paragraph, the AM\1348825EN.docx 75/158 PE791.123v02-00 EN Commission shall carry out an assessment of the economic, financial, social and environmental impacts of the proposed measures. That assessment shall consider, in particular, their effects on the viability of livestock farms, production capacity, the competitiveness of the sector, food security, competent administrations and small and medium-sized farms. The assessment shall be published before the submission of the draft implementing act.’ Or. es ((02010L0075-20240804)) Amendment 359 Carmen Crespo Díaz, Dolors Montserrat Proposal for a directive Article 2 – paragraph 1 – point 3 g (new) Directive 2010/75/EU Article 70i – paragraph 3 a (new) Present text Amendment (02010L0075-20240804) (3g) In Article 70i, the following paragraph is added: ‘3a. Uniform operating conditions adopted pursuant to this Article shall constitute harmonised requirements for the activities listed in Annex Ia. Member States may not adopt or maintain any additional or more stringent operational environmental requirements as regards the matters regulated by those uniform operating conditions, unless such requirements are demanded by Union law.’ Or. es ((02010L0075-20240804)) PE791.123v02-00 76/158 AM\1348825EN.docx EN Amendment 360 Carmen Crespo Díaz, Dolors Montserrat Proposal for a directive Article 2 – paragraph 1 – point 3 h (new) Directive 2010/75/EU Article 70i – paragraph 3 b (new) Present text Amendment (02010L0075-20240804) (3h) In Article 70i, the following paragraph is added: ‘3b. Notwithstanding the provisions in paragraph 2 of this Article and in Article 70c, the competent authority may, in duly justified and exceptional cases, set less stringent emission or environmental performance levels than those derived from the uniform operating conditions in respect of a specific installation, where it is proven by means of a documented assessment that achieving those levels would generate costs that are clearly disproportionate to the environmental benefits owing to: (a) the geographical location of the installation; (b) the local environmental conditions; (c) the climatic or regional conditions; (d) the technical, structural or production-related characteristics of the installation. In such cases, the competent authority shall explicitly justify the decision, including the outcome of the assessment carried out and the justification for the conditions imposed. Application of this derogation may not compromise compliance with the relevant environmental quality standards.’ Or. es ((02010L0075-20240804)) AM\1348825EN.docx 77/158 PE791.123v02-00 EN Amendment 361 Anna Zalewska Proposal for a directive Article 2 – paragraph 1 – point 3 b (new) Directive 2010/75/EU Article 70i – paragraph 2 Present text Amendment (3b) in Article 70i, paragraph 2 is replaced by the following: 2. The Commission shall adopt by 1 September 2026 an implementing act to establish uniform conditions for operating rules for each of the activities referred to in Annex Ia. ‘2 The Commission shall adopt by 1 September 2027 an implementing act to establish uniform conditions for operating rules for each of the activities referred to in Annex Ia. The uniform conditions for operating rules shall be consistent with the use of best available techniques for the activities listed in Annex Ia and shall take into account the nature, type, size and stocking density of those installations, the size of herds of single animal types in mixed farms, and the specificities of pasture-based rearing systems, where animals are only seasonally reared in indoor installations. They shall also include indicative information on emerging techniques, where available. The uniform conditions for operating rules shall be consistent with the use of best available techniques for the activities listed in Annex Ia and shall take into account the nature, type, size and stocking density of those installations, the size of herds of single animal types in mixed farms, and the specificities of pasture-based rearing systems, where animals are only seasonally reared in indoor installations. They shall also include indicative information on emerging techniques, where available. That implementing act shall be adopted in accordance with the examination procedure referred to in Article 75(2). That implementing act shall be adopted in accordance with the examination procedure referred to in Article 75(2). Before adopting the implementing act referred to in the first subparagraph of this Article, the Commission shall carry out and publish a comprehensive impact assessment. The impact assessment shall evaluate the expected economic, financial, social and environmental impacts of the proposed measures, including their effects on the competitiveness of Union industry and agriculture, the viability of agricultural holdings, food security, investment capacity, innovation, administrative burden, employment, rural PE791.123v02-00 78/158 AM\1348825EN.docx EN areas, security of supply, and the level playing field within the internal market and internationally. The assessment shall also examine the proportionality and cost- effectiveness of the proposed measures, including their cumulative impacts in combination with other relevant Union legislation. The implementing act shall not be adopted before that assessment has been completed and made publicly available.’ Or. en ((https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A02010L0075-20240804)) Amendment 362 Alexander Bernhuber Proposal for a directive Article 2 – paragraph 1 – point 3 e (new) Directive 2010/75/EU Article 70i Present text Amendment (3e) in Article 70i, the following paragraphs are added: ‘3a. When establishing uniform operating conditions pursuant to this Article, it shall be ensured that the requirements are defined having regard to technical feasibility and the economic viability of the installations concerned. In particular, due account shall be taken of the principle of proportionality, so that the economic burden for operators remains commensurate with the environmental benefit pursued. 3b. When establishing uniform operating conditions pursuant to this Article, it shall be ensured that requirements relating to monitoring, measurements, reporting and documentation do not go beyond what is necessary to ensure a high level of environmental protection overall. The AM\1348825EN.docx 79/158 PE791.123v02-00 EN specific characteristics of agricultural activities and the economic viability of the installations concerned shall be duly taken into account. With regard to small and medium-sized agricultural holdings within the meaning of Commission Recommendation 2003/361/EC, the uniform operating conditions shall respect the principle of proportionality and, where appropriate, allow for the application of simplified and standardised requirements.’; Or. en (Directive 2010/75/EU) Amendment 363 Michal Wiezik, Martin Hojsík Proposal for a directive Article 2 – paragraph 1 – point 3 c (new) Directive (EU) 2024/1785 Article 70i– paragraph 3 Present text Amendment (3c) Article 70i(3) is replaced by the following: Member States shall ensure that the competent authority follows or is informed of developments in best available techniques and of the publication of any new or updated uniform conditions for operating rules.’ ‘Member States shall ensure that the competent authority follows or is informed of developments in best available techniques, and of updated lists of pollutants and their quality standards, where applicable, and of the publication of any new or updated uniform conditions for operating rules. Uniform conditions for operating rules shall in particular follow any update in a potential classification of indicators of antimicrobial resistance as pollutants, following their removal from the watchlist, and propose appropriate measures to ensure high protection of environment and human health. ’ PE791.123v02-00 80/158 AM\1348825EN.docx EN Or. en (DIRECTIVE (EU) 2024/1785) Justification it is opportune to include in this omnibus a future-proof provision that in case indicators of antimicrobial resistance get to the list of priority substances, they might become as well new pollutants to take care of in case of livestock installations covered by this Directive. Amendment 364 François-Xavier Bellamy, Céline Imart Proposal for a directive Article 2 – paragraph 1 – point 3 i (new) Directive 2010/75/EU Article 73 – paragraph 3 Text proposed by the Commission Amendment (3i) In Article 73, paragraph 3 is deleted; Or. fr Amendment 365 Anne-Sophie Frigout, Valérie Deloge, Gilles Pennelle, Mathilde Androuët, Ondřej Knotek, Jana Nagyová, Antonín Staněk Proposal for a directive Article 2 – paragraph 1 – point 3 h (new) Directive 2010/75/EU Article 73 – paragraph 3 Text proposed by the Commission Amendment (3h) In Article 73, paragraph 3 is deleted; Or. fr Justification This report is not useful because it does not take account of mirror clauses and because European cattle farming is in a particularly sensitive situation. It would create a significant AM\1348825EN.docx 81/158 PE791.123v02-00 EN administrative burden and costs at a time when the number of livestock is falling and new rules would exacerbate the considerable challenges of generational renewal. Amendment 366 Alexander Bernhuber Proposal for a directive Article 2 – paragraph 1 – point 3 f (new) Directive 2010/75/EU Article 73 Present text Amendment (3f) Article 73 is replaced by the following: Article 73 ‘Article 73 Review Review 1. By 30 June 2028 and every 5 years thereafter, the Commission shall submit to the European Parliament and to the Council a report reviewing the implementation of this Directive. The report shall include information on activities for which BAT conclusions have or have not been adopted pursuant to Article 13(5) of this Directive, take into account the dynamics of innovation, including emerging techniques, the need for further pollution prevention measures and the review referred to in Article 8 of Directive 2003/87/EC. 1. By 30 June 2028 and every 5 years thereafter, the Commission shall submit to the European Parliament and to the Council a report reviewing the implementation of this Directive. The report shall include information on activities for which BAT conclusions have or have not been adopted pursuant to Article 13(5) of this Directive, take into account the dynamics of innovation, including emerging techniques, the need for further pollution prevention measures and the review referred to in Article 8 of Directive 2003/87/EC. That report shall include an assessment of the need for Union action through the establishment or updating of Union-wide minimum requirements for emission limit values and for rules on monitoring and compliance for activities within the scope of the BAT conclusions adopted during the previous five-year period, on the basis of the following criteria: That report shall include an assessment of the need for Union action through the establishment or updating of Union-wide minimum requirements for emission limit values and for rules on monitoring and compliance for activities within the scope of the BAT conclusions adopted during the previous five-year period, on the basis of the following criteria: (a) the impact of the activities concerned on the environment as a whole and on human health; (a) the impact of the activities concerned on the environment as a whole and on human health; PE791.123v02-00 82/158 AM\1348825EN.docx EN (b) the state of implementation of best available techniques for the activities concerned. (b) the state of implementation of best available techniques for the activities concerned. That assessment shall consider the opinion of the forum referred to in Article 13(4). That assessment shall consider the opinion of the forum referred to in Article 13(4). Chapter III and Annex V of this Directive shall be considered to represent the Union- wide minimum requirements in the case of large combustion plants. Chapter III and Annex V of this Directive shall be considered to represent the Union- wide minimum requirements in the case of large combustion plants. The report shall be accompanied by a legislative proposal where appro priate. Where the assessment referred to in the second subparagraph identifies such a need, the legislative proposal shall include provisions establishing or updating Union- wide minimum requirements for emission limit values and for rules on monitoring and compliance assessment for the activities concerned. The report shall be accompanied by a legislative proposal where appro priate. Where the assessment referred to in the second subparagraph identifies such a need, the legislative proposal shall include provisions establishing or updating Union- wide minimum requirements for emission limit values and for rules on monitoring and compliance assessment for the activities concerned. 2. The Commission shall, by 31 December 2012, review the need to control emissions from: 2. The Commission shall, by 31 December 2012, review the need to control emissions from: (a) the combustion of fuels in installations with a total rated thermal input below 50 MW; (a) the combustion of fuels in installations with a total rated thermal input below 50 MW; (b) the intensive rearing of cattle; and (b) the intensive rearing of cattle; and (c) the spreading of manure. (c) the spreading of manure. The Commission shall report the results of that review to the European Parliament and to the Council accompanied by a legislative proposal where appropriate. The Commission shall report the results of that review to the European Parliament and to the Council accompanied by a legislative proposal where appropriate. 3. The Commission shall, using an evidence-based methodology and taking into account the specificities of the sector, assess the need for Union action to: 3. The Commission shall, using an evidence-based methodology and taking into account the specificities of the sector, assess the need for Union action to: (a) comprehensively address the emissions from the rearing of livestock within the Union, in particular from cattle; and (b) further achieve the objective of global environmental protection with respect to products placed on the Union market, through the prevention and control of emissions from livestock farming, and in a (b) further achieve the objective of global environmental protection with respect to products placed on the Union market, through the prevention and control of emissions from livestock farming, and in a AM\1348825EN.docx 83/158 PE791.123v02-00 EN manner consistent with the Union’s international obligations. manner consistent with the Union’s international obligations; and (c) keep the economic impacts on the holdings concerned as limited as possible. The Commission shall report the results of that assessment by 31 December 2026 to the European Parliament and the Council. The report shall be accompanied by a legislative proposal where appropriate. The Commission shall report the results of that assessment by 31 December 2026 to the European Parliament and the Council. The report shall be accompanied by a legislative proposal where appropriate. 4. With regard to Chapter VIa, the Commission shall review: (a) the economic impacts on holdings, differentiated by size, type of production and regional conditions, with particular regard to family-run holdings and small and medium-sized enterprises; (b) administrative burdens, in particular reporting obligations as well as measurement and documentation requirements, and their costs, with the objective of reducing bureaucracy; (c) the appropriateness of thresholds and scope of application, in particular with regard to structurally disadvantaged regions and extensive or site-adapted farming systems; (d) the practical feasibility and technical availability of emission reduction measures as well as their cost- effectiveness; (e) potential distortions of competition within the internal market and in international trade, including the risk of production relocation; (f) coherence with other Union policies and legal acts, in particular the Common Agricultural Policy, in order to avoid double burdens; (g) impacts on security of supply, price development and the long-term viability of agricultural production in the Union. The Commission shall submit a report on the outcome of this review to the European Parliament and the Council PE791.123v02-00 84/158 AM\1348825EN.docx EN within five years of the entry into force of this Directive. That report shall, where appropriate, be accompanied by a legislative proposal. 5. A Member State may apply to the Commission for a derogation from specific provisions of Chapter VIa, provided that it demonstrates that: (a) an at least equivalent or higher level of environmental protection is achieved through national measures; (b) the functioning of the internal market is not adversely affected; and (c) no unjustified distortions of competition arise. The application shall be duly reasoned and accompanied by an impact assessment. The Commission shall decide on the application by means of an implementing act in accordance with the examination procedure referred to in Article [X]. That implementing act may lay down conditions, time limits or reporting obligations. The authorisation shall be granted for a maximum period of five years and may be extended, upon request by the Member State concerned, provided that the conditions continue to be fulfilled. 4. The Commission shall review: 6. The Commission shall review: (a) the need to control emissions from onshore and offshore explo ration and production of mineral oil and gas; (a) the need to control emissions from onshore and offshore explo ration and production of mineral oil and gas; (b) the need to control emissions from the on-site treatment and extraction of non- energy industrial minerals used in industry other than for construction, as well as the need to control emissions from the on-site treatment and extraction of ores which are newly carried out in the Union; (b) the need to control emissions from the on-site treatment and extraction of non- energy industrial minerals used in industry other than for construction, as well as the need to control emissions from the on-site treatment and extraction of ores which are newly carried out in the Union; (c) the need to revise the activity threshold in Annex I for the production of hydrogen by electrolysis of water. (c) the need to revise the activity threshold in Annex I for the production of hydrogen by electrolysis of water. AM\1348825EN.docx 85/158 PE791.123v02-00 EN The Commission shall include the results of that review in the first of the reports to the European Parliament and to the Council required under the first paragraph. The Commission shall include the results of that review in the first of the reports to the European Parliament and to the Council required under the first paragraph.’ Or. en (Directive 2010/75/EU) Amendment 367 Daniel Buda Proposal for a directive Article 2 – paragraph 1 – point 3 i (new) Directive 2024/1785 Article 73 – paragraph 3 Text proposed by the Commission Amendment (3i) in Article 73, paragraph 3 is deleted. Or. en Justification Livestock farming is fundamentally different from industrial activities. Cattle production is land-based, highly dependent on biological processes and local conditions, and cannot be effectively regulated through an installation-based framework such as the IED. Including livestock farms within the Directive would create disproportionate administrative burdens and legal uncertainty without delivering clear environmental benefits. Amendment 368 Jutta Paulus Proposal for a directive Article 2 – paragraph 1 – point 3 a (new) Directive 2010/75/EU Article 73 – paragraph 3 – point (a) Present text Amendment (3a) In Article 73(3), point (a) is replaced by the following: PE791.123v02-00 86/158 AM\1348825EN.docx EN (a) comprehensively address the emissions from the rearing of livestock within the Union, in particular from cattle; and ‘(a) comprehensively address the emissions from the rearing of livestock within the Union, in particular from cattle, and evaluate options for ensuring greater coherence in the regulatory framework covering organic rearing activities as well as possible adjustments to the calculation of installation capacity under Annex Ia;' Or. en Amendment 369 Sergio Berlato, Michele Picaro, Pietro Fiocchi, Stefano Cavedagna, Nicola Procaccini, Antonella Sberna, Paolo Inselvini Proposal for a directive Article 2 – paragraph 1 – point 3 b (new) Directive 2010/75/EU Article 73 – paragraph 3 – subparagraph 2 Present text Amendment (3b) In Article 73(3), the second subparagraph is replaced by the following: The Commission shall report the results of that assessment by 31 December 2026 to the European Parliament and the Council. The report shall, if appropriate, be accompanied by a legislative proposal. ‘The Commission shall report the results of that assessment by 31 December [7 years after the entry into force of the implementing act referred to in Article70i(2)] to the European Parliament and the Council.’ Or. it (https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=OJ:L_202401785) Amendment 370 Letizia Moratti, Massimiliano Salini, Flavio Tosi Proposal for a directive Article 2 – paragraph – 3 a (new) Directive 2010/75/EU Article 73 – paragraph 3 – point a AM\1348825EN.docx 87/158 PE791.123v02-00 EN Text proposed by the Commission Amendment (3a) In Article 73(3), point (a) is deleted; Or. en (In Directive (EU) 2024/1785, Article 73, paragraph (3) a)) Amendment 371 Jutta Paulus Proposal for a directive Article 2 – paragraph 1 – point 4 Directive 2010/75/EU Article 76 Text proposed by the Commission Amendment (4) Article 76 is amended as follows: deleted (i) in paragraph 2, the first sentence is replaced by the following: ‘The power to adopt delegated acts referred to in Article 48(5), and Article 74 shall be conferred on the Commission for a period of 5 years from 1 August 2024.;’ ‘The delegation of power referred to in Article 48(5), and Article 74 may be revoked at any time by the European Parliament or by the Council.;’ ‘A delegated act adopted pursuant to Article 48(5) or Article 74 shall enter into force only if no objection has been expressed either by the European Parliament or by the Council within a period of 2 months of notification of that act to the European Parliament and the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object.;’ Or. en PE791.123v02-00 88/158 AM\1348825EN.docx EN Amendment 372 Martin Günther, Sebastian Everding, Per Clausen Proposal for a directive Article 2 – paragraph 1 – point 4 Directive 2010/75/EU Article 76 Text proposed by the Commission Amendment (4) Article 76 is amended as follows: deleted (i) in paragraph 2, the first sentence is replaced by the following: ‘The power to adopt delegated acts referred to in Article 48(5), and Article 74 shall be conferred on the Commission for a period of 5 years from 1 August 2024.;’ ‘The delegation of power referred to in Article 48(5), and Article 74 may be revoked at any time by the European Parliament or by the Council.;’ ‘A delegated act adopted pursuant to Article 48(5) or Article 74 shall enter into force only if no objection has been expressed either by the European Parliament or by the Council within a period of 2 months of notification of that act to the European Parliament and the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object.;’ Or. en Amendment 373 Carmen Crespo Díaz, Dolors Montserrat Proposal for a directive Article 2 – paragraph 1 – point 4 a (new) Directive 2010/75/EU Article 79 – paragraph 3 a (new) Text proposed by the Commission Amendment AM\1348825EN.docx 89/158 PE791.123v02-00 EN (4a) In Article 79, the following paragraph is inserted: ‘3a. Member States shall ensure that, in relation to the activities cited in Annex Ia, the penalties laid down in this Article take due account of the following criteria: (a) the nature of the livestock-rearing activity; (b) the nature of the infringement; (c) the economic scale of the livestock farm; (d) the degree of negligence or intentionality; and (e) the economic capacity of the operator. The provisions of the second subparagraph of paragraph 2, relating to the maximum levels of penalty linked to turnover, shall not apply automatically to activities listed in Annex Ia where this could give rise to clearly disproportionate outcomes.’ Or. es ((02010L0075-20240804)) Amendment 374 François-Xavier Bellamy, Céline Imart Proposal for a directive Article 2 – paragraph 1 – point 4 a (new) Directive 2010/75/EU Article 79 – paragraph 4 a (new) Text proposed by the Commission Amendment (4a) In Article 79, the following paragraph is added: ‘4a. The activities referred to in Annex Ia fall exclusively under paragraph 1.’ Or. fr PE791.123v02-00 90/158 AM\1348825EN.docx EN Amendment 375 Anne-Sophie Frigout, Valérie Deloge, Gilles Pennelle, Mathilde Androuët, Ondřej Knotek, Jana Nagyová Proposal for a directive Article 2 – paragraph 1 – point 4 a (new) Directive 2010/75/EU Article 79 – paragraph 4 a (new) Text proposed by the Commission Amendment (4a) In Article 79, the following paragraph is added: ‘4a. Paragraphs 2 and 3 of this Article shall not apply to the activities listed in Annex Ia.’; Or. fr Amendment 376 François-Xavier Bellamy, Céline Imart Proposal for a directive Article 2 – paragraph 1 – point 4 b (new) Directive 2010/75/EU Article 79a – paragraph 3 a (new) Text proposed by the Commission Amendment (4b) In Article 79a, the following paragraph is added: ‘3a. The provisions of this Article shall not apply to the activities referred to in Annex Ia.’ Or. fr Amendment 377 Anne-Sophie Frigout, Valérie Deloge, Gilles Pennelle, Mathilde Androuët, Ondřej Knotek, Jana Nagyová Proposal for a directive AM\1348825EN.docx 91/158 PE791.123v02-00 EN Article 2 – paragraph 1 – point 4 b (new) Directive 2010/75/EU Article 79a – paragraph 3 a (new) Text proposed by the Commission Amendment (4b) In Article 79a, the following paragraph is added: ‘3a. The provisions of this article shall not apply to the activities listed in Annex Ia.’; Or. fr Amendment 378 Daniel Buda Proposal for a directive Article 2 – paragraph 1 – point 5 Directive 2010/75/EU Article 82 – paragraph 14 Text proposed by the Commission Amendment 14. In relation to installations carrying out activities referred to in Annex Ia, Member States shall apply the laws, regulations and administrative provisions adopted in accordance with this Directive within: deleted (a) 4 years of the entry into force of the implementing act referred to in Article 70i(2), if the installation has a capacity of 600 LSU or more; (b) 5 years of the entry into force of the implementing act referred to in Article 70i(2), if the installation has a capacity of 400 LSU or more; (c) 6 years of the entry into force of the implementing act referred to in Article 70i(2), for all other installations covered by Annex Ia. Until the relevant date of application, as referred to in the first subparagraph, the installations mentioned in that subparagraph which fall within the scope PE791.123v02-00 92/158 AM\1348825EN.docx EN of this Directive in the version in force on 3 August 2024, shall comply with that version. Or. en Justification Livestock farms should not be treated in the same way as industrial installations and should be removed from this Directive. Amendment 379 Alexander Bernhuber Proposal for a directive Article 2 – paragraph 1 – point 5 Directive 2010/75/EU Article 82 – paragraph 14 Text proposed by the Commission Amendment 14. In relation to installations carrying out activities referred to in Annex Ia, Member States shall apply the laws, regulations and administrative provisions adopted in accordance with this Directive within: deleted (a) 4 years of the entry into force of the implementing act referred to in Article 70i(2), if the installation has a capacity of 600 LSU or more; (b) 5 years of the entry into force of the implementing act referred to in Article 70i(2), if the installation has a capacity of 400 LSU or more; (c) 6 years of the entry into force of the implementing act referred to in Article 70i(2), for all other installations covered by Annex Ia. Until the relevant date of application, as referred to in the first subparagraph, the installations mentioned in that subparagraph which fall within the scope of this Directive in the version in force on AM\1348825EN.docx 93/158 PE791.123v02-00 EN 3 August 2024, shall comply with that version. Or. en Amendment 380 Anna Zalewska Proposal for a directive Article 2 – paragraph 1 – point 5 Directive 2010/75/EU Article 82 – paragraph 14 Text proposed by the Commission Amendment 14. In relation to installations carrying out activities referred to in Annex Ia, Member States shall apply the laws, regulations and administrative provisions adopted in accordance with this Directive within: deleted (a) 4 years of the entry into force of the implementing act referred to in Article 70i(2), if the installation has a capacity of 600 LSU or more; (b) 5 years of the entry into force of the implementing act referred to in Article 70i(2), if the installation has a capacity of 400 LSU or more; (c) 6 years of the entry into force of the implementing act referred to in Article 70i(2), for all other installations covered by Annex Ia. Until the relevant date of application, as referred to in the first subparagraph, the installations mentioned in that subparagraph which fall within the scope of this Directive in the version in force on 3 August 2024, shall comply with that version. Or. en PE791.123v02-00 94/158 AM\1348825EN.docx EN Amendment 381 François-Xavier Bellamy, Céline Imart Proposal for a directive Article 2 – paragraph 1 – point 5 Directive 2010/75/EU Article 82 – paragraph 14 – introductory part Text proposed by the Commission Amendment In relation to installations carrying out activities referred to in Annex Ia, Member States shall apply the laws, regulations and administrative provisions adopted in accordance with this Directive within: In relation to installations carrying out activities referred to in Annex Ia, Member States shall apply the laws, regulations and administrative provisions adopted in accordance with this Directive within four years from the entry into force of the implementing act referred to in Article 70 decies, paragraph 2. Or. en Amendment 382 François-Xavier Bellamy, Céline Imart Proposal for a directive Article 2 – paragraph 1 – point 5 Directive 2010/75/EU Article 82 – paragraph 14 – point a Text proposed by the Commission Amendment (a) 4 years of the entry into force of the implementing act referred to in Article 70i(2), if the installation has a capacity of 600 LSU or more; deleted Or. en Amendment 383 François-Xavier Bellamy, Céline Imart Proposal for a directive Article 2 – paragraph 1 – point 5 Directive 2010/75/EU Article 82 – paragraph 14 – subparagraph 1 – point b AM\1348825EN.docx 95/158 PE791.123v02-00 EN Text proposed by the Commission Amendment (b) 5 years of the entry into force of the implementing act referred to in Article 70i(2), if the installation has a capacity of 400 LSU or more; deleted Or. en Amendment 384 François-Xavier Bellamy, Céline Imart Proposal for a directive Article 2 – paragraph 1 – point 5 Directive 2010/75/EU Article 82 – paragraph 14 – subparagraph 1 – point c Text proposed by the Commission Amendment (c) 6 years of the entry into force of the implementing act referred to in Article 70i(2), for all other installations covered by Annex Ia. deleted Or. en Amendment 385 Michal Wiezik, Martin Hojsík Proposal for a directive Article 2 – paragraph 1 – point 5 Directive 2010/75/EU Article 82 – paragraph 14 – subparagraph 3 Text proposed by the Commission Amendment ‘By way of derogation from the first subparagraph of this paragraph, an installation which first falls within the scope of this Directive after the entry into force of the implementing act referred to in Article 70i(2), shall not be obliged to apply the rules of this Directive where it, on the day of it falling into scope, is in the PE791.123v02-00 96/158 AM\1348825EN.docx EN process of a transition towards resilient production systems, including conversion to organic farming and extensification of livestock production systems pursuant Article 10(1), point (b), of [CAP Regulation ], where the transition plan approved by the Member State details and solemnly declares that upon completion of the implementation of the transition action plan the installation ceases to fall within the scope of this Directive.’ Or. en (Directive 2010/75/EC) Justification In the industrial part of the IED there is a specific derogation from the obligation of updating the permit in case of a planned closure of the installation with a view to implement deep industrial transformation. while the provision presented herewith is of a different nature, it could be seen as analogous in that it prevents the sunk cost of an operator of a livestock installation which would first fall within the scope of the Directive in hte future, but is in the meantime started a transformation in accordance with the transition scheme as proposed in the CAP Regulation 2025/0241 (COD). Amendment 386 Carmen Crespo Díaz, Dolors Montserrat Proposal for a directive Article 2 – paragraph 1 – point 5 Directive 2010/75/EU Article 82 – paragraph 14 Text proposed by the Commission Amendment 14. In relation to installations carrying out activities referred to in Annex Ia, Member States shall apply the laws, regulations and administrative provisions adopted in accordance with this Directive within: ‘14. In relation to installations carrying out activities referred to in Annex Ia, Member States shall apply the laws, regulations and administrative provisions adopted in accordance with this Directive by: (a) 4 years of the entry into force of the implementing act referred to in Article 70i(2), if the installation has a capacity of 600 LSU or more; (a) 2032, if the plant has a capacity of 600 LSU or more; AM\1348825EN.docx 97/158 PE791.123v02-00 EN (b) 5 years of the entry into force of the implementing act referred to in Article 70i(2), if the installation has a capacity of 400 LSU or more; (b) 2036, if the plant has a capacity of 400 LSU or more; (c) 6 years of the entry into force of the implementing act referred to in Article 70i(2), for all other installations covered by Annex Ia. (c) 2040 for all other installations covered by Annex Ia. Until the relevant date of application, as referred to in the first subparagraph, the installations mentioned in that subparagraph which fall within the scope of this Directive in the version in force on 3 August 2024, shall comply with that version. Until the relevant date of application as referred to in the first subparagraph, the installations mentioned in that subparagraph which fall within the scope of this Directive in the version in force on 3 August 2024, shall comply with that version.’ Or. es Justification It is necessary to provide for adequate transitional periods to allow the intensive livestock rearing sector to adapt to the standards of the Directive. Amendment 387 Sergio Berlato, Michele Picaro, Pietro Fiocchi, Stefano Cavedagna, Nicola Procaccini, Antonella Sberna, Paolo Inselvini Proposal for a directive Article 2 – paragraph 1 – point 5 Directive 2010/75/EU Article 82 – paragraph 14 Present text Amendment In Article 82, paragraph 14 is amended as follows 14. In relation to installations carrying out activities referred to in Annex Ia, Member States shall apply the laws, regulations and administrative provisions adopted in accordance with this Directive within: ‘14. In relation to installations carrying out activities referred to in Annex Ia, Member States shall apply the laws, regulations and administrative provisions adopted in accordance with this Directive within 6 years of the entry into force of the implementing act referred to in Article 70i(2). PE791.123v02-00 98/158 AM\1348825EN.docx EN (a) 4 years of the entry into force of the implementing act referred to in Article 70i(2), if the installation has a capacity of 600 LSU or more; (b) 5 years of the entry into force of the implementing act referred to in Article 70i(2), if the installation has a capacity of 400 LSU or more; (c) 6 years of the entry into force of the implementing act referred to in Article 70i(2), for all other installations covered by Annex Ia. Until the relevant date of application, as referred to in the first subparagraph, the installations mentioned in that subparagraph which fall within the scope of Directive 2010/75/EU in the version in force on the day before this Directive enters into force, shall comply with Directive 2010/75/EU in that version. Until the relevant date of application as referred to in the first subparagraph the installations mentioned in that subparagraph, which fall within the scope of Directive 2010/75/EU, in the version in force on the day before this Directive enters into force, shall comply with Directive 2010/75/EU in that version.’ Or. it (https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=OJ:L_202401785) Amendment 388 Letizia Moratti, Massimiliano Salini, Flavio Tosi Proposal for a directive Article 2 – paragraph 1 – point 5 Directive 2010/75/EU Article 82 – paragraph 14 Present text Amendment In Article 82, paragraph 14 is replaced by the following: 14. In relation to installations carrying out activities referred to in Annex Ia, Member States shall apply the laws, regulations and administrative provisions adopted in accordance with this Directive within 14. In relation to installations carrying out activities referred to in Annex Ia, Member States shall apply the laws, regulations and administrative provisions adopted in accordance with this Directive within six years from the entry into force of the implementing act referred to in Article 70 decies(2). AM\1348825EN.docx 99/158 PE791.123v02-00 EN (a) 4 years of the entry into force of the implementing act referred to in Article 70i(2), if the installation has a capacity of 600 LSU or more; (b) 5 years of the entry into force of the implementing act referred to in Article 70i(2), if the installation has a capacity of 400 LSU or more; (c) 6 years of the entry into force of the implementing act referred to in Article 70i(2) for all other installations covered by Annex Ia. Until the relevant date of application, as referred to in the first subparagraph, the installations mentioned in that subparagraph which fall within the scope of this Directive in the version in force on 3 August 2024, shall comply with that version. Until the relevant date of application, as referred to in the first subparagraph, the installations mentioned in that subparagraph which fall within the scope of Directive 2010/75/EU in the version in force on the day before … [entry into force of this amending Directive], shall comply with Directive 2010/75/EU in that version. Or. en (Directive (EU) 2024/1785) Amendment 389 Anna Zalewska Proposal for a directive Article 2 – paragraph 1 – point 5 Directive 2010/75/EU Article 82 – paragraph 15 Text proposed by the Commission Amendment 15. Derogations granted by the competent authority in accordance with Article 15(5) before 1 July 2026 shall remain valid until the competent authority reassesses whether the derogation is justified under Article 15(5). The reassessment shall be carried out 4 years from 1 July 2026 or as part of the reconsideration of the permit conditions 15. Derogations granted by the competent authority in accordance with Article 15(5) before 1 July 2026 shall remain valid until the competent authority reassesses whether the derogation is justified under Article 15(5). The reassessment shall be carried out 6 years from 1 July 2026 or as part of the reconsideration of the permit conditions PE791.123v02-00 100/158 AM\1348825EN.docx EN pursuant to Article 21, whichever is the earlier. pursuant to Article 21, whichever is the earlier. Or. en Amendment 390 Jeannette Baljeu, Andreas Glück, Ilhan Kyuchyuk, Ana Vasconcelos Proposal for a directive Article 2 – paragraph 1 – point 5 Directive 2010/75/EU Article 82 – paragraph 16 a (new) Text proposed by the Commission Amendment ‘16a. For installations, or clearly separable parts of installations, whose purpose is linked to defence or national security, Member States may adjust the timetable or modalities for the application of the requirements referred to in paragraphs 10 to 14, where their application would demonstrably and directly affect essential security interests, operational defence readiness, or the protection of classified information. Any such adjustment shall be limited to what is strictly necessary and proportionate, shall not constitute a general exemption from the obligations of this Directive, Member States shall document the reasons for such adjustment, without requiring the disclosure of classified information.’ Or. en Justification Certain defence-related installations may face specific operational or security constraints, including the protection of classified information. A narrowly framed derogation, solely for defence and national security, within the transitional provisions ensures legal certainty without creating a general exemption from the Directive or lowering the level of protection of human health and the environment. Amendment 391 AM\1348825EN.docx 101/158 PE791.123v02-00 EN Ondřej Knotek, Jana Nagyová, Antonín Staněk, Roman Haider, Viktória Ferenc, Anne- Sophie Frigout Proposal for a directive Article 4 a (new) Text proposed by the Commission Amendment Article 4a Anti-gold-plating clause Member States shall not require economic operators to submit information, reports, notifications or registrations that duplicate obligations established under Union law in the areas covered by this Directive. Where a Member State considers additional requirements necessary to address a specific national circumstance, it shall demonstrate that such requirements are proportionate, non- discriminatory and cannot be satisfied through information already available under Union law. Or. en Amendment 392 Ondřej Knotek, Jana Nagyová, Antonín Staněk, Anne-Sophie Frigout, Viktória Ferenc Proposal for a directive Article 4 b (new) Text proposed by the Commission Amendment Article 4b Report-Once"-Principle Member States shall ensure that economic operators are not required to provide the same information more than once to public authorities under the legal acts covered by this Directive. Competent authorities shall make use of information already submitted under Union or national legislation where such PE791.123v02-00 102/158 AM\1348825EN.docx EN information is available through electronic means and may be reused for regulatory purposes. Or. en Amendment 393 Ondřej Knotek, Jana Nagyová, Antonín Staněk, Anne-Sophie Frigout, Viktória Ferenc Proposal for a directive Article 4 c (new) Text proposed by the Commission Amendment Article 4c Review of remaining reporting obligations By … [three years from the entry into force of this amending Directive], the Commission shall assess whether reporting, monitoring, registration and notification obligations under the legal acts covered by this Directive can be further simplified without reducing environmental protection. The assessment shall quantify the administrative costs borne by undertakings, with particular attention to small and medium-sized enterprises, and shall, where appropriate, be accompanied by legislative proposals. Or. en Amendment 394 Carmen Crespo Díaz, Dolors Montserrat, Peter Liese Proposal for a directive Article 4 a – paragraph 1 a (new) Directive (EU) 2024/3019 Article 9 – paragraph 1 Present text Amendment AM\1348825EN.docx 103/158 PE791.123v02-00 EN Article 4a Amendment to Directive (EU) 2024/3019 (1a) In Article 9(1), the first subparagraph is replaced by the following: 1. Member States shall take measures to ensure that by 31 December 2028, producers who place any of the products listed in Annex III on the market have extended producer responsibility. ‘1. Member States shall take measures to ensure that by 31 December 2030, producers who place any of the products listed in Annex III on the market have extended producer responsibility.’ Or. es Justification In view of the imminent implementation of extended producer responsibility obligations and with the aim of ensuring adequate legal certainty for the sectors concerned and preserving the production of medicines in the EU, an initial delay of 2 years is proposed for the implementation of these obligations. Amendment 395 Carmen Crespo Díaz, Dolors Montserrat, Peter Liese Proposal for a directive Article 4 a – paragraph 1 b (new) Directive (EU) 2024/3019 Article 9 – paragraph 1 – subparagraph 2 a (new) Text proposed by the Commission Amendment Article 4a Amendment to Directive (EU) 2024/3019 (1b) in Article 9(1), the following subparagraph is added: ‘The European Commission shall produce as soon as possible a new impact assessment to ascertain the list of substances present in urban wastewater, verify the costs of quaternary treatment, review the attribution of responsibility to the relevant sectors under the polluter pays principle, and determine the impact on the availability, affordability and accessibility of medicines, in particular PE791.123v02-00 104/158 AM\1348825EN.docx EN generic and critical medicines and their active substances. If the results demonstrate a risk to the affordability, availability and accessibility of those medicines and active substances, the Commission shall propose measures to address those risks, including legislative proposals and, in particular, the temporary suspension of extended producer responsibility obligations.’ Or. es Justification The attribution by the Commission of most of the micro-pollutant load to pharmaceutical and cosmetic products has been questioned on methodological and scientific grounds. If a new impact assessment identifies significant risks to the production of medicines and active substances in the EU, the Commission should propose a temporary suspension of these obligations. Amendment 396 Carmen Crespo Díaz, Dolors Montserrat, Peter Liese Proposal for a directive Article 4 a – paragraph 1 c (new) Directive (EU) 2024/3019 Article 9 – paragraph 2 – point b a (new) Text proposed by the Commission Amendment Article 4a Amendment to Directive (EU) 2024/3019 (1c) In Article 9, paragraph 2, the following point is inserted: ‘(ba) in relation to investment costs, there are no approved plans and milestones, independent audits of costs and compensation or claw-back mechanisms in relation to the date of entry into operation of the infrastructure;’ Or. es AM\1348825EN.docx 105/158 PE791.123v02-00 EN Justification In relation to extended producer responsibility obligations, safeguards should be provided for in case quaternary treatments are not in place or they are not functioning efficiently. Amendment 397 Carmen Crespo Díaz, Dolors Montserrat, Peter Liese Proposal for a directive Article 4 a – paragraph 1 d (new) Directive (EU) 2024/3019 Article – paragraph 2 – point b b (new) Text proposed by the Commission Amendment Article 4a Amendment to Directive (EU) 2024/3019 (1d) In Article 9, paragraph 2, the following point is inserted: ‘(bb) in relation to operational costs, the infrastructure is not operational or it is not operating efficiently.’ Or. es Justification In relation to extended producer responsibility obligations, safeguards should be provided for in case quaternary treatments are not in place or they are not functioning efficiently. Amendment 398 Andrea Wechsler, Christian Ehler, Jens Gieseke, Angelika Niebler, Oliver Schenk, Norbert Lins, Zala Černilec Tomašič, Peter Liese, Wouter Beke Proposal for a directive Article 4 a (new) Council Directive 92/43/EEC Article 2 – paragraph 3a (new) Text proposed by the Commission Amendment Article 4a Amendments to Council Directive 92/43/EEC PE791.123v02-00 106/158 AM\1348825EN.docx EN In Article 2 of Council Directive 92/43/EEC, the following paragraph is added: ‘3a. By way of derogation from paragraphs 1 and 2, and until 31 December 2035 and in order to achieve the climate neutrality objective and intermediate climate targets referred to in Articles 2 and 4 of Regulation (EU) 2021/1119, the following overarching objectives shall take precedence over the conservation objectives set out in those paragraphs: (a) the industrial transformation and decarbonisation of the Union economy; (b) the energy transition of the Union; (c) the digital transition of the Union. The conservation of natural habitats and of wild fauna and flora as provided for in this Directive shall not constitute an obstacle to the pursuit or achievement of the objectives referred to in the first subparagraph. By 31 December 2034, the Commission shall submit a report to the European Parliament and to the Council on the application of this paragraph, accompanied, where appropriate, by a legislative proposal.’ Or. en (https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A01992L0043-20250714) Justification The amendment supports the Directive’s objective of targeted simplification and more proportionate environmental permitting by introducing a clear legal basis for Member States to apply limited derogations from certain requirements where this is necessary and proportionate for the achievement of climate neutrality, security of energy supply and digital sovereignty. It reflects the strategic importance of accelerating Europe’s industrial transformation as well as the energy and digital transition, while preserving the overall objectives and safeguards of the Directive. In light of the transitional nature of this prioritisation, the amendment provides for a time limit for such projects. AM\1348825EN.docx 107/158 PE791.123v02-00 EN Amendment 399 Andrea Wechsler, Christian Ehler, Jens Gieseke, Angelika Niebler, Oliver Schenk, Norbert Lins, Zala Černilec Tomašič, Peter Liese, Wouter Beke Proposal for a directive Article 4 b (new) Council Directive 92/43/EEC Article 6 – paragraph 4 Present text Amendment Article 4b Amendments to Council Directive 92/43/EEC In Article 6 of Council Directive 92/43/EEC, paragraph 4 is replaced by the following: 4. If, in spite of a negative assessment of the implications for the site and in the absence of alternative solutions, a plan or project must nevertheless be carried out for imperative reasons of overriding public interest, including those of a social or economic nature, the Member State shall take all compensatory measures necessary to ensure that the overall coherence of Natura 2000 is protected. It shall inform the Commission of the compensatory measures adopted. Where the site concerned hosts a priority natural habitat type and/or a priority species, the only considerations which may be raised are those relating to human health or public safety, to beneficial consequences of primary importance for the environment or, further to an opinion from the Commission, to other imperative reasons of overriding public interest. ‘4. If, in spite of a negative assessment of the implications for the site and in the absence of alternative solutions, a plan or project must nevertheless be carried out for imperative reasons of overriding public interest, including those of a social or economic nature, the Member State shall take proportional compensatory measures to ensure that the overall coherence of Natura 2000 is protected. The compensatory measures may be implemented through geographically separate sites or areas. Compensatory measures shall be implemented as soon as practicable and shall be operational no later than five years after the commencement of the plan or project to which they relate. It shall inform the Commission of the compensatory measures adopted. Where the site concerned hosts a priority natural habitat type and/or a priority species, the only considerations which may be raised are those relating to human health or public safety, to beneficial consequences of primary importance for the environment or, further to an opinion from the Commission, to other imperative reasons of overriding public interest. By way of derogation from the second subparagraph, and until 31 December 2035, the objectives referred to in Article PE791.123v02-00 108/158 AM\1348825EN.docx EN 2(4) shall constitute imperative reasons of overriding public interest within the meaning of the first subparagraph of this paragraph, including where the plan or project concerned affects a site hosting a priority natural habitat type and/or a priority species. No opinion from the Commission shall be required in such cases.’ Or. en (https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A01992L0043-20250714) Justification The rebalancing is necessary to support the Directive’s objective of targeted simplification and more proportionate application of Union environmental legislation. Projects which are essential for Europe’s industrial transformation, energy security and digital transition must be capable of being delivered in practice and without disproportionate delays. Recognising such authorised projects as being in the overriding public interest provides greater legal certainty, accelerates permitting and helps ensure that environmental procedures remain efficient, effective and aligned with the Union’s strategic objectives, including climate neutrality and competitiveness. Amendment 400 Andrea Wechsler, Christian Ehler, Jens Gieseke, Angelika Niebler, Oliver Schenk, Norbert Lins, Zala Černilec Tomašič, Peter Liese, Wouter Beke Proposal for a directive Article 4 c (new) Council Directive 92/43/EEC Article 16 Present text Amendment Article 4c Amendments to Council Directive 92/43/EEC Article 16 of Council Directive 92/43/EEC is replaced by the following: 1. Provided that there is no satisfactory alternative and the dero gation is not detrimental to the maintenance of the populations of the species concerned at a favourable conservation status in their ‘1. Provided that there is no satisfactory alternative and the dero gation is not detrimental to the maintenance of the populations of the species concerned at a favourable conservation status in their AM\1348825EN.docx 109/158 PE791.123v02-00 EN natural range, Member States may derogate from the provisions of Articles 12, 13, 14 and 15 (a) and (b): (a) in the interest of protecting wild fauna and flora and conserving natural habitats; (b) to prevent serious damage, in particular to crops, livestock, forests, fisheries and water and other types of property; (c) in the interests of public health and public safety, or for other imperative reasons of overriding public interest, including those of a social or economic nature and beneficial consequences of primary importance for the environment; (d) for the purpose of research and education, of repopulating and re- introducing these species and for the breedings operations necessary for these purposes, including the artificial propagation of plants; (e) to allow, under strictly supervised conditions, on a selective basis and to a limited extent, the taking or keeping of certain specimens of the species listed in Annex IV in limited numbers specified by the competent national authorities. natural range, Member States may derogate from the provisions of Articles 12, 13, 14 and 15 (a) and (b): (a) in the interest of protecting wild fauna and flora and conserving natural habitats; (b) to prevent serious damage, in particular to crops, livestock, forests, fisheries and water and other types of property; (c) in the interests of public health and public safety, or for other imperative reasons of overriding public interest, including those of a social or economic nature, those set out in Article 2(4), and beneficial consequences of primary importance for the environment; (d) for the purpose of research and education, of repopulating and re- introducing these species and for the breedings operations necessary for these purposes, including the artificial propagation of plants; (e) to allow, under strictly supervised conditions, on a selective basis and to a limited extent, the taking or keeping of certain specimens of the species listed in Annex IV in limited numbers specified by the competent national authorities. 1a. Incidental capture, killing or disturbance of specimens of species listed in Annex IV(a), resulting from the planning, construction, repowering, operation or maintenance of energy infrastructure projects authorised in accordance with Union and national law, shall not be considered deliberate within the meaning of Article 12(1), provided that appropriate mitigation measures are applied and that the project does not jeopardise the maintenance of the populations of the species concerned at a favourable conservation status in their natural range. 2. Member States shall forward to the Commission every two years a report in accordance with the format established by the Committee on the derogations applied under paragraph 1. The Commission shall give its opinion on these derogations within a maximum time limit of 12 months 2. Member States shall forward to the Commission every two years a report in accordance with the format established by the Committee on the derogations applied under paragraph 1. The Commission shall give its opinion on these derogations within a maximum time limit of 12 months PE791.123v02-00 110/158 AM\1348825EN.docx EN following receipt of the report and shall give an account to the Committee. following receipt of the report and shall give an account to the Committee. 3. The reports shall specify: (a) the species which are subject to the derogations and the reason for the derogation, including the nature of the risk, with, if appropriate, a reference to alternatives rejected and scientific data used; (b) the means, devices or methods authorized for the capture or killing of animal species and the reasons for their use; (c) the circumstances of when and where such derogations are granted; (d) the authority empowered to declare and check that the required conditions obtain and to decide what means, devices or methods may be used, within what limits and by what agencies, and which persons are to carry out the task; (e) the supervisory measures used and the results obtained. 3. The reports shall specify: (a) the species which are subject to the derogations and the reason for the derogation, including the nature of the risk, with, if appropriate, a reference to alternatives rejected and scientific data used; (b) the means, devices or methods authorized for the capture or killing of animal species and the reasons for their use; (c) the circumstances of when and where such derogations are granted; (d) the authority empowered to declare and check that the required conditions obtain and to decide what means, devices or methods may be used, within what limits and by what agencies, and which persons are to carry out the task; (e) the supervisory measures used and the results obtained.’ Or. en (https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A01992L0043-20250714) Justification The amendment supports the Directive’s objective of targeted simplification and more proportionate environmental permitting. It clarifies that incidental capture, killing or disturbance linked to authorised climate-neutrality projects should not be considered deliberate where appropriate mitigation measures are applied and the conservation status of the species concerned is maintained. This strengthens legal certainty while preserving species protection and enabling the timely deployment of strategic projects necessary for the Union’s industrial transformation, energy security, digital transition and climate-neutrality objective. Amendment 401 Carmen Crespo Díaz, Dolors Montserrat, Peter Liese Proposal for a directive Article 4 a – paragraph 1 a (new) Directive (EU) 2019/904 Article 6 – paragraph 1 Text proposed by the Commission Amendment Article 4a Amendments to Directive (EU) 2019/904 AM\1348825EN.docx 111/158 PE791.123v02-00 EN (1a) in Article 6, paragraph1 is deleted. Or. en Justification Regulation (EU) 2025/40 already contains provisions in relation to packaging design, and recyclability, including the separability of certain elements such as caps and lids. The overly rigid provisions of Directive (EU) 2019/904 concerning straws, lids and caps should be removed due to the increased complexity of production, lack of proportionality and the rejection by a large number of citizens, who consider that there are other priority areas for environmental policies. Amendment 402 Carmen Crespo Díaz, Dolors Montserrat, Peter Liese Proposal for a directive Article 4 a – paragraph 1 b (new) Directive (EU) 2019/904 Article 6 – paragraph 3 Text proposed by the Commission Amendment Article 4a Amendments to Directive (EU) 2019/904 (1b) in Article 6, paragraph 3 is deleted. Or. en Justification Regulation (EU) 2025/40 already contains provisions in relation to packaging design, and recyclability, including the separability of certain elements such as caps and lids. The overly rigid provisions of Directive (EU) 2019/904 concerning straws, lids and caps should be removed due to the increased complexity of production, lack of proportionality and the rejection by a large number of citizens, who consider that there are other priority areas for environmental policies. Amendment 403 Carmen Crespo Díaz, Dolors Montserrat, Peter Liese Proposal for a directive Article 4 a – paragraph 1 c (new) Directive (EU) 2019/904 Article 6 – paragraph 4 PE791.123v02-00 112/158 AM\1348825EN.docx EN Text proposed by the Commission Amendment Article 4a Amendments to Directive (EU) 2019/904 (1c) in Article 6, paragraph 4 is deleted. Or. en Justification Regulation (EU) 2025/40 already contains provisions in relation to packaging design, and recyclability, including the separability of certain elements such as caps and lids. The overly rigid provisions of Directive (EU) 2019/904 concerning straws, lids and caps should be removed due to the increased complexity of production, lack of proportionality and the rejection by a large number of citizens, who consider that there are other priority areas for environmental policies. Amendment 404 Carmen Crespo Díaz, Dolors Montserrat, Peter Liese Proposal for a directive Article 4 a – paragraph 1 d (new) Directive (EU) 2019/904 Article 15 – paragraph 3 – point a Present text Amendment Article 4a Amendments to Directive (EU) 2019/904 (a) an assessment of the need to review the Annex listing single-use plastic products, including as regards caps and lids made of plastic which are used for glass and metal beverage containers; (1d) in Article 15(3), point (a) is replaced by the following: ‘(a) an assessment of the need to review the Annex listing single-use plastic products;’ Or. en Justification Regulation (EU) 2025/40 already contains provisions in relation to packaging design, and recyclability, including the separability of certain elements such as caps and lids. The overly rigid provisions of Directive (EU) 2019/904 concerning straws, lids and caps should be removed due to the increased complexity of production, lack of proportionality and the rejection by a large number of citizens, who consider that there are other priority areas for environmental policies. AM\1348825EN.docx 113/158 PE791.123v02-00 EN Amendment 405 Carmen Crespo Díaz, Dolors Montserrat, Peter Liese Proposal for a directive Article 4 a – paragraph 1 e (new) Directive (EU) 2019/904 Annex – Part B – point 4 Text proposed by the Commission Amendment Article 4a Amendments to Directive (EU) 2019/904 ‘(1e) in the Annex, Part B, point 4 is deleted.’ Or. en Justification Regulation (EU) 2025/40 already contains provisions in relation to packaging design, and recyclability, including the separability of certain elements such as caps and lids. The overly rigid provisions of Directive (EU) 2019/904 concerning straws, lids and caps should be removed due to the increased complexity of production, lack of proportionality and the rejection by a large number of citizens, who consider that there are other priority areas for environmental policies. Amendment 406 Carmen Crespo Díaz, Dolors Montserrat, Peter Liese Proposal for a directive Article 4 a – paragraph 1 f (new) Directive (EU) 2019/904 Annex – Part C Text proposed by the Commission Amendment Article 4a Amendments to Directive (EU) 2019/904 (1f) in the Annex, Part C is deleted. Or. en PE791.123v02-00 114/158 AM\1348825EN.docx EN Justification Regulation (EU) 2025/40 already contains provisions in relation to packaging design, and recyclability, including the separability of certain elements such as caps and lids. The overly rigid provisions of Directive (EU) 2019/904 concerning straws, lids and caps should be removed due to the increased complexity of production, lack of proportionality and the rejection by a large number of citizens, who consider that there are other priority areas for environmental policies. Amendment 407 Andrea Wechsler, Christian Ehler, Jens Gieseke, Angelika Niebler, Oliver Schenk, Norbert Lins, Zala Černilec Tomašič, Peter Liese, Wouter Beke Proposal for a directive Article 4 d (new) Directive 2009/147/EC Article 5 – paragraph 1 a (new) Text proposed by the Commission Amendment Article 4d Directive 2009/147/EC is amended as follows: In Article 5, the following paragraph is added: ‘1a. By way of derogation from paragraph 1, and until 31 December 2035, the prohibitions set out in that paragraph shall not apply to activities, plans or projects that contribute to the objectives referred to in Article 2(4) of Council Directive 92/43/EEC. Member States shall keep records of determinations made pursuant to this paragraph and shall communicate a summary thereof to the Commission annually. By 31 December 2034, the Commission shall submit a report to the European Parliament and to the Council on the application of this paragraph, accompanied, where appropriate, by a legislative proposal.’ Or. en (https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A02009L0147-20190626) AM\1348825EN.docx 115/158 PE791.123v02-00 EN Justification The amendment supports the Directive’s objective of targeted simplification and more proportionate environmental permitting by introducing a clear legal basis for Member States to apply limited derogations from certain requirements where this is necessary and proportionate for the achievement of climate neutrality, security of energy supply and digital sovereignty. It reflects the strategic importance of accelerating Europe’s industrial transformation as well as the energy and digital transition, while preserving the overall objectives, safeguards and existing framework of this Directive. Given the transitional nature of this prioritisation, the amendment provides for a time limit for such projects. Amendment 408 Andrea Wechsler, Christian Ehler, Jens Gieseke, Angelika Niebler, Oliver Schenk, Norbert Lins, Zala Černilec Tomašič, Peter Liese, Wouter Beke Proposal for a directive Article 4 e (new) Directive 2009/147/EC Article 9 – paragraph 1 – pont c a (new) Text proposed by the Commission Amendment Article 4e Directive 2009/147/EC is amended as follows: In Article 9(1), the following point is inserted: ‘(ca) until 31 December 2035, in order to achieve climate neutrality, to support activities, plans or projects that contribute to the objectives referred to in Article 2(4) of Council Directive 92/43/EEC.’ Or. en (https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A02009L0147-20190626) Justification Extending the possibility for Member States to apply limited and proportionate derogations from certain requirements of this Directive to climate-neutrality projects necessary for Europe’s industrial transformation, energy security and digital transition. Amendment 409 PE791.123v02-00 116/158 AM\1348825EN.docx EN Carmen Crespo Díaz, Dolors Montserrat Proposal for a directive Article 4 b (new) Directive 2000/60/EC Article 4 – paragraph 4 a (new) Text proposed by the Commission Amendment Article 4b In Article 4 of Directive 2000/60/EC, the following paragraph is added: ‘4a. By way of derogation from paragraph 4, point (c), the deadlines set out in paragraph 1 may be extended a third time through a further update of the river basin management plans in those Member States seriously affected by climate change and with very arid conditions. To measure the impact of climate change and aridity, an aridity index shall be used, which shall be calculated as the ratio of average annual evapotranspiration to average annual precipitation over a reference period of 30 years. Member States showing an aridity index higher than 1 shall be considered to have very arid conditions. That third extension shall only be possible if all the other conditions set out in paragraph 4 are also met.’ Or. es Justification La Directiva Marco de Aguas fue aprobada en un momento en el que los efectos del cambio climático no estaban completamente integrados en las políticas de la UE. El cumplimiento de los objetivos ambientales fijados en los primeros planes hidrológicos de cuenca es muy complicado en las regiones de la ribera del Mar Mediterráneo, el mar que más rápidamente se está calentando en el mundo, que sufren de forma directa las consecuencias del cambio climático y una aridez extrema que impide la recuperación de las masas de agua con peor calidad, especialmente las aguas subterráneas. Se propone una tercera prórroga para el cumplimiento de los objetivos ambientales de la Directiva, hasta 2033, para evitar impactos económicos y sociales en los países de la UE más afectados por el cambio climático. Mas información sobre el índice de aridez: Aridity Actual | Indicators | Discover the key services, thematic features and tools of Climate-ADAPT Climate-ADAPT AM\1348825EN.docx 117/158 PE791.123v02-00 EN Amendment 410 Andrea Wechsler, Christian Ehler, Jens Gieseke, Angelika Niebler, Oliver Schenk, Norbert Lins, Zala Černilec Tomašič, Peter Liese, Wouter Beke Proposal for a directive Article 4 f (new) Directive 2000/60/EC Article 4 – paragraph 8 a (new) Text proposed by the Commission Amendment Article 4f Amendments to Directive 2000/60/EC In Article 4 of Directive 2000/60/EC, the following paragraph is inserted: ‘8a. By way of derogation from paragraph 7, and until 31 December 2035, Member States shall not be in breach of this Directive where failure to achieve or maintain the objectives set out in paragraph 1 results from activities, plans or projects that contribute to the objectives referred to in Article 2(4) of Council Directive 92/43/EEC, provided that the reasons for the modification or deterioration are specifically set out and explained in the relevant river basin management plan or, where the relevant river basin management plan has not yet been updated, in a standalone notification submitted to the Commission within twelve months of the authorisation of the activity, plan or project concerned. The condition set out in paragraph 7(c) requiring demonstration of overriding public interest and the condition set out in paragraph 7(d) requiring demonstration that the beneficial objectives cannot be achieved by other means shall not apply to activities, plans or projects falling within the scope of this paragraph. For the purposes of applying the deterioration standard under paragraph 1(a)(i), a deterioration of the status of a surface water body shall be deemed to occur only where the overall ecological status PE791.123v02-00 118/158 AM\1348825EN.docx EN classification of the water body declines by one class or more. By 31 December 2034, the Commission shall submit a report to the European Parliament and to the Council on the application of this paragraph, accompanied, where appropriate, by a legislative proposal’ Or. en (https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A02000L0060-20260510) Justification The amendment introduces a clear legal basis for Member States to apply limited and proportionate derogations from certain requirements of this Directive where necessary to achieve climate neutrality, security of energy supply and digital sovereignty. It supports the acceleration of Europe’s industrial transformation as well as the energy and digital transition, while preserving the Directive’s overall objectives, safeguards and existing framework. Given the transitional nature of this prioritisation, the amendment provides for a time limit for such projects. Amendment 411 Andrea Wechsler, Christian Ehler, Jens Gieseke, Angelika Niebler, Oliver Schenk, Norbert Lins, Zala Černilec Tomašič, Peter Liese, Wouter Beke Proposal for a directive Article 4 g (new) Directive (EU) 2024/2881 Article 13 – paragraph 3 a (new) Text proposed by the Commission Amendment Article 4g In Article 13 of Directive (EU) 2024/2881, the following paragraph is inserted: ‘3a. By way of derogation from paragraph 1 and until 31 December 2035, Member States shall not be considered to have failed to fulfil their obligations under this Article where exceedances of the limit values set out in Annex I are attributable, in whole or in material part, to activities, plans or projects contributing to the objectives referred to in Article 2(4) of Council Directive 92/43/EEC. The AM\1348825EN.docx 119/158 PE791.123v02-00 EN Member State concerned shall notify the Commission of the exceedance and its causes. By 31 December 2034, the Commission shall submit a report to the European Parliament and to the Council on the application of this paragraph, accompanied, where appropriate, by a legislative proposal.’; Or. en (https://eur-lex.europa.eu/eli/dir/2024/2881/oj/eng) Justification The amendment supports targeted simplification and more proportionate permitting by introducing a clear legal basis for Member States to apply limited and proportionate derogations from certain requirements of this Directive where necessary to achieve climate neutrality, security of energy supply and digital sovereignty. It reflects the strategic importance of accelerating Europe’s industrial transformation as well as the energy and digital transition, while preserving the Directive’s overall objectives, safeguards and existing framework. Given the transitional nature of this prioritisation, the amendment provides for a time limit for such projects. Amendment 412 Andrea Wechsler, Christian Ehler, Jens Gieseke, Angelika Niebler, Oliver Schenk, Norbert Lins, Zala Černilec Tomašič, Peter Liese, Wouter Beke Proposal for a directive Article 4 h (new) Directive 2011/92/EU Article 4 – paragraph 4 a (new) Text proposed by the Commission Amendment Article 4h Amendments to Directive 2011/92/EU In Article 4 of Directive 2011/92/EU, the following paragraph is inserted: ‘4a. Activities, plans and pProjects that contribute to the objectives referred to in Article 2(4) of Council Directive 92/43/EEC shall, for the purposes of screening under this Article, be presumed not to have significant effects on the PE791.123v02-00 120/158 AM\1348825EN.docx EN environment within the meaning of paragraph 3.’ Or. en (https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A02011L0092-20140515) Justification The amendment introduces a clear legal basis for Member States to apply limited and proportionate derogations from certain requirements of this Directive where necessary to achieve climate neutrality, security of energy supply and digital sovereignty. It supports the timely deployment of projects essential for Europe’s industrial transformation and the energy and digital transition, while preserving the Directive’s overall objectives and safeguards. Given the transitional nature of this prioritisation, the amendment provides for a time limit for such projects. Amendment 413 Andrea Wechsler, Christian Ehler, Jens Gieseke, Angelika Niebler, Oliver Schenk, Norbert Lins, Zala Černilec Tomašič, Peter Liese, Wouter Beke Proposal for a directive Article 4 i (new) Directive 2008/56/EC Article 14 – paragraph 1 Present text Amendment Article 4i Amendments to Directive 2008/56/EC In Article 14 of Directive 2008/56/EC, paragraph 1 is replaced by the following: 1. A Member State may identify instances within its marine waters where, for any of the reasons listed under points (a) to (d), the envi ronmental targets or good environmental status cannot be achieved in every aspect through measures taken by that Member State, or, for reasons referred to under point (e), they cannot be achieved within the time schedule concerned: ‘1. A Member State may identify instances within its marine waters where, for any of the reasons listed under points (a) to (d) and (f), the environmental targets or good environmental status cannot be achieved in every aspect through measures taken by that Member State, or, for reasons referred to under point (e), they cannot be achieved within the time schedule concerned: (a) action or inaction for which the Member State concerned is not responsible; (a) action or inaction for which the Member State concerned is not responsible; (b) natural causes; (b) natural causes; AM\1348825EN.docx 121/158 PE791.123v02-00 EN (c) force majeure; (c) force majeure; (d) modifications or alterations to the physical characteristics of marine waters brought about by actions taken for reasons of overriding public interest which outweigh the negative impact on the environment, including any transboundary impact; (d) modifications or alterations to the physical characteristics of marine waters brought about by actions taken for reasons of overriding public interest, including activities, actions or projects, in order to achieve climate neutrality, that contribute to the objectives referred to in Article 2(4) of Council Directive 92/43/EEC, which outweigh the negative impact on the environment, including any transboundary impact; (e) natural conditions which do not allow timely improvement in the status of the marine waters concerned. (e) natural conditions which do not allow timely improvement in the status of the marine waters concerned; (f) activities, actions or projects, in order to achieve climate neutrality, that contribute to the objectives referred to in Article 2(4) of Council Directive 92/43/EEC. The Member State concerned shall identify such instances clearly in its programme of measures and shall substantiate its view to the Commission. In identifying instances a Member State shall consider the consequences for Member States in the marine region or subregion concerned. However, the Member State concerned shall take appropriate ad-hoc measures aiming to continue pursuing the environmental targets, to prevent further deterioration in the status of the marine waters affected for reasons identified under points (b), (c) or (d) and to mitigate the adverse impact at the level of the marine region or subregion concerned or in the marine waters of other Member States. The Member State concerned shall identify such instances clearly in its programme of measures and shall substantiate its view to the Commission. In identifying instances a Member State shall consider the consequences for Member States in the marine region or subregion concerned. However, the Member State concerned shall take appropriate ad-hoc measures aiming to continue pursuing the environmental targets, to prevent further deterioration in the status of the marine waters affected for reasons identified under points (b), (c) or (d) and to mitigate the adverse impact at the level of the marine region or subregion concerned or in the marine waters of other Member States.’ Or. en (https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A02008L0056-20170607) Justification The amendment introduces a clear legal basis for Member States to apply limited and proportionate derogations from certain requirements of this Directive where necessary to achieve climate neutrality, security of energy supply and digital sovereignty. It supports the PE791.123v02-00 122/158 AM\1348825EN.docx EN timely deployment of projects essential for Europe’s industrial transformation and the energy and digital transition, while preserving the Directive’s overall objectives and safeguards. Given the transitional nature of this prioritisation, the amendment provides for a time limit for such projects. Amendment 414 Jutta Paulus Proposal for a directive Article 5 – paragraph 1 – subparagraph 1 Text proposed by the Commission Amendment Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by [ 24 months from date of entry into force of this Directive] at the latest. They shall forthwith communicate to the Commission the text of those provisions. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with Article 1(2), point (a), of this Directive by … [six months from date of entry into force of this amending Directive] at the latest. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with the other provisions of this Directive by [ 24 months from date of entry into force of this Directive] at the latest. They shall forthwith communicate to the Commission the text of those provisions. Or. en Justification The use of the new standards for suppliers to notify substances of very high concern in articles to ECHA should be transposed within six months from the date of entry into force of this Directive so as to accelerate the simplification. Amendment 415 François-Xavier Bellamy Proposal for a directive Article 5 – paragraph 1 – subparagraph 1 Text proposed by the Commission Amendment AM\1348825EN.docx 123/158 PE791.123v02-00 EN Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by [ 24 months from date of entry into force of this Directive] at the latest. They shall forthwith communicate to the Commission the text of those provisions. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with the provisions of this Directive amending Directive 2010/75/EU by [36 months from date of entry into force of this Directive] at the latest. They shall forthwith communicate to the Commission the text of those provisions. Or. fr Amendment 416 Anna Zalewska Proposal for a directive Article 5 – paragraph 1 – subparagraph 1 Text proposed by the Commission Amendment Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by [ 24 months from date of entry into force of this Directive] at the latest. They shall forthwith communicate to the Commission the text of those provisions. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by [ 36 months from date of entry into force of this Directive] at the latest. They shall forthwith communicate to the Commission the text of those provisions. Or. en Amendment 417 Anne-Sophie Frigout, Valérie Deloge, Gilles Pennelle, Mathilde Androuët, Ondřej Knotek, Jana Nagyová Proposal for a directive Article 5 – paragraph 2 a (new) Text proposed by the Commission Amendment 2a. In relation to installations carrying out activities referred to in Annex Ia to Directive 2010/75/EU, Member States shall apply the laws, regulations and administrative provisions PE791.123v02-00 124/158 AM\1348825EN.docx EN adopted in accordance with this Directive within four years of the entry into force of the implementing act referred to in Article 70i(2). Until the relevant date of application, as referred to in the first subparagraph, the installations mentioned in that subparagraph which fall within the scope of Directive 2010/75/EU in the version in force on the day before this Directive enters into force shall comply with Directive 2010/75/EU. Or. fr Amendment 418 Daniel Buda Proposal for a directive Annex I – point 2 Directive 2010/75/EU Annex Ia Text proposed by the Commission Amendment 2 In Annex Ia to Directive 2010/75/EU, 2. Annex Ia to Directive 2010/75/EU is deleted A )Point 2 is complemented with a third sentence as follows:’ ‘Rearing activities that are carried out under organic production regimes in accordance with Regulation (EU) 2018/848 are excluded.’ b) In the first sentence of point 3, the words ‘or laying hens or other poultry categories’ are inserted after ‘excluding rearing of pigs’. c) Within the section on the LSU level of an installation, ‘Piglets ≤ 20 kg … 0,027’ is replaced by ‘weaners ≤ 20 kg … 0,027’. Or. en (Annex Ia of Directive 2010/75/EU) AM\1348825EN.docx 125/158 PE791.123v02-00 EN Justification Farmers should not be placed in the same category as heavy industrial polluters. Such provisions are disproportionate and lead to a loss of competitiveness of the agricultural sector Amendment 419 François-Xavier Bellamy, Céline Imart Proposal for a directive Annex I – point 2 Directive 2010/75/EU Annex Ia Text proposed by the Commission Amendment 2. In Annex Ia to Directive 2010/75/EU, 2. Annex Ia to Directive 2010/75/EU is replaced by the following: (a) Point 2 is complemented with a third sentence as follows: ‘Rearing of poultry or pigs: ‘Rearing activities that are carried out under organic production regimes in accordance with Regulation (EU) 2018/848 are excluded.’ (a) with more than 85 000 places for poultry; (b) In the first sentence of point 3, the words ‘or laying hens or other poultry categories’ are inserted after ‘excluding rearing of pigs’. (b) with more than 2 000 places for production pigs (over 30 kg); (c) Within the section on the LSU level of an installation, ‘Piglets ≤ 20 kg … 0,027’ is replaced by ‘weaners ≤ 20 kg … 0,027’. (c) with more than 750 places for sows.’ Or. fr Amendment 420 Anne-Sophie Frigout, Valérie Deloge, Gilles Pennelle, Mathilde Androuët, Ondřej Knotek, Jana Nagyová Proposal for a directive Annex I – point 2 Directive 2010/75/EU Annex Ia PE791.123v02-00 126/158 AM\1348825EN.docx EN Text proposed by the Commission Amendment 2. In Annex Ia to Directive 2010/75/EU, 2. Annex Ia to Directive 2010/75/EU is replaced by the following: (a) Point 2 is complemented with a third sentence as follows: ‘Installations fall within the scope of this annex if they come under one of the following activity categories: Intensive rearing of poultry or pigs: ‘Rearing activities that are carried out under organic production regimes in accordance with Regulation (EU) 2018/848 are excluded.’ (a) with more than 40 000 places for poultry; (b) In the first sentence of point 3, the words ‘or laying hens or other poultry categories’ are inserted after ‘excluding rearing of pigs’. (b) with more than 2 000 places for production pigs (over 30 kg); or (c) Within the section on the LSU level of an installation, ‘Piglets ≤ 20 kg … 0,027’ is replaced by ‘weaners ≤ 20 kg … 0,027’. (c) with more than 750 places for sows.’ Or. fr Justification With the new thresholds, too many pig and poultry holdings would have to make additional investments that would be disproportionate to the very limited emissions benefits. We therefore call for a return to the same thresholds and number of places in force under the 2010 directive and for cattle farms to be excluded. Amendment 421 Jessica Polfjärd Proposal for a directive Annex I – point 2 Directive 2010/75/EU Annex Ia Text proposed by the Commission Amendment 2. In Annex Ia to Directive 2010/75/EU, 2. Annex Ia to Directive 2010/75/EU is replaced by the following: AM\1348825EN.docx 127/158 PE791.123v02-00 EN a) Point 2 is complemented with a third sentence as follows: ‘Installations fall within the scope of this annex if they fall within one or more of the following activity categories: ‘Rearing activities that are carried out under organic production regimes in accordance with Regulation (EU) 2018/848 are excluded.’ 1. Rearing of pigs with more than 2,000 production pig places for pigs over 30 kg or with more than 750 sow places. b) In the first sentence of point 3, the words ‘or laying hens or other poultry categories’ are inserted after ‘excluding rearing of pigs’ 2.Rearing of poultry with more than 40,000 poultry places.’; c) Within the section on the LSU level of an installation, ‘Piglets ≤ 20 kg … 0,027’ is replaced by ‘weaners ≤ 20 kg … 0,027’. Or. en(02010L0075-20240804) Amendment 422 Letizia Moratti, Massimiliano Salini, Flavio Tosi Proposal for a directive Annex I – point 2 Directive 2010/75/EU Annex Ia Text proposed by the Commission Amendment 2. In Annex Ia to Directive 2010/75/EU, 2. Annex Ia to Directive 2010/75/EU is replaced by the following: a) Point 2 is complemented with a third sentence as follows: ‘Installations fall within the scope of this annex if they fall within one or more of the following activity categories: ‘Rearing activities that are carried out under organic production regimes in accordance with Regulation (EU) 2018/848 are excluded.’ 1.Rearing of pigs with more than 2,000 production pig places for pigs over 30 kg or with more than 750 sow places. b) In the first sentence of point 3, the words ‘or laying hens or other poultry categories’ are inserted after ‘excluding rearing of pigs’ 2.Rearing of poultry with more than 40,000 poultry places.’; c) Within the section on the LSU level of an installation, ‘Piglets ≤ 20 kg … 0,027’ is replaced by ‘weaners ≤ 20 kg … 0,027’. PE791.123v02-00 128/158 AM\1348825EN.docx EN Or. en(02010L0075-20240804) Amendment 423 Sergio Berlato, Michele Picaro, Pietro Fiocchi, Stefano Cavedagna, Nicola Procaccini, Antonella Sberna, Paolo Inselvini Proposal for a directive Annex I – point 2 Directive 2010/75/EU Annex I a Text proposed by the Commission Amendment 2. In Annex Ia to Directive 2010/75/EU, 2. Annex Ia to Directive 2010/75/EU is replaced by the following: (a) Point 2 is complemented with a third sentence as follows: ‘Activities referred to in Article 70a ‘Rearing activities that are carried out under organic production regimes in accordance with Regulation (EU) 2018/848 are excluded.’; Installations fall within the scope of this annex if they fall within one or more of the following activity categories: (b) In the first sentence of point 3, the words ‘or laying hens or other poultry categories’ are inserted after ‘excluding rearing of pigs’; 1. Rearing of pigs with more than 2 000 places for production pigs over 30 kg, or with more than 750 places for sows. (c) Within the section on the LSU level of an installation, ‘Piglets ≤ 20 kg … 0,027’ is replaced by ‘weaners ≤ 20 kg … 0,027’. 2. Rearing of poultry with more than 40 000 places for poultry.’ Or. it (https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=OJ:L_202401785) Amendment 424 Alexander Bernhuber Proposal for a directive Annex I – point 2 Directive 2010/75/EU Annex Ia Text proposed by the Commission Amendment 2. In Annex Ia to Directive 2010/75/EU, 2. Annex Ia is replaced by the following: AM\1348825EN.docx 129/158 PE791.123v02-00 EN a) Point 2 is complemented with a third sentence as follows: ‘Activities referred to in Article 70a ‘Rearing activities that are carried out under organic production regimes in accordance with Regulation (EU) 2018/848 are excluded.’ Installations carrying out organic production in accordance with Regulation (EU) 2018/848, as well as installations applying animal welfare measures exceeding applicable Union minimum requirements, shall be excluded from the scope of this Annex. Installations fall within the scope of this annex if they fall within one or more of the following activity categories: b) In the first sentence of point 3, the words ‘or laying hens or other poultry categories’ are inserted after ‘excluding rearing of pigs’. 1. Rearing of pigs representing 600 LSU or more, excluding rearing activities that are carried out under organic production regimes in accordance with Regulation (EU) 2018/848, or where the stocking density is less than 2 LSU/hectare used only for grazing or growing fodder or forage used for feeding the animals and the animals are reared outside for a significant amount of time in a year or seasonally reared outside. c) Within the section on the LSU level of an installation, ‘Piglets ≤ 20 kg … 0,027’ is replaced by ‘weaners ≤ 20 kg … 0,027’ 2. Rearing of only laying hens representing 560 LSU or more, or rearing of only other poultry categories representing 560 LSU or more. In installations rearing a mix of poultry including laying hens, the threshold shall be 560 LSU and the capacity shall be calculated using 0,93 as weighting factor ( 1 ) for laying hens. 3. Rearing of any mix of pigs or poultry representing 600 LSU or more, excluding rearing of pigs in installations operating under organic production regimes in accordance with Regulation (EU) 2018/848, or where the stocking density is less than 2 LSU/hectare used only for grazing or growing fodder or forage used for feeding the animals and the animals are reared outside for a significant amount of time in a year or seasonally reared outside. PE791.123v02-00 130/158 AM\1348825EN.docx EN The LSU level of an installation is calculated using the following conversion rates: Pigs: Breeding sows ≥ 50 kg … 0,500 Piglets ≤ 20 kg … 0,027 Other pigs … 0,300 Poultry: Broilers … 0,007 Laying hens … 0,014 Turkeys … 0,030 Ducks … 0,010 Geese … 0,020 Ostriches … 0,350 Other poultry fowls … 0,001’; Or. en (Directive 2010/75/EU) Amendment 425 Jutta Paulus Proposal for a directive Annex I – point 2 Directive 2010/75/EU Annex Ia Text proposed by the Commission Amendment 2. In Annex Ia to Directive 2010/75/EU, deleted a) Point 2 is complemented with a third sentence as follows: Rearing activities that are carried out under organic production regimes in accordance with Regulation (EU) 2018/848 are excluded. b) In the first sentence of point 3, the words ‘or laying hens or other poultry AM\1348825EN.docx 131/158 PE791.123v02-00 EN categories’ are inserted after ‘excluding rearing of pigs’. c) Within the section on the LSU level of an installation, ‘Piglets ≤ 20 kg … 0,027’ is replaced by ‘weaners ≤ 20 kg … 0,027’. Or. en Amendment 426 Grégory Allione Proposal for a directive Annex I –point 2 – point (-a) (new) Directive 2010/75/EU Annex Ia – point 1 Present text Amendment (-a) point 1 is replaced by the following: Rearing of pigs representing 350 LSU or more, excluding rearing activities that are carried out under organic production regimes in accordance with Regulation (EU) 2018/848, or where the stocking density is less than 2 LSU/hectare used only for grazing or growing fodder or forage used for feeding the animals and the animals are reared outside for a significant amount of time in a year or seasonally reared outside. ‘1. Rearing of pigs with more than 2 000 places for production pigs over 30 kg, or with more than 750 places for sows.’_; Or. en Amendment 427 Alexander Bernhuber Proposal for a directive Annex I – point 2 - point -a (new) 2010/75/EU Annex Ia – point 1 Present text Amendment PE791.123v02-00 132/158 AM\1348825EN.docx EN (-a) point 1 is replaced by the following Rearing of pigs representing 350 LSU or more, excluding rearing activities that are carried out under organic production regimes in accordance with Regulation (EU) 2018/848, or where the stocking density is less than 2 LSU/hectare used only for grazing or growing fodder or forage used for feeding the animals and the animals are reared outside for a significant amount of time in a year or seasonally reared outside. 1. Rearing of pigs with more than 2 000 places for production pigs over 30 kg, or with more than 750 places for sows. Or. en (Directive 2010/75/EU) Amendment 428 Sergio Berlato, Michele Picaro, Pietro Fiocchi, Stefano Cavedagna, Nicola Procaccini, Antonella Sberna, Paolo Inselvini Proposal for a directive Annex I – point 2 – point -a (new) Directive 2010/75/EU Annex I a – paragraph 1 Present text Amendment (-a) paragraph 1 is replaced by the following: 1. Rearing of pigs representing 350 LSU or more, excluding rearing activities that are carried out under organic production regimes in accordance with Regulation (EU) 2018/848, or where the stocking density is less than 2 LSU/hectare used only for grazing or growing fodder or forage used for feeding the animals and the animals are reared outside for a significant amount of time in a year or seasonally reared outside. ‘1. Rearing of pigs with more than 2 000 places for production pigs of more than 30 kg, or with more than 750 places for sows, excluding rearing activities that are carried out under organic production regimes in accordance with Regulation (EU) 2018/848, or where the stocking density is less than 2 LSU/hectare in nitrate vulnerable zones (ZVN) and 4 LSU/hectare in non-NVZ zones used only for grazing or growing fodder or forage used for feeding the animals and the animals are reared outside for a significant amount of time in a year or seasonally reared outside.’ AM\1348825EN.docx 133/158 PE791.123v02-00 EN Or. it (https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=OJ:L_202401785) Amendment 429 Alexander Bernhuber Proposal for a directive Annex I – point 2 – point a Directive 2010/75/EU Annex Ia – point 2 Text proposed by the Commission Amendment a) Point 2 is complemented with a third sentence as follows: a) Point 2 is replaced by the following: Rearing activities that are carried out under organic production regimes in accordance with Regulation (EU) 2018/848 are excluded. ‘Rearing of poultry with more than 40 000 places.’; Or. en Amendment 430 Grégory Allione Proposal for a directive Annex I – point 2 – point a Directive 2010/75/EU Annex Ia – point 2 Text proposed by the Commission Amendment a) Point 2 is complemented with a third sentence as follows: a) Point 2 is replaced by the following: Rearing activities that are carried out under organic production regimes in accordance with Regulation (EU) 2018/848 are excluded. Rearing of poultry with more than 40 000 places. Or. en Amendment 431 PE791.123v02-00 134/158 AM\1348825EN.docx EN Sergio Berlato, Michele Picaro, Pietro Fiocchi, Stefano Cavedagna, Nicola Procaccini, Antonella Sberna, Paolo Inselvini Proposal for a directive Annex I – point 2 – point a Directive (EU) 2010/75/EU Annex I a – point 2 Text proposed by the Commission Amendment (a) in point 2, the following text is added: (a) point 2 is replaced by the following: ‘Rearing activities that are carried out under organic production regimes in accordance with Regulation (EU) 2018/848 are excluded.’; ‘2. Rearing of poultry with more than 40 000 places for poultry, excluding rearing activities that are carried out under organic production regimes in accordance with Regulation (EU) 2018/848.’; Or. it (https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=OJ:L_202401785) Amendment 432 Grégory Allione Proposal for a directive Annex I – point 2 – point b Directive 2010/75/EU Annex Ia – point 3 Text proposed by the Commission Amendment b) In the first sentence of point 3, the words ‘or laying hens or other poultry categories’ are inserted after ‘excluding rearing of pigs’. b) point 3 is deleted. Or. en Amendment 433 Alexander Bernhuber Proposal for a directive Annex I – point 2 – point b AM\1348825EN.docx 135/158 PE791.123v02-00 EN Directive 2010/75/EU Annex Ia – point 3 Text proposed by the Commission Amendment b) In the first sentence of point 3, the words ‘or laying hens or other poultry categories’ are inserted after ‘excluding rearing of pigs’. deleted Or. en Amendment 434 Sergio Berlato, Michele Picaro, Pietro Fiocchi, Stefano Cavedagna, Nicola Procaccini, Antonella Sberna, Paolo Inselvini Proposal for a directive Annex I – point 2 – point b Directive 2010/75/EU Annex I a – point 3 Text proposed by the Commission Amendment (b) In the first sentence of point 3, the words ‘or laying hens or other poultry categories’ are inserted after ‘excluding rearing of pigs’; (b) Point 3 is deleted; Or. it (https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=OJ:L_202401785) Amendment 435 Jutta Paulus Proposal for a directive Annex I – point 2 – point b Directive 2010/75/EU Annex Ia – point 3 Text proposed by the Commission Amendment b) In the first sentence of point 3, the deleted PE791.123v02-00 136/158 AM\1348825EN.docx EN words ‘or laying hens or other poultry categories’ are inserted after ‘excluding rearing of pigs’. Or. en Amendment 436 Sergio Berlato, Michele Picaro, Pietro Fiocchi, Stefano Cavedagna, Nicola Procaccini, Antonella Sberna, Paolo Inselvini Proposal for a directive Annex I – point 2 – point b a (new) Directive 2010/75/EU Annex I a – subparagraph 2 (new) Text proposed by the Commission Amendment (ba) the following subparagraph is inserted after the first subparagraph: ‘By way of derogation from the previous subparagraph, an exclusion applies to rearing activities that are carried out under organic production regimes in accordance with Regulation (EU) 2018/848, or where the stocking density is less than 2 LSU/hectare in nitrate vulnerable zones (ZVN) and 4 LSU/hectare in non-NVZ zones used only for grazing or growing fodder or forage used for feeding the animals, and the animals are reared outside for a significant amount of time in a year or seasonally reared outside.’; Or. it Amendment 437 Sergio Berlato, Michele Picaro, Pietro Fiocchi, Stefano Cavedagna, Nicola Procaccini, Antonella Sberna, Paolo Inselvini Proposal for a directive Annex I – point 2 – point c Directive 2010/75/EU Annex I a – subparagraph 2 Text proposed by the Commission Amendment AM\1348825EN.docx 137/158 PE791.123v02-00 EN (c) Within the section on the LSU level of an installation, ‘Piglets ≤ 20 kg … 0,027’ is replaced by ‘Weaners ≤ 20 kg … 0,027’. (c) The second subparagraph is replaced by the following: ‘The LSU level of an installation is calculated using the following conversion rates: Pigs: Breeding sows ≥ 100 kg (including farrowing sows) … 0,500 Weaners ≤ 30 kg … 0,027 Other pigs … 0,300 Poultry: Broilers … 0,007 Laying hens … 0,014 Turkeys … 0,030 Ducks … 0,010 Geese … 0,020 Ostriches … 0,350 Other poultry fowls … 0,001’ Or. it (https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=OJ:L_202401785) Amendment 438 Jutta Paulus Proposal for a directive Annex I – point 2 – point c Directive 2010/75/EU Annex Ia Text proposed by the Commission Amendment c) Within the section on the LSU level of an installation, ‘Piglets ≤ 20 kg … 0,027’ is replaced by ‘weaners ≤ 20 kg … 0,027’. deleted Or. en PE791.123v02-00 138/158 AM\1348825EN.docx EN Amendment 439 Michal Wiezik, Martin Hojsík Proposal for a directive Annex I – point 2 – point c a (new) Directive 2010/75/EU Annex Ia Text proposed by the Commission Amendment ca) in the second paragraph, under the heading “Poultry”, ‘Pullets … 0,007’ is inserted after ‘Laying hens … 0,014’. Or. en Amendment 440 Ondřej Knotek, Jana Nagyová, Antonín Staněk, Anne-Sophie Frigout Proposal for a directive Annex I – point 3 – point (-a) (new) Directive 2010/75/EU Annex V – Part 1 – point 3 Present text Amendment (-a) in Part 1, point 3 is amended as follows: ANNEX V ‘ANNEX V Technical provisions relating to combustion plants Technical provisions relating to combustion plants PART 1 PART 1 Emission limit values for combustion plants referred to in Article 30(2) Emission limit values for combustion plants referred to in Article 30(2) (...) (...) 3. Emission limit values (mg/Nm 3 ) for SO 2 for combustion plants using gaseous fuels with the exception of gas turbines and gas engines 3. Emission limit values (mg/Nm 3 ) for SO 2 for combustion plants using gaseous fuels other than natural gas with the exception of gas turbines and gas engines (...) (...) Or. en (Directive (EU) 2024/1785, amending Directive 2010/75/EU) AM\1348825EN.docx 139/158 PE791.123v02-00 EN Justification Requiring continuous measurement of emissions of particulate matter and sulfur dioxide is not logical for boilers burning natural gas. Burning natural gas cannot release these pollutants into the air. This is therefore only an unnecessary administrative burden for the operators concerned. Amendment 441 Jeannette Baljeu, Andreas Glück, Ilhan Kyuchyuk, Katri Kulmuni Proposal for a directive Annex I – point 3 – point a Directive 2010/75/EU Annex V – Part 1 – point 6 – footnote 5 Text proposed by the Commission Amendment (5) The emission limit value is not applicable to combustion plants firing gas with more than 20 % (by volume) of hydrogen. In such case, Member States shall ensure that the overall load of NOx eventually released into the air over one year is not increased compared to the situation where the emissions from the installation concerned remained compliant with emission limit values set out in this point for NOx for the combustion of natural gas, without prejudice to stricter measures required pursuant to Article 18.; (5) The emission limit value is not applicable to combustion plants firing gas with more than 20 % by volume of hydrogen, or to combustion plants operating under a time-bound fuel- switching trajectory approved by the competent authority to progressively increase the share of hydrogen in the fuel mix. In both cases, Member States shall ensure that the overall load of NOx eventually released into the air over one year is not increased compared to the situation where the emissions from the installation concerned remained compliant with emission limit values set out in this point for NOx for the combustion of natural gas, without prejudice to stricter measures required pursuant to Article 18. The competent authority shall ensure appropriate monitoring of the hydrogen share and the annual NOx load and shall review the applicability of this footnote where the approved fuel-switching trajectory is not implemented.; Or. en PE791.123v02-00 140/158 AM\1348825EN.docx EN Justification The Commission proposal recognises that existing NOx concentration limits may create barriers for hydrogen combustion, while retaining the safeguard that the annual NOx load may not increase. Extending this approach to installations following a credible and approved fuel-switching trajectory avoids a cliff-edge at 20 % hydrogen and supports gradual industrial decarbonisation, while preserving the key environmental safeguard. Amendment 442 Michal Wiezik, Martin Hojsík Proposal for a directive Annex I – point 3 – point a Directive 2010/75/EU Annex V – Part 1 – point 6 – footnote 5 Text proposed by the Commission Amendment (5) The emission limit value is not applicable to combustion plants firing gas with more than 20 % (by volume) of hydrogen. In such case, Member States shall ensure that the overall load of NOx eventually released into the air over one year is not increased compared to the situation where the emissions from the installation concerned remained compliant with emission limit values set out in this point for NOx for the combustion of natural gas, without prejudice to stricter measures required pursuant to Article 18.; (5) The emission limit value is not applicable to combustion plants firing gas with more than 20 % (by volume) of hydrogen provided that the hydrogen is sourced from fossil-free sources, preferably renewable sources; and its use results in a significant reduction in lifecycle greenhouse gas emissions compared to conventional fossil fuel combustion and contributes to the deep industrial transformation referred to in Article 3(9a) of this Directive. Where this is the case, Member States shall ensure that the overall load of NOx eventually released into the air over one year is not increased compared to the situation where the emissions from the installation concerned remained compliant with emission limit values set out in this point for NOx for the combustion of natural gas, without prejudice to stricter measures required pursuant to Article 18.; Or. en Amendment 443 Ondřej Knotek, Jana Nagyová, Antonín Staněk, Anne-Sophie Frigout AM\1348825EN.docx 141/158 PE791.123v02-00 EN Proposal for a directive Annex I – point 3 – point a Directive 2010/75/EU Annex V – Part 1 – point 6 – footnote 5 Text proposed by the Commission Amendment (5) The emission limit value is not applicable to combustion plants firing gas with more than 20 % (by volume) of hydrogen. In such case, Member States shall ensure that the overall load of NOx eventually released into the air over one year is not increased compared to the situation where the emissions from the installation concerned remained compliant with emission limit values set out in this point for NOx for the combustion of natural gas, without prejudice to stricter measures required pursuant to Article 18.; (5) The emission limit value is not applicable to combustion plants firing gas with more than 5 % (by volume) of hydrogen. This without prejudice to stricter measures required pursuant to Article 18.; Or. en Justification It is unclear how it will be possible to meet the condition requiring that the amount of NOx emissions produced under the relevant emission limit when burning natural gas not be exceeded in case when the exemption from the NOx emission limit is applied. Amendment 444 Jutta Paulus Proposal for a directive Annex I – point 3 – point a Directive 2010/75/EU Annex V – Part 1 – point 6 – footnote 5 Text proposed by the Commission Amendment (5) The emission limit value is not applicable to combustion plants firing gas with more than 20 % (by volume) of hydrogen. In such case, Member States shall ensure that the overall load of NOx eventually released into the air over one (5) The emission limit value is not applicable to combustion plants firing gas with more than 20 % (by volume) of hydrogen, provided the substitution by hydrogen of previously used fuel results in at least 15% total greenhouse gas PE791.123v02-00 142/158 AM\1348825EN.docx EN year is not increased compared to the situation where the emissions from the installation concerned remained compliant with emission limit values set out in this point for NOx for the combustion of natural gas, without prejudice to stricter measures required pursuant to Article 18.; emissions reduction. In such case, Member States shall ensure that the overall load of NOx eventually released into the air over one year is not increased compared to the situation where the emissions from the installation concerned remained compliant with emission limit values set out in this point for NOx for the combustion of natural gas, without prejudice to stricter measures required pursuant to Article 18.; Or. en Amendment 445 Thomas Bajada, Annalisa Corrado Proposal for a directive Annex I – point 3 – point a Directive 2010/75/EC Annex V – Part 1 – point 6 – footnote 5 Text proposed by the Commission Amendment (5) The emission limit value is not applicable to combustion plants firing gas with more than 20 % (by volume) of hydrogen. In such case, Member States shall ensure that the overall load of NOx eventually released into the air over one year is not increased compared to the situation where the emissions from the installation concerned remained compliant with emission limit values set out in this point for NOx for the combustion of natural gas, without prejudice to stricter measures required pursuant to Article 18.; (5) The emission limit value is not applicable to combustion plants firing gas with more than 30 % (by volume) of hydrogen. In such case, Member States shall ensure that the overall load of NOx eventually released into the air over one year is not increased compared to the situation where the emissions from the installation concerned remained compliant with emission limit values set out in this point for NOx for the combustion of natural gas, without prejudice to stricter measures required pursuant to Article 18.; Or. en Amendment 446 Ondřej Knotek, Jana Nagyová, Antonín Staněk, Anne-Sophie Frigout Proposal for a directive Annex I, point 3, point (aa) (new) Directive 2010/75/EU AM\1348825EN.docx 143/158 PE791.123v02-00 EN Annex V – Part 1 – point 8 Present text Amendment (aa) in Part 1, point 8 is amended as follows: ANNEX V "ANNEX V Technical provisions relating to combustion plants Technical provisions relating to combustion plants PART 1 PART 1 Emission limit values for combustion plants referred to in Article 30(2) Emission limit values for combustion plants referred to in Article 30(2) (...) (...) 8. Emission limit values (mg/Nm 3 ) for SO 2 for combustion plants using gaseous fuels with the exception of gas turbines and gas engines 8. Emission limit values (mg/Nm 3 ) for SO 2 for combustion plants using gaseous fuels other than natural gas with the exception of gas turbines and gas engines (...) (...)" Or. en (Directive (EU) 2024/1785, amending Directive 2010/75/EU) Justification Requiring continuous measurement of emissions of particulate matter and sulfur dioxide is not logical for boilers burning natural gas. Burning natural gas cannot release these pollutants into the air. This is therefore only an unnecessary administrative burden for the operators concerned. Amendment 447 Michal Wiezik, Martin Hojsík Proposal for a directive Annex I – point 3 – point b Directive 2010/75/EC Annex V – part 2 – point 6 Text proposed by the Commission Amendment The emission limit value is not applicable to combustion plants firing gas with more than 20 % (by volume) of hydrogen. In such case, Member States shall ensure that the overall load of NOx eventually released The emission limit value is not applicable to combustion plants firing gas with more than 20 % (by volume) of hydrogen, provided that the hydrogen is sourced from fossil-free sources, preferably PE791.123v02-00 144/158 AM\1348825EN.docx EN into the air over one year is not increased compared to the situation where the emissions from the installation concerned remained compliant with emission limit values set out in this point for NOx , without prejudice to stricter measures required pursuant to Article 18.; renewable sources; and its use results in a significant reduction in lifecycle greenhouse gas emissions compared to conventional fossil fuel combustion and contributes to the deep industrial transformation referred to in Article 3(9a) of this Directive. Where this is the case, Member States shall ensure that the overall load of NOx eventually released into the air over one year is not increased compared to the situation where the emissions from the installation concerned remained compliant with emission limit values set out in this point for NOx , without prejudice to stricter measures required pursuant to Article 18.; Or. en Justification Related to the previous amendment on the footnote. combustion of hydrogen doesnt produce emissions, but also how hydrogen was produced should matter, and the lifecycle emissions of that hydrogen should be taken into account. Amendment 448 Thomas Bajada, Annalisa Corrado Proposal for a directive Annex I – point 3 – point b Directive 2010/75/EC Annex V – Part 2 – point 6 – last subparagraph Text proposed by the Commission Amendment The emission limit value is not applicable to combustion plants firing gas with more than 20 % (by volume) of hydrogen. In such case, Member States shall ensure that the overall load of NOx eventually released into the air over one year is not increased compared to the situation where the emissions from the installation concerned remained compliant with emission limit values set out in this point for NOx , without prejudice to stricter measures required pursuant to Article 18.; The emission limit value is not applicable to combustion plants firing gas with more than 30 % (by volume) of hydrogen. In such case, Member States shall ensure that the overall load of NOx eventually released into the air over one year is not increased compared to the situation where the emissions from the installation concerned remained compliant with emission limit values set out in this point for NOx , without prejudice to stricter measures required pursuant to Article 18.; AM\1348825EN.docx 145/158 PE791.123v02-00 EN Or. en Amendment 449 Ondřej Knotek, Jana Nagyová, Antonín Staněk, Anne-Sophie Frigout Proposal for a directive Annex I – point 3 – point b Directive 2010/75/EU Annex V – Part 2 – point 6 – last subparagraph Text proposed by the Commission Amendment The emission limit value is not applicable to combustion plants firing gas with more than 20 % (by volume) of hydrogen. In such case, Member States shall ensure that the overall load of NOx eventually released into the air over one year is not increased compared to the situation where the emissions from the installation concerned remained compliant with emission limit values set out in this point for NOx , without prejudice to stricter measures required pursuant to Article 18.; The emission limit value is not applicable to combustion plants firing gas with more than 5 % (by volume) of hydrogen. This without prejudice to stricter measures required pursuant to Article 18.; Or. en Justification It is unclear how it will be possible to meet the condition requiring that the amount of NOx emissions produced under the relevant emission limit when burning natural gas not be exceeded in case when the exemption from the NOx emission limit is applied. Amendment 450 Jutta Paulus Proposal for a directive Annex I – point 3 – point b Directive 2010/75/EU Annex V – Part 2 – point 6 – last subparagraph Text proposed by the Commission Amendment The emission limit value is not applicable to combustion plants firing gas with more than 20 % (by volume) of hydrogen. In The emission limit value is not applicable to combustion plants firing gas with more than 20 % (by volume) of hydrogen, PE791.123v02-00 146/158 AM\1348825EN.docx EN such case, Member States shall ensure that the overall load of NOx eventually released into the air over one year is not increased compared to the situation where the emissions from the installation concerned remained compliant with emission limit values set out in this point for NOx , without prejudice to stricter measures required pursuant to Article 18.; provided the substitution by hydrogen of the previously used fuel results in at least 15% total greenhouse gas emissions reduction. In such case, Member States shall ensure that the overall load of NOx eventually released into the air over one year is not increased compared to the situation where the emissions from the installation concerned remained compliant with emission limit values set out in this point for NOx , without prejudice to stricter measures required pursuant to Article 18.; Or. en Amendment 451 Ondřej Knotek, Jana Nagyová, Antonín Staněk, Anne-Sophie Frigout Proposal for a directive Annex I - point 3 - point ba (new) Directive 2010/75/EU Annex V – Part 2 – point 8 Present text Amendment (ba) in Part 2, point 8 is amended as follows: ANNEX V ‘ANNEX V Technical provisions relating to combustion plants Technical provisions relating to combustion plants PART 2 PART 2 Emission limit values for combustion plants referred to in Article 30(3) Emission limit values for combustion plants referred to in Article 30(3) (...) (...) 8. Emission limit values (mg/Nm 3 ) for dust for combustion plants using gaseous fuels with the exception of gas turbines and gas engines 8. Emission limit values (mg/Nm 3 ) for dust for combustion plants using gaseous fuels other than natural gas with the exception of gas turbines and gas engines (...) (...)’ Or. en AM\1348825EN.docx 147/158 PE791.123v02-00 EN (Directive (EU) 2024/1785, amending Directive 2010/75/EU) Justification Requiring continuous measurement of emissions of particulate matter and sulfur dioxide is not logical for boilers burning natural gas. Burning natural gas cannot release these pollutants into the air. This is therefore only an unnecessary administrative burden for the operators concerned. Amendment 452 Ondřej Knotek, Jana Nagyová, Antonín Staněk, Anne-Sophie Frigout Proposal for a directive Annex I - point 3 - point ba (new) Directive 2010/75/EU Annex V – Part 3 – point 3 Present text Amendment 3a. in Annex V, Part 3, point 3 is amended as follows ANNEX V "ANNEX V Technical provisions relating to combustion plants Technical provisions relating to combustion plants (...) (...) PART 3 PART 3 Emission monitoring Emission monitoring (...) (...) 3. Where continuous measurements are not required, measurements of SO 2 , NO x , dust and, for gas fired plants, also of CO shall be required at least once every 6 months. 3. Where continuous measurements are not required, measurements of SO 2 , NO x , dust and, for gas fired plants, also of CO shall be required at least once every 6 months. This shall not apply to combustion plants burning natural gas, where only NOx and CO shall be measured. (...) (...)" Or. en (Directive (EU) 2024/1785, amending Directive 2010/75/EU) PE791.123v02-00 148/158 AM\1348825EN.docx EN Justification Continuous measurement of emissions of particulate matter and sulfur dioxide is not mandatory for natural gas combustion sources in the case of turbines and engines. However, these sources still have to measure these pollutants on a one-off basis, even though the combustion of natural gas cannot release these pollutants into the air. This is therefore only an unnecessary administrative burden for the operators concerned. Amendment 453 Jutta Paulus Proposal for a directive Annex I – point 3 – point c Directive 2010/75/EU Annex V – Part 4 – point 5 Text proposed by the Commission Amendment 5. In the case of complete replacement of ambient air with oxygen, the emission limit values referred to in Article 30 shall be regarded as having been complied with if the emissions are not higher than the emissions from the combustion of the given fuel at the standardised O2 content. 5. In the case of complete replacement of ambient air with oxygen, the emission limit values referred to in Article 30 shall be regarded as having been complied with if the emissions are not higher than the emissions from the combustion of the given fuel at the standardised O2 content. In such case, Member States shall ensure that the overall load of pollutants eventually released into the air over one year is not increased compared to the situation where the emissions from the installation concerned remained compliant with the emission limit values set out under conventional air-firing conditions. Or. en Amendment 454 Sergio Berlato, Michele Picaro, Pietro Fiocchi, Stefano Cavedagna, Nicola Procaccini, Antonella Sberna, Paolo Inselvini Proposal for a directive Annex I – point 3 a (new) Directive 2010/75/EU Annex VI – Part 4 – paragraph 2.1 AM\1348825EN.docx 149/158 PE791.123v02-00 EN Present text Amendment 3a. in Annex VI, part 4, paragraph 2.1 is replaced by the following: The emission limit values set out in points 2.2 and 2.3 apply as daily average values for total dust, HCl, HF, NOx, SO2 and TOC (for continuous measurements), as average values over the sampling period of a minimum of 30 minutes and a maximum of 8 hours for heavy metals and as average values over the sampling period of a minimum of 6 hours and a maximum of 8 hours for dioxins and furans. ‘The emission limit values set out in points 2.2 and 2.3 apply as daily average values for total dust, HCl, HF, NOx, SO2 and TOC (for continuous measurements), as average values over the sampling period of a minimum of 30 minutes and a maximum of 8 hours for heavy metals and as average values over the sampling period of a minimum of 6 hours and a maximum of 8 hours for dioxins and furans. All values are standardised at 10 % oxygen. All values are standardised at 10 % oxygen. Half-hourly average values shall only be needed in view of calculating the daily average values. Half-hourly average values shall only be needed in view of calculating the daily average values. In the event that the competent authority chooses to set emission limit values in accordance with Art. 15 (3b) of this Directive, these limit values can be set as freight-related values, such as g/t product.’; Or. en (https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32010L0075) Amendment 455 Katri Kulmuni Proposal for a directive Annex II – point 1 Directive (EU) 2015/2193 Annex II Text proposed by the Commission Amendment 1. Annex II to Directive (EU) 2015/2193 is amended as follows: deleted (a) In Part 1, tables 1, 2 and 3 as regards the emission limit values for PE791.123v02-00 150/158 AM\1348825EN.docx EN emission of NOx when gaseous fuels other than natural gas are used, the following footnote is inserted after the figures mentioned in the seventh column regarding that pollutant: (*) The emission limit value is not applicable to combustion plants firing gas with more than 20 % (by volume) of hydrogen. Member States shall ensure that the overall load of NOx eventually released into the air over one year is not increased compared to the situation where the emissions from the installation concerned remained compliant with emission limit values set out in Part 1 of Annex II for NOx for the combustion of natural gas, without prejudice to stricter measures required pursuant to Article 6 (9).; (b) In Part 2, tables 1 and 2, as regards the emission limit values for emission of NOx when gaseous fuels other than natural gas are used, the following footnote is inserted after the figures mentioned in the sixth column regarding that pollutant: (*) The emission limit value is not applicable to combustion plants firing gas with more than 20 % (by volume) of hydrogen. Member States shall ensure that the overall load of NOx eventually released into the air over one year is not increased compared to the situation where the emissions from the installation concerned remained compliant with emission limit values set out in Part 2 of Annex II for NOx for the combustion of natural gas, without prejudice to stricter measures required pursuant to Article 6 (9).; Or. en Justification The MCP Directive contains specific emission limit values (ELVs) for the category “Other gaseous fuel” and these values are higher than the ELVs for natural gas. Under MCPD AM\1348825EN.docx 151/158 PE791.123v02-00 EN hydrogen is classified as other gaseous fuel. The MCPD contains a mixing rule, which sets weighted ELVs based on the share of each fuel in the combustion process. The ELVS established via mixing rule would be sufficient to take into account the slighthly higher NOx emission originating from the combustion of hydrogen, so the provisions proposed by the Commission are not necessary. Furthermore, the Commission proposal is very combersome to apply in practice and add administrative burden, thus working against the objectives of this proposal. Amendment 456 Ondřej Knotek, Jana Nagyová, Antonín Staněk, Anne-Sophie Frigout Proposal for a directive Annex II – point 1 – point a Directive (EU) 2015/2193 Annex II – Part 1 – tables 1, 2 and 3 – footnote Text proposed by the Commission Amendment (*) The emission limit value is not applicable to combustion plants firing gas with more than 20 % (by volume) of hydrogen. Member States shall ensure that the overall load of NOx eventually released into the air over one year is not increased compared to the situation where the emissions from the installation concerned remained compliant with emission limit values set out in Part 1 of Annex II for NOx for the combustion of natural gas, without prejudice to stricter measures required pursuant to Article 6 (9).; (*) The emission limit value is not applicable to combustion plants firing gas with more than 5 % (by volume) of hydrogen. This without prejudice to stricter measures required pursuant to Article 6 (9).; Or. en Justification It is unclear how it will be possible to meet the condition requiring that the amount of NOx emissions produced under the relevant emission limit when burning natural gas not be exceeded in case when the exemption from the NOx emission limit is applied. Amendment 457 Jutta Paulus Proposal for a directive PE791.123v02-00 152/158 AM\1348825EN.docx EN Annex II – point 1 – point a Directive 2015/2193 Annex II – Part 1 – tables 1, 2 and 3 – footnote Text proposed by the Commission Amendment (*) The emission limit value is not applicable to combustion plants firing gas with more than 20 % (by volume) of hydrogen. Member States shall ensure that the overall load of NOx eventually released into the air over one year is not increased compared to the situation where the emissions from the installation concerned remained compliant with emission limit values set out in Part 1 of Annex II for NOx for the combustion of natural gas, without prejudice to stricter measures required pursuant to Article 6 (9).; (*) The emission limit value is not applicable to combustion plants firing gas with more than 20 % (by volume) of hydrogen, provided the substitution by hydrogen of previously used fuel results in at least 15% greenhouse gas emissions reduction. Member States shall ensure that the overall load of NOx eventually released into the air over one year is not increased compared to the situation where the emissions from the installation concerned remained compliant with emission limit values set out in Part 1 of Annex II for NOx for the combustion of natural gas, without prejudice to stricter measures required pursuant to Article 6 (9).; Or. en Amendment 458 Thomas Bajada, Annalisa Corrado Proposal for a directive Annex II – point 1 – point a Directive (EU) 2015/2193 Annex II – Part 1 – tables 1, 2 and 3 – footnote Text proposed by the Commission Amendment (*) The emission limit value is not applicable to combustion plants firing gas with more than 20 % (by volume) of hydrogen. Member States shall ensure that the overall load of NOx eventually released into the air over one year is not increased compared to the situation where the emissions from the installation concerned remained compliant with emission limit values set out in Part 1 of Annex II for NOx for the combustion of natural gas, without (*) The emission limit value is not applicable to combustion plants firing gas with more than 30 % (by volume) of hydrogen. Member States shall ensure that the overall load of NOx eventually released into the air over one year is not increased compared to the situation where the emissions from the installation concerned remained compliant with emission limit values set out in Part 1 of Annex II for NOx for the combustion of natural gas, without AM\1348825EN.docx 153/158 PE791.123v02-00 EN prejudice to stricter measures required pursuant to Article 6 (9).; prejudice to stricter measures required pursuant to Article 6 (9).; Or. en Amendment 459 Alexander Bernhuber Proposal for a directive Annex II – point 1 – point a Directive (EU) 2015/2193 Annex II – Part 1 – tables 1, 2 and 3 – footnote Text proposed by the Commission Amendment (*) The emission limit value is not applicable to combustion plants firing gas with more than 20 % (by volume) of hydrogen. Member States shall ensure that the overall load of NOx eventually released into the air over one year is not increased compared to the situation where the emissions from the installation concerned remained compliant with emission limit values set out in Part 1 of Annex II for NOx for the combustion of natural gas, without prejudice to stricter measures required pursuant to Article 6 (9).; (*) The emission limit value is not applicable to combustion plants firing gas with more than 5 % (by volume) of hydrogen. Member States shall ensure that the overall load of NOx eventually released into the air over one year is not increased compared to the situation where the emissions from the installation concerned remained compliant with emission limit values set out in Part 1 of Annex II for NOx for the combustion of natural gas, without prejudice to stricter measures required pursuant to Article 6 (9).; Or. en Justification The proposed threshold of 20% hydrogen content must be lowered to 5% to ensure regulatory certainty during early application phases and enable hydrogen projects to proceed to implementation more rapidly. Amendment 460 Ondřej Knotek, Jana Nagyová, Antonín Staněk, Anne-Sophie Frigout Proposal for a directive Annex II – point 1 – point b Directive (EU) 2015/2193 Annex II – Part 2 – tables 1 and 2 – footnote PE791.123v02-00 154/158 AM\1348825EN.docx EN Text proposed by the Commission Amendment (*) The emission limit value is not applicable to combustion plants firing gas with more than 20 % (by volume) of hydrogen. Member States shall ensure that the overall load of NOx eventually released into the air over one year is not increased compared to the situation where the emissions from the installation concerned remained compliant with emission limit values set out in Part 2 of Annex II for NOx for the combustion of natural gas, without prejudice to stricter measures required pursuant to Article 6 (9).; (*) The emission limit value is not applicable to combustion plants firing gas with more than 5 % (by volume) of hydrogen. This without prejudice to stricter measures required pursuant to Article 6 (9).; Or. en Justification It is unclear how it will be possible to meet the condition requiring that the amount of NOx emissions produced under the relevant emission limit when burning natural gas not be exceeded in case when the exemption from the NOx emission limit is applied. Amendment 461 Jutta Paulus Proposal for a directive Annex II – point 1 – point b Directive (EU) 2015/2193 Annex II – PART 2 – tables 1 and 2 – footnote Text proposed by the Commission Amendment (*) The emission limit value is not applicable to combustion plants firing gas with more than 20 % (by volume) of hydrogen. Member States shall ensure that the overall load of NOx eventually released into the air over one year is not increased compared to the situation where the emissions from the installation concerned remained compliant with emission limit values set out in Part 2 of Annex II for NOx for the combustion of natural gas, without (*) The emission limit value is not applicable to combustion plants firing gas with more than 20 % (by volume) of hydrogen, provided the substitution by hydrogen of previously used fuel results in at least 15% greenhouse gas emissions reduction. Member States shall ensure that the overall load of NOx eventually released into the air over one year is not increased compared to the situation where the emissions from the installation concerned remained compliant with emission limit AM\1348825EN.docx 155/158 PE791.123v02-00 EN prejudice to stricter measures required pursuant to Article 6 (9).; values set out in Part 2 of Annex II for NOx for the combustion of natural gas, without prejudice to stricter measures required pursuant to Article 6 (9).; Or. en Amendment 462 Thomas Bajada, Annalisa Corrado Proposal for a directive Annex II – point 1 – point b Directive (EU) 2015/2193 Annex II – Part 2 – table 1 and 2 – footnote Text proposed by the Commission Amendment (*) The emission limit value is not applicable to combustion plants firing gas with more than 20 % (by volume) of hydrogen. Member States shall ensure that the overall load of NOx eventually released into the air over one year is not increased compared to the situation where the emissions from the installation concerned remained compliant with emission limit values set out in Part 2 of Annex II for NOx for the combustion of natural gas, without prejudice to stricter measures required pursuant to Article 6 (9).; (*) The emission limit value is not applicable to combustion plants firing gas with more than 30 % (by volume) of hydrogen. Member States shall ensure that the overall load of NOx eventually released into the air over one year is not increased compared to the situation where the emissions from the installation concerned remained compliant with emission limit values set out in Part 2 of Annex II for NOx for the combustion of natural gas, without prejudice to stricter measures required pursuant to Article 6 (9).; Or. en Amendment 463 Alexander Bernhuber Proposal for a directive Annex II – point 1 – point b Directive (EU) 2015/2193 Annex II – Part 2 – table 1 and 2 – footnote Text proposed by the Commission Amendment (*) The emission limit value is not applicable to combustion plants firing gas (*) The emission limit value is not applicable to combustion plants firing gas PE791.123v02-00 156/158 AM\1348825EN.docx EN with more than 20 % (by volume) of hydrogen. Member States shall ensure that the overall load of NOx eventually released into the air over one year is not increased compared to the situation where the emissions from the installation concerned remained compliant with emission limit values set out in Part 2 of Annex II for NOx for the combustion of natural gas, without prejudice to stricter measures required pursuant to Article 6 (9).; with more than 5 % (by volume) of hydrogen. Member States shall ensure that the overall load of NOx eventually released into the air over one year is not increased compared to the situation where the emissions from the installation concerned remained compliant with emission limit values set out in Part 2 of Annex II for NOx for the combustion of natural gas, without prejudice to stricter measures required pursuant to Article 6 (9).; Or. en Justification The proposed threshold of 20% hydrogen content must be lowered to 5% to ensure regulatory certainty during early application phases and enable hydrogen projects to proceed to implementation more rapidly. Amendment 464 Michal Wiezik, Martin Hojsík Proposal for a directive Annex II – point 2 – point c Directive (EU) 2015/2193 Annex III – Part 1– point 2 – first indent Text proposed by the Commission Amendment - three times the number of maximum average annual operating hours, applicable pursuant to Article 6(3) or (8), for medium combustion plants with a rated thermal input equal to or greater than 20 MW that meet the requirements applicable to ‘category NRG’ in respect to Stage V controls under Regulation (EU) 2016/1628 of the European Parliament and of the Council1 , - three times the number of maximum average annual operating hours, applicable pursuant to Article 6(3) or (8), for medium combustion plants with a rated thermal input equal to or greater than 20 MW that have adopted measures for the installation of retrofit emission control devices and advanced secondary abatement techniques for particulate pollutants and which meet the requirements applicable to ‘category NRG’ in respect to Stage V controls under Regulation (EU) 2016/1628 of the European Parliament and of the Council1 , _________________ _________________ AM\1348825EN.docx 157/158 PE791.123v02-00 EN 1 Regulation (EU) 2016/1628 of the European Parliament and of the Council of 14 September 2016 on requirements relating to gaseous and particulate pollutant emission limits and type-approval for internal combustion engines for non-road mobile machinery, amending Regulations (EU) No 1024/2012 and (EU) No 167/2013, and amending and repealing Directive 97/68/EC 1 Regulation (EU) 2016/1628 of the European Parliament and of the Council of 14 September 2016 on requirements relating to gaseous and particulate pollutant emission limits and type-approval for internal combustion engines for non-road mobile machinery, amending Regulations (EU) No 1024/2012 and (EU) No 167/2013, and amending and repealing Directive 97/68/EC Or. en Justification it should be required that the monitoring frequencies are reduced in cases of not only compliance with the limits, which might lack ambition in case of PM, also considering that data centres are increasingly deployed near populated areas and are currently exempted from emission limits on patricle number (PN), but also with the requirement that advanced emission control, also for PM and PN is in place to ensure the hightest possible protection of human heatlh and environmnet. Amendment 465 Jutta Paulus Proposal for a directive Annex II – point 2 – point d Directive (EU) 2015/2193 Annex III – Part 2 – paragraph 6 Text proposed by the Commission Amendment 6. In the case of complete replacement of ambient air with oxygen, the emission limit values referred to in Article 6 shall be regarded as having been complied with if the emissions are not higher than the emissions from the combustion of the given fuel at the standardised O2 content. 6. In the case of complete replacement of ambient air with oxygen, the emission limit values referred to in Article 6 shall be regarded as having been complied with if the emissions are not higher than the emissions from the combustion of the given fuel at the standardised O2 content. In such case, Member States shall ensure that the overall load of pollutants eventually released into the air over one year is not increased compared to the situation where the emissions from the installation concerned remained compliant with the emission limit values PE791.123v02-00 158/158 AM\1348825EN.docx EN set out under conventional air-firing conditions. Or. en

AESGP Issue 386 | July 2026 Euro OTC News Table of Contents MEDICINES _______________________________________________________________________________ 2 Regulatory News _____________________________________________________________________________________________ 2 • CMDh MAY minutes & JUN meeting report ___________________________________________________________________ 2 • EMA and DG SANTE sign Working Arrangement with New Zealand MoH ___________________________________________ 4 Herbal News ________________________________________________________________________________________________ 4 • HMPWG Meeting report - FEB 2026 ________________________________________________________________________ 4 Environment ________________________________________________________________________________________________ 6 • ECGT Directive - EU Commission publication - Common Understanding on old stock situations _________________________ 6 FOOD ___________________________________________________________________________________ 7 EFSA ______________________________________________________________________________________________________ 7 • EREN Food Supplement Project Report published _____________________________________________________________ 7 MEDICAL DEVICES ________________________________________________________________________ 8 Post Market Surveillance and Vigilance Medical Devices WG ________________________________________________________ 8 • Publication update of MIR 7.3.1. XSD files ___________________________________________________________________ 8 MDCG Standards WG _________________________________________________________________________________________ 8 • OJEU Publication of MDR Harmonised Standards - Corrigendum to Commission Implementing Decision (EU) 2026/1231 _____ 8 Expansion of the list of well-established technologies ______________________________________________________________ 9 • Delegated acts published in the OJEU ______________________________________________________________________ 9 MDR/IVDR Implementation _____________________________________________________________________________________ 9 • Overview on Applications for Designation as a NB - Update 01 July 2026 ___________________________________________ 9 • Notified Bodies Survey on Certifications & Applications - Data dated 28 February 2026 ________________________________ 9 • Updated list of notified bodies’ standard fees ________________________________________________________________ 10 • Publication of the European Parliament Draft Report __________________________________________________________ 10 Team NB __________________________________________________________________________________________________ 10 • Proposal for risk adaptive surveillance system (MDR) _________________________________________________________ 10 Study on Availability of MDs __________________________________________________________________________________ 10 • 3rd EO Survey - Survey Results __________________________________________________________________________ 10 Planned Meetings of Medical Device Coordination Group (MDCG) and Subgroups in 2026 _______________________________ 11 • Update _____________________________________________________________________________________________ 11 CROSS-SECTORIAL NEWS _________________________________________________________________ 12 COMBINE programme launches phase 2 of the pilot coordinated assessment procedure for combined studies _____________ 12 Implementation dialogue on the European Health Data Space Regulation with Commissioner Olivér Várhelyi - Summary conclusions ____________________________________________________________________________________________ 12 DG HERA RAMP UP - Pilot go-live ______________________________________________________________________________ 13 AESGP OTC News | July 2026 2 | 14 Regulatory News CMDh MAY minutes & JUN meeting report The minutes of the CMDh meeting held on 19-20 MAY 2026 have been published. For MDC members, the only relevant item is the COMBO update. Among the items reported, the following may be noted: Safety Outcome Survey (SOS) Working Group • The WG discussed the project on publishing the outcomes of important safety variations for NAPs. Development is planned to start in the second half of 2026 (to be finalised in 2027). • The WG also discussed the new project on publishing the outcomes of PRAC advice to MS on the CMDh website. It was proposed that the PRAC advice should only be brought back to the CMDh for potential publication once the underlying procedure is finalised. The SOS WG will further develop a proposal based on the discussion. • The WG also noted the publication of a new Q&A (Q31) on PSURs on the EMA website, explaining whether MAHs can extrapolate the PRAC recommendation on a PSUSA to medicinal products not included in the procedure. An update of the CMDh Q&As on PhV will be prepared until the next SOS WG meeting to refer to the new EMA Q&A New Pharmaceutical Legislation (NPL) A presentation was given on the NPL, focusing on the main changes in MRP/DCP, CMDh coordination with the EU governance structure, the CMDh roadmap, preliminary impact assessment and topic leads and how the CMDh can engage with industry during the NPL implementation. EC/EMA Operational Group on Combination Products and Consultation Procedures (COMBO) COMBO was established to clarify and streamline applications and assessments concerning combination products and consultation procedures for medical devices. COMBO aims to provide a regular forum for dialogue, sharing experiences, achieving mutual understanding. The group is working on guidance, e.g. to enhance the role of Notified Body Opinions in complementing the quality assessment of MAAs or guidance to standardise and harmonise the assessment of medical devices with ancillary medicinal substances. Electronic Product Information (ePI) EMA and ES presented an update on the ePI, including the use of PLM portal, the provisions in the NPL and the draft implementation roadmap. Additionally, please be informed that the report from the CMDh meeting held on 23-25 JUN has been published. Among the items reported, the following may be noted: Deletion of the requirement to provide cover letters for type IA variations The CMDh has agreed to delete the requirement to provide cover letters for type IA variations, starting from 1 JUL 2026. The following guidance documents have been updated to reflect the change: • Requirements on submissions for variations and renewals within MRP and national procedures • BPG on the use of eCTD in the MRP/DCP • Cover letter for variation applications in MRP • Questions and answers on variations • BPG for the allocation of the MRP variation number for Type I notifications, Type II variations, grouping and worksharing (Chapter 1) [Track version] Medicines https://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Agendas_and_Minutes/Minutes/2026_05_CMDh_Minutes.pdf https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/european-medicines-agency-post-authorisation-procedural-advice-users-centralised-procedure-document-tracked-changes_en.pdf https://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/CMDh_pressreleases/2026/CMDh_press_release_-_June_2026.pdf https://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/procedural_guidance/Variations/CMDh_291_2013_Rev24_2026_06_clean_-_Chapter_1_-_BPG_for_the_allocation_of_the_MR_number.pdf https://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/procedural_guidance/Variations/CMDh_291_2013_Rev24_2026_06_clean_-_Chapter_1_-_BPG_for_the_allocation_of_the_MR_number.pdf https://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/procedural_guidance/Variations/CMDh_291_2013_Rev24_2026_06_TC_-_Chapter_1_-_BPG_for_the_allocation_of_the_MR_number.pdf AESGP OTC News | July 2026 3 | 14 • BPG for the processing of Type IA minor variations (notifications) in MRP (Chapter 3) [Track version] • BPG for the processing of grouped applications in MRP (Chapter 6) [Track version] The tick box regarding annual update of type IA variation(s) has been removed from the cover letter template and will be included in the variation application form. The EMA/CMDh explanatory notes on variation application form (Human medicinal products only) have been updated to reflect the change. The document will be published once the updated variation application form is published. In addition, the document is updated to provide further clarification on how products should be listed in section 2 of the application form and to provide further guidance on the information to be included for grouped variations. Updated version of the MAA eAF The updated version 1.28.0.0 of the MAA eAF is now available on the eAF website for applicants and MAHs to familiarise themselves with the changes. The main reason for the changes in the form is to align the product data with the ISO IDMP model. The form can be used for new MAA submissions to the NCAs for NP, MRP and DCP procedures from 1 SEP 2026. It will be mandatory to use the updated form for all new MAA submissions to the NCAs from 1 JAN 2027. Applicants are reminded that the version of the form should not be changed during an ongoing procedure. Update of Q&As on QP declaration The CMDh and CMDv agreed an update of the joint QP declaration [Track version]. The document has been brought in line with the new Variations Guideline. Other minor changes have been included. Answers for human and veterinary medicinal products have been aligned where possible. Best Practice Guide on Variation Worksharing (Chapter 7) The CMDh agreed an update of the BPG on Variation Worksharing (Chapter 7) [Track version]. Further clarifications on the choice of the reference authority and the pre-submission activities have been added. Update of (Public) Assessment Report Templates The CMDh agreed an update of the following (public) assessment report templates: • DCP D70 Overview AR template (incl. instructions) [Track version] • DCP D70 Overview AR template (empty) [Track version] • Instructions for RMS when preparing the PAR based on the FAR [Track version] • PAR template (empty) when prepared based on FAR [Track version] A new standard wording for the non-clinical aspects has been added to be used, where relevant. Update of Q&As – Post-Brexit The CMDh agreed an update of its Post-Brexit [Track version]. The information on reference medicinal products authorised in the UK has been clarified in the document. Meeting with Interested Parties The CMDh convened a meeting with Interested Parties on 25 JUN 2026. The topics on the agenda included the NPL, the CMDh Multi-Annual Workplan, variations, safety label variations, multilingual packs, and trade name challenges. Change in the Presidency of the Council of the EU The June 2026 CMDh meeting was the last one under the Cypriot Presidency of the Council of the European Union. Ireland will take over the Presidency in July 2026. Nicole Kavanagh will be the appointed Presidency vice-chairperson of the CMDh during the Irish Presidency of the Council of the European Union. CMDh June meeting The following documents have been updated to reflect the decisions reached during the last CMDh meeting. The documents are also now available on the HMA website: • Questions and answers on variations [Track version] • Cover letter for Variation Applications in the Mutual Recognition Procedure [Track version] • CMDh Best Practice Guide on the use of eCTD in the MRP/DCP [Track version] • Requirements on submissions for Variations and Renewals within MRP and National Procedures [Track version] https://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/procedural_guidance/Variations/CMDh_293_2013_Rev.28_2026_06_clean_-_Chapter_3_-_BPG_for_the_Processing_of_Type_IA_Minor_Variations_in_MRP.pdf https://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/procedural_guidance/Variations/CMDh_293_2013_Rev.28_2026_06_TC_-_Chapter_3_-_BPG_for_the_Processing_of_Type_IA_Minor_Variations_in_MRP.pdf https://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/procedural_guidance/Variations/CMDh_296_2013_Rev32_2026_06_clean_-_Chapter_6_-_BPG_for_the_Processing_of_Grouped_Applications_in_MRP.pdf https://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/procedural_guidance/Variations/CMDh_296_2013_Rev32_2026_06_TC_-_Chapter_6_-_BPG_for_the_Processing_of_Grouped_Applications_in_MRP.pdf https://esubmission.ema.europa.eu/ https://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Questions_Answers/CMDh_340_2015_Rev.9_2026_06_clean_-_QA_on_QP_Declaration.pdf https://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Questions_Answers/CMDh_340_2015_Rev.9_2026_06_TC_-_QA_on_QP_Declaration.pdf https://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/procedural_guidance/Variations/CMDh_297_2013_Rev.36_2026_06_clean_-_Chapter_7_-_BPG_on_Worksharing.pdf https://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/procedural_guidance/Variations/CMDh_297_2013_Rev.36_2026_06_TC_-_Chapter_7_-_BPG_on_Worksharing.pdf https://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Templates/AR/DCP_AR_Comments/CMDh_440_2022_Rev6_2026_06_clean_-_Overview_AR_including_instructions.docx https://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Templates/AR/DCP_AR_Comments/CMDh_440_2022_Rev6_2026_06_TC_-_Overview_AR_including_instructions.pdf https://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Templates/AR/DCP_AR_Comments/CMDh_200_2007_Rev15_2026_06_clean_-_D70_Overview_AR.docx https://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Templates/AR/DCP_AR_Comments/CMDh_440_2022_Rev6_2026_06_TC_-_Overview_AR_including_instructions.pdf https://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Templates/AR/Public_AR/CMDh_454_2025_Rev3_2026_06_clean_-_Instructions_for_RMS_when_preparing_the_PAR_based_on_the_FAR.docx https://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Templates/AR/Public_AR/CMDh_454_2025_Rev3_2026_06_TC_-_Instructions_for_RMS_when_preparing_the_PAR_based_on_the_FAR.pdf https://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Templates/AR/Public_AR/CMDh_453_2025_Rev3_2026_06_clean_-_Empty_PAR_template_when_the_PAR_is_prepared_based_on_the_FAR.docx https://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Templates/AR/Public_AR/CMDh_453_2025_Rev3_2026_06_TC_-_Empty_PAR_template_when_the_PAR_is_prepared_based_on_the_FAR.pdf https://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Questions_Answers/CMDh_457_2025_Rev1_2026_06_clean_-_Q_A_Post-Brexit.pdf https://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Questions_Answers/CMDh_457_2025_Rev1_2026_06_TC_-_Q_A_Post-Brexit.pdf https://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Questions_Answers/CMDh_132_2009_Rev66_2026_06_clean_-_QAs_Variations.pdf https://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Questions_Answers/CMDh_132_2009_Rev66_2026_06_TC_-_QAs_Variations.pdf https://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Templates/Variations/CMDh_096_2009_Rev9_2026_06_clean_-_Cover_letter_for_Variation_Applications_in_MRP.docx https://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Templates/Variations/CMDh_096_2009_Rev9_2026_06_TC_-_Cover_letter_for_Variation_Applications_in_MRP.pdf https://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/procedural_guidance/eSubmissions/CMDh_084_2008_Rev8_2026_06_clean_-_BPG_on_the_use_of_eCTD_in_MRP_and_DCP.pdf https://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/procedural_guidance/eSubmissions/CMDh_084_2008_Rev8_2026_06_TC_-_BPG_on_the_use_of_eCTD_in_MRP_and_DCP.pdf https://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/procedural_guidance/eSubmissions/CMDh_006_2008_Rev_29_2026_06_clean_-_eSubmission_for_Variations_and_Renewals.pdf https://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/procedural_guidance/eSubmissions/CMDh_006_2008_Rev_29_2026_06_clean_-_eSubmission_for_Variations_and_Renewals.pdf https://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/procedural_guidance/eSubmissions/CMDh_006_2008_Rev_29_2026_06_TC_-_eSubmission_for_Variations_and_Renewals.pdf AESGP OTC News | July 2026 4 | 14 EMA and DG SANTE sign Working Arrangement with New Zealand MoH The European Commission’s DG SANTE and the European Medicines Agency (EMA) have signed a Working Arrangement with New Zealand Ministry of Health (incorporating the New Zealand Medicines and Medical Devices Safety Authority - Medsafe) this week, to strengthen collaboration and exchange of information on medicinal products. The agreement was signed by DG SANTE Director-General Sandra Gallina and EMA Executive Director Emer Cooke. Director-General Audrey Sonerson signed for the New Zealand Ministry of Health. The purpose of this Working Arrangement is to strengthen cooperation between signatories across a range of areas in public health, while promoting the timely, secure exchange of information. The working arrangement document is available here. Deliverables from the Arrangement will include: • Facilitate exchange of information regarding medicinal products quality, safety and efficacy. • Increase alignment and coordination on topics related to medicinal products for human-use, in-line with the application legislation. • Mutual learning, capacity building and the sharing of best practices in regulatory science and public health. The Arrangement is running from 6 July 2026, and is valid for an indefinite period of time, unless terminated by either party. Herbal News HMPWG Meeting report - FEB 2026 The public report of the 41st meeting of the Heads of Medicines Agencies’ Homeopathic Medicinal Products Working Group (HMPWG), that took place on 26-27 FEB 2026, has been uploaded to the HMA website. Please keep in mind that, since this meeting took place several months ago, some information may not reflect the latest developments. The following topics were discussed: Safety An overview of sub-working group First Safe Dilution (s-WG FSD) reactivated in March 2025, was presented. The group is composed by experts on FSD and HMPWG (secretariat) members. As the main focus of the s-WG FSD is the assessment of FSDs on new stocks, a draft “6th list FSD” is currently being elaborated. In view of the planned updated EMA guidance on the Establishment of Lactose Allergy Threshold in all Medicinal Products, including Homeopathic Medicinal Products (Annex to "Excipients Guideline"), the HMPWG discussed the potential impact on homeopathic products including the consistency of application across regulatory authorities. Homeophatic use A revised Consolidated List of Stocks for which Homeopathic Use is Justified was adopted for subsequent publication on the HMPWG website. Quality The Chairperson of the Quality Sub-Working Group (Qs-WG) summarised the activities undertaken since the last HMPWG meeting, including the group’s intention to develop new Q&A documents. https://www.ema.europa.eu/en/documents/other/working-arrangement-collaboration-exchange-information-therapeutic-products-medicinal-products-between-dg-sante-ema-new-zealand-ministry-health_en.pdf https://www.hma.eu/fileadmin/dateien/Human_Medicines/01-About_HMA/Working_Groups/HMPWG/06_2026_Public_Report_41st_HMPWG_Meeting_Cyprus_final.pdf https://www.hma.eu/fileadmin/dateien/Human_Medicines/01-About_HMA/Working_Groups/HMPWG/HU_rev_consolidated_list_de_1-6_February_2026.pdf AESGP OTC News | July 2026 5 | 14 The draft document Points to Consider on Pyrrolizidine Alkaloids in Homeopathic Medicinal Products was adopted for publication for public consultation on HMA website. Post-meeting note: AESGP submitted its feedback to this public consultation on 8 JUN 2026. Legislation Amendment of the regulations concerning homeopathic medicinal products An update on the New Pharmaceutical Legislation (NPL) was presented. Changes concerning homeopathic medicinal products were reported via detailed comparison to current valid legislation. SoHO Regulation Following a presentation concerning Regulation (EU) 2024/1938 (“SOHO Regulation”), its concrete impact on the regulation of homeopathic medicinal products was discussed among HMPWG members. In order to support a consistent regulatory interpretation and ensure alignment with the SoHO framework for homeopathic medicinal products, HMPWG plans to collect available information on the registration status of relevant products in member states. Status module 1.2 Homeopathic Application form This issue had been discussed, and it was agreed the need to have further clarifications in order to consider the applicability at European level. National Information Following comments received from HMPWG members on the proposed first draft concerning a Q&A on Bach Flower Remedies and Cell Mineral Products, a consolidated update will be elaborated for final agreement among HMPWG members. https://www.hma.eu/fileadmin/dateien/Human_Medicines/01-About_HMA/Working_Groups/HMPWG/202602_Draft_Points_to_consider_on__PA_26022026.pdf AESGP OTC News | July 2026 6 | 14 Environment ECGT Directive - EU Commission publication - Common Understanding on old stock situations There have been recent developments in the implementation of the Empowering Consumers for the Green Transition (ECGT) (Directive (EU) 2024/825), particularly the new EU Commission publication of the Common Understanding on ‘old stock’ situations which was agreed by the national authorities of the Consumer Protection Cooperation (CPC) network. • The link of the Common Understanding is available here: Common understanding on old stock situations under Directive (EU) 2024/825 on Empowering Consumers for the Green Transition | European Commission. Key takeaways • This document aims to support a coherent enforcement approach across the EU for products, packaging, and related communications that were manufactured, ordered, distributed, or placed on the market before the ECGT becomes applicable on 27 September 2026. • It acknowledges that some businesses may face transitional challenges where products or packaging bearing environmental claims or sustainability labels remain in the market after the application date due to factors such as packaging cycles, pre-existing production orders, supply chain constraints, stock volumes, or long product shelf-lives. • While the document is not legally binding and does not change companies’ legal obligations under the ECGT or the Unfair Commercial Practices Directive (UPCD), it provides insights into the enforcement approach that national authorities are expected to consider: o Traders are expected to continue working towards compliance without delay. o National authorities may take a phased and proportionate enforcement approach where specific transitional challenges can be demonstrated. o Practical constraints like stock volume, packaging cycles, prior orders, supply chain dependencies, and product shelf-life may be considered on a case-by-case basis. o Businesses are expected to undertake reasonable compliance efforts, including updating online claims, adapting future packaging, and maintaining evidence for their compliance activities. o Authorities may refrain from requiring disproportionate measures, including the destruction or recall of products, where this would result in excessive costs or unnecessary environmental harm. o In justified cases, national authorities may favour a compliance-oriented approach before considering sanctions. BACKGROUND • The ECGT introduces new requirements and prohibitions on environmental claims, sustainability labels, and business-to-consumer communications through amendments to the UPCD. • Member States were required to transpose the Directive by 27 March 2026; however, transposition has not been completed in a harmonised way across the EU and therefore the European Commission has initiated infringement proceedings against many Member States for failing to communicate national measures by the deadline. • Despite the delays, the Directive will apply from 27 September 2026, and companies should continue their compliance preparations accordingly. https://commission.europa.eu/document/264d8c70-2f9a-4955-8e7b-154d55a9b684_en https://commission.europa.eu/document/264d8c70-2f9a-4955-8e7b-154d55a9b684_en https://commission.europa.eu/document/264d8c70-2f9a-4955-8e7b-154d55a9b684_en AESGP OTC News | July 2026 7 | 14 EFSA EREN Food Supplement Project Report published EFSA’s supporting publication on “The European Food Supplement Project – Identification of emerging risks associated with food supplements, other than vitamins and minerals” has now been published. The project looked at possible emerging risks linked to food supplements other than vitamins and minerals, with a view to supporting prioritisation of substances that may be considered under Article 8 of Regulation (EC) No 1925/2006. The report highlights two main strands of work. The vigilance work package identified six ingredients as possible sources of emerging risks: Bifidobacterium, Coleus (Plectranthus barbatus), Guggul (Commiphora mukul), Toothed clubmoss (Huperzia serrata), Black radish (Raphanus sativus L.) and Ginseng (Panax ginseng). The plant work package examined 52 substances predicted to be toxic and their occurrence in food supplements on the EU market. Three substances were identified as being particularly widespread: furfural, emodin and chrysophanol. These substances were associated with a broad range of botanicals commonly found in food supplements, including acerola (Malpighia glabra), passionflower (Passiflora spp.), guarana (Paullinia cupana), grapefruit (Citrus paradisi), lemon (Citrus limon), rhubarb (Rheum spp.), buckthorn (Frangula spp.), Japanese knotweed (Fallopia japonica) and various Rumex species. The report also notes that, due to limitations in product labelling, EFSA assumed that all plant parts may contain the substances of concern, highlighting the need for further analytical and exposure data. As a next step, EFSA has launched a tender to identify a contractor for further work on these substances in food supplements sold across the EU, with EUR 200,000 made available for this activity. This follow-up will be important to better understand actual market presence and exposure, and to inform any further discussion on possible risk management or Article 8 prioritisation. Food https://efsa.onlinelibrary.wiley.com/doi/epdf/10.2903/sp.efsa.2026.EN-10226 https://efsa.onlinelibrary.wiley.com/doi/epdf/10.2903/sp.efsa.2026.EN-10226 AESGP OTC News | July 2026 8 | 14 Post Market Surveillance and Vigilance Medical Devices WG Publication update of MIR 7.3.1. XSD files The Commission was recently notified that there was an inconsistency between the business rules of the MIR 7.3.1. PDF and of the XSD files as regards the field 4.3.3.d. for the report types “Combined” and “Final reportable”. After examination by COM, it was concluded that the above mentioned XSD files should be updated for field 4.3.3.d. These very limited modifications of these XSD files have not impact on the PDF and XML files and therefore the MIR 7.3.1. PDF publication date remains unchanged. The revised XSD files have been published on EUROPA at the following link. MDCG Standards WG OJEU Publication of MDR Harmonised Standards - Corrigendum to Commission Implementing Decision (EU) 2026/1231 The Corrigendum to Commission Implementing Decision (EU) 2026/1231 has been published in the OJEU. It includes the correct application date for EN ISO 15223-1:2021/A1:2025 (introduction of the new ‘EU REP’ symbol), namely 7 JUN 2031. Medical Devices https://health.ec.europa.eu/medical-devices-sector/new-regulations/guidance-mdcg-endorsed-documents-and-other-guidance/pmsv-reporting-forms_en https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=OJ:L_202690511 AESGP OTC News | July 2026 9 | 14 Expansion of the list of well-established technologies Delegated acts published in the OJEU The two Commission delegated regulations amending MDR on Well-Established Technologies (WET) have been published in the Official Journal of the European Union today. • 2026/1359 Commission Delegated Regulation (EU) 2026/1359 of 20 March 2026 amending Regulation (EU) 2017/745 of the European Parliament and of the Council as regards the list of class IIb implantable devices exempted from the obligation to perform an assessment of the technical documentation for every device • 2026/1451 Commission Delegated Regulation (EU) 2026/1451 of 20 March 2026 amending Regulation (EU) 2017/745 of the European Parliament and of the Council as regards the list of implantable devices and class III devices exempted from the obligation to perform clinical investigations These regulations are binding in its entirety and directly applicable in all Member States. MDR/IVDR Implementation Overview on Applications for Designation as a NB - Update 01 July 2026 The overview on the applications for designation as a notified body under the MDR and IVDR has been updated by the Commission. The updated overview is accessible here. The presentation indicates that the MDCG recommendations equal the number of designated notified bodies. Notified Bodies Survey on Certifications & Applications - Data dated 28 February 2026 The Commission has published on its website the “Notified Bodies Survey on certifications and applications (MDR/IVDR)” based on data collected from notified bodies until 28 February 2026. The survey – accessible here – is based on data from 53 notified bodies designated under the MDR/IVDR. Please note that this data does not seem to be reflected yet in the dashboard of the corresponding study on the monitoring of availability of medical devices on the EU market. According to the data, there are 32.898 MDR applications (a decrease of 0.6%, explained by a change in methodology by some NBs, to October 2025 data) and 18.010 MDR certificates issued (an increase of 2.9% compared to October 2025 data). As usual, the survey also provides an overview of certifications and applications by annex and by type (QMS vs Product). Of further relevance, 9.724 applications have been lodged for changes received for already MDR issued certificates – this figure is included in the total number of applications (see slide 25). https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=OJ:L_202601359 https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=OJ:L_202601359 https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=OJ:L_202601359 https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=OJ:L_202601359 https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=OJ:L_202601451 https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=OJ:L_202601451 https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=OJ:L_202601451 https://health.ec.europa.eu/document/download/3d407427-fad0-498a-b1ef-2db28c9f4423_en?filename=notifiedbodies_overview_en.pdf https://health.ec.europa.eu/document/download/59b9d90e-be42-4895-9f6f-bec35138bb0a_en?filename=md_nb_survey_certifications_applications_en.pdf https://health.ec.europa.eu/study-supporting-monitoring-availability-medical-devices-eu-market_en https://health.ec.europa.eu/study-supporting-monitoring-availability-medical-devices-eu-market_en AESGP OTC News | July 2026 10 | 14 Furthermore, the survey indicates that 1175 applications under Rule 14 MDR have been filed and 387 certificates have been issued thereof. The survey also indicates that now 162 applications under Rule 21, first indent, have been filed, with no certificates that has been issued thereof (see slide 26). Regarding timelines, for 62% of the NBs, it takes 13-18 months to issue a new QMS certificate under the MDR. For 51% of the NBs, it takes 13-18 months to issue a certificate (QMS+Product) under the MDR and 31% of the NBs need 19-24 months to issue a certificate (QMS+Product) under the MDR. Updated list of notified bodies’ standard fees The list of notified bodies’ standard fees has been updated and published on Commission website. Publication of the European Parliament Draft Report The European Parliament has published its Draft Report on the Commission’s proposal to simplify the MDR/IVDR. The report is available below: • Draft EP Report (PDF version) • Draft EP Report (Word version) AESGP and members have advocated close to MEPs for proportionate amendments to the Commission’s proposal and we are glad to see that many of these have been reflected in the European Parliament’s Draft report. Overall, the targeted amendments introduced in the Draft Report are expected to further enhance predictability, transparency, and legal certainty of the regulatory framework for medical devices. Team NB Proposal for risk adaptive surveillance system (MDR) Team-NB has released a position paper which details their views and proposed amendments on how to adapt the surveillance system considering the Commission proposal to remove the maximum validity of certificates. Study on Availability of MDs 3rd EO Survey - Survey Results The survey results of the third economic operator survey with data status 31 October 2025 within the study “Supporting the Monitoring of Availability of Medical Devices on the EU Market” have been published on the Commission website. The results of this third survey – accessible here – are based on 213 responses from manufacturers of MDs and IVDs and authorised representatives. The dataset provides information, amongst others, concerning: • Written agreements with Notified Bodies • Refusal of applications by Notified Bodies • MDR Implementation (applications, certificates, re-certification, and time periods) https://health.ec.europa.eu/document/download/ff5716d5-fe77-4f45-b883-fcf3da4acd15_en?filename=md_nbs_fees_en.pdf https://health.ec.europa.eu/latest-updates/updated-list-notified-bodies-standard-fees-2026-07-13_en https://www.europarl.europa.eu/doceo/document/SANT-PR-787987_EN.pdf https://www.europarl.europa.eu/doceo/document/SANT-PR-787987_EN.docx https://www.team-nb.org/wp-content/uploads/2026/07/Team-NB-PositionPaper-MDR-Update-Risk_adaptive-surveillance-V1-20260630.pdf https://health.ec.europa.eu/document/download/61b46045-744a-41a7-bbcc-1af40fb92632_en?filename=md_availability_study_presentation_2025_en.pdf AESGP OTC News | July 2026 11 | 14 • Estimates on the completed transition • Discontinuation of medical devices • Manufacturer preparedness Planned Meetings of Medical Device Coordination Group (MDCG) and Subgroups in 2026 Update The Commission has published an update of the planned meeting dates of the MDCG and subgroups for 2026. The update concerns the addition of a market surveillance meeting in November and of a Nomenclature WG meeting (date still needs to be determined). https://health.ec.europa.eu/document/download/941b23fa-60e9-4efe-bd38-9b2d8649e70c_en?filename=md_events_2026_en.pdf https://health.ec.europa.eu/document/download/941b23fa-60e9-4efe-bd38-9b2d8649e70c_en?filename=md_events_2026_en.pdf AESGP OTC News | July 2026 12 | 14 COMBINE programme launches phase 2 of the pilot coordinated assessment procedure for combined studies The European Commission and EU Member States are launching the second phase of the COMBINE coordinated assessment pilot. Phase 1 offered the first experience of coordinated assessment for combined studies through the Clinical Trials Information System (CTIS). Phase 2, which is expected to remain open for at least one year, expands the scope of studies eligible to participate and introduces a more agile, rolling process with monthly slots for the submission of expressions of interest. The launch of phase 2 marks a major step towards more streamlined, efficient, and coordinated regulatory pathways across combined medicine-device therapies . By simplifying processes and enabling joint assessment, the pilot aims to support innovation while maintaining robust regulatory oversight across the EU. What’s New in phase 2 • Eligibility for multinational investigational medicinal product (IMP) clinical trials combined with: o Performance studies of IVDs or companion diagnostics requiring authorisation o Clinical investigations of medical devices requiring authorisation • Combined studies with Advanced Therapy Medicinal Products (ATMPs) possible • Options for single or separate sponsors • Procedure for substantial modifications in combined studies authorised in the pilot to be launched later in phase 2 • Exploration of single protocols and joint documents When to express interest for phase 2 Sponsors must submit their expressions of interest by the 23rd of the month preceding the month in which they intend to submit their application. The first monthly application window will open in SEP 2026. To apply to the September round, sponsors must submit their expressions of interest by 23 AUG 2026. For more information and to apply for the pilot COMBINE coordinated assessment procedure, visit the European Commission's website. Implementation dialogue on the European Health Data Space Regulation with Commissioner Olivér Várhelyi - Summary conclusions An implementation dialogue on the European Health Data Space Regulation (EHDS Regulation) was held in Brussels on 10 June 2026 with the participation of industry, researchers, healthcare providers and patient organisations. The dialogue pursued two principal objectives. • First, it aimed to take stock of the stakeholders’ state of preparations for the EHDS, including by gathering evidence on measures already being taken to ensure compliance with the Regulation and on the main challenges expected. Cross-Sectorial News https://health.ec.europa.eu/medical-devices-topics-interest/combine-programme_en https://health.ec.europa.eu/medical-devices-topics-interest/combine-programme/combine-project-1-pilot-all-one-coordinated-assessment_en AESGP OTC News | July 2026 13 | 14 • Second, it sought to collect views on possible measures to facilitate and simplify the forthcoming implementation of the EHDS Regulation and to foster innovation, including through actions beyond the scope of the EHDS that could contribute to enhanced efficiency and competitiveness in the digital health sector. Industry representatives reported having started their preparations for the implementation of the EHDS while underlining the importance of the timely adoption of the relevant implementing acts. In addition, they stressed the need to build on existing standards. Many participants asked for harmonised implementation of the EHDS across the EU as much as possible and for further clarification of certain notions and concepts. They also asked for clarification of the interplay with other Union rules. To access the full summary, please check here. DG HERA RAMP UP - Pilot go-live The Commission’s DG HERA has now launched the pilot phase of RAMP UP (Rapid Agile Manufacturing Partnerships for Union Protection), a voluntary preparedness network aimed at strengthening Europe’s ability to rapidly scale up the production and supply of medical countermeasures (MCMs) during health emergencies. The initial launch of RAMP UP is positioned as a pilot phase, focusing on engaging and onboarding stakeholders whose portfolios include medicinal products relevant for medical countermeasure preparedness. While the application process remains open to all eligible members, the first phase will focus on pharmaceutical companies with portfolios covering pharmacological classes identified for the purpose of this initial RAMP UP pilot phase. This will allow DG HERA and participating partners to test and refine the practical arrangements of the initiative, including data requirements, templates and data- sharing processes, while ensuring that these are proportionate and fit for purpose. Applicants whose portfolios include medicinal products falling within the list of pharmacological classes for RAMP UP pilot phase are invited to apply. Why join RAMP UP? By joining the RAMP UP network, your organization can: • Establish a dedicated channel of communication with DG HERA on manufacturing, supply chain, and crisis readiness. • Increase visibility and be included in the RAMP UP registry to help identify key capabilities and potential supply chain bottlenecks. • Shape the initiative by helping develop practical data-sharing templates, formats, and procedures from the ground up. • Network and collaborate via the HERA Stakeholders Hub to explore cooperation opportunities across the MCM ecosystem. Note: RAMP UP is a preparedness partnership designed to improve mutual coordination before a crisis occurs; it does not guarantee future contracts or provide privileged procurement status. Who is eligible? Legal entities with a proven role in ensuring access to crisis-relevant MCMs in the EU/EEA, including: • Marketing authorization holders and manufacturers of medicines • Manufacturers of medical devices, PPE, and IVDs • CDMOs and CMOs • Suppliers of APIs, raw materials, intermediates, and fill-finish services • Innovators of advanced manufacturing technologies How to apply 1. Register your organization on the HERA Stakeholders Hub. 2. Complete the RAMP UP application form, including the eligibility verification. 3. Onboarding: Once DG HERA reviews and confirms your eligibility, you will receive further details during an ad-hoc onboarding meeting. https://health.ec.europa.eu/events/implementation-dialogue-european-health-data-space-regulation-commissioner-oliver-varhelyi-2026-06-10_en https://health-preparedness-industry-hub.ec.europa.eu/ramp-up https://health-preparedness-industry-hub.ec.europa.eu/ramp-up https://health-preparedness-industry-hub.ec.europa.eu/system/files/2026-07/pharmacological-classes-for-ramp-up-pilot.pdf https://health-preparedness-industry-hub.ec.europa.eu/system/files/2026-07/pharmacological-classes-for-ramp-up-pilot.pdf https://health-preparedness-industry-hub.ec.europa.eu/home https://health-preparedness-industry-hub.ec.europa.eu/system/files/2026-06/2026-06-09-eligibility-criteria-final.pdf AESGP — Association of the European Self-Care Industry Avenue de Tervuren, 7 1040 Brussels Belgium info@aesgp.eu www.aesgp.eu

AESGP Issue 385 | June 2026 Euro OTC News Table of Contents MEDICINES _______________________________________________________________________________ 2 Regulatory News _____________________________________________________________________________________________ 2 • CMDh April minutes & May meeting report ___________________________________________________________________ 2 • 124th HMA meeting - 27-28 MAY 2026 - meeting report _________________________________________________________ 3 • EMA Management Board - JUN 2026 - Meeting highlights + Publication of EMA 2025 Annual Report _____________________ 4 • Preliminary Ruling - Case C-604/24 - Restriction of Online Sale of NPMs – Judgment _________________________________ 5 Herbal medicines ____________________________________________________________________________________________ 6 • EMA HMPC Meeting Report - 4-6 MAY 2026 _________________________________________________________________ 6 • HMPC RP on data recommendations for (T)HMPs used in paediatric patients published with overview of comments _________ 7 FOOD ___________________________________________________________________________________ 9 Law -13 May 2026 ____________________________________________________________________________________________ 9 • Summary report _______________________________________________________________________________________ 9 MEDICAL DEVICES _______________________________________________________________________ 11 MDCG Eudamed WG_________________________________________________________________________________________ 11 • Production release 2.27.0 deployed _______________________________________________________________________ 11 • Mandatory Use of First EUDAMED Modules from 28 May 2026 __________________________________________________ 11 • MDCG EUDAMED WG Meeting on 2 June 2026 _____________________________________________________________ 12 • MDCG Endorsement of Position Paper on SS(C)P Management in EUDAMED _____________________________________ 12 MDCG Standards WG ________________________________________________________________________________________ 12 • New references harmonised standards MDR/IVDR - Publication in the OJEU & Appendix 'EU REP' _____________________ 12 MDCG Nomenclature WG _____________________________________________________________________________________ 13 • EMDN Annual Update __________________________________________________________________________________ 13 MDR/IVDR Simplification Proposal _____________________________________________________________________________ 13 • Commission presentation to Council on EMA support, borderline & classification ____________________________________ 13 MDR/IVDR Implementation ____________________________________________________________________________________ 14 • Notified Bodies Survey on Certifications & Applications - Data dated 31 December 2025 ______________________________ 14 • Annex VII NB Requirements: AESGP statement and summary of timelines for NBs __________________________________ 14 Team NB Publications _______________________________________________________________________________________ 15 • Sector Survey 2025 ____________________________________________________________________________________ 15 • MDR Certification Process (including Pre-application, Application and Post Application phases) – Consensus document _____ 16 • IVDR Application and appropriate surveillance Transfer agreement _______________________________________________ 16 • Micro and Small Enterprise Considerations _________________________________________________________________ 16 Planned Meetings of Medical Device Coordination Group (MDCG) and Subgroups in 2026 _______________________________ 17 • Update _____________________________________________________________________________________________ 17 ESIP, AIM, TEAM-NB, CPME, TÜV Verband, IG-NB unified for a better WET approach ___________________________________ 17 CROSS-SECTORIAL NEWS _________________________________________________________________ 18 AI - Omnibus VII legislative package - Provisional agreement reached by the Council presidency and European Parliament negotiators _____________________________________________________________________________________________ 18 New Council of Europe Recommendation sets standards for remote and online medicine provision ______________________ 19 PPWR - EC guidance - 10 JUN 2026 ____________________________________________________________________________ 20 AESGP OTC News | June 2026 2 | 21 Regulatory News CMDh April minutes & May meeting report The minutes of the CMDh meeting held on 21-22 APR 2026 have been published. Among the items reported, the following may be noted: Working Party on Variations Regulation The WP Chair reported from the April 2026 meeting. The EMA presented a draft procedure for the preparation of the report laid down in Article 4 of the Variations Regulation, for adoption of the procedure at the May CMDh plenary meeting. Regarding the ROG proposal to delete the requirement for cover letters for Type IA variations, the WP Chair reported on the agreed changes to the CESP delivery file and eAF. The WP Chair presented updates to several CMDh guidance documents in relation to the deletion of the cover letter for Type IA variations. The publication of the updated documents is foreseen once the CESP delivery file is updated. The WP discussed several proposals to improve the process for requesting worksharing Reference Authorities (RA). It was proposed to clarify in the BPG that MSs acting as RMS or holding national MAs are expected to accept the RA role. MAHs should be reminded to give a list of proposed RAs in the order of priority and not only propose one MS. In addition, it was suggested that MAHs include a justification for the proposed RAs and the order of priority. The WP also discussed the regulatory consequences for products with already approved changes included in a worksharing procedure that is subsequently refused. It was agreed that this situation applies only to worksharing and not to super-grouping. In case of refusal of the worksharing, products retain their former status, and approved changes are not automatically reversed; however, the MAHs should consider the outcome of the worksharing procedure. In relation to the actions included in the new CMDh MAWP to 2028, the WP discussed the proposal from industry to set up a dedicated mailbox for questions about variations. It has been agreed that questions regarding variations should be addressed to the RMS/relevant NCA and answered by them by referring to the relevant guidance. Questions not covered by the guidance may be forwarded by the RMS/relevant NCA to and discussed by the VRWP, which will consider whether to develop new Q&As or update existing ones. Following the February WP meeting, the WP Chair confirmed that an amendment to the eAF has been implemented to add a type IAIN variation E.z to the RMS list. This change will allow the use of the eAF/PLM Portal for national transfers of MAs in specific MSs, where national legislation foresees the use of this procedure. Generally, the E.z code is currently not applicable for other type IA/IAIN notifications. In case any questions arise, it will be considered to prepare a Q&A. The WP discussed whether the approach agreed in February for annual updates (Type IA) including changes for which the variation codes are missing in the eAF, could be applied to Type IB and Type II procedures. It was clarified that this approach cannot be extrapolated to IB/II procedures, as these can be updated during validation or clock-stop. Missing Type IA codes or other changes cannot be added Medicines https://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Agendas_and_Minutes/Minutes/2026_04_CMDh_Minutes.pdf AESGP OTC News | June 2026 3 | 21 to an ongoing procedure once started but may be submitted in parallel or NCAs may request submission of single Type IA notifications. The WP discussed whether applicants may submit a variation of a higher classification than foreseen in the classification guideline. It was agreed that applicants may request a higher variation type under the same change code if justified, while retaining the correct classification category rather than using a z- category. The responsibility for selecting and justifying the variation type remains with the applicant. Finally, the WP discussed the lack of consistency in how applicants present changes when submitting multiple variations. It was suggested to develop a standardised annex template to improve clarity and consistency. A draft will be prepared for the next meeting. New Pharmaceutical Legislation (NPL) The EC gave a presentation on the simplification of DCP/MRP in the NPL. The final text is expected to be made available to NCAs shortly, and MSs were invited to carefully review the translations. Meetings attended by the CMDh chair 16th ISG Meeting The Commission presented an overview of the NPL, with adoption expected in Q4 2026, and most provisions applying from Q4 2028. The EMA presentation addressed NPL governance, the implementation planning, and a request for industry to provide input on implementation priorities. Industry representatives shared updates on PMS development and data quality. ROG plenary meeting with industry representatives Discussions focused on the impact of the NPL on industry and the EMRN Strategic Portfolio (IT projects and systems) and data interoperability. The ROG also provided an update on ongoing optimisation activities related to PMS data and Type IA variations. Electronic Application Form The EMA presented a summary of proposed changes to the Human Marketing Authorisation Application form (MAA eAF) to align where possible with the PMS IDMP format to improve the quality of product data and to address structural limitations in the current form. It was noted that currently the use of OMS is not proposed to be mandatory for CROs. The CMDh proposed that mandatory use of OMS could also be considered for CROs. It was noted that, once the proposed changes are agreed and implemented, the user guide of the eAF would also need to be updated. The EMA will keep the CMDh informed. Additionally, please be informed that the report from the CMDh meeting held on 19-20 MAY has been published. Among the items reported, the following may be noted: Template for the non-clinical and clinical assessment of a generic application in MRP/DCP The CMDh agreed an update of the template for the non-clinical and clinical assessment of a generic application in MRP/DCP. The wording in relation to the environmental risk assessment has been aligned with the wording used in other templates. The updated template can be found here. 124th HMA meeting - 27-28 MAY 2026 - meeting report The meeting report of the 124th Heads of Medicines Agencies (HMA) meeting, held on 27-28 May 2026, has now been published. Below is a brief overview of relevant items from the meeting. HMA MG Report The HMA Management Group provided updates on strategic and operational priorities across the EMRN, including work from HMA groups, Joint Actions, clinical trials developments, and potential implications of the proposed PFAS restriction. Updates were also given on preparations for the next EMANS and on international cooperation activities. EMA Update https://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/CMDh_pressreleases/2026/CMDh_press_release_-_May_2026.pdf https://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Templates/AR/DCP_AR_Comments/CMDh_202_2005_Rev7_2026_05_clean_-_NonClinical_Clinical_AR_forGenerics_MRP_DCP.docx https://www.hma.eu/fileadmin/dateien/HMA_joint/03-Stakeholders_Info/2026-05-HMA-II-Paphos-Stakeholders-Information.pdf AESGP OTC News | June 2026 4 | 21 EMA presented updates on crisis preparedness and scientific readiness, including responses related to viral outbreaks and the Middle East context. Additional topics included NPL, international cooperation through ICMRA and with China, vaccine confidence initiatives, collaboration with ECHA, and upcoming network activities. Commission Update The EC provided updates on public health preparedness (hantavirus, Ebola), implementation of the Clinical Trials Regulation via the CTA framework, NPL, the Biotech Act, and the Substances of Human Origin (SoHO) legislation. Cooperation of National Agencies/EMA in the Proposed MDR/IVDR Revision HMA discussed the importance of close cooperation between NCAs and the EMA in the context of the proposed MDR/IVDR revision. The discussion highlighted the need for coordinated regulatory approaches, efficient use of expertise across the network, and strengthened collaboration to support innovation, patient safety, and effective implementation of the revised legislative framework. CAMD Update CAMD updated HMA on discussions regarding the future governance and structure of the European medical devices network. Feedback from CAMD members showed support for strengthening cooperation between medicines and medical devices regulatory systems, while maintaining a dedicated medical devices network in the short term. Opportunities for closer collaboration were identified in training, clinical trials, innovation, enforcement and shared regulatory infrastructures, with a longer-term vision of greater integration across the two sectors. Trio-Theme Megatrends – HMA Concept Paper to Inform the Next EMANS HMA endorsed a Trio Presidency concept paper on megatrends affecting the EMRN, including technological innovation, digital transformation, demographic change, and evolving health needs. The paper provides a strategic basis for the next EMANS (from 2028) and was finalised after consultation with NCAs. Joint Session with EMACOLEX EMACOLEX updated HMA on legal and regulatory developments relevant to the network, supporting coordination, knowledge exchange, and regulatory preparedness. The Subgroup on Horizontal Scanning presented its work on monitoring external policy developments affecting medicines and medical devices, enabling early identification and proactive regulatory response. Upcoming Irish Presidency HMA was introduced to the upcoming Irish Presidency priorities and planned activities, with a focus on continued collaboration across the regulatory network and invitations to upcoming meetings and exchanges among MSs. EMA Management Board - JUN 2026 - Meeting highlights + Publication of EMA 2025 Annual Report The highlights of the EMA Management Board JUN 2026 meeting, have been published. Among the items reported, the following may be noted: Positive assessment of EMA’s activities in 2025 – Annual Report The Board positively assessed the Executive Director’s 2025 annual activity report, which describes the implementation of the Agency’s work programme and the management and control systems in place. The Board noted the work on marketing authorisations via the centralised procedure, both in human and veterinary medicines. EMA delivered 104 positive recommendations for new medicines for human use, including 38 containing a new active substance, many of them addressing unmet medical needs. The Agency issued 30 recommendations for new veterinary medicines – the highest number of recommendations for a second consecutive year. Of these, 13 had a new active substance. https://www.ema.europa.eu/en/news/ema-management-board-highlights-june-2026-meeting AESGP OTC News | June 2026 5 | 21 The Board also acknowledged activities carried out to accelerate and optimise assessment processes, as well as the Agency’s continued role in addressing challenges related to the availability of medicines and security of supply. The annual activity report will be published on the EMA website shortly. This complements EMA’s 2025 annual report (see here the digital version and here the PDF) that was published on 11 JUN. Preparations for implementation of the new EU pharmaceutical legislation Preparations for implementing the new EU pharmaceutical legislation (NPL) have progressed. The Board received a comprehensive overview of the activities under the NPL EMA Management Board governance structure. Planning is advancing across the delivery streams, aligned with the European Commission’s work on the delegated and implementing acts. The NPL Oversight Group has also endorsed a network collaboration model to ensure broad expert involvement from across the European medicines regulatory network in the preparations from the outset. Update from Network Data Steering Group EMA, in collaboration with the national medicines agencies, is further developing the product management service (PMS) to support regulatory activities across the EU with structured and standardised medicinal product master data for all human medicines authorised in the EU. These data are routinely used by regulators and industry, e.g. pharmacovigilance and shortages activities, and other targeted regulatory procedures. The Agency is now looking at enabling wider use beyond medicines development and regulation by the public. From 12 JUN 2026, PMS will make additional data publicly accessible through the release of a ‘beta’ version of an Application Programming Interface (API) for public use. PMS data are already available via a web interface, but the API will enable external access in a structured, machine- readable format. This is an important step towards greater transparency, improved accessibility and broader use of trusted EU medicinal product information. With the beta release, EMA and stakeholders can gain experience, test use cases, and further refine the service. Release of a final API version is planned for early 2027. Preliminary Ruling - Case C-604/24 - Restriction of Online Sale of NPMs – Judgment The Court of Justice of the European Union (CJEU) delivered its judgment in the Court proceedings C-604/24 concerning the request for a preliminary ruling by the Greek Council of State to provide clarity as regards the Member States’ discretion to restrict online sales of non-prescription medicines under Article 85c of Directive 2001/83/EC. Dispute in the main proceedings The applicant is a Greek company operating both a physical pharmacy and an online sales channel. In April 2022, Greece adopted a Ministerial Decision, which narrowed the previously unrestricted authorisation to sell all non-prescription medicines (NMPs) online to a single subcategory: over-the- counter (OTC) medicinal products classifiable as such under their marketing authorisation and available for sale outside pharmacies, without the presence of a pharmacist or an auxiliary pharmacist being required. The measure amounted in practice to a ban of online sales of NMPs because no product had been classified in the OTC subcategory on the Greek market. The questions referred by the Greek Council of State asked in essence whether Article 85c(1) and (2) of Directive 2001/83 must be interpreted as precluding national legislation which, on grounds of public health protection, prohibits the online sale of non-prescription medicinal products, with the exception of a subcategory thereof. Court Ruling In its ruling, the Court clarifies that the wording Article 85c(1) of Directive 2001/83 establishes an obligation on part of Member States to offer the online sale of all NPMs. Consequently, the Court finds that the Greek legislation under consideration prohibiting the online sale non-prescription medicinal products, with the exception of a subcategory, fails to fulfil the obligation arising from https://www.ema.europa.eu/assets/en/annual-report/2025/index.html https://www.ema.europa.eu/en/documents/annual-report/2025-annual-report-european-medicines-agency_en.pdf https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX:62024CJ0604 https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX:62024CJ0604 AESGP OTC News | June 2026 6 | 21 Article 85c(1) of Directive 2001/83. The only limitation in Article 85c(1) concerns prescription medicinal products. In addition, the Court specifies that national legislation prohibiting the online sale non-prescription medicinal products, with the exception of a subcategory, cannot be justified under Article 85c(2) as a "condition". Such legislation only partially authorises the offer for online sale of non-prescription medicinal products. The conditions referred to in Article 85c(2) of Directive 2001/83 cannot have the effect of rendering meaningless the obligation on Member States, under Article 85c(1), to ensure that medicinal products, at least all non-prescription medicinal products, are offered for online sale. The Court concludes therefore that Member States cannot rely on Article 85c(2) of Directive 2001/83 in order to impose conditions justified on grounds of public health protection as concerns the online sale of non-prescription medicinal products, where such conditions have the effect of depriving the obligation set out in Article 85c(1) of its effectiveness. At the same time, the Court provides guidance as to what “conditions” under Article 85c(2) may be permissible to regulate the online sale of NPMs. Such conditions must be justified on grounds of public health protection aimed at reducing the risks associated with the online sale of medicinal products and could consist, for example, of putting in place effective mechanisms to monitor the consumption of medicinal products, such as establishing order limits per consumer or the creation of an online system for identification and registration of consumer health data in order to combat overmedication. Nevertheless, in that context the Court stresses that those conditions must not call into question the possibility of offering NPMS for online sale by restricting access. Based on the foregoing, the Court stipulates that Article 85c(1) and (2) of Directive 2001/83/EC precludes national legislation that, on grounds of public health protection, prohibits the online sale of non-prescription medicinal products, with the exception of a subcategory thereof. Herbal medicines EMA HMPC Meeting Report - 4-6 MAY 2026 The report on European Union herbal monographs, guidelines, and other activities from the EMA Committee on Herbal Medicinal Products (HMPC) meeting, held on 4-6 May 2026 has been published. Among the reported items, the following may be noted: Revised European Union herbal monograph – final The HMPC adopted after systematic review, revision and public consultation the following revised monograph: • Revised EU herbal monograph on on Fragariae folium The final revised monograph together with supporting documents will be published on the European Medicines Agency's website. European Union herbal monographs’ review The HMPC adopted after systematic review and revision the following revised monograph (draft) for 3 month public consultation until 31 August 2026: • Draft revised EU herbal monograph on Lecithinum ex soya The review reports will be published as addenda to the existing assessment reports on the European Medicines Agency's website. Guidance documents The HMPC adopted the following reflection paper: https://www.ema.europa.eu/en/documents/committee-report/hmpc-meeting-report-european-union-herbal-monographs-guidelines-other-activities-4-6-may-2026_en.pdf https://www.ema.europa.eu/en/documents/committee-report/hmpc-meeting-report-european-union-herbal-monographs-guidelines-other-activities-4-6-may-2026_en.pdf https://www.ema.europa.eu/en/search?f%5B0%5D=ema_search_categories%3A85&f%5B1%5D=ema_search_content_type%3Aema_herbal&landing_from=73303 https://www.ema.europa.eu/en/search?f%5B0%5D=ema_search_categories%3A85&f%5B1%5D=ema_search_content_type%3Aema_herbal&landing_from=73303 AESGP OTC News | June 2026 7 | 21 • Reflection paper on data recommendations for herbal medicinal products and traditional herbal medicinal products used in paediatric patients (EMA/HMPC/71333/2023). The reflection paper will be published on the European Medicines Agency's website here. HMPC RP on data recommendations for (T)HMPs used in paediatric patients published with overview of comments The reflection paper on data recommendations for HMPs used in paediatric patients has been published by the EMA, together with the overview of comments received. At a glance, the RP has been minimally changed. The overview of comments responded to the general comments, pointing out the rather strict approach taken by the guideline in comparison with ICH E11, as follows: WEU and PK-PD It is agreed that WEU herbal medicinal products are not excluded from the scope of the ICH E11A extrapolation guideline and that the principles described in this guideline are applicable to WEU HMPs, despite the fact that WEU HMPs usually do not provide comprehensive pharmacokinetic and pharmacodynamic data. This is also acknowledged in the ICH guideline which states that when there is lack of correlation between systemic drug exposures/biomarker and therapeutic response, dose response relationships can rely on a clinical endpoint. The respective parts of the reflection paper have been therefore updated accordingly. [...] Extrapolation concerns safety and efficacy It must be underlined that in line with the ICH E11A guideline, extrapolation concerns both efficacy and safety. Therefore, it is not agreed that the main focus of extrapolation exercise in WEU HMPs should be on safety only. At the same time, in line with the ICH E11A guideline, the use of paediatric extrapolation ensures that the paediatric population only participates in clinical trials when necessary for further scientific understanding of the paediatric use of a medicinal product. First, available published data should be reviewed to confirm the acceptability of WEU status and to identify possible gaps in evidence. If any gaps in evidence are identified, an assessment in line with the ICH E11A guideline should take a place to understand whether it is acceptable to fill these gaps with extrapolation. Only if this is not possible, generation of additional paediatric data should be required. These principles are also described in the ICH E11A guideline; therefore, no additional changes are proposed to the reflection paper. It is agreed that HMPs tend to have good safety profiles with wider safety margins, although this is not always the case. This is also acknowledged in the ICH E11A guideline which states that if the safety margin is wide, it may be acceptable to target higher exposures than in adults. As the applicability of this guideline was acknowledged, no additional changes are proposed to the reflection paper. It is agreed that evidence from similar/same-class products could be included among alternative supportive data sources. This approach is also supported by the ICH E11A guideline. At the same time, the differences between products need to be reviewed critically in line with the guideline. As the applicability of this guideline was acknowledged, no additional changes are proposed to the reflection paper. Conditional approval and absence of unmet medical needs The proposed approach of conditional approval of adjacent paediatric age groups where generation of data in the adjacent paediatric age group would take place only after granting of conditional approval for the respective age group is not supported. This is because according to the current requirements for conditional marketing authorisation, the product has to fulfil an unmet medical need. However, HMPs are generally not used in indications where significant unmet medical need exists. Second, to grant a conditional marketing authorisation, the benefit-risk balance in the respective age group needs to be positive while according to this proposal, no data would be available in the respective age group for benefit-risk assessment. This way of extrapolation is also not in line with the requirements set by ICH https://www.ema.europa.eu/en/human-regulatory-overview/herbal-medicinal-products/procedures-monograph-list-entry-establishment https://www.ema.europa.eu/en/documents/scientific-guideline/reflection-paper-data-recommendations-herbal-medicinal-products-traditional-herbal-medicinal-products-used-paediatric-patients_en.pdf https://www.ema.europa.eu/en/documents/comments/overview-comments-draft-reflection-paper-data-recommendations-herbal-medicinal-products-traditional-herbal-medicinal-products-used-children-adolescents_en.pdf AESGP OTC News | June 2026 8 | 21 E11A guideline. Third and most importantly, according to the current legal requirements, such a conditional approval does not exist in monograph development. Traditional use As for TU herbal medicinal products, proof of TU requires the gathering of all available evidence for the specific herbal substance/ preparation and based on this evidence of use, the indication is granted. Such an approach ensures that plausibility of TU and safety is established by proven long-term use without any unacceptable reported issues while no actual hard clinical data are available. This means that extrapolation of TU, to age groups which are not explicitly mentioned in TU evidence, is not generally acceptable. AESGP OTC News | June 2026 9 | 21 Law -13 May 2026 Summary report The summary report of the Standing Committee on Plants, Animals, Food and Feed – Section General Food meeting of 13 May 2026 has been published and can be accessed here. The following topics of relevance have been discussed: ▪ Results of Priority Control Area on E-commerce Imports Action: Food Supplements. DG SANTE and DG TAXUD jointly presented the results of the Priority Control Area (PCA) on e-commerce imports of food supplements, integrating findings from food safety authorities (via the Alert and Cooperation Network) and customs controls. The PCA was carried out with a view to strengthening customs controls on food supplements sold online to EU consumers, with a particular focus on low-value consignments (under EUR 150) from major e-commerce platforms. It targeted food supplements containing ingredients unauthorised or prohibited in the EU, grouped into four categories: sexual enhancement; sports performance and bodybuilding; weight loss; and mental distress, pain relief and disease management. Under the PCA, customs authorities suspended suspect products and referred them to food safety authorities, which then decided on release, further examination or refusal of entry to the EU market. Member States requested that the presentation (or report) prepared by DG TAXUD be made available. However, the European Commission clarified that, as the work is still ongoing, these documents are to be treated as confidential and cannot be disclosed at this stage. ▪ Exchange of views and possible opinion of the Committee on a draft Commission Regulation (EU) amending Annex III to Regulation (EC) No 1925/2006 of the European Parliament and of the Council as regards monacolins from red yeast rice. The Commission presented to the Committee a draft Commission Regulation, aimed at prohibiting the use of monacolins from red yeast rice in food. This follows a period of Union scrutiny, during which interested parties may submit scientific evidence to demonstrate the safety of the substance in accordance with the procedure laid down in Article 8(4) of Regulation (EC) No 1925/2006. The Commission explained that the draft Regulation was based on the scientific opinion of the European Food Safety Authority (EFSA), adopted on 29 January 2025, which concluded that the safety of the substance could not be established based on the data submitted by interested parties. Furthermore, EFSA reiterated the concerns raised in its opinion of 3 August 2018 on the safety of monacolins in red yeast rice that exposure to monacolins from red yeast rice at intake levels as low as 3 mg/day could lead to severe adverse effects on the musculoskeletal system, including rhabdomyolysis, and on the liver. During the exchange of views, two Member States took the view that the 12-month transition period, as provided for in the draft Regulation for products lawfully placed on the market before the entry into force of the measure, should be extended until existing stocks are exhausted. One Member State noted that Food https://food.ec.europa.eu/document/download/54af8d7d-2d0d-4758-94d0-45412aa2df98_en?filename=reg-com_gfl_20260513_sum.pdf AESGP OTC News | June 2026 10 | 21 studies aimed at demonstrating the safety of monacolins from red yeast rice were being carried out by industry stakeholders. Another Member State considered that the use of monacolins from red yeast rice should be allowed in food, subject to certain conditions of use. The Commission explained that the industry had been given sufficient time to prepare for the possible risk-management actions, given that EFSA’s conclusions on monacolins from red yest rice had been known since 29 January 2025. It further explained that a 12-month transition period would ensure a smooth transition while considering the EFSA’s conclusions in its opinions of 3 August 2018 and 29 January 2025 regarding the severe adverse health effects. Therefore, any further delay in the entry into application of the measure would not be justified. AESGP OTC News | June 2026 11 | 21 MDCG Eudamed WG Production release 2.27.0 deployed The EUDAMED Production release 2.27.0 has been successfully deployed. This release will be the one for mandatory use, which will start on 28 May 2026. The main key additions are: • The Clinical Evaluation Consultation Procedure (CECP) feature in the Notified Bodies & Certificates module • The Mechanism for Scrutiny (MfS) feature in the Notified Bodies & Certificates module • The Market Surveillance module (mainly intended for the EC and CAs – and NBs/DAs in certain circumstances) Production Access: • EUDAMED restricted • EUDAMED public Documentation: See the details in the Release Notes and the updated documentation in the EUDAMED Information Centre. Mandatory Use of First EUDAMED Modules from 28 May 2026 As of 28 May 2026, the first four EUDAMED modules have become mandatory for use: • Actors • UDI/Devices • Notified Bodies & Certificates • Market Surveillance The mandatory use of these modules marks an important milestone in the implementation of the European medical devices regulatory framework and is expected to further support transparency, traceability, and regulatory cooperation across the EU medical devices sector. EUDAMED will be used by manufacturers, authorised representatives, importers, notified bodies, and competent authorities to ensure regulatory compliance, as it serves as the backbone of the MDR. Citizens, Medical Devices https://webgate.ec.europa.eu/eudamed/ https://ec.europa.eu/tools/eudamed/ https://webgate.ec.europa.eu/eudamed-help/en/files/EUDAMED%20-%20release%20notes.pdf https://webgate.ec.europa.eu/eudamed-help/en/welcome-to-the-eudamed-information-centre.html https://webgate.ec.europa.eu/eudamed-help/en/welcome-to-the-eudamed-information-centre.html AESGP OTC News | June 2026 12 | 21 patients, healthcare professionals, and all key actors in the sector will now have access to a wealth of essential information on devices placed on the EU market. MDCG EUDAMED WG Meeting on 2 June 2026 AESGP participated to the MDCG EUDAMED Working Group on 2 June 2026. The European Commission presented the state of play and upcoming developments of EUDAMED, reporting a significant increase in registrations following the mandatory use of the first four modules, with more than 2.3 million devices now registered. Despite a sharp rise in support requests, system performance remains stable. Development priorities include the finalisation of the Summary of Safety and Clinical Performance (SSCP) management functionality, enhancements to the Vigilance module, and continued work on M&A and UDI-related functionalities. A key topic was the transfer of responsibility for SSCP management in EUDAMED from notified bodies to manufacturers. The new functionality is expected to be available in the Playground environment in the second half of July and in production in October 2026. Until then, notified bodies will continue uploading master SSCPs, while manufacturers will remain responsible for translations. Industry representatives also highlighted the need for transition periods, improved support mechanisms, greater flexibility in the UDI module, and enhanced training and access arrangements for the Vigilance module. The next EUDAMED Working Group meeting is scheduled for 21 October 2026. MDCG Endorsement of Position Paper on SS(C)P Management in EUDAMED At the EUDAMED Working Group meeting which took place on 2 June 2026, one of the points for discussion was the Position Paper on management of SS(C)P in EUDAMED. During the WG discussion, representatives from industry associations raised a point regarding the timeline for uploading SS(C)Ps for devices placed on the market before the mandatory use of the UDI/Devices module. For devices placed on the market before mandatory use, since manufacturers will only be able to provide SS(C)Ps from October 2026 onwards, the original transitional period of 6 months for devices registration is de facto reduced substantially for the SS(C)P. Moreover, many devices may already be registered, but their corresponding certificates/SS(C)Ps might not yet be uploaded by notified bodies, which have a longer transition period (until 27 May 2027). This could create delays and operational bottlenecks, as the manufacturers will have to retrospectively upload those SS(C)Ps by 27 November 2026, deadline according to the transition period for device registration. To address these issues, the Commission amended the Position Paper previously shared with MDCG for endorsement, to allow manufacturers to upload SS(C)Ps for these devices until 27 February 2027 (unless a certificate update occurs after the mandatory use date). The Position Paper was endorsed by the MDCG on 19 June 2026. The MDCG-endorsed Position Paper is currently in the process of being published on the European Commission’s MDCG Guidance webpage. MDCG Standards WG New references harmonised standards MDR/IVDR - Publication in the OJEU & Appendix 'EU REP' https://health.ec.europa.eu/medical-devices-sector/new-regulations/guidance-mdcg-endorsed-documents-and-other-guidance_en AESGP OTC News | June 2026 13 | 21 Publications in the Official Journal of the European Union (OJEU) of new references of harmonised standards in support of the Regulations (EU) 2017/745 on medical devices (MDR) and (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) took place on 17 JUN 2026: • For the MDR: Commission Implementing Decision (EU) 2026/1231 of 11 June 2026 amending Implementing Decision (EU) 2021/1182 as regards harmonised standards for biological evaluation of medical devices, symbols to be used with information to be supplied by the manufacturer, medical electrical equipment, transfusion equipment for medical use, ophthalmic optics, non-active surgical implants, washer-disinfectors, prosthetics and sharps injury protection (OJ L, 2026/1231, 17.6.2026, https://eur-lex.europa.eu/eli/dec_impl/2026/1231/oj ). To correct the data of application of Commission Implementing Decision (EU) 2026/1231, a Corrigendum was published on 22 JUN 2026 – reaching 65 references overall • For the IVDR: Commission Implementing Decision (EU) 2026/1313 of 15 June 2026 amending Implementing Decision (EU) 2021/1195 as regards the harmonised standard for symbols to be used with information to be supplied by the manufacturer (OJ L, 2026/1313, 17.6.2026, https://eur- lex.europa.eu/eli/dec_impl/2026/1313/oj ) – keeping 23 references overall These publications include also the reference of EN ISO 15223-1:2021/A1:2025, amending the harmonised standard on “Symbols to be used with information to be supplied by the manufacturer”, to introduce the new symbol ‘EU REP’ for authorised representatives, with a transition period of 60 months (5 years) ending on 17 JUN 2031. A supporting guidance document, as Appendix “Transition to the ‘EU REP’ symbol in EN ISO 15223-1” to the main guidance document MDCG 2021-5 Rev. 1 Guidance on standardisation for medical devices, has been published as well, as endorsed by the MDCG and updated with the publication references. For further information on harmonised standards for medical devices, the dedicated Commission’s webpage is available here. MDCG Nomenclature WG EMDN Annual Update The EMDN technical team is currently assessing stakeholder requests submitted under the annual EMDN update procedure and will soon provide a summary of the requests and their status. Due to the volume of submissions and ongoing evaluations, the July EMDN meeting may be postponed to November, with the latter expected to focus on validating the annual update. In the meantime, a first draft of the update proposal will be circulated for consultation by the end of July. Regarding translations, the English version has been completed and validated, while translations into the remaining EU languages are expected in September 2026. The current three-year translation project will support annual EMDN updates throughout its duration. MDR/IVDR Simplification Proposal Commission presentation to Council on EMA support, borderline & classification In the context of the ongoing negotiations on the Commission proposal to revise the MDR/IVDR, please find below the presentation delivered by the Commission to Member State representatives in the Council on the provisions related to EMA support to the regulatory system, as well as borderline and classification. https://eur-lex.europa.eu/eli/dec_impl/2026/1231/oj https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=OJ:L_202690511 https://eur-lex.europa.eu/eli/dec_impl/2026/1313/oj https://eur-lex.europa.eu/eli/dec_impl/2026/1313/oj https://health.ec.europa.eu/document/download/e10f7694-67b4-4093-a969-6f7e43747c44_en?filename=md_mdcg_2021_5_appendix_en.pdf https://health.ec.europa.eu/document/download/e10f7694-67b4-4093-a969-6f7e43747c44_en?filename=md_mdcg_2021_5_appendix_en.pdf https://health.ec.europa.eu/medical-devices-topics-interest/harmonised-standards_en https://health.ec.europa.eu/medical-devices-topics-interest/harmonised-standards_en AESGP OTC News | June 2026 14 | 21 The Commission presentation on cluster 2 - Support to the regulatory system provides further details on the Commission’s rationale for proposing stronger EMA support in the regulatory system and on the envisaged coordination processes for borderline and classification issues. MDR/IVDR Implementation Notified Bodies Survey on Certifications & Applications - Data dated 31 December 2025 The Commission has published on its website the “Notified Bodies Survey on certifications and applications (MDR/IVDR)” based on data collected from notified bodies until 31 December 2025. The survey – accessible here – is based on data from 53 notified bodies designated under the MDR/IVDR. Please note that this data does not seem to be reflected yet in the dashboard of the corresponding study on the monitoring of availability of medical devices on the EU market. According to the data, there are 31.101 MDR applications (the decrease in the number is due to a change in the methodology used by one NB to count applications) and 21.791 MDR certificates issued, with 944 MDR applications refused. As usual, the survey also provides an overview of certifications and applications by annex and by type (QMS vs Product). However, this time, the report does not include data on the number of applications under Rule 14 and Rule 21, first indent. This data will be made available in the dashboard. Regarding timelines, only 32% of NBs have a system for monitoring conformity assessment activities that can provide data on certification timelines. For certification costs, only 30% of NBs have such a system. Please be reminded that, under the new Commission Implementing Regulation (EU) 2026/977, NBs will be required to document and implement a system to monitor the duration and costs of conformity assessment activities. Annex VII NB Requirements: AESGP statement and summary of timelines for NBs On 8 May 2026, the AESGP Secretariat published a statement on its website welcoming the adoption of the Commission Implementing Regulation (EU) 2026/977, highlighting its potential to improve predictability and efficiency in relation to the quality management and processes in the context of conformity assessment activities. Additionally, please find below an overview table of the maximum timelines and allowed clock stops for notified bodies per conformity assessment activity under the new implementing regulation. Please note that the regulation has entered into force on 25 May 2026, with several provisions applying mostly from 25 February 2027. Activity Maximum time Starting on Allowed number of clock stops* Date of application Application review and contract signing 30 days The day the NB receives the complete application One Feb. 25, 2027 https://data.consilium.europa.eu/doc/document/WK-5589-2026-INIT/en/pdf https://health.ec.europa.eu/document/download/59b9d90e-be42-4895-9f6f-bec35138bb0a_en?filename=md_nb_survey_certifications_applications_en.pdf https://health.ec.europa.eu/study-supporting-monitoring-availability-medical-devices-eu-market_en https://health.ec.europa.eu/study-supporting-monitoring-availability-medical-devices-eu-market_en https://eur-lex.europa.eu/eli/reg_impl/2026/977/oj https://aesgp.eu/articles/aesgp-statement-on-commission-implementing-regulation-eu-2026-977-setting-maximum-timelines-for-conformity-assessment-activities-of-medical-devices https://aesgp.eu/articles/aesgp-statement-on-commission-implementing-regulation-eu-2026-977-setting-maximum-timelines-for-conformity-assessment-activities-of-medical-devices AESGP OTC News | June 2026 15 | 21 Quality management system auditing 120 days The day the NB initiates the audit programme’s first activity Four + two for each additional site Feb. 25, 2027 Product verification 90 days The day the NB initiates the assessment of the technical documentation Four Feb. 25, 2027 Decision and certification 20 days The day after the completion of the last review One Feb. 25, 2027 Substantial change – review of proposed planned change 30 days The day the NB receives the information on the planned change Five Feb. 25, 2027 Substantial change – additional conformity assessment activities 90 days The day the NB initiates the audit’s programme first activity or the assessment of technical documentation, whichever is the earlier Five Feb. 25, 2027 Substantial change – certificate issued 20 days The day following that of the notification of the approval of the planned change One Feb. 25, 2027 Re-certification – products 90 days The day the NB receives the complete documentation Three Nov. 25, 2027 Re-certification – QMS 90 days The day the NB receives the complete application Three Nov. 25, 2027 Recertification – certificate decision 20 days The day after the final review One Nov. 25, 2027 * Please note that interruption from EMA opinions do not count as a clock stop. Team NB Publications Sector Survey 2025 Team NB has published a press release outlining the data received from their members for the annual sector survey 2025, as well as a slide deck presenting the data. The survey provides information, amongst others, on the evolution of MDR/IVDR certificates issued, the withdrawal of certificates, the number of ISO 13485 certificates, and the transition process from the Directives to the Regulations. According to the slides, in 2025, there was a slowdown in the growth of certificate issuance, with an increase of two-thirds compared to the doubling observed in 2023 and 2024. Compared with the results of the “Study supporting the monitoring of availability of medical devices on the EU market”, with data up to December 2025: https://www.team-nb.org/wp-content/uploads/2026/05/Team-NB-MD-Sector-Survey-PressRelease-20260518.docx https://www.team-nb.org/wp-content/uploads/2026/05/Survey-2025.pdf AESGP OTC News | June 2026 16 | 21 • Team NB Team-NB certificates represent 81% of the total issued; and • applications received by Team-NB members represent 84% of the total applications. MDR Certification Process (including Pre- application, Application and Post Application phases) – Consensus document Team-NB has published a position paper on the MDR Certification process. The purpose of this consensus document is to describe in detail the pre-application, application processes through which manufacturers may apply to Notified Bodies (NBs) for the certification of medical devices under the regulation (EU) 2017/745 (MDR). The document was developed by reviewing the application process and associated documents of individual Team-NB members and harmonising the processes where possible. This document is applicable to both legacy devices (pursuant to Article 120) transitioning to MDR, and devices that are new to the market and have not been certified under the Directives before. The document also briefly describes the certification activities that are undertaken after the application process is concluded. IVDR Application and appropriate surveillance Transfer agreement Team-NB members have adopted and published , a template Agreement form related to the transfer of IVDR formal application and of appropriate surveillance of legacy devices specifying the terms of the transfer in respect of legacy devices covered by Directives certificates. Micro and Small Enterprise Considerations Team NB has released a position paper commenting the changes brought by the ongoing revision of the European medical device regulatory framework (article 50 on access to notifies bodies and fees). As reminder, among the proposed measures is an expectation that notified bodies offer significantly reduced conformity assessment fees, up to a 50% discount for micro and small enterprises. The Team NB position paper highlight that the challenges faced by these organisations are structural and systemic in nature, extending far beyond notified body fees alone. Measures focused solely on fee reductions risk addressing symptoms rather than root causes, and may unintentionally undermine the capacity, independence, and sustainability of the conformity assessment system. According to them, the analysis presented in this paper demonstrates that the primary barriers encountered by micro and small manufacturers relate to limited regulatory experience, high costs associated with clinical evidence generation and external services, variability in the quality of regulatory advice, and inefficiencies arising from disproportionate or repetitive conformity assessment activities. They believe addressing these challenges requires a more balanced and ecosystem-wide approach. The most effective solutions lie in improving regulatory capability at source, increasing predictability of requirements, and ensuring that oversight activities are applied in a proportionate and risk-based manner. They propose the following measures : • Strengthening and formalising structured dialogue, including pre-submission interactions, to improve early alignment and reduce uncertainty; • Introducing greater flexibility in post-certification surveillance and sampling, enabling notified bodies to apply justified, risk-based approaches and avoid unnecessary duplication; • Establishing EU and Member State-funded programmes to support regulatory capability development and to offset the broader costs of clinical investigations, laboratory testing, and https://www.team-nb.org/wp-content/uploads/2026/06/Team-NB-PositionPaper-MDR-Certification-Process-Consensus-Document-V2-20260604.pdf https://www.team-nb.org/wp-content/uploads/2026/06/Team-NB-PositionPaper-IVDR-Application-and-appropriate-surveillance-Transfer-agreement-V1-20260610.pdf https://www.team-nb.org/wp-content/uploads/2026/06/Team-NB-PositionPaper-Micro-Small-Entreprise-Initiatives-V1-20260616.pdf https://health.ec.europa.eu/document/download/7c4e871e-ebaf-46e0-ae76-93478e3d3fbc_en?filename=md_sector_proposed-amendments-mdr-articles.pdf AESGP OTC News | June 2026 17 | 21 associated services; • Improving transparency, consistency, and assurance in the use of regulatory consultants, including mechanisms for validation of regulatory approaches through structured dialogue; • Expanding the use of remote and hybrid audit models where appropriate, reducing operational burden on smaller organisations; • Advancing harmonisation of guidance, templates, and submission frameworks to improve clarity, consistency, and first-time quality of submissions. Planned Meetings of Medical Device Coordination Group (MDCG) and Subgroups in 2026 Update The Commission has published an update of the planned meeting dates of the MDCG and subgroups for 2026. ESIP, AIM, TEAM-NB, CPME, TÜV Verband, IG-NB unified for a better WET approach The European Social Insurance Platform (ESIP), Team-NB, the Association of Mutual Benefit Societies (AIM), the Standing Committee of European Doctors (CPME), TÜV Verband and the Interest Group of Notified Bodies( IG-NB) have cosigned a joint statement which highlights shared concerns among healthcare insurers, medical doctors and notified bodies regarding the Commission’s Delegated Regulations on well-established technologies (WET) and calls for further refinement to ensure legal certainty and consistent application under MDR. The statement is accessible on Team-NB website. https://health.ec.europa.eu/document/download/941b23fa-60e9-4efe-bd38-9b2d8649e70c_en?filename=md_events_2026_en.pdf https://health.ec.europa.eu/document/download/941b23fa-60e9-4efe-bd38-9b2d8649e70c_en?filename=md_events_2026_en.pdf https://www.team-nb.org/wp-content/uploads/2026/06/Joint-Stakeholder-Statement-MDR-WET.pdf https://www.team-nb.org/esip-team-nb-cpme-tuv-verband-ig-nb-unified-for-a-better-wet-approach/ AESGP OTC News | June 2026 18 | 21 AI - Omnibus VII legislative package - Provisional agreement reached by the Council presidency and European Parliament negotiators On 7 MAY, the Council presidency and European Parliament negotiators reached a provisional agreement on a proposal to streamline certain rules regarding artificial intelligence (AI), which has been published on the Council’s website. The proposal forms part of the so-called ‘Omnibus VII’ legislative package under the EU’s simplification agenda, comprising two proposed regulations intended to simplify the EU’s digital legislative framework and the implementation of harmonised rules on AI. What did the Commission originally proposed? 1. An adjustment of the timeline for the application of rules on high-risk AI systems by up to 16 months, so that the rules would start applying once the Commission confirms that the necessary standards and implementing tools are in place; 2. Targeted amendments to the AI Act to extend certain regulatory exemptions granted to SMEs to small mid-caps (SMCs), reduce requirements in a limited number of cases, extend the possibility to process sensitive personal data for bias detection and mitigation, reinforce the AI Office’s powers and reduce governance fragmentation. What are the main amendments introduced by the co-legislators at political agreement stage? Timelines for high-risk AI systems • The introduction of a fixed timeline for the delayed application of rules for high risk AI systems: ➢ 2 DEC 2027 (new application date) for stand alone high risk AI systems; and ➢ 2 AUG 2028 (new application date) for high risk AI systems embedded in products. Obligations and standard for the processing of personal data • An obligation for providers to register AI systems in the EU database for high-risk AI systems, where they consider their systems to be exempted from classification as high-risk. • The introduction of a standard of strict necessity for the processing of special categories of personal data for the purpose of ensuring bias detection and correction. Regulatory sandboxes and transparency • Postponement of the deadline for the establishment of AI regulatory sandboxes by competent authorities at national level until 2 AUG 2027. • A reduction of the grace period for providers to implement transparency solutions for artificially generated content from 6 months to 3 months, with the new deadline set on 2 DEC 2026. Governance and supervision Cross-Sectorial News https://www.consilium.europa.eu/en/press/press-releases/2026/05/07/artificial-intelligence-council-and-parliament-agree-to-simplify-and-streamline-rules/ AESGP OTC News | June 2026 19 | 21 • Clarification of the competences of the AI Office for the supervision of AI systems based on general-purpose AI models where the model and that system are developed by the same provider by listing exceptions where national authorities remain competent, including law enforcement, border management, judicial authorities and financial institutions. Interaction with sectoral legislation • The introduction of a mechanism allowing the resolution of situations, where sectoral legislation contains AI-specific requirements similar to those of the AI Act, by limiting the latter’s application in such cases through implementing acts. This is particularly relevant to the AI Act’s provisions on industrial AI and their interaction with sectoral legislation governing areas such as medical devices, toys, lifts, machinery, and watercraft. • An exemption of the machinery regulation from direct applicability of the AI act. • An empowerment for the Commission to adopt delegated acts under the machinery regulation which would add health and safety requirements in respect of AI systems that are classified as high-risk pursuant to the AI act, with a aim to effectively addresses any possible overlaps between the high-risk requirements from the AI act and those from sectoral legislation. • The addition of a new obligation for the Commission to provide guidance to assist economic operators of high-risk AI systems covered by sectoral harmonisation legislation in complying with the high-risk requirements of the AI act in a manner that minimises compliance burden. New prohibitions • The addition of a new provision to the AI Act prohibiting AI practices regarding the generation of non-consensual sexual and intimate content or child sexual abuse material (CSAM). Team-NB has released a statement regarding the provisional agreement reached by the Council Presidency and the European Parliament on the AI omnibus. BACKGROUND • In OCT 2024, the European Council called on all EU institutions, member states and stakeholders, as a matter of priority, to take work forward, notably in response to the challenges identified in the reports by Enrico Letta (‘Much more than a market’) and Mario Draghi (‘The future of European competitiveness’). • The Budapest declaration of 8 NOV 2024 subsequently called for ‘launching a simplification revolution’, by ensuring a clear, simple and smart regulatory framework for businesses and drastically reducing administrative, regulatory and reporting burdens, in particular for SMEs. • Since February 2025, as a follow-up to the call by EU Leaders at that and subsequent meetings, the Commission has put forward ten ‘Omnibus’ packages aiming to simplify existing legislation on sustainability, investment, agriculture, small mid-caps, digitalisation and common specifications, defence readiness, chemical products, digital issues including on AI, environment, the automotive sector and food and feed safety. New Council of Europe Recommendation sets standards for remote and online medicine provision The Council of Europe Committee of Ministers has adopted Recommendation CM/Rec(2026)7, setting out best practices for the remote and online provision of medicines. Co-ordinated by the European Directorate for the Quality of Medicines & HealthCare, the Recommendation responds to the expansion of digital healthcare which has highlighted both the benefits of remote access to medicines and the need for robust safeguards. As a Council of Europe Recommendation, the instrument is non-binding and now serves as a framework for Member States to consider and implement through national policies, legislation and regulatory practice. For more details, the following news are available here. https://www.team-nb.org/artificial-intelligence-council-parliament-agree-to-simplify-and-streamline-rules/ https://search.coe.int/cm#{%22CoEIdentifier%22:[%2209125948802b8d9e%22],%22sort%22:[%22CoEValidationDate%20Descending%22]} https://www.edqm.eu/en/-/new-council-of-europe-recommendation-sets-standards-for-remote-and-online-medicine-provision AESGP OTC News | June 2026 20 | 21 PPWR - EC guidance - 10 JUN 2026 The European Commission has published its final, non-binding guidance on the Packaging and Packaging Waste Regulation (PPWR) on 10 June 2026. This guidance document follows the draft guidance endorsed in March 2026 and comes just over two months ahead of the start of PPWR application on 12 August 2026. The link to the guidance document is available here: Commission Notice – Guidance document for Regulation (EU) 2025/40 on packaging and packaging waste https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=OJ:C_202603084 https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=OJ:C_202603084 AESGP — Association of the European Self-Care Industry Avenue de Tervuren, 7 1040 Brussels Belgium info@aesgp.eu www.aesgp.eu

AESGP Issue 384 | May 2026 Euro OTC News Table of Contents MEDICINES _______________________________________________________________________________ 2 Regulatory News _____________________________________________________________________________________________ 2 • CMDh Report - 21-22 APR 2026 ___________________________________________________________________________ 2 • CMDh Minutes - 24-25 MAR 2026 _________________________________________________________________________ 2 • 131st EMA Management Board Meeting - 12 MAR 2026 – Minutes ________________________________________________ 5 • 103rd meeting of the EC Pharmaceutical Committee – Summary record ____________________________________________ 7 Herbal medicines ____________________________________________________________________________________________ 9 • EMA - Revised Q&A on implementation of Ph. Eur. Medicinal Product Monographs (MPM) _____________________________ 9 FOOD __________________________________________________________________________________ 10 Setting Maximum Levels for Vitamins & Minerals _________________________________________________________________ 10 • Timelines on EC Webpage ______________________________________________________________________________ 10 MEDICAL DEVICES _______________________________________________________________________ 11 Borderline & Classification WG ________________________________________________________________________________ 11 • MDCG Guidance 2021-24 Rev.1 published _________________________________________________________________ 11 • Borderline Manual under MDR and IVDR - Updated Version (Version 5) Published ___________________________________ 11 CIEPS WG _________________________________________________________________________________________________ 11 • Member States-specific national requirements for clinical investigations and performance studies _______________________ 11 MDR/IVDR Simplification _____________________________________________________________________________________ 12 • AESGP Final Position Published on AESGP Website __________________________________________________________ 12 • AESGP Final Position Submitted to EC Public Consultation _____________________________________________________ 12 MDR/IVDR Annex VII NB Requirements _________________________________________________________________________ 12 • Commission Implementing Regulation (EU) 2026/977 Published in OJ ____________________________________________ 12 MDR/IVDR Implementation ____________________________________________________________________________________ 12 • Revised Team-NB Best Practice Guidance for the Submission of TD Published _____________________________________ 12 Nomenclature WG ___________________________________________________________________________________________ 13 • Updated EMDN documents _____________________________________________________________________________ 13 Post Market Surveillance and Vigilance Medical Devices WG _______________________________________________________ 13 • MIR 7.3.1. PDF publication update ________________________________________________________________________ 13 • MIR publication update _________________________________________________________________________________ 13 EMA expert panel support for BtX medical devices _______________________________________________________________ 14 • Pilot programme ______________________________________________________________________________________ 14 Team NB __________________________________________________________________________________________________ 14 • Updated Code of Conduct for NBs under the MDR/IVDR _______________________________________________________ 14 • Clinical Evaluation Based on Non-Clinical Data ______________________________________________________________ 14 ENVIRONMENT __________________________________________________________________________ 15 WFD+GWD+EQSD - Entry into force on 11 May 2026 ______________________________________________________________ 15 EU Deforestation Regulation - EC report and supportive materials___________________________________________________ 15 CROSS-SECTORIAL NEWS _________________________________________________________________ 17 Shortages - Updated ESMP User guide for MAHs _________________________________________________________________ 17 AESGP OTC News | May 2026 2 | 18 Regulatory News CMDh Report - 21-22 APR 2026 The report from the CMDh meeting held on 21-22 APR 2026, has been published. Among the items reported, the following may be noted: CMDh Guidance on the Informal Work-Sharing procedure for follow-up for PSUSA for NAPs (PSUFU procedure) The CMDh agreed an update of its guidance on PSUFU procedures to bring it in line with the new EC guidelines on the details of the various categories of variations and operation of the procedures. The updated document will be published on the CMDh website. [Post-meeting note: The clean and tracked versions of the updated document have been published on the CMDh website.] CMDh Presidency meeting under the Cypriot Presidency of the Council of the EU The CMDh convened for a Presidency meeting on 8 and 9 April 2026 in Larnaca, Cyprus, held as part of a programme of events organised under the Cypriot Presidency of the Council of the EU. In the meeting the CMDh discussed, amongst others, topics related to the future of the CMDh, the new pharmaceutical legislation, well-established use applications, workflow management systems, antimicrobial resistance, environmental risk assessment, reduction of medicine waste, ePL projects and use cases of AI. CMDh Minutes - 24-25 MAR 2026 The minutes of the CMDh meeting held on 24-25 MAR 2026 have been published. Among the items reported, the following may be noted: Working Party on Pharmacovigilance Procedures Worksharing The WP Chair reported from the March 2026 WP meeting. The WP Chair informed the CMDh about the changes in the EURD list regarding NAP entries. MSs were reminded to review the updated list. In addition, the template for requesting amendments of or addition of active substances/combinations to the EURD list has been amended to reflect that synonymous terms of the active substances/combinations should also be included. The WP adopted the LoSCs for several products while awaiting the new web-based system for its publication. The CMDh was informed about the progress of the small temporary group created to improve the implementation of patient cards following referral procedures. The WP will establish a DG to develop a CMDh BPG on aRMM in MRP/DCP that will incorporate the work of the small temporary group (activity foreseen in the CMDh MAWP to 2028). A call for interest/rapporteur will be launched shortly. Medicines https://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/CMDh_pressreleases/2026/CMDh_press_release_-_April_2026.pdf https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=OJ:C_202505045 https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=OJ:C_202505045 https://www.hma.eu/human-medicines/cmdh/pharmacovigilance/psur/psur-follow-up.html#c7151 https://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Pharmacovigilance_Legislation/PSUR/CMDh_367-2017_Rev8_2026_04_clean_-_Guidance_on_PUSFU_procedure.pdf https://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Pharmacovigilance_Legislation/PSUR/CMDh_367-2017_Rev8_2026_04_TC_-_Guidance_on_PUSFU_procedure.pdf https://www.hma.eu/human-medicines/cmdh/pharmacovigilance/psur/psur-follow-up.html#c7151 https://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Agendas_and_Minutes/Minutes/2026_03_CMDh_Minutes.pdf AESGP OTC News | May 2026 3 | 18 The work on a Q&A to provide guidance on PhV obligations and responsibilities in MRP/DCP will be temporarily postponed. The group reviewed the responses to a NUI on issues identified during linguistic review in PSUSA procedures. It was noted that unclear English wording should be corrected when identified. Inconsistencies were also identified between CMDh position/EC decision and the PRAC AR. The WP recommended that EMA introduce a final double-check to ensure accurate transfer of PRAC recommendations and correct wording for linguistic review. RMSs/LMSs should also carefully check final documents and verify consistency, including procedures other than PSUSAs (e.g. referrals). Meeting with Interested Parties in June 2026 A first draft agenda for the CMDh meeting with Interested Parties in June 2026 was presented. The draft agenda will be shared with Interested Parties for their input before the May CMDh meeting. ROG PMS operational group DE presented the preliminary results of the feasibility study on the PMS Data Qualification process that aims to assess the feasibility of implementing a data qualification process for nationally authorised products by National Competent Authorities (NCAs) and to provide recommendations for EU-wide implementation. NCAs are encouraged to prioritise mapping their databases to RMS and OMS for the basic PMS data elements. Collaborative qualification (e.g., RMS/CMS data responsibility sharing) could significantly improve efficiency and use of resources. Quarterly Strategic Portfolio Review DE reported from the Quarterly Strategic Portfolio Review, a ceremony of the Network Portfolio within the Agile framework, which also includes industry representatives. DE outlined the network’s current priorities, focusing on stakeholder engagement, ongoing parallel legislative initiatives, and digitalisation. It was also noted an ongoing project exploring the use of databases to update purely administrative information, replacing the need for type IA notifications. New Pharmaceutical Legislation (NPL) The EC provided a brief oral update on the NPL timeline, its application and planned implementation (including the need to prepare implementing and delegated acts). The CMDh stressed the need for consistent interpretation within the network, close involvement in all relevant workstreams, and alignment through the mapping of provisions to avoid overlap and ensure timely handling of these topics. Member States were reminded to submit any questions or expectations in advance to the EC, in preparation for the next CMDh plenary meeting. Questions and Answers on QP declaration The CMDh discussed an update of the Q&As on QP declaration to bring the document in line with the new Variations Guideline and remove references to the previous guideline. During the update also other minor changes were introduced to add clarification. Comments from MSs were discussed and taken into consideration, where appropriate. The CMDh agreed the update. As the document is a joint document with CMDv and some of the proposed changes also affect questions and answers for veterinary medicinal products, the CMDh will forward the proposal for update to CMDv for agreement before publication. Variation-related questions from Interested Parties The CMDh discussed and agreed answers to variation-related questions from Medicines for Europe, mainly related to conditions of quality-related changes and variation worksharing. The answers were prepared jointly by the EMA and the VRWP chair. Some of the questions will be further discussed in a future VRWP meeting. AESGP OTC News | May 2026 4 | 18 CEP 2.0 The CMDh discussed questions to QWP in relation to the practical implementation of CEP 2.0 based on issues raised by Medicines for Europe (as discussed in February 2026, item 3.10). The questions were agreed and will be sent to QWP. Multiple use of legal base Art. 10b NL informed the CMDh about the submission of pre-judicial questions to the Court of Justice of the European Union (CJEU) about the possibility for multiple use of legal basis Article 10b of Directive 2001/83/EC for the same combination of active substances. The questions follow a previous judgement of a national court in NL which excluded multiple applicants from obtaining a marketing authorisation for the same combination through this legal basis. It was noted that many MSs accept the multiple use of Art. 10b for the same fixed dose combination and the EC has expressed their agreement with this approach in the past. The judgement has been appealed by NL and a MAH and the necessity for asking pre-judicial questions to the CJEU to ensure consistent interpretation of EU law across all Member States was confirmed. MSs were informed that written observations can be submitted to the court until 21 April 2026. It was further noted that the wording of the legal basis has been updated in the proposal for the New Pharmaceutical Legislation. FR and ES informed the CMDh that they had national rulings in the past allowing the use of Article 10b for the same combination of active substances by multiple applicants. FR and ES were asked to share their court outcome with the CMDh. It was proposed that the case could also be brought to the attention of EMACOLEX. The judgement of the CJEU will be brought back to the attention of the CMDh once available. Medical Device Regulation Following the discussions in the CMDh in May/June 2024, NL informed the CMDh of the outcome of the discussions in the MDCG Borderline & Classification Working Group on the classification of micro-enemas with a long nozzle as medical device or as container closure system. The WG concluded that the package would fall under the definition of a medical device: The package for a medicinal product, used as laxative, is made to be used for rectal insertion and administration of the medicine. The package is a single dose mini-tube, with a long nozzle. In this case, the packaging for a medicinal product, used as laxative, is designed for rectal insertion and administration of the medicinal product into the body, thereby falling under the definition of a medical device. Thus, it cannot be considered to being purely a “simple” packaging solution. Because the product forms a single integral medicinal product, which is intended exclusively for use in the given combination and which is not reusable, the medical device part (the packaging) must comply with the requirements of the MDR in accordance with article 117 MDR. Proof of conformity with annex I MDR must be provided in the marketing authorisation dossier of the integral medicinal product. Article 117 is implemented in the Annex I to Directive 2001/83/EC, point 12 of section 3.2. The outcome will be published in the Manual on Borderline & Classification for Medical Devices. The outcome has also been shared with QWP. Acceptability of an UK reference medicinal product The CMDh discussed the acceptability of an UK reference medicinal product (RefMP) and the concept of same applicant/MAH in a generic application. The application was submitted in 2022 and used a UK RefMP for the BE studies. The BE studies were finalised in 2009 and 2015 and would therefore be acceptable for submissions in the EU. However, the applicant did not provide yet evidence that the MAH(s) of the RefMP used for data protection and the MAH of the UK RefMP used for the BE studies can be considered the same (i.e. the RefMP(s) belong to the same GMA). As in the meantime there have been changes of the MAHs, the CMDh confirmed a previous agreement that the relevant time for the evaluation of the same global marketing authorisation is the submission date of the generic application. AESGP OTC News | May 2026 5 | 18 It was noted that generally it’s the applicant’s responsibility to provide information that the RefMP(s) belong to the same GMA. The CMDh agreed that both RefMPs can be considered as belonging to the same GMA and can both be included in the AF. The applicant will be asked to update the AF accordingly. A.O.B. Excipients warnings for isomalt, maltitol and sucrose The CMDh discussed the need to update the warnings for excipients such as isomalt, maltitol, and sucrose, which are sources of sorbitol/fructose and therefore pose a risk to patients with hereditary fructose intolerance (HFI). In order to ensure the safe use of medicines in HFI patients, the CMDh agreed to request the CHMP to review the warnings in the product information of medicinal products containing excipients that are sources of sorbitol/fructose and update the relevant guidance documents to align them with the current warnings for fructose and sorbitol as appropriate. It was also noted that this inconsistency should be also reviewed for other excipients, i.e. lactitol (and any additional relevant sweeteners). Usage patents The CMDh discussed a proposal to amend the information of a generic ongoing application due to a usage patent of the RefMP. The deleted information related to the patent in sections 4.1, 4.2 and 4.4. of the SmPC concerns only information regarding the deleted indication. The proposed deletion of information in section 4.8 was not supported by CMDh as it concerns safety-related information. The CMDh agreed to keep all safety-related information and concluded that it is not necessary to rewrite section 4.8, in line with previous discussions and Q&A 4 of the CMDh Questions & Answers on Usage Patents. Delayed type IA variations submitted after 15 January 2026 DE informed the CMDh of a communication that had been sent to MHRA regarding the CMDh approach for delayed type IA variations submitted after 15 January 2026. Reference was made to previous CMDh discussions as well as to the CMDh press release of January 2026. DE will share the communication for information. 131st EMA Management Board Meeting - 12 MAR 2026 – Minutes The minutes from the131th EMA Management Board meeting held on 12 MAR 2026, have been published. Among the items reported, the following issues of high relevance to our sector may be noted: Highlights of the Executive Director Regarding the conflict in the Middle East, EMA, the MSSG and the SPOC Working Party are closely monitoring the effects on medicine supply in the EU. No critical shortages had been reported to date, though companies had flagged varying degrees of logistical disruption and rising costs. The situation remains dynamic. Coordinated actions were under way and MSSG recommendations were being finalised. The methodology to identify vulnerabilities in supply chains of critical medicines had also been adopted and published on 10 March, with an exercise covering several active substances set to begin in 2026. A few members of the Board stressed the importance of close monitoring of supply chain disruptions in particular with the conflict in the Middle East and requested for regular updates through the MSSG. The Executive Director provided reassurance that extensive supply chain monitoring was under way, with some 500 INNs assessed, and committed to providing a detailed briefing to the Management Board ahead of the MSSG meeting on 23 March. Several Board members also suggested that the potential impact of PFAS restrictions on medicine availability should feature in the planned EMA-ECHA Stakeholder meeting. The DG SANTE representative stated the need for caution on non-core expenditure and encouraged NCAs’ engagement in the forthcoming ECHA public consultation on PFAS. The Executive https://www.ema.europa.eu/en/documents/minutes/minutes-management-board-meeting-12-march-2026_en.pdf AESGP OTC News | May 2026 6 | 18 Director clarified that the EMA-ECHA Stakeholder meeting would focus on ways of working rather than on specific regulatory interventions, but undertook to explore with ECHA whether complementary information sharing with the NCAs on PFAS could be considered. Report from the European Commission The Management Board noted updates from the representatives of DG SANTE and DG RTD. The DG SANTE representative presented the next steps in the adoption of the new EU pharmaceutical legislation, the aspects relevant to EMA in the legal proposals for the Biotech Act and the revision of the EU medical device legislation, and a state of play on the Critical Medicines Act. The new pharmaceutical legislation is expected to enter into force in Q4 2026 and become applicable two years thereafter, except for some specific provisions with earlier applicability. The revision of the medical devices legislation proposes, amongst other aspects, to strengthen EMA’s role in supporting the regulatory framework thanks to its technical and scientific contributions, without altering Member States’ competences. Key proposed changes for EMA include reinforced management of expert panels, broadened panel membership to incorporate regulatory expertise, and an expanded use of the panels’ advice to support national and EU level decisions, such as on product classification and the recognition of breakthrough and orphan devices. EMA would also provide technical support to coordination of national activities on borderline and classification issues, clinical and performance investigation and evaluation, vigilance, market surveillance, and derogations to conformity assessment procedures in emergency situations. In addition, the revision mandates EMA, in collaboration with MDSSG, to develop a Union list of critical devices (including its methodology) and to support, where needed, the European Commission in developing and maintaining a central IT tool for reporting and information exchange regarding cases of interruption or discontinuation of supply. The interinstitutional negotiations on the Critical Medicines Act are ongoing and the Cyprus presidency of the Council is planning to conclude them by June. The Board was also informed that a call for evidence to prepare the Global Health Resilience Initiative will be launched shortly and the initiative will be published as a Commission Communication in Q2 of this year. Update on the preparations for implementation of the new EU pharmaceutical legislation, once adopted The Management Board noted an oral update from the European Commission and from EMA on the preparations for implementation of the new EU pharmaceutical legislation, once adopted. The DG SANTE representative outlined the implementation timeline of the new pharmaceutical legislation, explaining that the majority of provisions in both the regulation and the directive will apply 24 months after entry into force. If adoption occurs in late 2026, most obligations would therefore become binding towards the end of 2028, by which time all regulatory systems and processes at EU and national level must be fully operational. Several provisions, however, apply earlier. Measures related to security of supply, regulatory sandboxes, AMR incentives, and certain provisions for financial and international collaboration will take effect immediately upon entry into force. Provisions concerning availability monitoring and shortages management will apply after six months, while access-related obligations will apply 12 months after entry into force. The environmental risk-assessment prioritisation programme for legacy products authorised before 2005, as well as the register of designated orphan medicines, will become applicable six months after the general date of entry into application. Effective implementation will require close coordination among the European Commission, EMA and national competent authorities. More than 30 implementing and delegated acts must be adopted by the Commission before the date of application, each requiring formal procedures and consultation with Member States and the regulatory network. Joint work, such as on the electronic product information (ePI), was highlighted as essential for meeting legal obligations and ensuring coherent EU-wide implementation. On 6 March, EMA met with the Chairs of the scientific committees and CMDh to discuss their involvement in implementation of the new legislation. The Oversight Group is meeting on 12 March for its first organisational session to discuss working practices and governance arrangements. Delivery streams are analysing the legal text, as a basis to define work plans and integrate them into a consolidated implementation roadmap to support a formal programme launch in the margins of the June Management Board meeting. AESGP OTC News | May 2026 7 | 18 The Chair welcomed the progress and reiterated the need for strong coordination across the EU Medicines Regulatory Network and reaffirmed the importance of the Governance for the effective implementation of such structural changes. A Board member asked about a comparison between the new and existing legislation, to support national implementation activities. EMA indicated that it could present an overview of major changes at the June kick-off meeting. Draft ePI roadmap The Management Board noted an update from Member States and EMA on the draft Road Map for implementation of the electronic Product Information (ePI) for human medicinal products. The Board member from Spain introduced the ePI initiative, which aims to provide authorised, statutory product information for EU medicines - including the SmPC, labelling and package leaflet - in a semi-structured digital format. Using the FHIR standard, ePI can be accessed through web platforms via an application programming interface or printed as a traditional leaflet. The ePI key principles, including the use of a global standard, were jointly agreed by EMA, HMA/NCAs, the European Commission, and representatives of industry, patients and healthcare professionals. The initiative seeks to deliver timely, accurate and continuously updated information to patients and healthcare professionals, while increasing regulatory efficiency. Key advantages include enhanced accessibility, alignment with future EU legislation (which will make ePI mandatory), GDPR compliance, and interoperability with national and global standards. Major milestones so far included publication of the ePI principles (2020), harmonisation of the EU ePI Common Standard (2021), and integration of ePI into the EMA’s Product Lifecycle Management (PLM) Portal FHIR repository. A 2023–24 pilot involving 23 companies and five agencies successfully generated ePIs in real procedures. EMA outlined the ongoing work to prepare processes, guidance and IT systems for implementation. Business processes for centrally authorised products are being adapted, user acceptance testing is ongoing, and ePI functionality is being fully embedded into the PLM Portal. Implementation will start at the end of 2026 with a stepwise approach: vaccines first (due to frequent updates and accessibility needs), followed by oncology products and then other therapeutic areas. Initially, ePI creation will be an additional procedural step after the scientific assessment, with full integration into digital assessment processes planned later. ePI will first be available in English only, with multilingual versions optional and becoming mandatory once the revised legislation becomes applicable. The central EU repository at EMA is ready to scale up as more ePIs are submitted. For national use, Member States will need to undertake preparatory work, including adapting their national systems and developing their own implementation plans and guidance. Spain, as network product owner, will coordinate rollout with EMA support, starting with a workshop at EMA on 10 June to assess NCAs’ readiness, after which Member States’ timelines will be consolidated into a final roadmap by year-end. During the discussion, the Chair welcomed the strong alignment of ePI implementation with the upcoming legislation. Board members praised the work and stressed the need to onboard more NCAs. One Board member asked whether ePI could support shortages management in small markets; it was explained that its multilingual, structured format facilitates cross-border information-sharing, voluntary solidarity mechanisms as well as identification of therapeutic alternatives and analysis of manufacturing options. Industry feedback also indicates that multilingual ePI may help generics launch products in small markets where paper requirements may currently discourage marketing. Other Board members emphasised the importance of readability, integration with national systems and maintaining NCAs as the authoritative source of product information. EMA confirmed that authorities, not marketing authorisation holders, will continue to publish ePI and that the digital format enables significant accessibility improvements, such as adaptable layouts and enhanced navigation. The Commission underscored the need to expand from early adopters to a second wave of NCAs and reiterated its support for coordinated EU-wide implementation. 103rd meeting of the EC Pharmaceutical Committee – Summary record AESGP OTC News | May 2026 8 | 18 The summary record and background documents of the 103rd meeting of the EC Pharmaceutical Committee, held on 27 MAR 2026, have been published on the Commission website. Among the items reported in the summary record, the following may be noted: Main elements of the new EU pharmaceutical legislation and preparatory steps for its implementation after formal adoption The Commission (DG SANTE) presented the main elements of the draft agreement and outlined preparatory work for implementing the new legislation. EMA introduced the New Pharmaceutical Legislation (NPL) oversight group and its delivery streams as a working structure of the network to facilitate the implementation of the legislation. The ensuing discussion covered clarifications on timelines for delegated and implementing acts and Commission and EMA guidance and other implementing actions. The Members of the Committee stressed the importance of timely EU-level implementation to give Member States sufficient time to transpose provisions into national law. The discussion also highlighted the willingness to closely collaborate on the implementation between the Commission, EMA and Committee members. The Commission will define collaboration formats for each deliverable based on input required and its priority, with a preference for using existing fora for policy discussions (Pharmaceutical Committee or STAMP expert group). For the official procedures the Pharmaceutical Committee will be the working group used for Delegated acts and the Standing Committee will be used for Implementing Acts. The Commission highlighted close collaboration as key to anticipating national-level implementation. Preparation for the implementation of the new EU Pharmaceutical legislation a. Electronic package leaflet of medicines The Commission (DG SANTE) presented the electronic product information (ePI) provisions of the new EU Pharmaceutical legislation. EMA followed with an overview of the opportunities offered by ePI, the state of play of the network’s ePI pilot project and how it will support in the implementation. Additional presentations from ES (ePI co-project owner) and SE shared national experiences with the ePI project which were very positive. The discussion included an exchange of questions on the ePI and views on next steps. Clarifications addressed the scope of the provision, the role of paper leaflets, the division of responsibilities, and technical aspects around the centralised database. Committee members stressed the need for timely EU level implementation to allow for sufficient time for national transposition. The EMA will organise a workshop on ePI on the 10th of June 2026. This will be the first opportunity for more technical discussions. b. Regulatory Sandboxes The Commission (DG SANTE) presented the provision on regulatory sandboxes under the new EU pharmaceutical legislation, including its implementation timeline as sandbox provisions will be applicable immediately when the legislation enters into force. This was followed by an exchange of views among Committee members. Discussions highlighted the value of regulatory sandboxes as exceptional tools for medicine authorisation, to be used when no other regulatory option is suitable. Members of the Committee stressed that their development should be driven not only by technological novelty but by specific regulatory questions they can address. The potential value of mapping existing horizon-scanning initiatives was also noted. The Commission stressed the need for a disambiguation of the term ‘regulatory sandboxes’ as there are still many misconceptions. In the context of pharmaceutical policy, regulatory sandboxes are not meant as an additional regulatory pathway, nor are they a new form of enhanced scientific advice. They are a novel regulatory possibility to assess (through monitored testing and control) truly innovative and exceptional medicines that would otherwise pose challenges for the regulatory framework. The standards for quality, safety and efficacy (QSE) of medicines do not change, it is the tools that allow regulators to assess QSE that are adapted to better fit the characteristics of the innovative products placed under a regulatory sandbox. Updates to the Committee on issues linked to pharmaceutical policy https://health.ec.europa.eu/document/download/3b29c79a-a287-4efa-9186-e8ef8930679b_en?filename=mp_20260326_sr_en.pdf https://health.ec.europa.eu/medicinal-products/other-topics/pharmaceutical-committee-veterinary-pharmaceutical-committee-and-expert-groups/human-pharmaceutical-committee-meetings_en https://health.ec.europa.eu/document/download/3b29c79a-a287-4efa-9186-e8ef8930679b_en?filename=mp_20260326_sr_en.pdf AESGP OTC News | May 2026 9 | 18 b. Results of the study on “Updated estimation of the costs of quaternary wastewater treatment in the EU - A comparison of cost models” The Commission (DG ENV) presented some elements of the Urban Wastewater Treatment Directive 2024/3019, this was complemented by a Joint Research Centre (JRC) presentation on the methodology used for the study on “Updated estimation of the costs of quaternary wastewater treatment in the EU - A comparison of cost models”. Committee members raised concerns regarding specific aspects of the study, notably costs to health systems and for operators (especially generics) as well as the need for a level playing field in the application of environmental standards in 3rd countries. Following the request of IE, the Commission (DG SANTE) provided a brief update on the proposal to restrict per- and polyfluoroalkyl substances (PFAS) under the REACH Regulation (EC) No 1907/2006. This update followed a recent risk assessment opinion by ECHA, which supported the proposed restrictions. Committee members expressed concerns regarding the absence of derogations for medicinal products. The Commission (DG SANTE) emphasised that the next step would be a Member State vote on whether to include the PFAS restriction in the REACH committee. Regulation on fees and charges payable to the European Medicines Agency (‘new fee Regulation’) discussion on inflation rate, following the annual monitoring The Commission (DG SANTE) briefed the Committee members on an upcoming revision to the fees and charges payable to the EMA, which will be adjusted in line with inflation. Unlike last year, when no inflation- based adjustments were made due to actual inflation falling below projections, the Commission (DG SANTE) intends to proceed with an inflation-linked update for the next year. To ensure a smooth process, the Commission (DG SANTE) plans to finalise calculations in Q2 2026, allowing sufficient time for the adoption of the delegated act. The inflation-adjusted fees will be applicable as of 1st of January 2027. Herbal medicines EMA - Revised Q&A on implementation of Ph. Eur. Medicinal Product Monographs (MPM) The revised Q&A on implementation of Ph. Eur. Medicinal Product Monographs (MPM) has been published on the EMA website. The document is structured to address, in particular, the demonstration of compliance with European Pharmacopoeia (Ph. Eur.) Medicinal Product Monographs (MPMs), including when and how MPM requirements apply, as well as questions related to variation submissions where changes are needed to align existing products with official monographs. https://www.ema.europa.eu/en/documents/other/questions-answers-implementation-pheur-medicinal-product-monographs-mpm_en.pdf AESGP OTC News | May 2026 10 | 18 Setting Maximum Levels for Vitamins & Minerals Timelines on EC Webpage The Commission updated its website outlining the indicative timelines regarding individual steps pertaining to the initiative to set maximum levels for vitamins or minerals in food supplements and fortified foods. Pursuant to the updated webpage, a Commission adoption is planned for first quarter 2028 while a public consultation is foreseen for third quarter 2026. As regards the expected call for evidence, no specific timeline is indicated. Food https://ec.europa.eu/info/law/better-regulation/have-your-say/initiatives/12750-Food-safety-vitamins-and-minerals-added-to-food-minimum-and-maximum-levels-_en AESGP OTC News | May 2026 11 | 18 Borderline & Classification WG MDCG Guidance 2021-24 Rev.1 published The Commission has published a revision of the MDCG Guidance 2021-24. Updates have been made regarding Rule 2,8,9,10,12,16 and 22. Borderline Manual under MDR and IVDR - Updated Version (Version 5) Published The Commission has published an updated version of the Manual on borderline and classification for medical devices under Regulation (EU) 2017/745 on medical devices and Regulation (EU) 2017/746 on in vitro diagnostic medical devices on its website. The updated document (Version 5) includes the following new entries: • 1.1.9.7 Device used intended to administer a medicinal product • Rule 1 o 1.2.1.2 Penis holster • Rule 3 o 1.2.3.1 Syringe containing glass beads • Rule 6 o 1.2.6.1 Needles for root canal irrigation • Rule 21 o 1.2.21. Saline solutions for nasal irrigation CIEPS WG Member States-specific national requirements for clinical investigations and performance studies The Commission has published an update of the specific national requirements for clinical investigations and performance studies (Articles 62, 74, and 82 MDR). Medical Devices https://health.ec.europa.eu/document/download/cbb19821-a517-4e13-bf87-fdc6ddd1782e_en?filename=mdcg_2021-24_en.pdf https://health.ec.europa.eu/document/download/71a87df8-5ca1-4555-b453-b65bdf8de909_en?filename=md_borderline_manual_en.pdf https://health.ec.europa.eu/document/download/71a87df8-5ca1-4555-b453-b65bdf8de909_en?filename=md_borderline_manual_en.pdf https://health.ec.europa.eu/document/download/71a87df8-5ca1-4555-b453-b65bdf8de909_en?filename=md_borderline_manual_en.pdf https://health.ec.europa.eu/latest-updates/update-member-states-specific-national-requirements-clinical-investigations-and-performance-studies-2026-04-21_en https://health.ec.europa.eu/latest-updates/update-member-states-specific-national-requirements-clinical-investigations-and-performance-studies-2026-04-21_en AESGP OTC News | May 2026 12 | 18 MDR/IVDR Simplification AESGP Final Position Published on AESGP Website AESGP's position paper has now also been published on the website of AESGP. AESGP Final Position Submitted to EC Public Consultation AESGP's position to the Commission’s legislative proposal for amending the MDR as regards simplifying and reducing the burden of the rules on medical devices has been submitted in the enclosed version to the public consultation on the Commission's “Have your say” website. AESGP's feedback can be directly accessed here. MDR/IVDR Annex VII NB Requirements Commission Implementing Regulation (EU) 2026/977 Published in OJ Following the positive vote of the Committee on Medical Devices, please be informed that the Commission Implementing Regulation (EU) 2026/977 of 4 May 2026 laying down certain uniform quality management and procedural requirements for the conformity assessment activities carried out by a notified body designated under Regulations (EU) 2017/745 and (EU) 2017/746 has been published in the Official Journal of the European Union. The Implementing Regulation will generally apply from 25 February 2027 with the exception of Article 4(4) requiring notified bodies to draw up annual reports on timelines and costs of conformity assessment activities that will apply from 1 January 2028. As stated in published statement on its website, AESGP welcomes the adoption of Commission Implementing Regulation as its measures will contribute to improved predictability and efficiency in relation to the quality management and processes in the context of conformity assessment activities. MDR/IVDR Implementation Revised Team-NB Best Practice Guidance for the Submission of TD Published Team-NB has published the updated 4th version of its “Best Practice Guidance for the Submission of Technical Documentation under Annex II and III of Medical Device Regulation (EU) 2017/745”. The document can be accessed here. https://aesgp.eu/articles/aesgp-position-on-the-european-commissions-proposal-to-simplify-medical-devices-rules https://ec.europa.eu/info/law/better-regulation/have-your-say/initiatives/14808-Medical-devices-and-in-vitro-diagnostics-targeted-revision-of-EU-rules_en https://ec.europa.eu/info/law/better-regulation/have-your-say/initiatives/14808-Dispositifs%20médicaux%20et%20diagnostics%20in%20vitro%20—%20révision%20ciblée%20des%20règles%20de%20l’UE/F33394875_en https://eur-lex.europa.eu/eli/reg_impl/2026/977/oj https://eur-lex.europa.eu/eli/reg_impl/2026/977/oj https://eur-lex.europa.eu/eli/reg_impl/2026/977/oj https://aesgp.eu/articles/aesgp-statement-on-commission-implementing-regulation-eu-2026-977-setting-maximum-timelines-for-conformity-assessment-activities-of-medical-devices https://www.team-nb.org/wp-content/uploads/2026/04/Team-NB-PositionPaper-BPG-TechnicalDocEU-MDR-2017-745-V4-20260421.pdf AESGP OTC News | May 2026 13 | 18 Nomenclature WG Updated EMDN documents In the context of the annual revision of the European Medical Device Nomenclature (EMDN), please be informed that the European Commission has published and/or updated the following documents: • Summary of EMDN 2025 Submissions and outcome of annual revision • 2025-2026 Annual Revision Change Log • 2026 EMDN Version History Post Market Surveillance and Vigilance Medical Devices WG MIR 7.3.1. PDF publication update The business rules for the field 4.3.1.a on serious similar incidents were revised through the publication of the MIR 7.3.1. PDF version 11010 published on the 26th March 2026 . For that publication only the MIR 7.3.1. PDF was modified. The MIR Helptext was later updated to mainly reflect the revised business rules made for field 4.3.1.a. The Commission has been notified recently that some changes in the XSD files need also to be made in relation to that field. The publication update of 23rd April 2026 provides the updated version (SB-11154) of the XSD-XSL files together with the corresponding Changelog. The MIR 7.3.1. PDF and the XML files remain unchanged. MIR publication update Following the PMSV WG meetings of 29-30 April, the Commission proceeded with a new MIR publication dated of 7 May 2026. This new publication update was necessary as a new identified bug has now been fixed in the PDF file. There is also an editorial change for the XSD and XSL files without impact on the files and the Changelog was updated accordingly (see detailed information below). No change for the XML. MIR 7.3.1. PDF (SB-11154) This update of 06/05/2026 fixes the bug on field 4.2.i. 'Final comments from the manufacturer on cause investigation and conclusion': the bug related to a “User” missed display of box red border while importing XML file with report types "Combined" and "Final Reportable" XSD and XSL files (SB-11154) On all XSD files and XSL files, the date and version number (version 7.3.1 of 06.05.2026 - SB-11154) on the top of the text have been updated and aligned for all files but no change as regards the content. Changelog file (SB-11154) Version: 7.3.1 (06/05/2026) The latest changes made in the PDF and in the XSD and XSL files have been added. https://health.ec.europa.eu/document/download/56772d7d-ce71-4ce5-801e-a82f267e61f4_en?filename=mdcg_2026-1_en.pdf https://health.ec.europa.eu/document/download/5e21e80e-2fdf-4ff7-873d-a2ffddf618ff_en?filename=mdcg_2026-2_en.xlsx https://health.ec.europa.eu/document/download/67c60ba0-32fb-498d-9b05-a6cefe08919c_en?filename=mdcg_2026-3_en.xlsx https://health.ec.europa.eu/medical-devices-sector/new-regulations/guidance-mdcg-endorsed-documents-and-other-guidance/pmsv-reporting-forms_en https://health.ec.europa.eu/medical-devices-sector/new-regulations/guidance-mdcg-endorsed-documents-and-other-guidance/pmsv-reporting-forms_en https://health.ec.europa.eu/medical-devices-sector/new-regulations/guidance-mdcg-endorsed-documents-and-other-guidance/pmsv-reporting-forms_en https://health.ec.europa.eu/medical-devices-sector/new-regulations/guidance-mdcg-endorsed-documents-and-other-guidance/pmsv-reporting-forms_en https://health.ec.europa.eu/medical-devices-sector/new-regulations/guidance-mdcg-endorsed-documents-and-other-guidance/pmsv-reporting-forms_en AESGP OTC News | May 2026 14 | 18 As agreed at PMSV WG meetings, the publication update also underlines that any of the MIR 7.3.1. versions published from the December 2025 publication can be used by operators. EMA expert panel support for BtX medical devices Pilot programme The EMA is set to launch the pilot programme for expert panel support to manufacturers of breakthrough medical devices (BtX) on 28 April 2026. The pilot is designed to provide free advice to selected manufacturers of high-risk medical devices on: • possible breakthrough medical device status - for medical devices seeking this type of designation; • additional advice on how to implement the guidance that the Medical Device Coordination Group provided - for designated breakthrough medical devices. As part of the pilot, manufacturers seeking breakthrough designation submit a request for an opinion to the medical device expert panels. The pilot is set to run in three phases until 2027, subject to available resources. Additionally, the EMA has made available application templates, for information purposes only before the launch of the pilot: • Breakthrough status request: template for applicant for breakthrough medical devices pilot • Advice request: template for applicants for breakthrough medical devices pilot The dedicated EMA page is available here. Team NB Updated Code of Conduct for NBs under the MDR/IVDR The version 5.2 of the Team NB Code of Conduct has been published on the Team NB website. This new version aligns the timelines to review software between the MDR and the IVDR and includes the addition of a table of contents. Clinical Evaluation Based on Non-Clinical Data Team-NB members have adopted, a paper aimed to outline the approach taken by the NB when considering the acceptability of a manufacturer’s justification for relying on non-clinical data for the purpose of demonstrating safety and performance of a device. It provides guidance on best practice for preparing a robust justification for its use. https://health.ec.europa.eu/document/download/edca94c7-62ab-4dd5-8539-2b347bd14809_en?filename=mdcg_2025-9.pdf https://www.ema.europa.eu/en/documents/other/breakthrough-status-request-template-applicants-breakthrough-medical-devices-pilot_en.pdf https://www.ema.europa.eu/en/documents/other/advice-request-template-applicants-breakthrough-medical-devices-pilot_en.pdf https://www.ema.europa.eu/en/human-regulatory-overview/medical-devices/expert-panel-support-breakthrough-medical-devices-pilot-programme https://www.team-nb.org/wp-content/uploads/2026/04/Code-of-Conduct-Team-NB-V5-2-20260421.pdf https://www.team-nb.org/ https://www.team-nb.org/wp-content/uploads/2026/04/Team-NB-PositionPaper-Article61-10-V1-20260421.pdf https://www.team-nb.org/wp-content/uploads/2026/04/Team-NB-PositionPaper-Article61-10-V1-20260421.pdf https://www.team-nb.org/wp-content/uploads/2026/04/Team-NB-PositionPaper-Article61-10-V1-20260421.pdf AESGP OTC News | May 2026 15 | 18 WFD+GWD+EQSD - Entry into force on 11 May 2026 The revised Water Framework Directive (WFD), Environmental Quality Standards (EQSD), and Groundwater Directive (GWD) package (Directive (EU) 2026/805) has now officially entered into force on 11 May 2026. • The press release is available here: Stricter rules for protecting water in EU enter into force - Environment. EU Deforestation Regulation - EC report and supportive materials The European Commission has published a report on the simplification and implementation of the EU Deforestation Regulation (EUDR), together with updated guidance, FAQs, a draft Delegated Act, and updates to the Information System on 4 May 2026. Please find the press release, the EU Commissions’ full report, and the draft Delegated Act below: • Press release • EU Commission full report • Draft Delegated Act on Annex I Key takeaways are available below: Core framework and timeline • The Commission did not propose any further amendments to the EUDR itself, highlighting the need for legal stability and predictability for operator: the focus has now moved towards implementation phase. • The EUDR will fully apply to most operators and traders, including large and medium-sized companies, importers placing relevant commodities / products on the EU market, and exporters from 30 December 2026. • These companies must ensure products are deforestation-free, conduct due diligence, and submit due diligence statements via the EU Information System. • The EUDR will apply to micro and small enterprises (SMEs) from 30 June 2027, benefitting from simplified obligations like one-off declarations instead of full due diligence statements and reduced administrative burden. ➔ However, please note that smaller operators that act in roles that qualify them as ‘operators’ rather than purely downstream users must comply with the earlier obligations (December 2026). Updated guidance & FAQs Environment https://environment.ec.europa.eu/news/stricter-rules-protecting-water-eu-enter-force-2026-05-11_en https://environment.ec.europa.eu/news/stricter-rules-protecting-water-eu-enter-force-2026-05-11_en https://ec.europa.eu/commission/presscorner/api/files/document/print/en/ip_26_941/IP_26_941_EN.pdf https://environment.ec.europa.eu/document/download/a3c5c3a0-232e-43c4-b0b8-1eecb1df45c7_en?filename=Report%20from%20the%20Commission%20to%20the%20Council%20and%20Parliament%20on%20the%20EUDR.pdf https://ec.europa.eu/info/law/better-regulation/have-your-say/initiatives/18053-Deforestation-proposal-to-amend-and-simplify-the-rules-and-make-technical-fixes-to-Annex-I_en AESGP OTC News | May 2026 16 | 18 • The Commission’s updated guidance and FAQs clarify the role of downstream operators. • The downstream operators are mainly required to retain supplier information and, where applicable, due diligence references, without re-performing due diligence but responsible to act in case of identified risks. ➔ The overarching message is that, following the 2025 revision and new clarifications, compliance responsibilities are now more clearly concentrated upstream, while downstream obligations are more limited and relatively passive. Refinement of product scope • The Commission also published a draft Delegated Act proposing targeted adjustments to the list of products covered by the EUDR Annex I with the objective of making the scope more coherent, targeted, and feasible based on stakeholder feedback and early implementation experience. • The Commission proposes adding specific downstream or derived products like soluble coffee, certain palm oil derivatives, and particular animal-derived products while excluding from the scope products like leather and re-treaded tyres. ➔ The draft of the Delegated Act is open for public consultation until 1 June 2026. Implementation tools • The Commission strengthened the operational toolkit supporting EUDR implementation through the development of the central EU Information System to submit due diligence statements and creation of centralised EU repositories of producer-country legislation and certification schemes to support companies in meeting legal requirements. Simplification efforts • The Commission estimates that the cumulative simplification measures will reduce compliance costs by around 75%, mainly by shifting due diligence responsibilities upstream, introducing simplified regimes for small operators, applying a more risk-based approach, and clarifying downstream obligations while keeping the core requirements of the EUDR unchanged. AESGP OTC News | May 2026 17 | 18 Shortages - Updated ESMP User guide for MAHs The EMA has just published a new version of the European Shortages Monitoring Platform (ESMP) User Guide for Marketing Authorisation Holders. The new Version 1.4 includes the following updates: Routine reporting of shortages of CAPs (Chapter 3): • Chapter 3.2.2: Reference to readable RMS IDs added. • Chapter 3.3: Addition of further guidance on reporting and updating shortage notifications. • Chapter 3.4: Explanation added on automated notification alert to MAH for outdated shortage reports. Crisis and MSSG-led preparedness submissions (Chapter 4): • Preliminary requirements, point 1: Paragraph edited on mandatory PMS data completeness (including structured package and manufacturing information data). • Preliminary requirements, point 2: clarification that CAP marketing status affects generation of Availability information template only, other submissions not affected by products’ marketing status. • Chapters 4.3.2 and 4.4.2: Reference to readable RMS IDs added. • Chapter 4.5: The inclusion of NAP manufacturing data from PMS, where available, in the data submission templates for Manufacturing information. • Chapter 4.6: Added updated screenshots of the search bar for substances and compositions in the webform for the submission of Alternative therapies. Cross-Sectorial News https://www.ema.europa.eu/en/documents/other/european-shortages-monitoring-platform-esmp-user-guide-marketing-authorisation-holders_en.pdf https://www.ema.europa.eu/en/documents/other/european-shortages-monitoring-platform-esmp-user-guide-marketing-authorisation-holders_en.pdf AESGP — Association of the European Self-Care Industry Avenue de Tervuren, 7 1040 Brussels Belgium info@aesgp.eu www.aesgp.eu

AESGP Issue 380 | April 2026 Euro OTC News Table of Contents MEDICINES _______________________________________________________________________________ 2 Regulatory News _____________________________________________________________________________________________ 2 • EMA Updated guidance on mobile scanning and other technologies in the labelling and/or PL of centrally authorised medicinal products _____________________________________________________________________________________________ 2 • CMDh Minutes - 24-25 FEB 2026 __________________________________________________________________________ 3 • CMDh Meeting Report - 24-25 MAR 2026 ___________________________________________________________________ 5 • CMDh Multi-Annual Workplan (MAWP) to 2028 – Published _____________________________________________________ 6 • EC - EURL ECVAM Status Report on Non-Animal Methods in Science and Regulation ________________________________ 6 • EMA/HMA roadmap on ePI implementation published __________________________________________________________ 7 • HMA/EMA Final Report of the European Medicines Agencies Network Strategy to 2025 – Published ______________________ 7 • Data Quality Framework for EU Medicines Regulation Application to Real-World Data – Published _______________________ 8 Pharmacovigilance ___________________________________________________________________________________________ 9 • EMA - 2025 Annual Report on EudraVigilance – Published ______________________________________________________ 9 • EMA - EU implementation strategy of ICH E2D(R1) Guideline - Post-approval safety data: Definitions and standards for management and reporting of ICSRs ______________________________________________________________________ 10 Herbal medicines ___________________________________________________________________________________________ 10 • EMA HMPC launches 18 calls for scientific data - FOR INPUT by 1 JUN ___________________________________________ 10 • EMA's Draft Guideline on declaration of herbal substances and herbal preparations in HMPs / THMPs - Revision 2 - For Comments by 16 JUN __________________________________________________________________________________ 11 FOOD __________________________________________________________________________________ 13 EFSA _____________________________________________________________________________________________________ 13 • Safety of carbon dioxide extract from Cannabis sativa L. as a novel food __________________________________________ 13 MEDICAL DEVICES _______________________________________________________________________ 14 Planned Meetings of Medical Device Coordination Group (MDCG) and Subgroups in 2026 _______________________________ 14 • Update _____________________________________________________________________________________________ 14 ENVIRONMENT __________________________________________________________________________ 15 PPWR - EC guidelines on the implementation of PPWR & FAQ document - 30 MAR 2026 ________________________________ 15 WFD+GWD+EQSD - Publication in OJ - 20 APR 2026 ______________________________________________________________ 15 CROSS-SECTORIAL NEWS _________________________________________________________________ 18 European Commission DG SANTE's FAQs on the European Health Data Space Regulation (EU) 2025/327 – Published _______ 18 European Parliament's position on a simplification proposal amending the Artificial Intelligence Act (AIA) – Adopted ________ 18 EC – Launch of Initiatives to Develop Implementing Regulation for the European Health Data Space (EHDS) _______________ 19 EHDS Board operations - Commission Implementing Regulation (EU) 2026/771 – Published _____________________________ 20 Draft Commission Implementing Regulations concerning the European Health Data Space (EHDS) - Published for consultation 20 AESGP OTC News | April 2026 2 | 22 Regulatory News EMA Updated guidance on mobile scanning and other technologies in the labelling and/or PL of centrally authorised medicinal products The revised version of the EMA guidance on “Mobile scanning and other technologies in the labelling and/or package leaflet of centrally authorised medicinal products” outlining the general principles of acceptability and rules of procedure, has been published. The updated guidance introduces several changes, including: • Broader scope and terminology updates ❖ Use of “intended users” instead of “patients/users/healthcare professionals.” ❖ Clarification that the guidance applies to labelling and/or package leaflet throughout the document. • Expanded scope of platform ownership ❖ Mobile technology platforms may now be hosted not only by MAHs or NCAs, but also by third parties acting on their behalf. • Earlier regulatory engagement encouraged ❖ Applicants/MAHs are now expected to inform the EMA as early as possible of their intention to use mobile technology features on the packaging materials and/or PL. ❖ Applicants/MAHs should make use of the pre-submission phase to present their strategy and address any potential issues before the procedure starts. • More explicit rules for the URL ❖ The name chosen for the URL should ideally allow proper identification of the medicinal product (e.g. www.productname.eu). If that is not feasible, the name should be simple and easy to type (e.g. avoid using symbols), non-promotional, and as concise as possible. • Clearer MAH accountability/Strengthened responsibilities ❖ MAH must ensure that the information provided electronically is available when the product is launched in a Member State. ❖ It should be kept up to date for as long as the medicinal product is placed in the market. ❖ If different batches coexist with different product information (e.g. differences in excipients, storage conditions or packaging material, co-packaged device, etc.), MAH must ensure the information for those batches is available. • Submission procedure ❖ Applicants/MAHs are required to submit to EMA a completed request/declaration form accompanied by relevant information (material to be linked (video, etc.) as well as the updated mock-ups and product information annexes describing the intended exact location of the mobile technology feature) in Module 1.3.1 of the dossier. Please also note that the request/declaration Medicines https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/mobile-scanning-other-technologies-labelling-or-package-leaflet-centrally-authorised-medicinal-products_en.pdf https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/mobile-scanning-other-technologies-labelling-or-package-leaflet-centrally-authorised-medicinal-products_en.pdf http://www.productname.eu/ AESGP OTC News | April 2026 3 | 22 form for the provision of information via mobile scanning and other technologies in the centralised procedure has been updated (attached). • New explicit handling of deletion/decommissioning ❖ Requests for the deletion of a mobile technology feature are considered as any other post- authorisation change, and the procedural guidance remain applicable. ❖ If the platform/website provided by the mobile technology feature is decommissioned and there are still batches of the product in the market, the MAH is responsible for informing intended users accordingly when they scan the mobile technology feature. CMDh Minutes - 24-25 FEB 2026 The minutes of the CMDh meeting held on 24-25 FEB 2026 have been published. Among the items reported, the following may be noted: Working Party on Variation Regulation The WP Chair reported from the February 2026 WP meeting. The WP discussed the ROG proposal to delete the requirement for cover letters for type IA variations. Some technical aspects need to be implemented before the cover letter can be deleted (minor changes to the CESP delivery file, update of eAF, work-around for mandatory cover letter in eCTD). For the implementation, a Q&A will be prepared to explain the correct completion of the delivery file and to explain that the requirement of the cover letter as mentioned in the variations guidelines will not be applicable anymore for type IA/IAIN variations. With regard to the Variations Guidelines, the WP was informed that EMA will draft a procedure for the annual guidelines update laid down in Article 4 of the Variations Regulation and the collection of the necessary updates to be included in the guidelines. Corrections in the eAF/PLM should be communicated to the EMA contact person. The WP discussed again a possible grouping of related type IA with IAIN variations outside the annual update of Type IA variations. A majority of the WP proposed to update Chapter 6 to allow grouping of type IA with IAIN for “related” changes, similar to the EMA. The update should include a non-exhaustive list of examples and guidance that not related changes will be invalidated without any option to correct the submission. The decision on the validation, if the changes are related, is left to the RMS. The CMDh agreed with the proposal. An update of the BPG will be prepared for the next meeting. The WP also discussed how to handle cases when the present/proposed table of a type IA annual update variation application shows additional changes not covered by the variation(s) submitted. The CMDh agreed by majority that a type IA submission is a one-way process and no updates can be done. The annual update can be approved but the changes related to the missing variation codes have to be deleted from the dossier and resubmitted in a new single or grouped type IA variation (as they cannot wait for the next annual update due to the implementation time). The WP was informed about the actions included in the new CMDh MAWP to 2028 in relation to variations. The actions will be taken forward in the coming meetings. The WP agreed a proposal for update of the EMA/CMDh explanatory notes on variation eAF (human only) to include an example of how the products should be listed in the table “Products concerned by this application” in alphabetical order. The update will be included in the next scheduled update of the guidance in Q2. The update was also agreed by the CMDh. Results of a survey by AESGP related to variations was shared for information. The WP also discussed how to handle nitrosamine risk assessment reports included in non related variation submissions. It was agreed that the nitrosamine risk assessment should not be included and will not be considered in type IA variations within or outside the annual updates. In such cases, a note should be added in the approval letter for type IA variations that the risk assessment was not considered in the procedure, that the assessment needs to be removed from the dossier and has to be submitted separately according to the available guidance on nitrosamines. In type IB and type II variations, a justification needs to be included why the risk assessment is part of that variation or it should be deleted from the dossier. https://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Agendas_and_Minutes/Minutes/2026_02_CMDh_Minutes.pdf AESGP OTC News | April 2026 4 | 22 Normally, no variation is required for the submission of a risk evaluation. MAHs should consider the correct handling of step 2 and step 3 according to available nitrosamine guidance. Finally, the WP discussed if the update of the combined product information in only two MSs of an MRP/DCP can be submitted as variation worksharing. It was agreed that the update of national versions of combined product information is not applicable for a (mandatory) worksharing procedure. CMDh Multi-Annual Workplan (MAWP) The CMDh was informed that the MAWP to 2028 was sent to Interested Parties for comments as agreed in the January CMDh meeting. The comments will be discussed in the March CMDh meeting. No comments have been received on the summary report of the MAWP to 2025. The CMDh agreed to publish the summary report on the CMDh website. Reference to CEP number and CEP revision number in individual eCTD sections Following a question raised by a company, the CMDh discussed the guidance provided in Q&A 3.2 (General for all sections) of the QWP Questions and answers (Q&A): how to use a CEP in the context of a Marketing Authorisation Application (MAA) or a Marketing Authorisation Variation (MAV). The CMDh agreed that including the CEP number and its revision number in every CTD section 3.2.S does not provide additional value. The CMDh agreed to request that the QWP consider this position in the next revision of the guidance. Environmental Risk Assessment (ERA) Following the CMDh January discussion, IT prepared an overview of the feedback received from MSs on the assessment of ERA Phase II data in generic applications. The CMDh agrees that the scientific conclusions reached for the relevant originator ERA remain applicable to the generic product and the applicant can refer to this ERA. Consequently, repetition of ERA studies would generally not be required. Discrepancies were identified regarding the requirement for generic applicants to obtain a Letter of Access. The CMDh also discussed situations in which the reference ERA does not comply with the current ERA guideline. The CMDh acknowledged the EMA publication on the “Second industry stakeholder webinar on the revised guideline on the environmental risk assessment of medicinal products for human use”. The CMDh noted the need for a harmonised approach and referred the outstanding questions to the EMA and the NcWP. The CMDh will continue the discussion once further input and experience is gathered. Reference to studies in hybrid dossier as per Q4 of Q&As on generic applications The CMDh discussed the possibility for a hybrid application using a RefMP to also refer to non-clinical and clinical studies of a dossier of an already approved hybrid application whereas no differences of the clinical particulars listed in Q&A 4 of the CMDh Q&As on generics (indication, strength, route of administration and pharmaceutical form) are present. The CMDh agreed that the application can be validated and it would be determined during the clinical assessment whether the studies are applicable/can be used for this product. The CMDh may rediscuss this topic following completion of the assessment and will consider whether this case should be reflected in the CMDh guidance, as needed. A.O.B. Paracetamol / pseudoephedrine Based on a recent request from a MAH, the CMDh discussed if the outcome of the PSUSA on paracetamol / pseudoephedrine (PSUSA/00002307/202306) can be extrapolated to other fixed-dose combinations (FDC) containing other active substances in addition to paracetamol / pseudoephedrine. The CMDh position on the PSUSA was adopted in February 2024. An extrapolation was not recommended at the time. In October 2024, the EURD list entry for the PSUSA was updated and grouped with two additional FDCs under the same entry. The CMDh agreed that the outcome of the PSUSA should not retrospectively be extrapolated to other FDCs. The inclusion of the outcome of the PSUSA for other FDCs should be discussed in the next upcoming PSUSA for those products. If the MAH intends to implement the changes in their products before the next PSUSA, they can submit a type II variation with relevant supporting documentation. PRAC advice could be sought during the variation assessment. AESGP OTC News | April 2026 5 | 22 A proposal to further liaise between PRAC and CMDh on newly combined EURD list entries will not be taken forward. CMDh Meeting Report - 24-25 MAR 2026 The report from the CMDh meeting held on 24-25 MAR 2026, has been published. Among the items reported, the following may be noted: CMDh guidance documents related to variations The CMDh agreed to update the CMDh Q&A on Variations, the Position paper common grounds seen for invalidation/delaying day 0 for variations, the Examples for acceptable and not acceptable groupings for MRP/DCP products (see also below), and the Preliminary Variation Assessment Report Template. These guidance documents have been revised to reflect the principles of the recently published Q&A 7.3.1 in the European Medicines Agency post authorisation procedural advice for users of the centralised procedure, which addresses the impact of changes in the clinical use of a product on quality documentation. During its February meeting, the CMDh agreed on the possibility of accepting the grouping of Type IA and Type IAIN variations outside the annual update of Type IA variations, provided that the changes are very clear and obviously related. The CMDh has now adopted updates to the CMDh BPG for the Processing of (Super-)Grouped Applications in MRP (Chapter 6) and to the Examples for acceptable and not acceptable groupings for MRP/DCP products to reflect this agreement. In addition, the CMDh agreed to update the CMDh BPG for the allocation of the Mutual Recognition variation number for Type I notifications, Type II variations, grouping and worksharing (Chapter 1), to clarify the allocation of procedure numbers for annual update of Type IA variations. The updated guidance documents will be published on the CMDh website. Guidance for preparation of Public Assessment Reports The CMDh agreed on an update of its guidance for preparation of Public Assessment Reports: D70 Overview AR template (empty), D70 Overview AR template (incl. instructions), Instructions for RMS when preparing the PAR based on the FAR, and PAR template (empty). The documents have been updated to include reference to the requirement for applicants to comply with the applicable EU legislation on clinical trials of medicinal products for human use, as relevant to their specific application The guidance and template documents will be published on the CMDh website. CMDh position paper on the use of mobile scanning and other technologies to be included in the labelling and/or package leaflet in order to provide information about the medicinal product The CMDh agreed an update of the position paper on the use of mobile scanning and other technologies to be included in the labelling and/or package leaflet, along with its annexes, in order to clarify the conditions under which applicants/MAHs may include links to statutory information hosted on platforms created and operated by third parties. The documents have been revised to provide updated information on all aspects of the inclusion of mobile technologies for products applied for/authorised via MRP/DCP. The EMA QRD Working Group and the EC have been consulted on certain aspects of the update to ensure an aligned approach with products authorised via the centralised procedure, as much as possible. The updated documents will be published on the CMDh website. CMDh Multi-Annual Workplan (MAWP) to 2028 During its March 2026 meeting, the CMDh adopted the final MAWP to 2028. Following a one-month consultation period with Interested Parties, the CMDh reviewed the comments received and concluded that only minor revisions to the MAWP were required. The work plan centres on four key priority areas: • Optimisation of procedures • Information technology and digitalisation • Training • Implementation of the new pharmaceutical legislation The CMDh Multi-Annual Workplan to 2028 will be published on the CMDh website. https://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/CMDh_pressreleases/2026/CMDh_press_release_-_March_2026.pdf https://www.hma.eu/human-medicines/cmdh/procedural-guidance/variation.html https://www.hma.eu/human-medicines/cmdh/templates/assessment-reports/public-ar.html https://www.hma.eu/human-medicines/cmdh/procedural-guidance/general-info.html https://www.hma.eu/human-medicines/cmdh/about-cmdh/cmdh-activities.html AESGP OTC News | April 2026 6 | 22 Summary of CMDh activities in 2025 The CMDh has agreed to publish a summary of the main activities carried out by the CMDh and its working groups/working parties in 2025. A list of new and revised CMDh documents published by the CMDh in 2025 is included as an Annex to the document. The document will be published on the CMDh website. CMDh Multi-Annual Workplan (MAWP) to 2028 – Published The CMDh multi-annual workplan (MAWP) to 2028, outlining the priorities of the CMDh and reflecting the need for a coordinated approach to address the network’s key challenges and opportunities, has been published. CMDh multi-annual workplan (MAWP) to 2028 should be seen as complementary to the multiple routine tasks of the CMDh as laid down in legislation, including providing a forum for discussion between Member States on points of disagreement in procedures, providing regulatory and procedural guidance and fostering harmonisation in the EU regulatory network. The document has been developed in parallel and is complementary to the HMA/EMA European Medicines Agencies Network Strategy (EMANS) to 2028. The following four main priority areas have been included: • Optimisation of procedures • Information technology and digitalisation • Training • Implementation of the new pharmaceutical legislation The paper now introduces “The timelines mentioned in this document (short/medium/long term) serve as a tool for prioritisation of the actions and they roughly correlate to the implementation (or to the start) of the action within year 1/2/3 of the MAWP. Depending on complexity, planning, resources and time for implementation, the (long term) actions might be ongoing in 2028 and will be further considered in the next cycle.” EC - EURL ECVAM Status Report on Non-Animal Methods in Science and Regulation The 2025 EU Reference Laboratory for alternatives to animal testing (EURL ECVAM) Status Report on Non-Animal Methods in Science and Regulation was published on the European Commission website. With the European Commission preparing to publish in 2026 a roadmap for phasing out animal testing, this status report serves as a critical resource documenting scientific, regulatory, societal, and economic progress. The report documents how EU-funded research, regulatory science, and international coordination are helping build the evidence base for a phased transition away from animal testing in chemical safety assessment. In particular, the report presents: • A comprehensive overview of recent advancements of the EURL ECVAM in the development, validation, and regulatory integration of non-animal methods, as well as progress made elsewhere. • Innovative scientific breakthroughs including organ-on-chip technologies, artificial intelligence, and multiomics approaches that collectively enhance the predictivity, efficiency, and ethical standards of safety assessment in line with 3Rs principles. https://www.hma.eu/human-medicines/cmdh/about-cmdh/cmdh-reports.html https://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/About_CMDh/CMDh_Activities/Workplans/CMDh_Multi-annual_Workplan_to_2028.pdf https://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/About_CMDh/CMDh_Activities/Workplans/CMDh_Multi-annual_Workplan_to_2028.pdf The%20document%20has%20been%20developed%20in%20parallel%20and%20is%20complementary%20to%20the%20HMA/EMA%20European The%20document%20has%20been%20developed%20in%20parallel%20and%20is%20complementary%20to%20the%20HMA/EMA%20European https://publications.jrc.ec.europa.eu/repository/handle/JRC145459 https://publications.jrc.ec.europa.eu/repository/handle/JRC145459 AESGP OTC News | April 2026 7 | 22 • EURL ECVAM’s active participation in Horizon Europe initiatives, international standardisation efforts, and strategic partnerships. EMA/HMA roadmap on ePI implementation published The European Medicines Agency and the network have released a draft roadmap regarding electronic Product Information (ePI) implementation on their website. The roadmap describes features in development for 2026, the phased CAPs go live, the kickoff implementation, the foreseen NCA implementation and what will be ePI public interface. Below the elements of particular relevance are available. Roadmap ❖ For CAPs Following an industry user acceptance testing, there will be a voluntary go live period for vaccines (Q4 2026), oncology products (H1 2027) and all centrally authorized products (H2 2027). ❖ For NAPs A NCA survey and readiness assessment will take place during 2027 followed by NCA implementation in 2027/2028 based on the assessment. Kick Off implementation • Initial implementation will not interfere with the assessment o Applicants will be requested to author / upload ePI at the PLM portal through an extra step in process (alongside current Word/PDF submission) o Future vision: ePI integrated in a fully digitalised assessment • Once a product’s PI is available in electronic format, it will remain electronic in all subsequent variations • CAPs: Initial ePI implementation for English, with all languages optional – fully multilingual at a later stage ePI public interface ▪ ePI to be displayed on the European Medicines Web Portal (EMWP) for all EU medicines (multilingual) once developed ▪ For CAPs, in the interim period until EMWP is available, it will be displayed on EMA website (on EPAR page of each medicine) ▪ For NAPs, in addition to the EMWP, NCAs may decide to also display ePI in their own national websites ▪ ePI will be publicly available for any other third-party use HMA/EMA Final Report of the European Medicines Agencies Network Strategy to 2025 – Published The final report of the European medicines agencies network strategy to 2025, has been published on the EMA website, outlining the main achievements of the network in implementing the strategy from January 2021 to the end of 2025. The strategy identified six priority focus areas, each with clear strategic goals and objectives. The final report presents the main achievements for each strategic focus area, as outlined below: • Availability and accessibility of medicines https://www.ema.europa.eu/en/documents/other/electronic-product-information-epi-roadmap_en.pdf https://www.ema.europa.eu/en/human-regulatory-overview/marketing-authorisation/product-information-requirements/electronic-product-information-epi https://www.ema.europa.eu/en/documents/report/european-medicines-agencies-network-strategy-emans-2025-final-report_en.pdf AESGP OTC News | April 2026 8 | 22 • Data analytics, digital tools and digital transformation • Innovation • Antimicrobial resistance and other emerging health threats • Supply chain challenges • Sustainability of the network and operational excellence For each objective, the report has a section ‘Follow-up actions in EMANS 2028’ which describes further related activities the network will carry out as it implements the next strategy (EMANS 2028) from 2026 to 2028. The achievements described in this report have informed EMANS 2028 strategy, adopted in March 2026 under the overarching theme of ‘seizing opportunities in a changing medicines landscape’. Data Quality Framework for EU Medicines Regulation Application to Real-World Data – Published On 27 MAR, the updated “Data Quality Framework for EU Medicines Regulation application to Real- World Data (RW-DQF)”, as well as the “Outcome of the public consultation on the RW-DQF” were published by the EMA. Outcome of the public consultation on the RW-DQF The European Medicines Regulatory Network (EMRN) Data Quality Framework (DQF) for EU Medicines regulation was first published in 2022 to provide general considerations on data quality that are relevant for regulatory decision-making. The RW-DQF, which focuses on data quality underpinning real-world evidence generation encountered in medicines regulation, underwent public consultation for comments from 29 NOV 2024 to 28 FEB 2025. Overall, respondents expressed strong support for the initiative and its aim to strengthen data quality assurance for real-world data (RWD), while seeking: (1) greater clarity and consistency in terminology, (2) more precise definitions (e.g., RWD vs RWE, primary vs secondary use), (3) practical guidance and threshold requirements for data quality metric assessment, (4) feasible, proportionate expectations for data providers and sponsors. The feedback received has materially shaped revisions to the aforementioned RW-DQF. The updated RW-DQF had been adopted by the Methodology Working Party (MWP), the Network Data Steering Group (NDSG) and the Committee for Medicinal Products for Human Use (CHMP) and was published on the EMA website. Data Quality Framework for EU Medicines Regulation application to Real-World Data (RW-DQF) This document describes the Real-World Data (RWD) specific recommendations as derived from the EMRN DQF for EU Medicines regulation. The EMRN DQF for EU Medicines regulation sets out the principles, concepts, and definitions as intended to be applied widely across datasets used in medicine regulatory use cases. It also provides examples and in-depth clarifications on the developed framework elements for characterising, assessing, and assuring Data Quality (DQ) in the regulatory context. It is therefore recommended to use the EMRN DQF as a companion document when reading the updated RW-DQF. The application of RW-DQF, which is strongly encouraged by the EMA as a best practice framework for guiding the assessment of RWD quality, sets out the specificities of RWD and enable regulators to evaluate the quality of data underpinning Real-World Evidence (RWE) as used in the regulatory assessment. It builds upon existing regulatory guidance, such as EMA’s recommendations on RWE and ICH E6 (2) DQ principles, by offering specific methodological approaches tailored to secondary data use in regulatory decision-making. It also provides guidance on the relevance assessment of such data, as well as data reliability assessment to a research question based on DQ metrics and evidence of systems and processes underpinning data. These parts provide actionable and focused recommendations for assessing DQ of RWD, with the goal of supporting both the regulatory submission and assessment process and ultimately facilitate the use of RWE for regulatory purposes. Scope of the RW-DQF https://www.ema.europa.eu/en/documents/other/seizing-opportunities-changing-medicines-landscape-european-medicines-agencies-network-strategy-2028-final_en.pdf https://www.ema.europa.eu/en/documents/other/data-quality-framework-eu-medicines-regulation-application-real-world-data_en.pdf https://www.ema.europa.eu/en/documents/other/data-quality-framework-eu-medicines-regulation-application-real-world-data_en.pdf https://www.ema.europa.eu/en/documents/smop/outcome-public-consultation-data-quality-framework-eu-medicines-regulation-application-real-world-data_en.pdf https://www.ema.europa.eu/en/documents/smop/outcome-public-consultation-data-quality-framework-eu-medicines-regulation-application-real-world-data_en.pdf https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/data-quality-framework-eu-medicines-regulation_en.pdf https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/data-quality-framework-eu-medicines-regulation_en.pdf https://www.ema.europa.eu/en/documents/other/data-quality-framework-eu-medicines-regulation-application-real-world-data_en.pdf https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/data-quality-framework-eu-medicines-regulation_en.pdf https://www.ema.europa.eu/en/documents/other/data-quality-framework-eu-medicines-regulation-application-real-world-data_en.pdf https://www.ema.europa.eu/en/documents/other/data-quality-framework-eu-medicines-regulation-application-real-world-data_en.pdf AESGP OTC News | April 2026 9 | 22 RW-DQF applies to RWD recorded within routine clinical practice when used in the context of a specific research question and in line with the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP) guide on Methodological Standards in Pharmacoepidemiology and the ICH M14 Guideline, including datasets available through the Data Analysis and Real-World Interrogation Network (DARWIN EU) and the EHDS. The following are examples of clinical practice data which could be considered in scope: administrative or claims data, Electronic Medical/Health Records (EMRs/EHRs), pharmacy/prescription data, patient registries, etc. Existing guidance specific to particular data types (e.g., guidance on registry-based studies for the use of patient registry data) still applies and the RW-DQF should be read in conjunction with any other relevant guidance documents. RW-DQF is intended to serve as a structured guide on the DQ elements to be assessed and documented for regulatory purposes. It is not designed to function as a detailed SOP or methodology manual. Methodological guidance is already covered in other existing guidance documents. Next Step • Future iterations of the RW-DQF may expand to address additional data types and emerging technologies that are increasingly relevant to regulatory decision-making. These could include direct- from-patient (or direct-from-user) data such as PROs, patient engagement and preference data, or non-prescription medicinal products. • The evolving landscape of RWD will likely be also shaped by innovations in artificial intelligence, wearable technologies, mobile health inputs, and social media-derived insights. • While all these areas are not within the scope of the current version, they represent important frontiers for future guidance, which will be addressed in the future, in alignment with regulatory needs and scientific advancements. Pharmacovigilance EMA - 2025 Annual Report on EudraVigilance – Published The EMA has published its 2025 Annual Report on EudraVigilance for the European Parliament, the Council and the Commission; highlighting the continued central role of EudraVigilance in EU pharmacovigilance and patient safety. This annual report is produced in accordance with Regulation (EC) No. 726/2004, Article 24(2) and summarises the EudraVigilance-related activities for medicines for human use performed in 2025, including: • Operation of EudraVigilance, including its new functionalities, • Collecting and processing suspected adverse drug reaction reports, • Screening for, and review of, potential safety signals, • Supporting the central role of the PRAC in assessing and monitoring the safety of human vaccines and medicines in the EU, • Transparency and public access to aggregated EudraVigilance data, • Training and support activities. Several annexes are provided throughout the document, namely: • Annex I – Summary of EudraVigilance related activities • Annex II – EudraVigilance data-processing network and number of suspected adverse reaction reports processed by the EudraVigilance database • Annex III - Total number of medicinal product submissions by MAHs • Annex IV - EudraVigilance data quality activities • Annex V – Signal detection • Annex VI - Signal management process and methods • Annex VII - Requests for information and documents https://www.ema.europa.eu/en/documents/other/data-quality-framework-eu-medicines-regulation-application-real-world-data_en.pdf https://encepp.europa.eu/document/download/f6e403a6-8033-4c22-a5ff-195ba3666299_en?filename=01.ENCePPMethodsGuideRev.11.pdf https://encepp.europa.eu/document/download/f6e403a6-8033-4c22-a5ff-195ba3666299_en?filename=01.ENCePPMethodsGuideRev.11.pdf https://www.ema.europa.eu/en/documents/scientific-guideline/ich-m14-guideline-general-principles-planning-designing-analysing-reporting-non-interventional-studies-utilise-real-world-data-safety-assessment-medicines-step-5_en.pdf https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-registry-based-studies_en.pdf https://www.ema.europa.eu/en/documents/other/data-quality-framework-eu-medicines-regulation-application-real-world-data_en.pdf https://www.ema.europa.eu/en/documents/report/2025-annual-report-eudravigilance-european-parliament-council-commission_en.pdf AESGP OTC News | April 2026 10 | 22 The report briefly highlights several key developments in EudraVigilance, including sustained increase in reporting volume, with continued growth in ICSRs reinforcing its role as a central EU safety database. The report also underlines the system’s core role in signal detection, supporting the work of PRAC and national competent authorities. In addition, enhanced data analytics and monitoring are emphasised, with increasing use of large datasets and statistical tools to strengthen proactive safety surveillance. Ongoing system and process improvements are also noted, particularly regarding optimisation of functionalities, guidance, and data quality. The full report is available here. EMA - EU implementation strategy of ICH E2D(R1) Guideline - Post-approval safety data: Definitions and standards for management and reporting of ICSRs The EMA published the EU implementation strategy of ICH E2D(R1) Guideline - Post-approval safety data: Definitions and standards for management and reporting of individual case safety reports, following its adoption by the PRAC. The document aims to provide instructions on the practical implementation of the ICH E2D(R1) Guideline - Post-approval safety data: definitions and standards for management and reporting of individual case safety reports in the European Union (EU). It is intended to provide guidance for Marketing Authorisation Holders (MAHs), as well as for National Competent Authorities and Inspectors. The document provides guidance and clarification, in particular on: • Implementation of ICH E2D(R1) in the EU • Implementation of the definition for Patient Support Program • Implementation of the detailed documentations required for Organised Data Collection Systems not conducted according to a protocol The implementation strategy in detail is available here. Herbal medicines EMA HMPC launches 18 calls for scientific data - FOR INPUT by 1 JUN Further to the adoption by the EMA Committee on Herbal Medicinal Products (HMPC) on 4 March 2026, the calls for scientific data have been published in the context of the periodic review of several herbal medicinal product monographs. The HMPC invites the submission of relevant scientific literature published since the end date of the respective public consultations on these monographs and their supporting documents. The submission period will remain open until 15 JUN 2026. Current and recent calls for scientific data • Absinthii herba https://www.ema.europa.eu/en/documents/report/2025-annual-report-eudravigilance-european-parliament-council-commission_en.pdf https://www.ema.europa.eu/en/documents/scientific-guideline/eu-implementation-strategy-ich-e2dr1-guideline-post-approval-safety-data-definitions-standards-management-reporting-individual-case-safety-reports_en.pdf https://www.ema.europa.eu/en/documents/scientific-guideline/eu-implementation-strategy-ich-e2dr1-guideline-post-approval-safety-data-definitions-standards-management-reporting-individual-case-safety-reports_en.pdf https://www.ema.europa.eu/en/documents/scientific-guideline/eu-implementation-strategy-ich-e2dr1-guideline-post-approval-safety-data-definitions-standards-management-reporting-individual-case-safety-reports_en.pdf https://www.ema.europa.eu/en/documents/scientific-guideline/ich-e2dr1-guideline-post-approval-safety-data-definitions-standards-management-reporting-individual-case-safety-reports_en.pdf https://www.ema.europa.eu/en/documents/scientific-guideline/ich-e2dr1-guideline-post-approval-safety-data-definitions-standards-management-reporting-individual-case-safety-reports_en.pdf https://www.ema.europa.eu/en/documents/scientific-guideline/ich-e2dr1-guideline-post-approval-safety-data-definitions-standards-management-reporting-individual-case-safety-reports_en.pdf https://www.ema.europa.eu/en/documents/scientific-guideline/eu-implementation-strategy-ich-e2dr1-guideline-post-approval-safety-data-definitions-standards-management-reporting-individual-case-safety-reports_en.pdf https://www.ema.europa.eu/en/human-regulatory-overview/herbal-medicinal-products/procedures-monograph-list-entry-establishment https://www.ema.europa.eu/en/human-regulatory-overview/herbal-medicinal-products/procedures-monograph-list-entry-establishment https://www.ema.europa.eu/en/documents/herbal-monograph/call-scientific-data-periodic-review-monograph-absinthii-herba_en.pdf AESGP OTC News | April 2026 11 | 22 • Arctii radix • Chamomillae romanae flos • Filipendulae ulmariae flos • Filipendulae ulmariae herba • Herniariae herba • Leonuri cardiacae herba • Menthae piperitae aetheroleum • Menthae piperitae folium • Millefolii flos • Millefolii herba • Phaseoli fructus (sine semine) • Quercus cortex • Tanaceti parthenii herba • Taraxaci folium • Taraxaci radix cum herba • Thymi aetheroleum • Tormentillae rhizoma ACTION: • Any scientific data on EU herbal monographs listed above can be sent by 1 JUN in accordance with the guidance outlined in the procedure for calls for scientific data for use in HMPC assessment work for the submission of data. EMA's Draft Guideline on declaration of herbal substances and herbal preparations in HMPs / THMPs - Revision 2 - For Comments by 16 JUN On 1 APR, the EMA published the draft second revision of Guideline on declaration of herbal substances and herbal preparations in herbal medicinal products / traditional herbal medicinal products. The draft guideline is open for public consultation until 30 JUN 2026. Scope and background This guideline outlines the principles for the uniform declaration of herbal substances/preparations when being the active substance of herbal medicinal products (HMPs) as well as traditional herbal medicinal products (THMPs). It focuses on the different types of herbal substances/preparations in relation to the quality documentation given. Examples of declaration of such active substances, including standardised, quantified, and other herbal substances/preparations are provided. While the main guideline describes only the declaration of herbal substances/preparations in HMPs (including fixed combinations) in the SmPC, detailed guidance on package leaflets, labelling and other herbal specific provisions, for SmPC, package leaflets and labelling, is provided in Annex 1. This guideline supports applications for marketing authorisations or registrations according to Directive 2001/83/EC and Regulation (EU) 2019/6 as amended as well as the simplified registration procedure for THMPs for human use under Directive 2001/83/EC as amended by Directive 2004/24/EC. The principles for declaration of herbal substances/preparations in HMPs apply equally to such THMPs for human use. THMPs may additionally contain vitamins and/or minerals. Declaration of these chemically defined substances is not covered by this guideline. Reference is given to the INN-system and to “A Guideline on Summary of Product Characteristics (SmPC)”. This guideline should also be read in conjunction with current EU/(V)ICH guidelines and the relevant QRD templates. The main changes in Revision 2 • General guidance and examples for declaration of extracts and other herbal drug preparations have been updated, to specify that in European procedures, declarations with both of two options (the genuine drug extract ratio; DERgenuine and the corresponding mass of herbal substance) should now be stated in the common SmPC. It is noted that application of the preferred one of the two options for the national SmPC is considered a national issue to be solved after the end of the procedure. https://www.ema.europa.eu/en/documents/herbal-call-data/call-scientific-data-periodic-review-monograph-arctii-radix_en.pdf https://www.ema.europa.eu/en/documents/herbal-call-data/call-scientific-data-periodic-review-monograph-chamomillae-romanae-flos_en.pdf https://www.ema.europa.eu/en/documents/herbal-call-data/call-scientific-data-periodic-review-monograph-filipendulae-ulmariae-flos_en.pdf https://www.ema.europa.eu/en/documents/herbal-call-data/call-scientific-data-periodic-review-monograph-filipendulae-ulmariae-herba_en.pdf https://www.ema.europa.eu/en/documents/herbal-call-data/call-scientific-data-periodic-review-monograph-herniariae-herba_en.pdf https://www.ema.europa.eu/en/documents/herbal-call-data/call-scientific-data-periodic-review-monograph-leonuri-cardiacae-herba_en.pdf https://www.ema.europa.eu/en/documents/herbal-call-data/call-scientific-data-periodic-review-monograph-menthae-piperitae-aetheroleum_en.pdf https://www.ema.europa.eu/en/documents/herbal-call-data/call-scientific-data-periodic-review-monograph-menthae-piperitae-folium_en.pdf https://www.ema.europa.eu/en/documents/herbal-call-data/call-scientific-data-periodic-review-monograph-millefolii-flos_en.pdf https://www.ema.europa.eu/en/documents/herbal-call-data/call-scientific-data-periodic-review-monograph-millefolii-herba_en.pdf https://www.ema.europa.eu/en/documents/herbal-call-data/call-scientific-data-periodic-review-monograph-phaseoli-fructus-sine-semine_en.pdf https://www.ema.europa.eu/en/documents/herbal-call-data/call-scientific-data-periodic-review-monograph-quercus-cortex_en.pdf https://www.ema.europa.eu/en/documents/herbal-call-data/call-scientific-data-periodic-review-monograph-tanaceti-parthenii-herba_en.pdf https://www.ema.europa.eu/en/documents/herbal-call-data/call-scientific-data-periodic-review-monograph-taraxaci-folium_en.pdf https://www.ema.europa.eu/en/documents/herbal-call-data/call-scientific-data-periodic-review-monograph-taraxaci-radix-cum-herba_en.pdf https://www.ema.europa.eu/en/documents/herbal-call-data/call-scientific-data-periodic-review-monograph-thymi-aetheroleum_en.pdf https://www.ema.europa.eu/en/documents/herbal-call-data/call-scientific-data-periodic-review-monograph-tormentillae-rhizoma_en.pdf https://www.ema.europa.eu/documents/regulatory-procedural-guideline/procedure-calls-scientific-data-use-hmpc-assessment-work_en.pdf https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-declaration-herbal-substances-herbal-preparations-herbal-medicinal-products-traditional-herbal-medicinal-products-revision-2_en.pdf https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-declaration-herbal-substances-herbal-preparations-herbal-medicinal-products-traditional-herbal-medicinal-products-revision-2_en.pdf https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-declaration-herbal-substances-herbal-preparations-herbal-medicinal-products-traditional-herbal-medicinal-products-revision-2_en.pdf AESGP OTC News | April 2026 12 | 22 • Chapters 5 and 6 have been updated to elaborate the guidance on declaration of herbal substances and herbal preparations, most notably regarding naming of herbal substances, and declaration of fresh and frozen herbal substances, extraction solvents, excipients, and combination products. • Editorial changes have been made throughout the guideline, primarily to take account of updated legislation, revisions of relevant Ph. Eur. provisions, and EU guidelines. ACTION: • Major comments, together with their rationale, can be sent by using this template to AESGP- medicines@aesgp.eu by 16 JUN 2026. https://view.officeapps.live.com/op/view.aspx?src=https%3A%2F%2Fwww.ema.europa.eu%2Fen%2Fdocuments%2Ftemplate-form%2Fform-submission-comments-scientific-guidelines_en.doc&wdOrigin=BROWSELINK mailto:AESGP-medicines@aesgp.eu mailto:AESGP-medicines@aesgp.eu AESGP OTC News | April 2026 13 | 22 EFSA Safety of carbon dioxide extract from Cannabis sativa L. as a novel food On 30 MAR, the EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA) published its Safety of carbon dioxide extract from Cannabis sativa L. as a novel food pursuant to Regulation (EU) 2015/2283 The opinion was delivered following a request from the European Commission concerning the proposed novel food (NF) intended for use in food supplements at maximum use levels ranging from 1.12 mg/day for children above 3 years of age to 3.60 mg/day for adults, excluding pregnant and lactating women. The NF contains cannabidiol (CBD) as well as other cannabinoids. The Panel notes that a substantial proportion of the NF remains uncharacterised. The absence of adequate stability and of toxicological studies performed with a representative test item prevents the Panel from drawing conclusions on the safety assessment of the NF. Additionally, no data were provided by the applicant to address the safety of the NF in the general population above 3 years of age. Therefore, the safety of the NF under the proposed conditions of use cannot be established. Food https://efsa.onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2026.10004 https://efsa.onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2026.10004 AESGP OTC News | April 2026 14 | 22 Planned Meetings of Medical Device Coordination Group (MDCG) and Subgroups in 2026 Update The Commission has published an update of the planned meeting dates of the MDCG and subgroups for 2026. The update concerns the MDCG Nomenclature and market surveillance WG. AESGP Position on MDR Revision Proposal AESGP's position to the Commission’s legislative proposal for amending the MDR as regards simplifying and reducing the burden of the rules on medical devices has been submitted in to the public consultation on the Commission's “Have your say” website. The position has also been published on the website of AESGP and may be accessed here. Medical Devices https://health.ec.europa.eu/document/download/941b23fa-60e9-4efe-bd38-9b2d8649e70c_en?filename=md_events_2026_en.pdf https://health.ec.europa.eu/document/download/941b23fa-60e9-4efe-bd38-9b2d8649e70c_en?filename=md_events_2026_en.pdf https://aesgp.eu/articles/aesgp-position-on-the-european-commissions-proposal-to-simplify-medical-devices-rules AESGP OTC News | April 2026 15 | 22 PPWR - EC guidelines on the implementation of PPWR & FAQ document - 30 MAR 2026 On 30 March 2026, the European Commission published its guidelines on the implementation of the Packaging and Packaging Waste Regulation (PPWR) and the FAQ document. • the press release here. • the guidelines on the implementation of PPWR here. • the FAQ document here. The guidelines explain several aspects of the PPWR, including definitions and roles, which items fall under the definition of ‘packaging’, application of the restrictions on single-use packaging, enforcement of the PFAS limits in food-contact materials, interpretations of the new re-use targets, and guidance on EPR obligations for setting up deposit and return systems. Alongside the guidance, the EC also shared a FAQ document addressing practical questions raised since the adoption of the PPWR and which will be updated periodically. OFFICIAL NEXT STEPS • The guidelines will now be translated into all EU languages before its formal adoption. • EC will continue to support MS and stakeholders to ensure an effective roll-out of the new rules. • Several delegated and implementing acts are under preparation, notably on harmonised registration and reporting formats for EPR schemes, consumer waste-sorting labelling, recycled content in plastic packaging, and recyclability criteria. WFD+GWD+EQSD - Publication in OJ - 20 APR 2026 The revised Water Framework Directive (WFD), Environmental Quality Standards (EQS), and Groundwater Directive (GWD) package (Directive (EU) 2026/805) has been published in the Official Journal on 20 April 2026. The Directive was formally adopted on 30 March and will enter into force 20 days after publication, approximately 10 May 2026. The publication is available here: Directive (EU) 2026/805 of the European Parliament and of the Council of 30 March 2026 amending Directive 2000/60/EC establishing a framework for Community action in the field of water policy, Directive 2006/118/EC on the protection of groundwater against pollution and deterioration and Directive 2008/105/EC on environmental quality standards in the field of water policy (Text with EEA relevance). While the final text will be assessed in more detail, a few elements of relevance have been highlighted below: Extended producer responsibility (EPR) • As anticipated, the final text does not introduce an EPR system, but it requires the Commission to prepare a report by 2029 on the feasibility of introducing EPR under the WFD. Environment https://ec.europa.eu/commission/presscorner/detail/en/ip_26_664 https://environment.ec.europa.eu/document/download/3d59ca88-539c-4b6b-a623-0f61068e853e_en?filename=Annex%20to%20the%20Communication%20to%20the%20Commission.pdf file:///C:/Users/Ville-WaltteriVirtan/Downloads/packaging%20and%20packaging%20waste%20regulation%20ppwr-KH0126006ENN.pdf https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=OJ:L_202600805 https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=OJ:L_202600805 https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=OJ:L_202600805 https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=OJ:L_202600805 https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=OJ:L_202600805 AESGP OTC News | April 2026 16 | 22 • The Directive also explicitly refers to monitoring costs linked to substances listed under the EQS and GWD. ➔ This keeps EPR relevant in the EU water policy, but without immediate legal or financial obligations for producers; instead, the scope remains exploratory and politically sensitive with clear parallels to UWWTD. ‘Total pharmaceuticals’ vs. substance-specific approach • The Directive introduces binding standards for a limited number of individual pharmaceuticals, notably in groundwater, and explicitly defers decisions on ‘total pharmaceuticals’ or grouped standards to future reviews. • The Directive adds ‘sum(s) of selected pharmaceuticals by mode of action’ only to lists for future considerations, not as enforceable standards. ➔ This confirms that currently the legislators have not endorsed a blanket approach on pharmaceuticals, preferring substance-specific approach with pilots on mixtures and effect-based monitoring. Pharmaceuticals used in self-care products • Diclofenac and ibuprofen are listed as priority substance with binding EQS for surface water. ➔ As an important outcome from the trilogue, OTC medicinal substances like paracetamol, acetylsalicylic acid, naproxen, and caffeine are not listed as priority substances, not listed in groundwater standards, nor have assigned EQS. PFAS prioritisation • The Directive expands PFAS coverage by prioritising certain PFAS explicitly in surface water and groundwater and by introducing ‘PFAS total’ as a future monitoring concept not yet binding to EQS. • Trifluoroacetic acid (TFA) receives particular attention, including a mandate to consider setting a standalone standard for this substance at the next review. ➔ Importantly, all these PFAS are environmental degradation products rather than substances placed on the market. Bishpenol A • Bisphenol A (BPA) is listed as a priority substance with binding EQS for surface water and assumes possible future review of bisphenols as a substance group (for example, ‘sum of bisphenols’), without binding EQS at this stage. ➔ Bisphenols are not used as APIs, but their relevance relates to packaging and materials use and their endocrine-disrupting properties. ‘Metabolites’ or degradation products • The Directive continues to use the concept of ‘metabolites’ in places, but in practice refers more to degradation and transformation products in water. • Some of the substances like TFA are formed in the environment, not intentionally manufactured; this weakens the analytical link between chemical regulation at source and environmental concentration control. ➔ This also potentially complicates any future discussion on EPR or producer accountability. Links with the Drinking Water Directive (DWD) & Urban Wastewater Treatment Directive (UWWTD) DWD • The Directive does not introduce new obligations for the self-care sector; however, it does frame groundwater quality standards to support compliance with drinking water parametric values and references methodologies used in DWD for certain substances like PFAS. UWWTD • The Directive links to the UWWTD by monitoring and pollution control along the entire water cycle (surface water, groundwater, wastewater, reuse). • The Directive draws experience from EPR under UWWTD as a reference point for future assessment under WFD. ➔ However, the Directive does not introduce no EPR mechanism under the water acquis, no new obligations related to sewage sludge or sludge quality standards and refers to UWWTD primarily as a context and precedent. OFFICIAL NEXT STEPS • The Directive will enter into force 20 days after the publication in the Official Journal which would be around 10 May 2026. AESGP OTC News | April 2026 17 | 22 • Member States must transpose the Directive into national law by 21 December 2027. • Following entry into force, the Commission is formally empowered to adopt a significant number of implementing and delegated acts notably on: o Monitoring methods and technical specifications for effect-based monitoring and watchlist sampling and reporting formats o Watchlists for surface water and groundwater (first updates are due from mid-2028) o Reporting formats and indicators of progress to be used by MS. • For newly introduced or revised substances: o Monitoring obligations generally apply first (from 2027) o Programs of measures follow (from 2030) o Achievement of good status is expected by 2033 or 2039, depending on the substance and concerned annex. • EU agencies are working in several preparatory workstreams: o ECHA will prepare scientific reports to support future reviews and provide input to watchlist prioritization and substance grouping. o EEA will align reporting streams and increase public availability of monitoring data. • Two formally mandated EU Commission reports will be prepared: o By 11 November 2027 – Commission report on the feasibility of a joint EU monitoring facility. o By 11 May 2029 – Commission report on the possible introduction of an EPR mechanism in WFD, explicitly referring to experience under UWWTD and waste regulation. • The next comprehensive EU-level review of pollutant lists and standards is scheduled for 11 May 2032, and every six years thereafter. AESGP OTC News | April 2026 18 | 22 European Commission DG SANTE's FAQs on the European Health Data Space Regulation (EU) 2025/327 – Published The European Commission’s Directorate-General for Health and Food Safety (DG SANTE) has published an updated version (version 1.1) of the Frequently Asked Questions (FAQs) on the European Health Data Space (EHDS) Regulation (EU) 2025/327. This living document provides answers to frequently asked questions (FAQs), complements other information related to the EHDS Regulation, and may be updated in the future. Compared to the previous version, the updated FAQs introduce the following changes: • Corrections of typos and cross-references throughout the document, • Expanded content for questions 22, and 55-56, • The addition of questions 24, 40, 48, 66, and 67. Please also note that, any views expressed in this document are the preliminary views of the European Commission services and may not under any circumstances be regarded as stating an official position of the European Commission. The replies to the frequently asked questions do not extend or restrict in any way the rights and obligations deriving from applicable legislation nor introduce any additional requirements. The expressed views are not authoritative and cannot prejudge any future actions the European Commission may take, including potential positions before the Court of Justice of the European Union. Only the Court of Justice of the European Union is competent to authoritatively interpret EU law. European Parliament's position on a simplification proposal amending the Artificial Intelligence Act (AIA) – Adopted On Thursday, 26 MAR 2026, the European Parliament adopted its position on a simplification (“omnibus”) proposal amending the Artificial Intelligence Act (AIA), by 569 votes in favour, 45 against, and 23 abstentions. The proposal aims to simplify existing artificial intelligence rules and introduce clear application timelines for high-risk system requirements, as well as a ban on AI “nudifier” systems. It would also delay the application of certain rules on high-risk artificial intelligence (AI) systems to ensure that guidance and standards to support implementation are in place. In particular, Members of the European Parliament have agreed on proposals to: • Introduce fixed dates for application to ensure predictability and legal certainty, namely: ➢ For high-risk AI systems specifically listed in the regulation (including those involving biometrics, and those used in critical infrastructure, education, employment, essential services, law enforcement, justice and border management), 2 DEC 2027 as the proposed date of application. Cross-Sectorial News https://health.ec.europa.eu/latest-updates/frequently-asked-questions-european-health-data-space-2026-03-26_en https://health.ec.europa.eu/latest-updates/frequently-asked-questions-european-health-data-space-2026-03-26_en https://www.europarl.europa.eu/news/en/press-room/20260323IPR38829/artificial-intelligence-act-delayed-application-ban-on-nudifier-apps https://www.europarl.europa.eu/news/en/press-room/20260323IPR38829/artificial-intelligence-act-delayed-application-ban-on-nudifier-apps AESGP OTC News | April 2026 19 | 22 ➢ For AI systems that are covered by EU sectoral legislation on safety and market surveillance, 2 AUG 2028 as the proposed date of application. • Provide for a transitional period allowing providers until 2 NOV 2026 to comply with rules on watermarking AI-created audio, image, video or text content to indicate its origin. • Ban “nudifier” systems/apps that use AI to create or manipulate images that are sexually explicit or intimate and resemble an identifiable real person without that person’s consent. The ban would not apply to AI systems with effective safety measures preventing users from creating such images. • Introduce measures aimed at increasing flexibility and supporting small mid-cap enterprises (SMCs), including: ➢ Allowing service providers to process personal data for the purposes of detecting and correcting biases in AI systems, subject to appropriate safeguards, and only where such processing is strictly necessary. ➢ Extending certain support measures currently available to small and medium-sized enterprises (SMEs) to small mid-cap enterprises (SMCs), in order to support EU companies as they scale up beyond SME status. ➢ Reducing the risk of overlapping regulatory requirements by allowing obligations under the Artificial Intelligence Act to be less stringent for AI systems integrated into products already regulated under EU sectoral legislation (e.g. medical devices, radio equipment, toy safety, and others). NEXT STEP • Negotiations with the Council on the final form of the law can now begin. BACKGROUND • The legislation voted is part of the seventh omnibus package on simplification proposed by the European Commission on 19 NOV 2025 (“the digital omnibus”). • Parliament is also currently working on the other proposals in the package: the digital omnibus on amending laws on data use and data protection, and the proposal establishing European business wallets. EC – Launch of Initiatives to Develop Implementing Regulation for the European Health Data Space (EHDS) The two initiatives related to the implementing regulation on European Health Data Space (EHDS) have been launched and published on the European Commission website, as outlined below: • European Health Data Space – common specifications for the European digital testing environment • European Health Data Space – specifications for the European electronic health exchange format (EEHRxF) European Health Data Space – common specifications for the European digital testing environment The EHDS Regulation requires electronic health record (EHR) systems to have the two harmonised software components tested in a digital testing environment. This initiative sets out the common specifications, functional and non-functional requirements for the European digital testing environment. The European Commission will provide this European digital testing environment as an open-source reference implementation. The Member States will deploy and operate their digital testing environments. The adoption of the implementing regulation by the European Commission is currently planned for Q1 2027. European Health Data Space – specifications for the European electronic health exchange format (EEHRxF) https://oeil.europarl.europa.eu/oeil/en/procedure-file?reference=2025/0360(COD) https://oeil.europarl.europa.eu/oeil/en/procedure-file?reference=2025/0358(COD) https://oeil.europarl.europa.eu/oeil/en/procedure-file?reference=2025/0358(COD) https://ec.europa.eu/info/law/better-regulation/have-your-say/initiatives/17513-European-Health-Data-Space-common-specifications-for-the-European-digital-testing-environment_en https://ec.europa.eu/info/law/better-regulation/have-your-say/initiatives/17513-European-Health-Data-Space-common-specifications-for-the-European-digital-testing-environment_en https://ec.europa.eu/info/law/better-regulation/have-your-say/initiatives/17512-European-Health-Data-Space-specifications-for-the-European-electronic-health-exchange-format-EEHRxF-_en https://ec.europa.eu/info/law/better-regulation/have-your-say/initiatives/17512-European-Health-Data-Space-specifications-for-the-European-electronic-health-exchange-format-EEHRxF-_en https://ec.europa.eu/info/law/better-regulation/have-your-say/initiatives/17513-European-Health-Data-Space-common-specifications-for-the-European-digital-testing-environment_en https://ec.europa.eu/info/law/better-regulation/have-your-say/initiatives/17513-European-Health-Data-Space-common-specifications-for-the-European-digital-testing-environment_en https://ec.europa.eu/info/law/better-regulation/have-your-say/initiatives/17512-European-Health-Data-Space-specifications-for-the-European-electronic-health-exchange-format-EEHRxF-_en https://ec.europa.eu/info/law/better-regulation/have-your-say/initiatives/17512-European-Health-Data-Space-specifications-for-the-European-electronic-health-exchange-format-EEHRxF-_en AESGP OTC News | April 2026 20 | 22 The European electronic health record exchange format (EEHRxF) will be the format to be used for cross-border exchanges of electronic health data. This initiative sets out the specifications for the EEHRxF. It will cover the exchange of patient summaries, electronic prescriptions, electronic dispensations, medical imaging studies and related imaging reports, medical test results (including laboratory and other diagnostic results and related reports), and discharge reports. The adoption of the implementing regulation by the European Commission is currently planned for Q4 2026. EHDS Board operations - Commission Implementing Regulation (EU) 2026/771 – Published On 8 APR, Commission Implementing Regulation (EU) 2026/771 of 7 April 2026 laying down the necessary measures for the establishment and operation of the European Health Data Space Board, was published on the Official Journal of the European Union (OJEU). This Regulation lays down the necessary rules for the establishment, the management and the functioning of the European Health Data Space Board (the ‘EHDS Board’). This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union. It shall be binding in its entirety and directly applicable in all Member States. Draft Commission Implementing Regulations concerning the European Health Data Space (EHDS) - Published for consultation The European Commission has published three draft Implementing Regulations concerning the European Health Data Space (EHDS), as outlined below. 1. European Health Data Space – dataset descriptions • As part of the European Health Data Space, health data holders will have to provide descriptions of their datasets to the health data access bodies so they can be included in the dataset catalogues. This initiative lays down the minimum metadata elements for dataset descriptions, and the characteristics of those elements, that health data holders are required to provide to health data access bodies pursuant to Article 60(3) of Regulation (EU) 2025/327 for the secondary use of electronic health data, as well as the metadata framework to be used for that purpose. • The draft implementing regulation is currently open for public consultation until 12 MAY 2026. The Commission adoption is planned for Q3 2026, and the implementing regulation is anticipated to apply from 26 MAR 2029. 2. European Health Data Space – requirements for cross-border exchange of personal health data (MyHealth@EU) • MyHealth@EU is the infrastructure set up under the European Health Data Space that supports the cross-border exchange of personal electronic health data, such as patient summaries and prescriptions. This initiative sets out detailed requirements for this infrastructure including cybersecurity, technical interoperability, semantic interoperability, operations and service management in relation to the processing by the Commission as processor for MyHealth@EU and its responsibilities towards the joint controllers. • The draft implementing regulation is currently open for public consultation until 07 MAY 2026. The Commission adoption is planned for Q2 2026, and the implementing regulation is anticipated to apply from 26 MAR 2027. 3. European Health Data Space – identity management https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=OJ:L_202600771 https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=OJ:L_202600771 https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=OJ:L_202600771 https://ec.europa.eu/info/law/better-regulation/have-your-say/initiatives/15673-European-Health-Data-Space-dataset-descriptions_en https://ec.europa.eu/info/law/better-regulation/have-your-say/initiatives/15594-European-Health-Data-Space-requirements-for-cross-border-exchange-of-personal-health-data-MyHealth@EU-_en https://ec.europa.eu/info/law/better-regulation/have-your-say/initiatives/15594-European-Health-Data-Space-requirements-for-cross-border-exchange-of-personal-health-data-MyHealth@EU-_en https://ec.europa.eu/info/law/better-regulation/have-your-say/initiatives/15353-European-Health-Data-Space-identity-management_en AESGP OTC News | April 2026 21 | 22 • This initiative lays down the requirements for the interoperable, cross-border identification and authentication mechanism for natural persons, health professionals and healthcare providers for the purposes of cross-border exchange of electronic health data, in line with the eIDAS Regulation. These requirements provide the foundation for EU countries and the Commission to implement the mechanism in MyHealth@EU, supporting the cross-border exchange of personal electronic health data. • The draft implementing regulation is currently open for public consultation until 07 MAY 2026. The Commission adoption is planned for Q2 2026, and the implementing regulation is anticipated to apply from 26 MAR 2027, whereas Article 3(3) and Article 5(2) are anticipated to apply from 26 MAR 2029. AESGP — Association of the European Self-Care Industry Avenue de Tervuren, 7 1040 Brussels Belgium info@aesgp.eu www.aesgp.eu

EU reference dates list The convention used to present the active substances and combinations of active substances has changed. From the 29th October 2015 the following principles apply: - A slash ('/') is used to separate the different active substances contained in a combination, this can be a fixed-dose combination or a combination pack. - A comma (',') is used to indicate that a single PSUR assessment covering the different substances and/or combinations of active substances will be produced. 26 August 2026 EMA/630645/2012 Rev.163 Procedure Management Department List of Union reference dates and frequency of submission of periodic safety update reports (PSURs) Related Information: Introductory cover note to the List of European Union reference dates and frequency of submission of PSURs including requirements for PSURs submission https://www.ema.europa.eu/documents/other/introductory-cover-note-list-european-union-reference-dates-frequency-submission-periodic-safety_en.pdf Requests for amendments of the EU reference dates list https://www.ema.europa.eu/documents/template-form/template-request-amendments-addition-active-substances-combinations-active-substances-european-union_en-1.docx The PSUR assessment procedure will start according to the Timetables published on EMA website following the Submission Dates indicated in column E and G below https://www.ema.europa.eu/documents/other/timetable-periodic-safety-update-report-psur-psur-single-assessment-psusa_en.pdf Single Assessment Reports of PSURs are shared among all Marketing Authorisation Holders involved in the concerned procedure. ID Active substances and combinations of active substances European Union reference date (EURD) Not Available* = EURD not provided during the consultation phases PSUR Submission Frequency DLP Submission date (According to the timelines defined in GVP Module VII, Section A) Next DLP (For active substances or combination of active substances with a PSUR frequency of less than one year) Next Submission date (According to the timelines defined in GVP Module VII, Section A - For active substances or combination of active substances with a PSUR frequency of less than one year) Are PSURs required for products referred to in Articles 10(1), 10a, 16a of Directive 2001/83/EC as amended? Yes/No Publication Date (in accordance with Article 107c(7) of Directive 2001/83/EC as amended) Notes Procedure number of the PSUR single assessment (DLP) Procedure number of the PSUR single assessment procedure (Next DLP) PRAC representative of the PSUR single assessment procedure (Lead) Member State of the PSUR single assessment procedure Centrally authorised product(s) (CAP) Nationally authorised product(s) (NAP) 2 calcium chloride / histidine / magnesium chloride / mannitol / potassium chloride / sodium chloride / tryptophan / oxogluric acid 24/11/1989 6 years 31/01/2030 01/05/2030 No 28/06/2023 Lead MS and PRAC Rapporteur name added on 18/10/2023 New entry added on 28/06/2023 PSUSA/00000002/203001 Jean-Michel Dogné Belgium NAP 4 131i-6-iodo-norcholesterol 21/06/1990 9 years 31/01/2029 01/05/2029 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00000004/202901 NAP 5 (3s,10s,14s)-1-[4-[[(2s)-4-carboxy-2-[(2s)-4-carboxy-2-(6-[18f] fluoropyridin-3-amido) butanamido] butanamido]methyl]phenyl]-3-[(naphthalen-2-YL)methyl]-1,4,12-trioxo-2,5,11,13-tetraazahexadecane-10,14,16-tricarboxylic acid 09/12/2021 3 years 08/12/2027 07/03/2028 No 28/06/2023 New entry added on 28/06/2023 PSUSA/00000005/202712 not yet assigned none NAP 6 ¹³C-urea, ¹4C-urea 14/08/1997 5 years 15/01/2028 14/04/2028 No 20/09/2023 DLP amended on 20/09/2023 PSUSA/00000006/202801 Jan Neuhauser Austria CAP NAP 7 5 fluorouracil (IV use) 16/12/1977 3 years 16/12/2026 16/03/2027 Yes 25/09/2024 DLP was amended on 25/09/2024 PSUSA/00000007/202612 Dennis Lex Germany NAP 8 5 fluorouracil / salicylic acid 25/05/1994 5 years 25/05/2026 23/08/2026 No 17/02/2022 DLP and PSUR frequency were updated on 02/02/2022 PRAC representative was updated on 22/12/2021 PRAC representative was updated on 06/05/2020 DLP was updated on 06/02/2019 Next DLP was updated on 04/02/2016 Lead MS was added on 06/03/2015 PSUSA/00000008/202605 Jana Pecherova Slovakia NAP 9 5-aminolevulinic acid (glioma) 07/09/2007 3 years 07/03/2027 05/06/2027 No 20/11/2024 DLP was amended on 20/11/2024 PSUSA/00000009/202703 Carla Torre Portugal CAP 10 abacavir 29/06/1998 3 years 31/12/2025 31/03/2026 No 27/05/2026 Reference to NAP removed on 27/05/2026 Information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" was amended on 25/06/2025 PSUSA/00000010/202512 Zoubida Amimour France CAP 11 abacavir / lamivudine 14/11/2003 3 years 31/12/2025 31/03/2026 No 04/02/2026 Reference to NAP removed on 04/02/2026 Information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" was amended on 25/06/2025 PSUSA/00000011/202512 Zoubida Amimour France CAP 13 abatacept 22/12/2005 3 years 22/12/2025 22/03/2026 No 20/09/2023 DLP amended on 20/09/2023 PSUSA/00000013/202512 Kimmo Jaakkola Finland CAP 15 abiraterone 28/04/2011 5 years 28/04/2029 27/07/2029 No 05/02/2025 PSUR frequency amended and DLP updated on 05/02/2025 PSUSA/00000015/202904 Maria del Pilar Rayon Spain CAP NAP 16 acamprosate 24/07/1987 8 years 01/07/2030 29/09/2030 No 01/03/2023 DLP was updated on 01/03/2023 Transferred from the List of substances under PSUR Work Sharing scheme and other substances contained in Nationally Authorised Products with DLP synchronised on 06/03/2015 PSUSA/00000016/203007 Rhea Fitzgerald Ireland NAP 17 acarbose 31/03/1990 5 years 31/03/2028 29/06/2028 No 20/12/2023 DLP was amended on 20/12/2023 PSUSA/00000017/202803 Maria del Pilar Rayon Spain NAP 18 acebutolol 16/12/1974 8 years 16/12/2030 16/03/2031 No 15/01/2025 PRAC Rapporteur name was amended on 18/10/2023 PSUSA/00000018/203012 Eva Jirsova Czech Republic NAP 22 aceclofenac 19/03/1990 5 years 31/03/2028 29/06/2028 No 20/12/2023 PSUR frequency amended and DLP updated on 20/12/2023 PSUSA/00000022/202803 Melinda Palfi Hungary NAP 25 sirolimus (indicated for treatment of angiofibroma associated with tuberous sclerosis complex) 15/05/2023 1 year 14/11/2026 23/01/2027 14/11/2027 23/01/2028 No 01/07/2026 DLP was amended on 01/07/2026 PSUSA/00000025/202611 PSUSA/00000025/202711 Jenny-Maria Jönsson Sweden CAP NAP 26 acemetacin Not available* 6 years 01/05/2030 30/07/2030 No 05/02/2025 DLP was amended on 05/02/2025 PSUSA/00000026/203005 Melinda Palfi Hungary NAP 27 acenocoumarol 06/07/1955 3 years 01/07/2027 29/09/2027 No 05/03/2025 DLP was amended on 05/03/2025 PSUSA/00000027/202707 Maria Popova-Kiradjieva Bulgaria NAP 29 acetazolamide 27/07/1953 16 years 26/10/2028 24/01/2029 Yes 28/03/2017 DLP was updated on 28/03/2017 PSUSA/00000029/202810 NAP 31 respiratory Syncytial Virus (RSV) vaccine (recombinant, adjuvanted) 03/05/2023 1 year 02/05/2026 11/07/2026 02/05/2027 11/07/2027 No 01/07/2026 Active substance name was amended on 01/07/2026 DLP was amended on 30/07/2025 PSUR frequency amended and DLP updated on 25/06/2025 DLP was amended on 18/12/2024 PSUSA/00000031/202605 PSUSA/00000031/202705 Maria del Pilar Rayon Spain CAP 33 acetylcholine 09/06/1965 16 years 01/06/2028 30/08/2028 No 01/10/2012 PSUSA/00000033/202806 NAP 34 acetylcysteine 14/09/1963 5 years 13/09/2028 12/12/2028 No 05/06/2024 DLP was amended on 05/06/2024 PSUSA/00000034/202809 Adam Przybylkowski Poland NAP 39 acetylsalicylic acid 17/10/1942 8 years 01/02/2030 02/05/2030 No 28/06/2023 PSUR frequency amended and DLP updated on 28/06/2023 DLP was updated on 19/10/2022 PRAC representative was updated on 06/05/2020 DLP was updated on 23/10/2019 Next DLP was amended on 19/10/2016 Lead MS was added on 31/07/2015 PSUSA/00000039/203002 Melinda Palfi Hungary NAP 40 acetylsalicylic acid / glycine Not available* 18 years 01/01/2030 01/04/2030 No 01/10/2012 Active substance name was amended on 06/03/2015 PSUSA/00000040/203001 NAP 41 acetylsalicylic acid / caffeine Not available* 18 years 01/01/2030 01/04/2030 No 01/10/2012 PSUSA/00000041/203001 NAP 42 acetylsalicylic acid / caffeine / codeine phosphate Not available* 18 years 01/01/2030 01/04/2030 No 01/10/2012 PSUSA/00000042/203001 NAP 43 acetylsalicylic acid / caffeine / etenzamide Not available* 18 years 01/01/2030 01/04/2030 No 01/10/2012 PSUSA/00000043/203001 NAP 45 ublituximab 28/12/2022 1 year 27/12/2026 07/03/2027 27/12/2027 06/03/2028 No 29/07/2026 DLP was amended on 29/07/2026 PSUSA/00000045/202612 PSUSA/00000045/202712 Liana Martirosyan Netherlands CAP 46 acetylsalicylic acid / codeine phosphate Not available* 18 years 01/01/2030 01/04/2030 No 01/10/2012 PSUSA/00000046/203001 NAP 48 aciclovir 10/06/1981 3 years 09/06/2027 07/09/2027 No 05/02/2025 PSUR frequency amended and DLP updated on 05/02/2025 PSUSA/00000048/202706 Marie Louise Schougaard Christiansen Denmark NAP 49 mirikizumab 27/03/2023 1 year 27/03/2026 05/06/2026 27/03/2027 05/06/2027 No 27/05/2026 PSUR frequency amended and DLP updated on 27/05/2026 DLP was amended on 19/11/2025 PSUSA/00000049/202603 PSUSA/00000049/202703 Sonja Radowan Austria CAP 50 acipimox 05/05/1984 5 years 05/05/2026 03/08/2026 No 16/10/2023 PRAC Rapporteur name was amended on 18/10/2023 PSUSA/00000050/202605 Karin Erneholm Denmark NAP 51 acitretin 01/12/1987 2 years 30/10/2026 28/01/2027 Yes 25/06/2025 PSUR frequency amended and DLP updated on 25/06/2025 PSUSA/00000051/202610 Marie Louise Schougaard Christiansen Denmark NAP 54 acrivastine, acrivastine / pseudoephedrine 31/12/1990 7 years 02/12/2031 01/03/2032 No 30/07/2025 DLP was amended on 30/07/2025 PSUSA/00000054/203112 Terhi Lehtinen Finland NAP 58 adapalene 03/07/1992 8 years 31/07/2026 29/10/2026 No 03/04/2019 DLP was updated on 03/04/2019 PRAC Rapporteur name updated on 23/10/2018 PRAC Representative and Lead MS were added on 19/12/2017 PSUSA/00000058/202607 Eamon O'Murchu Ireland NAP 59 adapalene / benzoyl peroxide 30/09/2007 3 years 30/09/2026 29/12/2026 No 02/02/2026 DLP was amended on 05/06/2024 PSUSA/00000059/202609 Polona Golmajer Slovenia NAP 61 ademetionine 28/04/1993 8 years 03/08/2033 01/11/2033 No 01/04/2026 DLP was amended on 01/04/2026 PSUSA/00000061/203308 Amelia Cupelli Italy NAP 62 adenosine 14/08/1991 5 years 14/08/2027 12/11/2027 No 03/05/2023 DLP was amended on 03/05/2023 Lead MS and PRAC Rapporteur name amended on 19/12/2018 DLP was updated on 07/05/2018 PRAC representative and Lead Member State were added on 30/01/2017 PSUSA/00000062/202708 Adam Przybylkowski Poland NAP 66 sodium thiosulfate 20/09/2022 1 year 19/03/2026 28/05/2026 19/03/2027 28/05/2027 No 22/10/2025 DLP was amended on 22/10/2025 PSUSA/00000066/202603 PSUSA/00000066/202703 Karin Erneholm Denmark CAP 67 glofitamab 24/03/2023 1 year 23/03/2026 01/06/2026 23/03/2027 01/06/2027 No 17/12/2025 DLP was amended on 17/12/2025 DLP was amended on 19/11/2025 PSUSA/00000067/202603 PSUSA/00000067/202703 Veronika Macurova Czech Republic CAP 68 futibatinib 30/09/2022 6 months 29/03/2026 07/06/2026 29/09/2026 08/12/2026 No 02/06/2026 PSUSA/00000068/202603 PSUSA/00000068/202609 Jenny-Maria Jönsson Sweden CAP 69 agalsidase alfa 03/08/2001 3 years 03/08/2027 01/11/2027 No 02/04/2025 DLP was amended on 02/04/2025 PSUSA/00000069/202708 Liana Martirosyan Netherlands CAP 70 agalsidase beta 03/08/2001 3 years 31/07/2028 29/10/2028 No 01/04/2026 DLP was amended on 01/04/2026 PSUSA/00000070/202807 Liana Martirosyan Netherlands CAP 71 agomelatine 19/02/2009 5 years 19/02/2029 20/05/2029 No 20/10/2021 DLP was updated on 20/10/2021 PSUR Frequency and DLP updated on 26/09/2018 PRAC Rapporteur name amended on 04/07/2018 Next DLP was amended on 25/09/2017 PRAC Rapporteur name was amended on 20/12/2016 Next DLP was updated on 22/09/2016 DLP updated on 06/10/2015 PSUSA/00000071/202902 Pernille Harg Norway CAP 72 ajmaline 09/11/1962 10 years 22/08/2026 20/11/2026 No 26/04/2017 PSUR Frequency amended and DLP updated on 26/04/2017 Entry restored to the list on 20/12/2016 PSUSA/00000072/202608 Dennis Lex Germany NAP 73 albendazole 10/07/1981 5 years 10/07/2030 08/10/2030 No 04/03/2026 DLP was amended on 04/03/2026 PSUSA/00000073/203007 Adam Przybylkowski Poland NAP 74 mavacamten 28/04/2022 1 year 27/04/2026 06/07/2026 27/04/2027 06/07/2027 No 25/06/2025 PSUR frequency amended and DLP updated on 25/06/2025 DLP was amended on 18/12/2024 PSUSA/00000074/202604 PSUSA/00000074/202704 Kimmo Jaakkola Finland CAP 75 alclometasone 03/06/1987 18 years 01/01/2030 01/04/2030 No 01/10/2012 PSUSA/00000075/203001 NAP 76 aldesleukin 03/07/1989 7 years 31/12/2029 31/03/2030 No 31/01/2024 PRAC representative updated on 31/01/2024 PSUSA/00000076/202912 Bianca Mulder Netherlands NAP 77 miglustat (for treatment of Pompe disease) 20/03/2023 1 year 19/03/2026 28/05/2026 19/03/2027 28/05/2027 No 02/06/2026 PSUSA/00000077/202603 PSUSA/00000077/202703 Jenny-Maria Jönsson Sweden CAP 78 alendronate 10/11/2000 5 years 15/01/2026 15/04/2026 No 16/10/2023 PRAC Rapporteur name was amended on 18/10/2023 PSUSA/00000078/202601 Karin Erneholm Denmark NAP 79 alendronic acid / colecalciferol, alendronic acid / calcium / colecalciferol 24/08/2005 5 years 15/01/2026 15/04/2026 No 22/09/2021 DLP was updated on 22/09/2021 LMS and PRAC representative were updated on 05/06/2019 Next DLP was updated on 22/09/2016 Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended? Yes/No" was amended on 16/07/2015 Active substance name was amended on 12/05/2015 PSUSA/00000079/202601 Jan Neuhauser Austria CAP NAP 80 alfacalcidol 31/01/1978 7 years 15/06/2032 13/09/2032 No 01/04/2026 PSUR frequency amended and DLP updated on 01/04/2026 DLP was amended on 04/03/2026 PSUSA/00000080/203206 Terhi Lehtinen Finland NAP 81 neomycin / triamcinolone 30/12/1991 9 years 01/08/2033 30/10/2033 No 02/04/2025 PSUR frequency amended and DLP updated on 02/04/2025 PSUSA/00000081/203308 Eva Jirsová Czech Republic NAP 82 alfentanil Not available* 3 years 14/09/2027 13/12/2027 No 25/05/2022 DLP was updated on 25/05/2022 DLP was amended on 05/06/2019 PRAC Rapporteur name was amended on 23/10/2018 Next DLP was amended on 03/06/2016 Lead MS added on 12/05/2015 PSUSA/00000082/202709 Eamon O'Murchu Ireland NAP 84 alfuzosin 12/11/1987 5 years 12/11/2027 10/02/2028 No 02/06/2026 PSUSA/00000084/202711 Jenny Jönsson Sweden NAP 85 potassium chloride / sodium chloride / magnesium chloride / sodium acetate / sodium gluconate and/or glucose 22/03/1971 20 years 02/09/2044 01/12/2044 Yes 26/07/2023 Active substance name was amended on 26/07/2023 New entry added on 26/07/2023 PSUSA/00000085/204409 not yet assigned none NAP 86 alglucosidase alfa 29/03/2006 3 years 28/09/2027 27/12/2027 No 19/09/2024 PSUSA/00000086/202709 Zoubida Amimour France CAP 88 alimemazine 05/06/1956 18 years 01/01/2030 01/04/2030 No 01/10/2012 PSUSA/00000088/203001 NAP 89 aliskiren, aliskiren / hydrochlorothiazide 22/08/2007 3 years 30/09/2027 29/12/2027 No 29/06/2022 DLP was updated on 29/06/2022 PRAC representative was updated on 17/11/2021 PRAC representative was updated on 25/09/2019 DLP updated on 30/04/2019 PRAC Rapporteur name amended on 04/07/2018 Entry name and DLP were updated on 07/05/2018 DLP was updated on 23/05/2017 Next DLP was amended on 03/05/2016 "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended? Yes/No" was amended on 16/07/2015 PSUSA/00000089/202709 Amelia Cupelli Italy CAP 91 alizapride 09/01/1979 5 years 09/01/2026 09/04/2026 No 28/04/2022 PRAC representative was updated on 19/10/2022 PRAC Representative amended on 28/04/2022 DLP was updated on 22/09/2021 PRAC Representative amended on 18/11/2016 Next DLP was updated on 22/09/2016 Lead MS was added on 06/10/2015 DLP was amended on 16/06/2015 PSUSA/00000091/202601 Jo Robays Belgium NAP 92 allantoin Not available* 18 years 01/01/2030 01/04/2030 No 01/10/2012 PSUSA/00000092/203001 NAP 93 ganaxolone 18/03/2022 6 months 17/03/2026 26/05/2026 17/09/2026 26/11/2026 No 29/04/2026 DLP was amended on 29/04/2026 PSUSA/00000093/202603 PSUSA/00000093/202609 Adam Przybylkowski Poland CAP 95 allopurinol 01/01/1966 3 years 31/12/2026 31/03/2027 No 25/09/2024 DLP was amended on 25/09/2024 PSUSA/00000095/202612 Dennis Lex Germany NAP 97 piflufolastat (18F) 26/05/2021 1 year 25/05/2026 03/08/2026 25/05/2027 03/08/2027 No 04/03/2026 Correction of DLP on 04/03/2026 PSUR frequency amended and DLP updated on 04/02/2026 DLP was amended on 30/07/2025 PSUSA/00000097/202605 PSUSA/00000097/202705 Kimmo Jaakkola Finland CAP 98 alminoprofen Not available* 10 years 03/05/2035 01/08/2035 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00000098/203505 NAP 99 talquetamab 09/08/2023 6 months 08/02/2026 19/04/2026 08/08/2026 17/10/2026 No 01/04/2026 DLP was amended on 01/04/2026 PSUSA/00000099/202602 PSUSA/00000099/202608 Barbara Kovacic Bytyqi Croatia CAP 100 atogepant 28/09/2021 6 months 27/03/2026 05/06/2026 27/09/2026 06/12/2026 No 27/05/2026 DLP was amended on 27/05/2026 PSUSA/00000100/202603 PSUSA/00000100/202609 Rugile Pilviniene Lithuania CAP 101 almotriptan 23/12/1999 5 years 30/06/2028 28/09/2028 No 28/02/2024 PSUR frequency amended and DLP updated on 28/02/2024 PSUSA/00000101/202806 Maria del Pilar Rayon Spain NAP 102 respiratory syncytial virus vaccine (bivalent, recombinant) 31/05/2023 1 year 30/05/2026 08/08/2026 30/05/2027 08/08/2027 No 04/02/2026 DLP was amended on 04/02/2026 PSUSA/00000102/202605 PSUSA/00000102/202705 Liana Martirosyan Netherlands CAP 104 alfa amylase 06/06/1967 10 years 01/01/2032 31/03/2032 No 19/09/2024 PSUSA/00000104/203201 Zoubida Amimour France NAP 107 epcoritamab 22/09/2023 6 months 21/03/2026 30/05/2026 21/09/2026 30/11/2026 No 29/04/2026 DLP was amended on 29/04/2026 PSUSA/00000107/202603 PSUSA/00000107/202609 Maria Martinez Gonzalez Spain CAP 108 human alfa1-proteinase inhibitor (apart from the centrally authorised product) 21/03/2006 5 years 31/12/2029 31/03/2030 No 24/09/2025 DLP was amended on 24/09/2025 PSUSA/00000108/202912 Marie Louise Schougaard Christiansen Denmark NAP 109 alprazolam 12/03/1980 5 years 11/03/2030 09/06/2030 No 19/11/2025 PSUR frequency amended and DLP updated on 19/11/2025 PSUSA/00000109/203003 Tiphaine Vaillant France NAP 110 alprostadil (erectile dysfunction) 23/07/1981 5 years 31/01/2026 01/05/2026 Yes 20/10/2021 DLP was updated on 20/10/2021 Next DLP was amended on 19/10/2016 Lead MS added on 31/07/2015. PSUSA/00000110/202601 Eva Jirsová Czech Republic NAP 111 alprostadil (indicated in peripheral arterial occlusive diseases) 28/11/1984 8 years 31/07/2030 29/10/2030 No 05/04/2023 PSUR frequency amended and DLP updated on 05/04/2023 DLP and information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" were updated on 07/05/2018 PRAC representative and Lead Member State were added on 30/01/2017 PSUSA/00000111/203007 Eva Jirsová Czech Republic NAP 112 alteplase 06/06/1987 5 years 31/05/2027 29/08/2027 No 01/02/2023 DLP was updated on 01/02/2023 DLP was amended on 31/01/2018 Lead MS and PRAC Rapporteur name was added on 19/10/2016 PSUSA/00000112/202705 Dennis Lex Germany NAP 115 aluminium Not available* 9 years 03/03/2029 01/06/2029 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00000115/202903 NAP 116 cabotegravir (for pre-exposure prophylaxis of HIV-1 infection) 18/03/2020 1 year 17/03/2026 26/05/2026 17/03/2027 26/05/2027 No 22/10/2025 DLP was amended on 22/10/2025 PSUSA/00000116/202603 PSUSA/00000116/202703 Dennis Lex Germany CAP 118 decitabine / cedazuridine 06/07/2020 1 year 06/07/2026 14/09/2026 06/07/2027 14/09/2027 No 04/03/2026 DLP was amended on 04/03/2026 PSUSA/00000118/202607 PSUSA/00000118/202707 Marie Louise Schougaard Christiansen Denmark CAP 119 aluminium chlorhydroxide-complex Not available* 10 years 03/05/2035 01/08/2035 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00000119/203505 none NAP 120 elacestrant 28/12/2022 6 months 27/06/2026 05/09/2026 27/12/2026 07/03/2027 No 29/07/2026 DLP was amended on 29/07/2026 PSUSA/00000120/202606 PSUSA/00000120/202612 Sonja Radowan Austria CAP 122 aluminium oxide hydrated / magnesium hydroxide / monmectite Not available* 9 years 03/03/2029 01/06/2029 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00000122/202903 NAP 123 Any combinations of alginate sodium, alginic acid (antacids) Not available* 7 years 03/06/2031 01/09/2031 No 27/05/2026 DLP was amended on 05/02/2025 PSUSA/00000123/203106 Terhi Lehtinen Finland NAP 124 alverine, alverine / simeticone 10/02/1950 10 years 01/02/2032 01/05/2032 No 28/05/2025 Active substance name was amended on 28/05/2025 PRAC Rapporteur updated on 15/11/2023 PSUSA/00000124/203202 Petar Mas Croatia NAP 126 amantadine 14/12/1965 6 years 01/01/2030 01/04/2030 No 25/09/2024 DLP was amended on 25/09/2024 PSUSA/00000126/203001 Dennis Lex Germany NAP 127 ambazone Not available* 7 years 03/06/2031 01/09/2031 Yes 18/12/2024 Information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" was amended on 18/12/2024 PSUR frequency and DLP amended on 28/02/2024 PSUSA/00000127/203106 Roxana Dondera Romania NAP 128 ambenonium 14/12/1956 11 years 03/10/2037 01/01/2038 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00000128/203710 NAP 129 ambrisentan 21/04/2008 3 years 14/06/2026 12/09/2026 No 28/02/2024 DLP was amended on 28/02/2024 PSUSA/00000129/202606 Maria del Pilar Rayon Spain CAP 130 ambroxol 23/08/1978 5 years 30/09/2027 29/12/2027 No 31/05/2023 PSUR frequency amended and DLP updated on 31/05/2023 DLP was updated on 03/06/2020 Next DLP was amended on 27/06/2017 Correction of PRAC Rapporteur name on 28/02/2017 PRAC Rapporteur name updated on 30/01/2017 PRAC Rapporteur name was amended on 20/12/2016 PRAC representative and Lead Member State were added on 03/05/2016 PSUSA/00000130/202709 Ana Sofia Diniz Martins Portugal NAP 131 ambroxol / clenbuterol 27/06/1984 5 years 30/09/2027 29/12/2027 No 31/05/2023 PSUR frequency amended and DLP updated on 31/05/2023 DLP was updated on 03/06/2020 Next DLP was amended on 27/06/2017 Correction of PRAC Rapporteur name on 28/02/2017 PRAC representative and Lead Member State were added on 03/05/2016 PSUSA/00000131/202709 Ana Sofia Diniz Martins Portugal NAP 132 gefapixant 20/01/2022 6 months 19/01/2026 30/03/2026 19/07/2026 27/09/2026 No 04/03/2026 DLP was amended on 04/03/2026 PSUSA/00000132/202601 PSUSA/00000132/202607 Jan Neuhauser Austria CAP 133 ritlecitinib 23/06/2023 1 year 22/12/2026 02/03/2027 22/12/2027 01/03/2028 No 29/07/2026 DLP was amended on 29/07/2026 PSUSA/00000133/202612 PSUSA/00000133/202712 Adam Przybylkowski Poland CAP 135 amcinonide Not available* 10 years 03/05/2035 01/08/2035 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00000135/203505 NAP 136 tislelizumab 26/12/2019 3 years 25/12/2028 25/03/2029 No 29/07/2026 PSUR frequency amended and DLP updated on 29/07/2026 PSUSA/00000136/202812 Bianca Mulder Netherlands CAP 138 amfepramone 01/06/1961 13 years 01/06/2033 30/08/2033 Yes 03/02/2021 DLP was updated on 03/02/2021 PRAC representative was added on 06/05/2020 LMS was added on 25/09/2019 DLP and Information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" was amended on 30/04/2019 PSUSA/00000138/203306 Marie Louise Schougaard Christiansen Denmark NAP 141 amifampridine 23/12/2009 3 years 23/12/2027 22/03/2028 No 24/09/2025 DLP was amended on 24/09/2025 PSUSA/00000141/202712 Karin Bolin Sweden CAP 143 amikacin (except for centrally authorised products) 06/06/1975 5 years 05/06/2027 03/09/2027 No 01/02/2023 DLP was updated on 01/02/2023 Active substance name was amended on 18/11/2020 DLP was updated on 28/02/2018 Information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" was amended on 30/01/2017 PRAC representative and Lead Member State were added on 18/11/2016 PSUSA/00000143/202706 Maia Uusküla Estonia NAP 148 amiloride, amiloride / furosemide, amiloride / hydrochlorothiazide, amiloride / hydrochlorothiazide / timolol, amiloride / bumetanide, amiloride / chlortalidone 25/04/1969 8 years 03/06/2033 01/09/2033 No 04/02/2026 DLP was amended on 04/02/2026 PSUSA/00000148/203306 Guðrún Stefánsdóttir Iceland NAP 152 aminaphtone 07/07/2005 13 years 06/07/2032 04/10/2032 Yes 28/02/2024 Entry re-activated on 28/02/2024 PSUSA/00000152/203207 none NAP 155 pirtobrutinib 27/01/2023 6 months 27/01/2026 07/04/2026 27/07/2026 05/10/2026 No 04/03/2026 DLP was amended on 04/03/2026 PSUSA/00000155/202601 PSUSA/00000155/202607 Bianca Mulder Netherlands CAP 156 sodium hypochlorite (concentrated solution) 09/12/1991 8 years 09/12/2031 08/03/2032 No 20/12/2023 New entry added on 20/12/2023 PSUSA/00000156/203112 none NAP 157 aminoacridine / lidocaine Not available* 12 years 06/09/2036 05/12/2036 No 30/04/2025 DLP was amended on 30/04/2025 PSUSA/00000157/203609 John Joseph Borg Malta NAP 159 aminocaproic acid Not available* 9 years 03/03/2029 01/06/2029 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00000159/202903 NAP 163 aminomethylbenzoic acid 17/09/1970 10 years 02/09/2034 01/12/2034 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00000163/203409 NAP 164 aminophylline 24/02/1963 14 years 01/01/2026 01/04/2026 No 26/05/2025 PSUSA/00000164/202601 Ana Sofia Diniz Martins Portugal NAP 166 amiodarone 20/12/1966 3 years 20/12/2026 20/03/2027 No 25/09/2024 DLP was amended on 25/09/2024 PSUSA/00000166/202612 Bianca Mulder Netherlands NAP 167 amisulpride 20/01/1986 3 years 20/01/2026 20/04/2026 No 20/09/2023 DLP amended on 20/09/2023 PSUSA/00000167/202601 Eamon O'Murchu Ireland NAP 168 magnesium gluconate 21/02/2005 9 years 21/02/2032 21/05/2032 No 20/12/2023 New entry added on 20/12/2023 PSUSA/00000168/203202 none NAP 169 zilucoplan 25/09/2023 1 year 24/09/2026 03/12/2026 24/09/2027 03/12/2027 No 29/04/2026 DLP was amended on 29/04/2026 PSUSA/00000169/202609 PSUSA/00000169/202709 Karin Erneholm Denmark CAP 170 amitriptyline / perphenazine 31/07/1961 3 years 01/01/2027 01/04/2027 No 25/09/2024 DLP was amended on 25/09/2024 PSUSA/00000170/202701 Georgia Gkegka Greece NAP 173 palopegteriparatide 17/11/2023 1 year 16/05/2026 25/07/2026 16/05/2027 25/07/2027 No 01/07/2026 PSUR frequency amended and DLP updated on 01/07/2026 DLP was amended on 04/02/2026 PSUSA/00000173/202605 PSUSA/00000173/202705 Lina Seibokiene Lithuania CAP 174 amlodipine 08/03/1989 5 years 07/03/2027 05/06/2027 No 16/10/2023 PRAC Rapporteur name was amended on 18/10/2023 PSUSA/00000174/202703 Karin Erneholm Denmark NAP 175 lebrikizumab 16/11/2023 1 year 13/09/2026 22/11/2026 13/09/2027 22/11/2027 No 29/04/2026 DLP was amended on 29/04/2026 PSUSA/00000175/202609 PSUSA/00000175/202709 Liana Martirosyan Netherlands CAP 176 quizartinib 18/06/2019 1 year 17/06/2026 26/08/2026 17/06/2027 26/08/2027 No 04/03/2026 Correction of DLP on 04/03/2026 PSUR frequency amended and DLP updated on 04/02/2026 DLP was amended on 30/07/2025 PSUSA/00000176/202606 PSUSA/00000176/202706 John Joseph Borg Malta CAP 177 amlodipine / atorvastatin 30/01/2004 5 years 31/01/2030 01/05/2030 No 22/10/2025 PSUR frequency amended and DLP updated on 22/10/2025 PSUSA/00000177/203001 Zoubida Amimour France NAP 179 amlodipine / perindopril 23/04/2008 5 years 22/10/2026 20/01/2027 No 16/10/2023 PRAC Rapporteur name was amended on 18/10/2023 PSUSA/00000179/202610 Karin Erneholm Denmark NAP 180 amlodipine / telmisartan, amlodipine / telmisartan / hydrochlorothiazide 07/10/2010 5 years 31/03/2030 29/06/2030 No 23/10/2024 Active substance name was amended on 23/10/2024 PSUR frequency and DLP were updated on 16/12/2020 PRAC Rapporteur name was amended on 31/07/2018 DLP was updated on 19/12/2017 Reference to NAP products was added on 23/05/2017 Next DLP was amended on 01/12/2014 Next DLP was amended on 02/07/2014 Correction of the DLP was done on the 01/04/2014 Next DLP was amended on 29/11/2013 PSUSA/00000180/203003 Dennis Lex Germany CAP NAP 182 ammonia solutions 19/09/1984 16 years 01/01/2028 31/03/2028 No 01/10/2012 PSUSA/00000182/202801 NAP 183 ichthammol Not available* 16 years 01/01/2028 31/03/2028 No 01/10/2012 PSUSA/00000183/202801 NAP 184 ammonium chloride, ammonium chloride combinations Not available* 16 years 01/01/2028 31/03/2028 No 01/10/2012 PSUSA/00000184/202801 NAP 185 amorolfine 10/06/1991 5 years 30/06/2027 28/09/2027 No 01/03/2023 DLP was updated on 01/03/2023 PRAC representative was updated on 06/05/2020 DLP was updated on 27/03/2018 Lead MS and PRAC Rapporteur name was added on 20/12/2016 PSUSA/00000185/202706 Melinda Palfi Hungary NAP 186 amoxapine 01/06/1973 9 years 03/06/2028 01/09/2028 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00000186/202806 NAP 187 amoxicillin 07/03/1972 5 years 07/03/2027 05/06/2027 No 16/11/2022 DLP was updated on 16/11/2022 DLP was amended on 15/11/2017 Lead MS was added on 22/09/2016 Information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" was amended on 28/06/2016 PSUSA/00000187/202703 Jan Neuhauser Austria NAP 188 amoxicillin / clavulanate 07/03/1972 5 years 07/03/2027 05/06/2027 No 16/11/2022 DLP was updated on 16/11/2022 Lead MS and PRAC Rapporteur name amended on 19/12/2018 DLP was amended on 15/11/2017 Lead MS was added on 22/09/2016 Information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" was amended on 28/06/2016 PSUSA/00000188/202703 Dennis Lex Germany NAP 193 amphotericin b 19/03/1958 15 years 18/03/2027 16/06/2027 Yes 01/10/2012 PSUSA/00000193/202703 NAP 194 amphotericin b / tetracycline 19/03/1958 11 years 02/04/2038 01/07/2038 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00000194/203804 NAP 195 ampicillin 01/03/1962 9 years 01/02/2028 01/05/2028 Yes 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00000195/202802 NAP 196 ampicillin / cloxacillin 01/03/1962 10 years 03/05/2034 01/08/2034 No 03/10/2024 Updated & published on 23/10/2024 PSUSA/00000196/203405 NAP 197 ampicillin / sulbactam 24/02/1987 3 years 28/02/2027 29/05/2027 No 19/10/2022 PRAC representative was updated on 19/10/2022 PRAC representative was updated on 27/07/2022 DLP corrected on 02/02/2022 DLP was updated on 17/11/2021 PRAC representative was updated on 30/06/2021 DLP was updated on 21/11/2018 PRAC Rapporteur name amended on 04/07/2018 PRAC Rapporteur name amended. PRAC Rapporteur name amended. Next DLP was amended on 29/10/2015 Lead MS added on 04/02/2015 PSUSA/00000197/202702 Amelia Cupelli Italy NAP 199 amsacrine 23/04/1982 5 years 01/06/2029 30/08/2029 Yes 23/10/2024 Information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" was amended on 23/10/2024 PRAC representative updated on 31/01/2024 PSUSA/00000199/202906 Bianca Mulder Netherlands NAP 201 enalapril maleate (centrally authorised product for use in children below the age of 18) 15/11/2023 1 year 31/03/2026 09/06/2026 31/03/2027 09/06/2027 No 02/06/2026 PSUSA/00000201/202603 PSUSA/00000201/202703 Karin Bolin Sweden CAP 202 latanoprost (eye drop emulsions containing CKC) 15/11/2023 1 year 14/11/2026 23/01/2027 14/11/2027 23/01/2028 No 01/07/2026 DLP was amended on 01/07/2026 PSUSA/00000202/202611 PSUSA/00000202/202711 Jean-Michel Dogné Belgium CAP 204 amylmetacresol / dichlorobenzyl alcohol, amylmetacresol / ascorbic acid / dichlorobenzyl alcohol 01/09/1958 9 years 03/03/2029 01/06/2029 No 28/05/2025 Entry updated following merge on 28/05/2025 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00000204/202903 none NAP 205 amylmetacresol / dichlorobenzyl alcohol / levomenthol 01/09/1958 18 years 01/01/2030 01/04/2030 No 01/10/2012 PSUSA/00000205/203001 NAP 206 amylmetacresol / dichlorobenzyl alcohol / lidocaine 01/09/1958 18 years 01/01/2030 01/04/2030 No 01/10/2012 PSUSA/00000206/203001 NAP 208 anagrelide 16/11/2004 5 years 13/09/2027 12/12/2027 No 31/05/2023 PSUR frequency amended and DLP updated on 31/05/2023 Correction: Information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" was amended on 21/10/2022 PSUR frequency and DLP were updated on 28/04/2021 PRAC representative was updated on 29/07/2020 PRAC representative was updated on 03/06/2020 DLP was updated on 06/05/2020 DLP was updated on 30/04/2019 DLP was updated and information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" was updated on 07/05/2018 PRAC Rapporteur name updated on 21/07/2017 Next DLP was amended on 26/04/2017 PRAC Rapporteur name was amended on 28/07/2016 PRAC Rapporteur name updated on 03/06/2016 Next DLP was amended on 03/05/2016 "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended? Yes/No" was amended on 16/07/2015 Rapporteur name amended on 04/11/2014 PSUSA/00000208/202709 Tiphaine Vaillant France CAP NAP 209 anakinra 08/03/2002 5 years 01/05/2030 30/07/2030 No 04/02/2026 PSUR frequency amended and DLP updated on 04/02/2026 PSUSA/00000209/203005 Karin Erneholm Denmark CAP 210 anastrozole 11/08/1995 3 years 11/08/2028 09/11/2028 No 01/04/2026 PSUR frequency amended and DLP updated on 01/04/2026 PSUSA/00000210/202808 Zane Neikena Latvia NAP 213 anethole trithione Not available* 28 years 01/01/2040 31/03/2040 No 01/10/2012 PSUSA/00000213/204001 NAP 214 adagrasib 12/12/2022 6 months 11/06/2026 20/08/2026 11/12/2026 19/02/2027 No 29/07/2026 DLP was amended on 29/07/2026 PSUSA/00000214/202606 PSUSA/00000214/202612 Kimmo Jaakkola Finland CAP 215 anidulafungin 20/09/2007 5 years 31/01/2027 01/05/2027 No 19/10/2022 DLP and Information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" were updated on 19/10/2022 PRAC Rapporteur name was amended on 23/10/2018 PSUR Frequency amended and DLP updated on 17/10/2017 PRAC Rapporteur name was amended on 25/09/2017 PSUSA/00000215/202701 Liana Martirosyan Netherlands CAP NAP 216 rozanolixizumab 26/06/2023 1 year 25/06/2026 03/09/2026 25/06/2027 03/09/2027 No 04/02/2026 DLP was amended on 04/02/2026 PSUSA/00000216/202606 PSUSA/00000216/202706 Maria del Pilar Rayon Spain CAP 217 antazoline Not available* 23 years 01/01/2035 01/04/2035 No 01/10/2012 PSUSA/00000217/203501 NAP 218 antazoline / naphazoline 01/06/1961 11 years 03/06/2039 01/09/2039 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00000218/203906 NAP 219 antazoline / tetryzoline 03/10/1972 10 years 01/12/2034 01/03/2035 No 30/07/2025 DLP was amended on 30/07/2025 PSUSA/00000219/203412 John Joseph Borg Malta NAP 220 antazoline / xylometazoline 01/01/1966 11 years 02/12/2039 01/03/2040 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00000220/203912 NAP 221 rezafungin 22/03/2023 1 year 21/03/2026 30/05/2026 21/03/2027 30/05/2027 No 29/04/2026 PSUR frequency amended and DLP updated on 29/04/2026 Reference to NAP removed on 04/02/2026 DLP was amended on 19/11/2025 PSUSA/00000221/202603 PSUSA/00000221/202703 Adam Przybylkowski Poland CAP 222 pegzilarginase 14/12/2023 1 year 13/12/2026 21/02/2027 13/12/2027 21/02/2028 No 29/07/2026 DLP was amended on 29/07/2026 PSUSA/00000222/202612 PSUSA/00000222/202712 Dennis Lex Germany CAP 223 vamorolone 26/10/2023 6 months 25/04/2026 04/07/2026 25/10/2026 03/01/2027 No 01/07/2026 DLP was amended on 01/07/2026 PSUSA/00000223/202604 PSUSA/00000223/202610 Rhea Fitzgerald Ireland CAP 225 elranatamab 14/08/2023 6 months 13/02/2026 24/04/2026 13/08/2026 22/10/2026 No 01/04/2026 DLP was amended on 01/04/2026 PSUSA/00000225/202602 PSUSA/00000225/202608 Barbara Kovacic Bytyqi Croatia CAP 226 apixaban 18/05/2011 3 years 17/05/2027 15/08/2027 No 05/02/2025 DLP was amended on 05/02/2025 PSUSA/00000226/202705 Bianca Mulder Netherlands CAP 227 apomorphine 28/05/2001 5 years 19/11/2030 17/02/2031 Yes 29/07/2026 PSUR frequency amended and DLP updated on 29/07/2026 PSUSA/00000227/203011 Karin Erneholm Denmark NAP 228 apraclonidine 16/08/1967 10 years 03/08/2034 01/11/2034 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00000228/203408 NAP 229 aprepitant 25/03/2003 5 years 25/03/2029 23/06/2029 No 02/06/2026 PSUSA/00000229/202903 Jenny-Maria Jönsson Sweden CAP NAP 230 aprotinin Not available* 2 years 28/02/2026 29/05/2026 No 16/11/2022 DLP was updated on 16/11/2022 PRAC Rapporteur name was amended on 28/04/2022 DLP was updated on 21/10/2020 PRAC Rapporteur name was amended on 03/04/2019 DLP was updated on 21/11/2018 PSUR Frequency amended and DLP updated on 18/11/2016 Lead MS and PRAC Rapporteur name was added on 07/04/2016 The DLP was amended on 27/11/2015. The DLP was amended on 02/07/2014 PSUSA/00000230/202602 Marie Louise Schougaard Christiansen Denmark NAP 231 fezolinetant 12/05/2023 1 year 11/11/2026 20/01/2027 11/11/2027 20/01/2028 No 17/12/2025 DLP was amended on 17/12/2025 PSUR frequency amended and DLP updated on 25/06/2025 DLP was amended on 18/12/2024 PSUSA/00000231/202611 PSUSA/00000231/202711 Dennis Lex Germany CAP 232 gadopiclenol 21/09/2022 2 years 30/04/2027 29/07/2027 No 04/02/2026 DLP was amended on 04/02/2026 PSUSA/00000232/202704 Dennis Lex Germany CAP NAP 233 arginine hydrochloride / cyanocobalamin / cyproheptadine hydrochloride / levocarnitine Not available* 9 years 03/03/2029 01/06/2029 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00000233/202903 NAP 234 aripiprazole 04/06/2004 3 years 16/07/2026 14/10/2026 No 27/03/2024 DLP was amended on 27/03/2024 PSUSA/00000234/202607 Ana Sofia Diniz Martins Portugal CAP NAP 235 arsenic trioxide 05/03/2002 5 years 30/09/2028 29/12/2028 No 05/06/2024 PSUR frequency amended and DLP updated on 05/06/2024 PSUSA/00000235/202809 Tiphaine Vaillant France CAP 236 artemether / lumefantrin (apart from the dispersible tablet) 14/10/1998 3 years 01/10/2028 30/12/2028 No 01/07/2026 DLP was amended on 01/07/2026 PSUSA/00000236/202810 Jenny Jönsson Sweden NAP 238 articaine 29/04/1975 20 years 01/01/2032 31/03/2032 No 01/10/2012 PSUSA/00000238/203201 NAP 239 articaine / epinephrine 29/04/1975 20 years 01/01/2032 31/03/2032 No 01/10/2012 PSUSA/00000239/203201 NAP 240 triamcinolone / lidocaine (rectal use) 01/03/1974 9 years 28/02/2031 29/05/2031 No 28/02/2024 New entry added on 28/02/2024 PSUSA/00000240/203102 n/a none NAP 241 acetylsalicylic acid / ascorbic acid, acetylsalicylic acid / citric acid / sodium hydrogen carbonate 28/07/1972 23 years 04/02/2035 05/05/2035 No 23/10/2024 PSUSA/00000241/203502 none NAP 242 acetylsalicylic acid / ascorbic acid / bioflavonoids Not available* 23 years 01/01/2035 01/04/2035 No 01/10/2012 PSUSA/00000242/203501 NAP 243 acetylsalicylic acid / ascorbic acid / codeine phosphate hemihydrate Not available* 23 years 01/01/2035 01/04/2035 No 01/10/2012 PSUSA/00000243/203501 NAP 244 exagamglogene autotemcel 15/11/2023 6 months 14/05/2026 23/07/2026 14/11/2026 23/01/2027 No 01/07/2026 DLP was amended on 01/07/2026 PSUSA/00000244/202605 PSUSA/00000244/202611 Bianca Mulder Netherlands CAP 245 omaveloxolone 28/02/2023 1 year 27/02/2026 08/05/2026 27/02/2027 08/05/2027 No 01/07/2026 PSUR frequency amended and DLP updated on 01/07/2026 DLP was amended on 01/04/2026 PSUSA/00000245/202602 PSUSA/00000245/202702 Amelia Cupelli Italy CAP 246 alfatocopherol / ascorbic acid / biotin / calcium pantothenate / colecalciferol / cyanocobalamin / magnesium / manganese / pyridoxine / riboflavin / thiamine / vitamin a / zinc Not available* 23 years 01/01/2035 01/04/2035 No 01/10/2012 PSUSA/00000246/203501 NAP 248 ascorbic acid / dichlorobenzyl alcohol Not available* 23 years 01/01/2035 01/04/2035 No 01/10/2012 PSUSA/00000248/203501 NAP 249 alfatocopherol acetate / ascorbic acid / ergocalciferol / retinol Not available* 23 years 01/01/2035 01/04/2035 No 01/10/2012 PSUSA/00000249/203501 NAP 250 ascorbic acid / caffeine / glucuronamide Not available* 23 years 01/01/2035 01/04/2035 No 01/10/2012 PSUSA/00000250/203501 NAP 251 ascorbic acid / paracetamol Not available* 23 years 01/01/2035 01/04/2035 No 01/10/2012 PSUSA/00000251/203501 NAP 252 acetylsalicylic acid / ascorbic acid / paracetamol, acetylsalicylic acid / paracetamol 13/12/1985 15 years 01/01/2035 01/04/2035 Yes 29/07/2026 Information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" was amended on 29/07/2026 PSUR frequency amended on 29/07/2026 Active substance name was amended on 29/07/2026 PSUSA/00000252/203501 none NAP 253 ascorbic acid / caffeine / paracetamol Not available* 23 years 01/01/2035 01/04/2035 No 01/10/2012 PSUSA/00000253/203501 NAP 255 ascorbic acid / paracetamol / phenylephrine hydrochloride Not available* 5 years 15/06/2030 13/09/2030 No 04/03/2026 DLP was amended on 04/03/2026 PSUSA/00000255/203006 Rugile Pilviniene Lithuania NAP 256 asenapine 01/09/2010 5 years 12/08/2030 10/11/2030 No 27/05/2026 DLP was corrected on 27/05/2026 PSUR frequency amended and DLP updated on 29/04/2026 PSUSA/00000256/203008 Ana Sofia Diniz Martins Portugal CAP 257 ascorbic acid / potassium aspartate / potassium bicarbonate Not available* 28 years 01/01/2040 31/03/2040 No 01/10/2012 PSUSA/00000257/204001 NAP 258 atazanavir 02/03/2004 5 years 19/06/2029 17/09/2029 No 05/03/2025 PSUR frequency amended and DLP updated on 05/03/2025 PSUSA/00000258/202906 Tiphaine Vaillant France CAP 259 atenolol 19/02/1976 12 years 19/02/2037 20/05/2037 No 22/10/2025 DLP was amended on 22/10/2025 PSUSA/00000259/203702 Terhi Lehtinen Finland NAP 260 atenolol / chlortalidone 09/09/1997 7 years 09/09/2031 08/12/2031 No 03/06/2020 PRAC representative was updated on 22/12/2021 DLP was updated on 03/06/2020 PRAC representative was updated on 06/05/2020 PRAC representative was added on 21/11/2018 Lead MS was added on 06/03/2015 PSUSA/00000260/203109 Miroslava Gocova Slovakia NAP 262 atomoxetine 26/11/2002 5 years 26/11/2028 24/02/2029 No 31/07/2024 DLP was amended on 31/07/2024 PSUSA/00000262/202811 Maria del Pilar Rayon Spain NAP 263 momelotinib 15/09/2023 1 year 14/09/2026 23/11/2026 14/09/2027 23/11/2027 No 02/06/2026 PSUSA/00000263/202609 PSUSA/00000263/202709 Jenny-Maria Jönsson Sweden CAP 264 atosiban 20/01/2000 5 years 31/01/2029 01/05/2029 No 19/10/2022 PRAC representative was updated on 19/10/2022 PRAC representative was updated on 17/11/2021 DLP was updated on 20/10/2021 PRAC representative was updated on 25/09/2019 DLP was updated on 23/10/2018 Reference to NAP added on 25/09/2017 Next DLP was amended on 29/10/2015 PRAC Rapporteur name amended on PSUSA/00000264/202901 Amelia Cupelli Italy CAP NAP 265 atovaquone 25/11/1992 13 years 30/11/2027 28/02/2028 No 19/09/2024 PSUSA/00000265/202711 Zoubida Amimour France NAP 266 atovaquone / proguanil 21/10/1996 5 years 31/10/2027 29/01/2028 No 28/06/2023 Next DLP was updated on 28/06/2023 Lead MS and PRAC Rapporteur name amended on 19/12/2018 DLP was updated on 04/07/2018 PRAC representative and Lead Member State were added on 28/03/2017 PSUSA/00000266/202710 Ana Sofia Diniz Martins Portugal NAP 267 atracurium 16/12/1982 10 years 16/12/2032 16/03/2033 No 20/09/2023 DLP amended on 20/09/2023 PSUSA/00000267/203212 Dennis Lex Germany NAP 268 atropine (except myopia indication) 31/08/1945 14 years 31/08/2026 29/11/2026 No 25/06/2025 Active substance name was amended on 25/06/2025 PSUSA/00000268/202608 none NAP 269 atropine / diphenoxylate 29/09/1960 14 years 01/01/2026 01/04/2026 No 17/02/2026 PSUSA/00000269/202601 Jana Pecherova Slovakia NAP 273 etrasimod 12/10/2023 1 year 11/10/2026 20/12/2026 11/10/2027 20/12/2027 No 27/05/2026 PSUR frequency amended and DLP updated on 27/05/2026 PSUR frequency corrected on 04/03/2026 DLP was amended on 19/11/2025 PSUSA/00000273/202610 PSUSA/00000273/202710 Karin Bolin Sweden CAP 274 azacitidine 17/12/2008 5 years 18/05/2029 16/08/2029 No 05/02/2025 PSUR frequency amended and DLP updated on 05/02/2025 PSUSA/00000274/202905 Bianca Mulder Netherlands CAP 275 azathioprine 13/12/1965 6 years 12/12/2030 12/03/2031 No 30/07/2025 DLP was amended on 30/07/2025 PSUSA/00000275/203012 Karin Erneholm Denmark CAP NAP 276 azelaic acid 27/10/1988 8 years 03/06/2033 01/09/2033 No 04/02/2026 DLP was amended on 04/02/2026 PSUSA/00000276/203306 Jan Neuhauser Austria NAP 277 azelastine 20/11/1990 3 years 31/12/2026 31/03/2027 No 25/09/2024 DLP was amended on 25/09/2024 PSUSA/00000277/202612 Jan Neuhauser Austria NAP 280 azilsartan medoxomil, azilsartan medoxomil/chlortalidone 07/12/2011 3 years 24/08/2026 22/11/2026 No 30/04/2024 DLP was amended on 30/04/2024 PSUSA/00000280/202608 Bianca Mulder Netherlands CAP NAP 282 hydroxyethyl salicylate / mephenesin / methyl nicotinate 19/07/2003 10 years 19/07/2035 17/10/2035 Yes 30/04/2024 New entry added on 30/04/2024 PSUSA/00000282/203507 none none NAP 283 aztreonam (inhalation use) 21/09/2009 5 years 11/09/2028 10/12/2028 No 05/06/2024 PSUR frequency amended and DLP updated on 05/06/2024 PSUSA/00000283/202809 Liana Martirosyan Netherlands CAP 284 bacillus clausii multi-antibioresistant spores 03/11/1978 5 years 30/11/2027 28/02/2028 No 26/07/2023 PSUR frequency amended and DLP updated on 26/07/2023 PSUSA/00000284/202711 Amelia Cupelli Italy NAP 285 bacitracin, bacitracin / neomycin, bacitracin / polymyxin, bacitracin / neomycin / polymyxin, bacitracin / hydrocortisone / neomyicin, bacitracin zinc / cysteine / glycine / neomycin/ threonine 02/04/1962 9 years 03/05/2029 01/08/2029 No 20/12/2023 Active substance name, PSUR frequency and DLP were amended on 20/12/2023 PSUSA/00000285/202905 none NAP 286 efbemalenograstim alfa 06/05/2023 1 year 05/05/2026 14/07/2026 05/05/2027 14/07/2027 No 25/06/2025 PSUR frequency amended and DLP updated on 25/06/2025 DLP was amended on 18/12/2024 PSUSA/00000286/202605 PSUSA/00000286/202705 Bianca Mulder Netherlands CAP 293 baclofen (intrathecal use) 16/01/1963 5 years 31/01/2026 01/05/2026 Yes 20/10/2021 Active substance name and DLP were updated on 20/10/2021 Next DLP was amended on 19/10/2016 DLP was amended on 06/10/2015 Lead MS was added on 13/07/2015 PSUSA/00000293/202601 Adam Przybylkowski Poland NAP 294 baclofen (oral use, for muscle spasticity indication) 17/09/1970 3 years 30/09/2026 29/12/2026 No 05/06/2024 DLP was amended on 05/06/2024 PSUSA/00000294/202609 Eamon O'Murchu Ireland NAP 295 bambuterol 07/12/1990 5 years 07/12/2027 06/03/2028 No 12/09/2025 Next DLP was updated on 26/07/2023 PSUSA/00000295/202712 Veronika Macurová Czech Republic NAP 296 bamifylline Not available* 9 years 03/05/2029 01/08/2029 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00000296/202905 NAP 297 bamipine Not available* 10 years 03/06/2035 01/09/2035 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00000297/203506 NAP 299 barium sulphate, barium sulphate combinations 03/07/1973 28 years 01/01/2040 31/03/2040 No 01/10/2012 EURD was amended on 02/07/2014 PSUSA/00000299/204001 NAP 300 barnidipine 01/07/2000 7 years 03/03/2031 01/06/2031 No 20/11/2024 DLP was amended on 20/11/2024 PSUSA/00000300/203103 Bianca Mulder Netherlands NAP 301 basiliximab 09/10/1998 3 years 30/04/2027 29/07/2027 No 06/10/2025 DLP was amended on 05/02/2025 PSUSA/00000301/202704 Dirk Mentzer Germany CAP 302 bazedoxifene 17/04/2009 10 years 16/10/2034 14/01/2035 No 25/06/2025 PSUR frequency amended and DLP updated on 25/06/2025 PSUSA/00000302/203410 Dennis Lex Germany CAP 303 BCG (bacillus calmette-guérin) for Immunotherapy 02/03/1988 5 years 02/03/2028 31/05/2028 No 06/10/2025 DLP was amended on 15/11/2023 PSUSA/00000303/202803 Dirk Mentzer Germany NAP 304 BCG vaccine (freeze-dried) Not available* 5 years 02/03/2028 31/05/2028 No 02/06/2026 PSUSA/00000304/202803 Jenny Jönsson Sweden NAP 305 cefepime / enmetazobactam 29/06/1993 3 years 28/06/2028 26/09/2028 No 04/03/2026 DLP was amended on 04/03/2026 PSUSA/00000305/202806 Liana Martirosyan Netherlands CAP 306 beclometasone 13/12/1966 5 years 31/12/2026 31/03/2027 No 20/05/2026 DLP was updated on 21/09/2022 Lead MS and PRAC Rapporteur name amended on 19/12/2018 Next DLP was amended on 25/09/2017 European Union reference date was amended on 21/07/2017 Lead MS and PRAC Rapporteur name was added on 28/07/2016 PSUSA/00000306/202612 Katarzyna Ziolkowska Poland NAP 308 beclometasone dipropionate / neomycin sulfate Not available* 11 years 03/03/2040 01/06/2040 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00000308/204003 NAP 309 beclometasone / salbutamol Not available* 5 years 01/01/2027 01/04/2027 No 21/09/2022 DLP was updated on 21/09/2022 PSUR Frequency amended and next DLP updated on 25/09/2017 Entry name corrected on 23/05/2017 PRAC Rapporteur name corrected on 28/02/2017 PRAC Rapporteur name was amended on 20/12/2016 Lead MS and PRAC Rapporteur name was added on 28/07/2016 Active substance name was amended on 03/06/2016 Transferred from the List of substances under PSUR Work Sharing scheme and other substances contained in Nationally Authorised Products with DLP synchronised on 06/03/2015 PSUSA/00000309/202701 Ana Sofia Diniz Martins Portugal NAP 311 belatacept 17/06/2011 5 years 14/06/2028 12/09/2028 No 02/06/2026 PSUSA/00000311/202806 Karin Bolin Sweden CAP 312 bemiparin 16/04/1998 5 years 30/04/2027 29/07/2027 No 19/09/2025 PSUR frequency and DLP were updated on 01/02/2023 PRAC Representative updated on 16/11/2022 DLP was updated on 05/02/2020 Next DLP amended and PRAC Rapporteur name updated on 30/01/2017 PRAC Rapporteur and Lead Member State added on 27/11/2015. PSUSA/00000312/202704 Maria Martinez Gonzalez Spain NAP 313 benazepril 28/11/1989 5 years 20/11/2030 18/02/2031 No 29/07/2026 DLP was amended on 29/07/2026 PSUSA/00000313/203011 Amelia Cupelli Italy NAP 314 benazepril / hydrochlorothiazide 19/05/1992 5 years 31/05/2026 29/08/2026 No 19/09/2024 PSUSA/00000314/202605 Zoubida Amimour France NAP 315 bendazac 09/11/1968 10 years 03/08/2034 01/11/2034 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00000315/203408 NAP 329 benperidol 01/08/1967 6 years 31/07/2030 29/10/2030 No 02/04/2025 DLP was amended on 02/04/2025 PSUSA/00000329/203007 Dennis Lex Germany NAP 330 benserazide / levodopa 27/06/1973 5 years 26/06/2027 24/09/2027 No 01/03/2023 DLP was updated on 01/03/2023 PRAC representative was updated on 06/05/2020 DLP was updated on 28/02/2018 PRAC representative and Lead Member State were added on 18/11/2016 PSUSA/00000330/202706 Melinda Palfi Hungary NAP 331 bentazepam 01/07/1980 9 years 03/11/2028 01/02/2029 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00000331/202811 NAP 332 benzalkonium (exluding vaginal use), benzalkonium chloride / hexylresorcinol Not available* 7 years 01/11/2028 30/01/2029 No 23/10/2024 Active substance name was amended on 23/10/2024 PSUR frequency amended and DLP updated on 23/10/2024 Active substance name changed on 28/04/2022 PSUSA/00000332/202811 Amelia Cupelli Italy NAP 339 benzalkonium chloride / dequalinium chloride Not available* 9 years 03/06/2029 01/09/2029 Yes 23/10/2024 Information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" was amended on 23/10/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00000339/202906 none NAP 342 benzalkonium / ethyl alcohol Not available* 7 years 03/07/2031 01/10/2031 No 24/09/2025 Entry name updated on 24/09/2025 Entry name updated on 30/07/2025 DLP was amended on 05/03/2025 PSUSA/00000342/203107 Guðrún Stefánsdóttir Iceland NAP 349 acetylcysteine / tuaminoheptane, acetylcysteine / benzalkonium chloride / tuaminoheptane 01/03/1971 9 years 03/06/2028 01/09/2028 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00000349/202806 Amelia Cupelli Italy NAP 354 benzbromarone 15/10/1970 9 years 03/05/2028 01/08/2028 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00000354/202805 NAP 357 benzocaine Not available* 18 years 01/01/2030 01/04/2030 No 01/10/2012 PSUSA/00000357/203001 NAP 361 benzocaine / chloroxylenol Not available* 18 years 01/01/2030 01/04/2030 No 01/10/2012 PSUSA/00000361/203001 NAP 362 benzocaine / dequalinium hydrochloride 09/04/1991 18 years 01/01/2030 01/04/2030 No 01/10/2012 PSUSA/00000362/203001 NAP 363 benzocaine / hamamelis water / racephedrine hydrochloride Not available* 18 years 01/01/2030 01/04/2030 No 01/10/2012 PSUSA/00000363/203001 NAP 364 benzocaine / menthol / phenol, racemic / thymol Not available* 18 years 01/01/2030 01/04/2030 No 01/10/2012 PSUSA/00000364/203001 NAP 365 benzocaine / phenazone Not available* 18 years 01/01/2030 01/04/2030 No 01/10/2012 PSUSA/00000365/203001 NAP 366 benzocaine / triclosan Not available* 18 years 01/01/2030 01/04/2030 No 01/10/2012 PSUSA/00000366/203001 NAP 368 benzododecinium / boric acid Not available* 11 years 03/03/2040 01/06/2040 No 28/02/2024 PSUR frequency amended and DLP updated on 28/02/2024 Active substance name was amended on 28/02/2024 PSUSA/00000368/204003 none NAP 372 benzoxonium chloride / lidocaine hydrochloride 17/04/1989 9 years 31/01/2029 01/05/2029 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00000372/202901 NAP 373 benzoyl peroxide 01/03/1950 10 years 01/12/2032 01/03/2033 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00000373/203212 NAP 375 benzydamine 10/07/1964 5 years 31/10/2029 29/01/2030 No 25/06/2025 PSUR frequency amended and DLP updated on 25/06/2025 PSUSA/00000375/202910 Amelia Cupelli Italy NAP 378 benzydamine / cetylpyridine Not available* 7 years 01/01/2026 01/04/2026 No 27/07/2022 PRAC representative was updated on 27/07/2022 PRAC representative was updated on 30/06/2021 DLP was updated on 25/09/2019 PRAC Representative and Lead Member state assigned on 04/07/2018 PSUSA/00000378/202601 Amelia Cupelli Italy NAP 379 benzylbenzoate Not available* 18 years 01/01/2030 01/04/2030 No 01/10/2012 PSUSA/00000379/203001 NAP 380 benzylnicotinate Not available* 18 years 01/01/2030 01/04/2030 No 01/10/2012 PSUSA/00000380/203001 NAP 383 benzylpenicillin, benzathine benzylpenicillin, benzathine benzylpenicillin / lidocaine, procaine benzylpenicillin, benzathine benzylpenicillin / procaine benzylpenicillin 27/06/1952 5 years 15/06/2030 13/09/2030 No 04/03/2026 DLP was amended on 04/03/2026 PSUSA/00000383/203006 Maia Uusküla Estonia NAP 385 besilesomab 11/01/2010 5 years 10/01/2029 10/04/2029 No 19/09/2025 DLP was amended on 25/09/2024 PSUSA/00000385/202901 Maria Martinez Gonzalez Spain CAP 387 beta-carotene Not available* 9 years 03/06/2029 01/09/2029 No 15/01/2025 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00000387/202906 Adam Przybylkowski Poland NAP 389 betahistine 16/05/1968 3 years 31/12/2026 31/03/2027 No 25/09/2024 DLP was amended on 25/09/2024 PSUSA/00000389/202612 Zane Neikena Latvia NAP 390 betaine anhydrous (centrally authorised product only) 15/02/2007 3 years 28/02/2026 29/05/2026 Yes 15/11/2023 DLP was amended on 15/11/2023 Information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" was amended on 15/11/2023 New CAP authorised on 05/05/2022 DLP was updated on 21/10/2020 PRAC Rapporteur name was amended on 31/07/2018 PSUR Frequency amended and DLP updated on 17/10/2017 Next DLP was amended on 19/10/2016 DLP amended on 06/10/2015 Active substance name was amended on 13/03/2015 PSUSA/00000390/202602 Dennis Lex Germany CAP 391 betamethasone 25/09/1961 9 years 01/01/2030 01/04/2030 No 22/09/2021 DLP was updated on 22/09/2021 PRAC representative and LMS were added on 01/07/2020 PSUSA/00000391/203001 Eamon O'Murchu Ireland NAP 393 betamethasone dipropionate / calcipotriol Not available* 9 years 01/01/2030 01/04/2030 No 22/09/2021 DLP was updated on 22/09/2021 PRAC representative and LMS were added on 01/07/2020 PSUSA/00000393/203001 Eamon O'Murchu Ireland NAP 394 betamethasone dipropionate / clotrimazole Not available* 9 years 01/01/2030 01/04/2030 No 22/09/2021 LMS was updated on 27/07/2022 DLP was updated on 22/09/2021 PRAC representative and LMS were added on 01/07/2020 PSUSA/00000394/203001 Portugal NAP 395 betamethasone dipropionate / salicylic acid Not available* 9 years 01/01/2030 01/04/2030 No 22/09/2021 DLP was updated on 22/09/2021 PRAC representative and LMS were added on 01/07/2020 PSUSA/00000395/203001 Eamon O'Murchu Ireland NAP 397 betamethasone sodium phosphate / neomycin sulfate Not available* 9 years 01/01/2030 01/04/2030 No 22/09/2021 DLP was updated on 22/09/2021 PRAC representative and LMS were updated on 01/07/2020 PSUSA/00000397/203001 Eamon O'Murchu Ireland NAP 398 betamethasone valerate / clioquinol Not available* 9 years 01/01/2030 01/04/2030 No 22/09/2021 DLP was updated on 22/09/2021 PRAC representative and LMS were updated on 01/07/2020 PSUSA/00000398/203001 Eamon O'Murchu Ireland NAP 399 betamethasone valerate / fusidic acid Not available* 9 years 01/01/2030 01/04/2030 No 22/09/2021 DLP was updated on 22/09/2021 PRAC representative and LMS were updated on 01/07/2020 PSUSA/00000399/203001 Eamon O'Murchu Ireland NAP 401 betaxolol 10/05/1982 5 years 10/05/2027 08/08/2027 No 01/02/2023 DLP was updated on 01/02/2023 PRAC representative was updated on 06/05/2020 DLP was amended on 31/01/2018 Lead MS and PRAC Rapporteur name was added on 19/10/2016 PSUSA/00000401/202705 Melinda Palfi Hungary NAP 402 bethanechol Not available* 5 years 15/06/2030 13/09/2030 No 04/03/2026 DLP was amended on 04/03/2026 PSUSA/00000402/203006 Jan Neuhauser Austria NAP 403 bevacizumab 12/01/2005 3 years 25/02/2028 25/05/2028 No 22/10/2025 DLP was amended on 22/10/2025 PSUSA/00000403/202802 Karin Erneholm Denmark CAP 404 bexarotene 29/03/2001 3 years 15/09/2026 14/12/2026 No 05/06/2024 DLP was amended on 05/06/2024 PSUSA/00000404/202609 Tiphaine Vaillant France CAP 405 bezafibrate 21/07/1978 7 years 01/01/2026 01/04/2026 No 26/05/2025 PRAC representative updated on 31/01/2024 PSUSA/00000405/202601 Carla Torre Portugal NAP 406 bibrocathol Not available* 7 years 03/08/2031 01/11/2031 No 02/04/2025 DLP was amended on 02/04/2025 PSUSA/00000406/203108 Karin Bolin Sweden NAP 407 bicalutamide 28/02/1995 3 years 28/02/2026 29/05/2026 No 15/11/2023 DLP was amended on 15/11/2023 PSUSA/00000407/202602 Karin Erneholm Denmark NAP 408 biclotymol 11/06/2003 7 years 03/05/2031 01/08/2031 No 05/02/2025 DLP was amended on 05/02/2025 PSUSA/00000408/203105 Zoubida Amimour France NAP 409 biclotymol / enoxolone / muramidase hydrochloride Not available* 8 years 01/12/2033 01/03/2034 No 29/07/2026 DLP was amended on 29/07/2026 PSUSA/00000409/203312 Guðrún Stefánsdóttir Iceland NAP 411 bifonazole 01/12/1982 8 years 03/05/2033 01/08/2033 No 04/02/2026 DLP was amended on 04/02/2026 PSUSA/00000411/203305 Dennis Lex Germany NAP 412 bifonazole / urea 02/06/1985 9 years 01/12/2028 01/03/2029 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00000412/202812 NAP 413 bimatoprost 08/03/2002 5 years 07/03/2026 05/06/2026 No 17/11/2021 DLP and frequency were updated on 17/11/2021 PRAC Rapporteur name was corrected on 03/04/2019 DLP was updated on 21/11/2018 PRAC Rapporteur name was amended on 06/06/2018 PRAC Representative amended on 17/10/2017 Next DLP updated on 27/11/2015. PSUSA/00000413/202603 Karin Erneholm Denmark CAP NAP 414 biotin Not available* 7 years 01/01/2026 01/04/2026 No 25/09/2019 DLP was updated on 25/09/2019 PRAC Representative and Lead Member state assigned on 04/07/2018 PSUSA/00000414/202601 Jan Neuhauser Austria NAP 415 biperiden 16/08/1955 3 years 31/08/2028 29/11/2028 No 29/04/2026 DLP was amended on 29/04/2026 PSUSA/00000415/202808 Jan Neuhauser Austria NAP 416 bisacodyl, bisacodyl / senna dry extract / senna pods / sennae folium, sennosides calcium salts, cassia angustifolia / cassia fistula, senna glycosides 01/06/1954 10 years 01/01/2034 01/04/2034 No 17/12/2025 Active substance name was amended on 17/12/2025 Active substance name was amended on 28/05/2025 Active substance name, PSUR frequency and DLP were amended on 20/12/2023 PSUSA/00000416/203401 none NAP 419 bisoprolol 28/01/1986 6 years 30/09/2030 29/12/2030 No 01/07/2026 PSUR frequency amended and DLP updated on 01/07/2026 DLP was updated on 30/06/2021 Next DLP was amended on 03/06/2016 PRAC Rapporteur name updated on 06/10/2015 Lead MS added on 12/05/2015 PSUSA/00000419/203009 Kimmo Jaakkola Finland NAP 420 bisoprolol / hydrochlorothiazide 30/01/1992 7 years 30/11/2031 28/02/2032 No 30/07/2025 PSUR frequency amended and DLP updated on 30/07/2025 PSUSA/00000420/203111 Zoubida Amimour France NAP 421 bivalirudin 20/09/2004 5 years 20/09/2030 19/12/2030 Yes 27/05/2026 DLP was amended on 27/05/2026 PSUSA/00000421/203009 Veronika Macurová Czech Republic NAP 422 bleomycin 18/03/1970 10 years 31/03/2032 29/06/2032 No 21/12/2022 DLP was updated on 21/12/2022 PRAC Rapporteur name was amended on 28/04/2022 LMS and PRAC representative were added on 20/10/2021 PSUSA/00000422/203203 Marie Louise Schougaard Christiansen Denmark NAP 423 borax / boric acid Not available* 23 years 01/01/2035 01/04/2035 No 01/10/2012 PSUSA/00000423/203501 NAP 424 bortezomib 26/04/2004 3 years 25/04/2026 24/07/2026 Yes 20/12/2023 DLP was amended on 20/12/2023 PSUSA/00000424/202604 Amelia Cupelli Italy CAP NAP 425 bosentan 15/05/2002 3 years 19/11/2027 17/02/2028 No 30/07/2025 DLP was amended on 30/07/2025 PSUSA/00000425/202711 Zoubida Amimour France CAP NAP 426 botulinum toxin a (except for centrally authorised products) 29/12/1989 3 years 31/12/2027 30/03/2028 Yes 24/09/2025 DLP was amended on 24/09/2025 PSUSA/00000426/202712 Eamon O'Murchu Ireland NAP 427 botulinum toxin a - haemagglutinin complex 06/12/1990 3 years 31/12/2027 30/03/2028 Yes 24/09/2025 DLP was amended on 24/09/2025 PSUSA/00000427/202712 Karin Bolin Sweden NAP 430 brimonidine (except for the centrally authorised product) 06/09/1996 5 years 30/09/2026 29/12/2026 No 29/06/2022 DLP was updated on 29/06/2022 Lead MS and PRAC Rapporteur name amended on 19/12/2018 Next DLP was amended on 27/06/2017 PRAC representative and Lead Member State were added on 03/05/2016 Name of active substance was amended on 02/05/2014 PSUSA/00000430/202609 Eamon O'Murchu Ireland NAP 431 brimonidine / timolol 06/09/1996 5 years 30/09/2026 29/12/2026 No 29/06/2022 DLP was updated on 29/06/2022 Lead MS and PRAC Rapporteur name amended on 19/12/2018 Next DLP was amended on 27/06/2017 PRAC representative and Lead Member State were added on 03/05/2016 PSUSA/00000431/202609 Dennis Lex Germany NAP 432 brinzolamide 09/03/2000 5 years 31/08/2026 29/11/2026 No 28/04/2022 PRAC Representative updated on 16/11/2022 DLP was updated on 28/04/2022 PSUR Frequency amended and DLP updated on 23/05/2017 Reference to NAP products added on 18/11/2016 PRAC Representative amended on 28/06/2016 PSUSA/00000432/202608 Maria del Pilar Rayon Spain CAP NAP 433 brinzolamide / timolol 25/11/2008 5 years 30/04/2029 29/07/2029 No 05/02/2025 DLP was amended on 05/02/2025 PSUSA/00000433/202904 Karin Erneholm Denmark CAP NAP 434 brivudine 06/07/2000 5 years 05/07/2029 03/10/2029 No 05/03/2025 DLP was amended on 05/03/2025 PSUSA/00000434/202907 Dennis Lex Germany NAP 435 bromazepam 01/09/1973 3 years 31/08/2026 29/11/2026 No 30/04/2024 DLP was amended on 30/04/2024 PSUSA/00000435/202608 Tiphaine Vaillant France NAP 436 bromfenac 18/05/2011 5 years 30/05/2030 28/08/2030 No 04/02/2026 PSUR frequency amended and DLP updated on 04/02/2026 PSUSA/00000436/203005 Karin Erneholm Denmark CAP NAP 437 bromhexine 01/07/1963 5 years 30/09/2030 29/12/2030 No 01/07/2026 PSUR frequency amended and DLP updated on 01/07/2026 Next DLP was updated on 31/05/2023 PSUSA/00000437/203009 Amelia Cupelli Italy NAP 438 bromocriptine 15/10/1975 7 years 15/10/2030 13/01/2031 No 03/07/2024 PSUR frequency amended and DLP updated on 03/07/2024 PSUSA/00000438/203010 Maria del Pilar Rayon Spain NAP 439 bromperidol 30/09/1980 5 years 15/11/2027 13/02/2028 No 26/07/2023 Next DLP was updated on 26/07/2023 PSUSA/00000439/202711 Liana Martirosyan Netherlands NAP 443 brompheniramine / caffeine / paracetamol, brompheniramine / caffeine / calcium / paracetamol Not available* 11 years 03/03/2040 01/06/2040 No 25/09/2024 Entry name updated on 25/09/2024 PSUSA/00000443/204003 none NAP 444 brotizolam 15/05/1983 3 years 01/12/2028 01/03/2029 No 29/07/2026 DLP was amended on 29/07/2026 PSUSA/00000444/202812 Ana Sofia Diniz Martins Portugal NAP 448 caffeine / codeine / paracetamol Not available* 5 years 03/08/2030 01/11/2030 No 29/07/2026 Active substance name was amended on 29/07/2026 PSUR frequency amended and DLP updated on 01/04/2026 PSUSA/00000448/203008 Rhea Fitzgerald Ireland NAP 449 budesonide (nationally authorised products only) 30/04/1992 5 years 30/04/2026 29/07/2026 No 22/12/2021 PRAC Rapporteur name was amended on 28/04/2022 DLP updated on 22/12/2021 PRAC Rapporteur name was amended on 21/11/2018 Entry name was corrected on 07/05/2018 Next DLP updated on 30/01/2017 Next DLP and Submission deadline were corrected on 04/03/2016 PSUR Frequency amended and DLP updated on 04/02/2016 PRAC Rapporteur and Lead Member State added on 27/11/2015. Transferred from the List of substances under PSUR Work Sharing scheme and other substances contained in Nationally Authorised Products with DLP synchronised on 06/03/2015 PRAC Rapporteur name updated on 05/11/2018 PSUSA/00000449/202604 Marie Louise Schougaard Christiansen Denmark NAP 454 bumetanide 30/09/1972 9 years 03/06/2028 01/09/2028 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00000454/202806 NAP 459 buprenorphine (all formulations except implants) 30/03/1982 4 years 30/09/2027 29/12/2027 No 05/06/2024 New CAP authorised on 19/12/2024 PSUR frequency amended and DLP updated on 05/06/2024 PSUSA/00000459/202709 Tiphaine Vaillant France CAP NAP 461 bupropion 30/12/1985 5 years 31/12/2029 31/03/2030 No 24/09/2025 PSUR frequency amended and DLP updated on 24/09/2025 PSUSA/00000461/202912 Liana Martirosyan Netherlands NAP 462 buserelin 16/08/1984 5 years 16/08/2026 14/11/2026 No 02/06/2026 PSUSA/00000462/202608 Jenny Jönsson Sweden NAP 463 buspirone 29/04/1983 3 years 30/04/2027 29/07/2027 No 05/02/2025 PSUR frequency amended and DLP updated on 05/02/2025 PSUSA/00000463/202704 Karin Erneholm Denmark NAP 464 busulfan 09/07/2003 3 years 08/07/2027 06/10/2027 Yes 19/09/2025 PSUR frequency amended and DLP updated on 05/03/2025 PSUSA/00000464/202707 Maria Martinez Gonzalez Spain NAP 468 butamirate 18/03/1967 10 years 03/07/2034 01/10/2034 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00000468/203407 NAP 469 butamirate / guaifenesin Not available* 9 years 03/06/2029 01/09/2029 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00000469/202906 NAP 471 butoconazole 24/10/2003 5 years 28/02/2026 29/05/2026 No 17/11/2021 DLP was updated on 17/11/2021 PRAC representative was updated on 06/05/2020 Next DLP was updated on 18/11/2016 Lead MS was added on 06/10/2015 PSUSA/00000471/202602 Melinda Palfi Hungary NAP 474 hyoscine butylbromide 01/01/1952 9 years 02/12/2027 01/03/2028 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00000474/202712 NAP 476 cabazitaxel 17/06/2010 5 years 17/06/2029 15/09/2029 Yes 05/03/2025 PSUR frequency amended and DLP updated on 05/03/2025 PSUSA/00000476/202906 Tiphaine Vaillant France CAP NAP 477 cabergoline 13/03/1992 5 years 12/03/2027 10/06/2027 No 16/11/2022 PSUR frequency and DLP were updated on 16/11/2022 PRAC representative was updated on 19/10/2022 PRAC representative was updated on 17/11/2021 PRAC representative was updated on 30/06/2021 PSUR frequency and DLP were updated on 23/10/2019 PSUR frequency amended and DLP updated on 21/11/2018 PRAC Rapporteur name amended on 04/07/2018 Information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" was amended on 17/10/2017 PRAC Rapporteur name updated on 04/02/2016 Next DLP updated and PRAC Rapporteur amended on 27/11/2015. Lead MS was added on 04/02/2015 PSUSA/00000477/202703 Amelia Cupelli Italy NAP 480 cafedrine hydrochloride / theodrenaline hydrochloride Not available* 9 years 03/06/2029 01/09/2029 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00000480/202906 NAP 481 caffeine 14/04/1969 28 years 01/01/2040 31/03/2040 No 01/10/2012 PSUSA/00000481/204001 NAP 482 caffeine (apnea) 02/07/2009 3 years 02/07/2026 30/09/2026 Yes 28/02/2024 DLP was amended on 28/02/2024 PSUSA/00000482/202607 Sonja Hrabcik Austria CAP NAP 483 caffeine / dihydroergocryptine mesilate Not available* 28 years 01/01/2040 31/03/2040 No 01/10/2012 PSUSA/00000483/204001 NAP 484 caffeine / diphenhydramine Not available* 28 years 01/01/2040 31/03/2040 No 01/10/2012 PSUSA/00000484/204001 NAP 485 caffeine / ergotamine Not available* 3 years 30/11/2028 28/02/2029 Yes 29/07/2026 DLP was amended on 29/07/2026 PSUSA/00000485/202811 Tiphaine Vaillant France NAP 486 caffeine / isometheptene / metamizole Not available* 28 years 01/01/2040 31/03/2040 No 01/10/2012 PSUSA/00000486/204001 NAP 487 caffeine / metamizole Not available* 28 years 01/01/2040 31/03/2040 No 07/05/2018 Entry name updated on 07/05/2018 PSUSA/00000487/204001 NAP 488 caffeine / phenazone Not available* 28 years 01/01/2040 31/03/2040 No 01/10/2012 PSUSA/00000488/204001 NAP 489 caffeine citrate / glyceryl trinitrate Not available* 28 years 01/01/2040 31/03/2040 No 01/10/2012 PSUSA/00000489/204001 NAP 491 calcifediol Not available* 5 years 23/06/2030 21/09/2030 No 01/04/2026 DLP was corrected on 01/04/2026 PSUR frequency amended and DLP updated on 04/03/2026 PSUSA/00000491/203006 Dennis Lex Germany NAP 492 calcipotriol 30/11/1990 8 years 03/06/2033 01/09/2033 No 04/02/2026 DLP was amended on 04/02/2026 PSUSA/00000492/203306 Rhea Fitzgerald Ireland NAP 494 calcitonin salmon, synthetic analogue of eel calcitonin 13/05/1975 5 years 19/06/2026 17/09/2026 No 19/09/2025 PRAC Representative updated on 16/11/2022 PSUR frequency and DLP were updated on 02/03/2022 Next DLP was updated on 06/03/2019 PRAC Representative updated on 26/09/2018 PRAC Rapporteur name updated on 03/06/2016 Next DLP was updated on 04/03/2016 Lead MS added on 01/04/2015 PSUSA/00000494/202606 Maria Martinez Gonzalez Spain NAP 495 calcitriol 01/01/1978 5 years 01/01/2026 01/04/2026 No 19/10/2022 PRAC representative was updated on 19/10/2022 PRAC representative was updated on 27/07/2022 PSUR frequency and DLP were updated on 22/09/2021 PRAC representative was updated on 25/09/2019 DLP was updated on 26/09/2018 PRAC Rapporteur name amended on 04/07/2018 DLP updated on 06/10/2015 Lead MS was added on 22/12/2014 PSUSA/00000495/202601 Amelia Cupelli Italy NAP 496 calcium 15/06/1935 15 years 01/01/2027 01/04/2027 No 01/10/2012 PSUSA/00000496/202701 NAP 500 Any combinations or monocomponents of aluminium, calcium, magnesium, potassium, sodium salts (antacids) Not available* 15 years 01/01/2027 01/04/2027 No 27/05/2026 Active substance name was amended on 28/04/2022 Active substance name was amended on 06/03/2015 PSUSA/00000500/202701 none NAP 501 calcium bromolactobionate Not available* 15 years 01/01/2027 01/04/2027 No 01/10/2012 PSUSA/00000501/202701 NAP 502 calcium carbonate Not available* 9 years 03/06/2029 01/09/2029 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00000502/202906 NAP 507 calcium chloride Not available* 11 years 03/03/2040 01/06/2040 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00000507/204003 NAP 508 calcium chloride / dipotassium phosphate / magnesium chloride hexahydrate / potassium chloride / potassium phosphate monobasic / sodium chloride, disodium phosphate dihydrate/ potassium dihydrogen phosphate/ potassium hydroxide Not available* 15 years 01/01/2027 01/04/2027 No 08/07/2026 New active substances added to the entry on 31/07/2018 PSUSA/00000508/202701 Katarzyna Ziolkowska Poland NAP 509 calcium chloride / glucose anhydrous / glutathione disulphide / magnesium chloride hexahydrate Not available* 15 years 01/01/2027 01/04/2027 No 01/10/2012 PSUSA/00000509/202701 NAP 511 calcium chloride / glycine / magnesium aspartate dihydrate / sodium succinate hexahydrate Not available* 15 years 01/01/2027 01/04/2027 No 01/10/2012 PSUSA/00000511/202701 NAP 513 calcium chloride / glucose monohydrate / magnesium chloride hexahydrate Not available* 15 years 01/01/2027 01/04/2027 No 01/10/2012 PSUSA/00000513/202701 NAP 517 calcium folinate / cyanocobalamin Not available* 15 years 01/01/2027 01/04/2027 No 01/10/2012 PSUSA/00000517/202701 NAP 519 calcium folinate 5-hydrate / glutamine Not available* 15 years 01/01/2027 01/04/2027 No 01/10/2012 PSUSA/00000519/202701 NAP 520 calcium gluconate Not available* 11 years 03/03/2040 01/06/2040 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00000520/204003 NAP 521 calcium carbonate / calcium lactate Not available* 10 years 03/06/2035 01/09/2035 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00000521/203506 NAP 525 camphor, camphor and other terpene derivates Not available* 9 years 03/07/2029 01/10/2029 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00000525/202907 NAP 526 canakinumab 23/10/2009 5 years 30/06/2029 28/09/2029 No 06/10/2025 PSUR frequency amended and DLP updated on 05/03/2025 PSUSA/00000526/202906 Dirk Mentzer Germany CAP 527 candesartan, candesartan / hydrochlorothiazide 29/04/1997 5 years 28/04/2027 27/07/2027 No 02/06/2026 PSUSA/00000527/202704 Karin Bolin Sweden NAP 531 capecitabine 30/04/1998 5 years 29/04/2029 28/07/2029 No 05/02/2025 PSUR frequency amended and DLP updated on 05/02/2025 PSUSA/00000531/202904 Dennis Lex Germany CAP NAP 532 capreomycin 19/01/1968 9 years 02/04/2028 01/07/2028 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00000532/202804 NAP 533 capsaicin 15/05/2009 5 years 15/05/2026 13/08/2026 No 02/02/2022 DLP was updated on 02/02/2022 Correction of PRAC Rapporteur name on 28/02/2017 'PSUR submission frequency and DLP were updated on 30/01/2017 'PRAC Rapporteur name was amended on 20/12/2016 'PRAC Rapporteur name updated on 04/02/2016 'Information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" was amended on 22/12/2014 Rapporteur name amended on 04/11/2014 The DLP was amended on 08/01/2014 PSUSA/00000533/202605 Ana Sofia Diniz Martins Portugal CAP NAP 535 captopril 15/04/1980 5 years 14/04/2030 13/07/2030 No 16/12/2020 PRAC representative was updated on 22/12/2021 DLP was updated on 16/12/2020 PRAC representative was updated on 06/05/2020 Lead MS and PRAC Rapporteur name amended on 19/12/2018 Next DLP was updated on 21/12/2015. PSUSA/00000535/203004 Miroslava Gocova Slovakia NAP 536 captopril / hydrochlorothiazide 15/04/1980 5 years 14/04/2026 13/07/2026 No 05/08/2025 PSUSA/00000536/202604 Tiphaine Vaillant France NAP 537 carbachol 10/11/1965 10 years 03/06/2034 01/09/2034 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00000537/203406 NAP 538 carbaethopendecinium Not available* 10 years 03/06/2035 01/09/2035 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00000538/203506 NAP 539 carbamazepine 12/12/1961 7 years 11/12/2027 10/03/2028 No 22/09/2021 DLP and PRAC representative were updated on 22/09/2021 PRAC representative was added on 06/05/2020 LMS was added on 01/04/2020 DLP was corrected on 20/11/2019 PSUR frequency, "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?Yes/No" and DLP were updated on 25/09/2019 PSUSA/00000539/202712 Liana Martirosyan Netherlands NAP 541 carbasalate 16/07/1981 9 years 03/11/2028 01/02/2029 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00000541/202811 NAP 543 carbazochrome 19/03/1951 11 years 03/11/2036 01/02/2037 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00000543/203611 NAP 545 boric acid / carbethopendecinium bromide / sodium tetraborate Not available* 11 years 03/03/2040 01/06/2040 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00000545/204003 NAP 546 carbetocin 24/06/1997 5 years 30/06/2027 28/09/2027 No 12/09/2025 DLP was updated on 01/03/2023 Lead MS and PRAC Rapporteur name amended on 19/12/2018 DLP was updated on 27/03/2018 Lead MS and PRAC Rapporteur name was added on 20/12/2016 PSUSA/00000546/202706 Veronika Macurová Czech Republic NAP 547 carbidopa / entacapone / levodopa 17/10/2003 3 years 17/10/2027 15/01/2028 No 25/06/2025 DLP was amended on 25/06/2025 PSUSA/00000547/202710 Terhi Lehtinen Finland CAP NAP 548 carbidopa / levodopa 13/08/1973 3 years 01/10/2028 30/12/2028 No 01/07/2026 DLP was amended on 01/07/2026 PSUSA/00000548/202810 Barbara Kovacic Bytyqi Croatia NAP 550 carbimazole 31/08/1988 7 years 02/12/2030 02/03/2031 No 31/07/2024 DLP was amended on 31/07/2024 PSUSA/00000550/203012 Dennis Lex Germany NAP 554 carbocisteine 14/09/1963 9 years 03/03/2028 01/06/2028 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00000554/202803 NAP 555 carbocisteine / prenoxidiazine Not available* 9 years 03/07/2029 01/10/2029 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00000555/202907 NAP 557 carbomers Not available* 5 years 31/01/2027 01/05/2027 No 19/10/2022 DLP was updated on 19/10/2022 PRAC representative was updated on 28/07/2021 PRAC representative was updated on 28/04/2021 DLP was updated on 17/10/2017 Lead MS was amended on 22/09/2016 Lead MS and PRAC Rapporteur name was added on 28/07/2016 Active substance name was amended on 03/06/2016 PSUSA/00000557/202701 Polona Golmajer Slovenia NAP 558 carbon dioxide Not available* 8 years 01/12/2033 01/03/2034 No 30/10/2024 PSUR frequency amended and DLP updated on 31/07/2024 PSUSA/00000558/203312 Melinda Pálfi Hungary NAP 559 carboplatin 23/01/1986 5 years 23/01/2027 23/04/2027 Yes 19/10/2022 PSUR frequency and DLP were updated on 19/10/2022 PRAC representative was updated on 17/11/2021 PRAC representative was updated on 30/06/2021 DLP was udpated on 25/09/2019 Next DLP was amended on 19/10/2016 PRAC Representative was amended on 27/11/2015. EURD and DLP amended on 06/10/2015 Lead MS added on 31/07/2015. PSUSA/00000559/202701 Amelia Cupelli Italy NAP 560 carboprost 09/01/1979 5 years 08/01/2026 08/04/2026 No 22/09/2021 DLP was updated on 22/09/2021 PRAC Rapporteur name updated on 27/06/2017 Next DLP was updated on 22/09/2016 Lead MS was added on 13/07/2015 PSUSA/00000560/202601 Eva Jirsová Czech Republic NAP 562 carmellose (eye preparation) 01/10/1990 15 years 03/06/2040 01/09/2040 No 04/02/2026 PSUR frequency amended and DLP updated on 04/02/2026 PSUSA/00000562/204006 Karin Bolin Sweden NAP 564 carglumic acid 24/01/2003 5 years 31/01/2030 01/05/2030 No 22/10/2025 DLP was amended on 22/10/2025 PSUSA/00000564/203001 Ana Sofia Diniz Martins Portugal CAP 572 carnitine, levocarnitine 01/09/1969 10 years 03/08/2034 01/11/2034 No 29/07/2026 Active substance name was amended on 29/07/2026 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00000572/203408 none NAP 574 carteolol 07/03/1984 5 years 31/03/2029 29/06/2029 No 18/12/2024 DLP was amended on 18/12/2024 PSUSA/00000574/202903 Miroslava Gocova Slovakia NAP 575 carvedilol 18/04/1990 5 years 17/04/2027 16/07/2027 No 21/12/2022 DLP was updated on 21/12/2022 DLP was updated on 19/12/2017 Lead MS and PRAC Rapporteur name was added on 19/10/2016 PSUSA/00000575/202704 Kimmo Jaakkola Finland NAP 576 caspofungin 24/10/2001 3 years 13/12/2027 12/03/2028 No 24/09/2025 DLP was amended on 24/09/2025 PSUSA/00000576/202712 Jo Robays Belgium CAP 582 estrogen / medroxyprogesterone 01/08/1987 5 years 31/08/2029 29/11/2029 No 12/09/2025 DLP was amended on 30/04/2025 PSUSA/00000582/202908 Veronika Macurová Czech Republic NAP 583 cefaclor 19/08/1976 8 years 03/03/2033 01/06/2033 No 19/11/2025 DLP was amended on 19/11/2025 PSUSA/00000583/203303 Melinda Palfi Hungary NAP 584 cefadroxil 12/07/1976 5 years 11/07/2027 09/10/2027 No 05/04/2023 DLP was updated on 05/04/2023 DLP was updated on 27/03/2018 Lead MS and PRAC Rapporteur name was added on 20/12/2016 PSUSA/00000584/202707 Jan Neuhauser Austria NAP 585 cefalexin 15/03/1967 8 years 02/12/2026 02/03/2027 No 27/05/2026 PSUR frequency amended and DLP updated on 27/05/2026 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00000585/202612 none NAP 586 cefalotin Not available* 10 years 03/06/2035 01/09/2035 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00000586/203506 NAP 587 cefamandole 29/08/1977 9 years 03/11/2028 01/02/2029 No 15/01/2025 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00000587/202811 Zane Neikena Latvia NAP 588 cefatrizine 27/08/1979 9 years 03/11/2028 01/02/2029 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00000588/202811 NAP 589 cefazolin 29/11/1972 5 years 30/11/2026 28/02/2027 No 27/07/2022 DLP was updated on 27/07/2022 Next DLP was amended on 25/09/2017 Lead MS and PRAC Rapporteur name was added on 28/07/2016 PSUSA/00000589/202611 Jan Neuhauser Austria NAP 592 cefditoren 01/04/1994 8 years 31/03/2033 29/06/2033 No 30/10/2024 DLP was amended on 23/10/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00000592/203303 Maria del Pilar Rayon Spain NAP 593 cefepime 29/06/1993 5 years 28/06/2029 26/09/2029 Yes 05/02/2025 PSUR frequency amended and DLP updated on 05/02/2025 Information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" was amended on 18/12/2024 DLP was updated on 02/03/2022 Next DLP was updated on 06/03/2019 Correction of PRAC Rapporteur name on 28/02/2017 PRAC Rapporteur name was amended on 20/12/2016 Next DLP was amended on 04/03/2016 Information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" was amended on 04/03/2016 Lead MS added on 01/04/2015 PSUSA/00000593/202906 Ana Sofia Diniz Martins Portugal NAP 594 cefixime 30/06/1987 5 years 03/06/2030 01/09/2030 No 04/02/2026 PSUR frequency amended and DLP updated on 04/02/2026 PSUSA/00000594/203006 Eva Jirsová Czech Republic NAP 596 cefonicid Not available* 9 years 03/07/2029 01/10/2029 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00000596/202907 NAP 597 cefoperazone, cefoperazone / sulbactam 12/01/1981 5 years 12/01/2028 11/04/2028 Yes 29/07/2026 Information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" was amended on 29/07/2026 Active substance name was amended on 29/07/2026 DLP was updated on 22/09/2021 PRAC Rapporteur name was amended on 06/03/2019 Next DLP was updated on 22/09/2016 Lead MS was added on 13/07/2015 PSUSA/00000597/202801 Lina Seibokiene Lithuania NAP 599 cefotaxime 18/12/1979 3 years 18/12/2027 17/03/2028 No 24/09/2025 DLP was amended on 24/09/2025 PSUSA/00000599/202712 Sonja Hrabcik Austria NAP 601 cefoxitin 16/03/1977 9 years 03/10/2028 01/01/2029 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00000601/202810 NAP 604 cefpodoxim 02/08/1990 7 years 02/12/2030 02/03/2031 No 31/07/2024 DLP was amended on 31/07/2024 PSUSA/00000604/203012 Amelia Cupelli Italy NAP 605 cefprozil 23/12/1991 5 years 22/12/2027 21/03/2028 No 20/09/2023 DLP amended on 20/09/2023 PSUSA/00000605/202712 Polona Golmajer Slovenia NAP 606 cefradine 23/11/1971 9 years 03/06/2028 01/09/2028 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00000606/202806 NAP 608 ceftazidime 17/10/1983 5 years 17/10/2028 15/01/2029 No 12/02/2025 DLP was amended on 03/07/2024 PSUSA/00000608/202810 Karin Bolin Sweden NAP 612 ceftizoxime 07/12/1981 9 years 03/11/2028 01/02/2029 No 15/01/2025 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00000612/202811 Ana Sofia Diniz Martins Portugal NAP 613 ceftriaxone, ceftriaxone / lidocaine 27/05/1982 5 years 26/05/2028 24/08/2028 No 29/07/2026 Active substance name was amended on 29/07/2026 DLP was amended on 31/01/2024 PSUSA/00000613/202805 Zane Neikena Latvia NAP 615 cefuroxime sodium (except for intracameral use) 18/08/1987 5 years 07/04/2027 06/07/2027 No 21/12/2022 DLP was updated on 21/12/2022 DLP was updated on 19/12/2017 Lead MS and PRAC Rapporteur name was added on 19/10/2016 Name of entry was amended on 03/03/2014 Information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" was amended on 30/11/2012 PSUSA/00000615/202704 Maia Uusküla Estonia NAP 616 celecoxib 31/12/1998 5 years 31/12/2028 31/03/2029 No 01/04/2026 PSUR frequency amended and DLP updated on 01/04/2026 DLP was amended on 25/09/2024 PSUSA/00000616/202812 Karin Bolin Sweden NAP 617 celiprolol 17/01/1983 8 years 16/01/2028 15/04/2028 No 23/09/2020 DLP was updated on 23/09/2020 PRAC representative was added on 06/05/2020 LMS was added on 31/07/2019 PSUSA/00000617/202801 Maia Uusküla Estonia NAP 624 certolizumab 01/10/2009 3 years 06/03/2026 04/06/2026 No 15/11/2023 DLP was amended on 15/11/2023 PSUSA/00000624/202603 Karin Bolin Sweden CAP 625 certoparin Not available* 5 years 01/04/2027 30/06/2027 No 21/12/2022 DLP was updated on 21/12/2022 PRAC representative added on 21/09/2022 LMS was added on 02/02/2022 PSUR frequency and DLP updated on 17/11/2021 PSUSA/00000625/202704 Dennis Lex Germany NAP 626 cetalkonium / choline salicylate, choline salicylate 24/04/1995 8 years 03/08/2033 01/11/2033 No 29/07/2026 Active substance name was amended on 29/07/2026 DLP was amended on 01/04/2026 PSUSA/00000626/203308 Zoubida Amimour France NAP 628 cetirizine 06/11/1986 5 years 05/11/2027 03/02/2028 No 26/07/2023 Next DLP was updated on 26/07/2023 PSUSA/00000628/202711 Terhi Lehtinen Finland NAP 629 cetirizine / pseudoephedrine 04/09/1995 5 years 31/08/2026 29/11/2026 No 28/04/2022 PRAC representative was updated on 19/10/2022 DLP and PRAC Representative were updated on 28/04/2022 DLP was updated on 23/05/2017 PRAC Representative amended on 18/11/2016 Lead MS and PRAC Rapporteur name was added on 07/04/2016 PSUSA/00000629/202608 Jo Robays Belgium NAP 630 cetrimide / chlorhexidine Not available* 9 years 03/07/2029 01/10/2029 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00000630/202907 NAP 631 cetrimide / lidocaine, cetrimide / lidocaine hydrochloride / zinc sulphate Not available* 10 years 03/06/2035 01/09/2035 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00000631/203506 Jo Robays Belgium NAP 632 cetrimide / quinisocain chlorhydrate Not available* 8 years 01/12/2033 01/03/2034 No 31/07/2024 PSUR frequency amended and DLP updated on 31/07/2024 PSUSA/00000632/203312 none NAP 633 cetrorelix 13/04/1999 5 years 12/04/2030 11/07/2030 No 17/12/2025 PSUR frequency amended and DLP updated on 17/12/2025 PSUSA/00000633/203004 Dennis Lex Germany CAP NAP 635 cetuximab 29/06/2004 5 years 30/09/2028 29/12/2028 No 02/06/2026 PSUSA/00000635/202809 Jenny-Maria Jönsson Sweden CAP 636 cetylpyridinium, benzocaine / cetylpyridinium 23/03/1939 11 years 03/11/2036 01/02/2037 Yes 29/07/2026 Information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" was amended on 29/07/2026 Active substance name was amended on 29/07/2026 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00000636/203611 none NAP 639 cetylpyridinium / lidocaine, lidocaine / chlorocresol / cetylpyridinium Not available* 10 years 03/06/2035 01/09/2035 No 18/12/2024 Active substance name was amended on 18/12/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00000639/203506 none NAP 640 cetylpyridinium / lysozyme, lysozyme / pyridoxine 12/01/1994 10 years 03/08/2035 01/11/2035 No 01/04/2026 PSUR frequency amended and DLP updated on 01/04/2026 PSUSA/00000640/203508 Zoubida Amimour France NAP 645 charcoal activated 06/04/1949 28 years 01/01/2040 31/03/2040 No 01/10/2012 PSUSA/00000645/204001 NAP 646 bismuth subgallate / charcoal activated / citric acid Not available* 7 years 03/08/2031 01/11/2031 No 12/09/2025 PSUR frequency and DLP amended on 27/03/2024 PSUSA/00000646/203108 Veronika Macurová Czech Republic NAP 650 chlorambucil 14/09/1956 10 years 31/01/2034 01/05/2034 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00000650/203401 NAP 651 chloramphenicol 25/06/1949 18 years 30/06/2030 28/09/2030 No 01/10/2012 PSUSA/00000651/203006 NAP 652 aminoacids / chloramphenicol / vitamin a Not available* 18 years 01/01/2030 01/04/2030 No 01/10/2012 PSUSA/00000652/203001 NAP 654 chloramphenicol / dexamethasone 19/05/1964 18 years 31/05/2030 29/08/2030 No 01/10/2012 PSUSA/00000654/203005 NAP 655 chloramphenicol / hydrocortisone (ocular) 06/11/1958 18 years 01/01/2030 01/04/2030 No 01/10/2012 PSUSA/00000655/203001 NAP 660 chlordiazepoxide 31/01/1960 10 years 02/04/2034 01/07/2034 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00000660/203404 NAP 661 chlordiazepoxide / clidinium, amitriptyline / chlordiazepoxide Not available* 3 years 10/01/2027 10/04/2027 No 23/10/2024 PSUR frequency amended and DLP updated on 23/10/2024 Active substance name was amended on 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00000661/202701 none NAP 662 chlorhexidine 11/08/1976 8 years 03/03/2033 01/06/2033 No 19/11/2025 DLP was amended on 19/11/2025 PSUSA/00000662/203303 Rugile Pilviniene Lithuania NAP 663 cetrimonium / chlorhexidine Not available* 9 years 03/07/2029 01/10/2029 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00000663/202907 NAP 664 chlorhexidine / dexpanthenol Not available* 9 years 03/11/2029 01/02/2030 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00000664/202911 NAP 665 chlorhexidine / lidocaine 11/09/1963 10 years 03/05/2034 01/08/2034 No 03/10/2024 Updated & published on 23/10/2024 PSUSA/00000665/203405 NAP 669 chlorhexidine gluconate / isopropyl alcohol (covers other synonymous terms such as 2-propanol) Not available* 8 years 01/12/2033 01/03/2034 No 29/07/2026 DLP was amended on 29/07/2026 PSUSA/00000669/203312 Jo Robays Belgium NAP 677 chlormadinone 18/11/1974 3 years 31/01/2027 01/05/2027 Yes 21/10/2022 PSUR frequency and DLP updated on 21/10/2022 Information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" and DLP was amended on 29/06/2022 Next DLP was amended on 25/09/2017 Lead MS and PRAC Rapporteur name was added on 28/07/2016 The DLP was amended on 01/04/2014 PSUSA/00000677/202701 Dennis Lex Germany NAP 679 chlormadinone acetate / ethinylestradiol Not available* 3 years 31/01/2027 01/05/2027 No 21/10/2022 PSUR frequency and DLP updated on 21/10/2022 Next DLP was amended on 29/06/2022 Next DLP was amended on 25/09/2017 Lead MS and PRAC Rapporteur name was added on 28/07/2016 PSUSA/00000679/202701 Dennis Lex Germany NAP 682 chlorocresol Not available* 9 years 03/11/2029 01/02/2030 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00000682/202911 NAP 684 chloropyramine Not available* 8 years 01/12/2028 01/03/2029 Yes 27/05/2026 Information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" was amended on 27/05/2026 DLP was amended on 27/05/2026 PSUR frequency amended and DLP updated on 31/07/2024 PSUSA/00000684/202812 Zane Neikena Latvia NAP 685 chloroquine 20/08/1947 5 years 18/04/2026 17/07/2026 No 16/10/2025 DLP updated on 22/12/2021 DLP was updated on 03/06/2020 PSUR frequency and DLP were amended on 30/04/2019 European Union reference date, DLP and Submission date were amended on 28/02/2018 PRAC Representative amended on 19/12/2017 Next DLP was amended on 07/04/2016 Lead MS added on 01/04/2015 PSUSA/00000685/202604 Liana Martirosyan Netherlands NAP 689 chloroxylenol 01/01/1933 11 years 03/05/2040 01/08/2040 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00000689/204005 NAP 692 chlorphenamine 07/06/1954 10 years 01/01/2034 01/04/2034 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00000692/203401 NAP 693 chlorphenamine / paracetamol / pseudoephedrine, chlorphenamine / paracetamol / phenylephrine Not available* 10 years 03/05/2035 01/08/2035 No 30/04/2024 PSUR frequency amended and DLP updated on 30/04/2024 Active substance name was amended on 30/04/2024 PSUSA/00000693/203505 none NAP 694 acetylsalicylic acid / chlorphenamine / phenylephrine Not available* 8 years 03/11/2033 01/02/2034 No 01/07/2026 DLP was amended on 01/07/2026 PSUSA/00000694/203311 Adam Przybylkowski Poland NAP 696 ascorbic acid / chlorphenamine / paracetamol Not available* 6 years 03/11/2029 01/02/2030 No 19/09/2024 PSUSA/00000696/202911 Zoubida Amimour France NAP 697 ascorbic acid / caffeine / chlorphenamine / paracetamol Not available* 10 years 03/05/2035 01/08/2035 No 30/04/2024 PSUR frequency amended and DLP updated on 30/04/2024 Active substance name was amended on 30/04/2024 PSUSA/00000697/203505 none NAP 699 chlorphenamine / dextromethorphan hydrobromide / paracetamol Not available* 10 years 03/11/2034 01/02/2035 Yes 19/09/2025 PSUR frequency amended and DLP updated on 30/07/2025 PSUSA/00000699/203411 Maria Martinez Gonzalez Spain NAP 703 chlorphenamine / paracetamol 22/08/2001 7 years 03/03/2031 01/06/2031 No 20/11/2024 DLP was amended on 20/11/2024 PSUSA/00000703/203103 Zoubida Amimour France NAP 710 chlorphenamine / pseudoephedrine, chlorphenamine / phenylephrine Not available* 10 years 03/05/2035 01/08/2035 Yes 30/04/2024 Information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" was amended on 30/04/2024 PSUR frequency amended and DLP updated on 30/04/2024 Active substance name was amended on 30/04/2024 PSUR frequency and DLP amended on 27/03/2024 PSUSA/00000710/203505 none NAP 715 chlorpromazine 29/05/1952 5 years 29/05/2028 27/08/2028 No 31/01/2024 PSUR frequency amended and DLP updated on 31/01/2024 PSUSA/00000715/202805 Tiphaine Vaillant France NAP 717 chlorprothixene 31/03/1959 3 years 31/03/2027 29/06/2027 No 18/12/2024 DLP was amended on 18/12/2024 PSUSA/00000717/202703 Zane Neikena Latvia NAP 718 chlortalidone 24/06/1959 10 years 31/01/2034 01/05/2034 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00000718/203401 NAP 720 chlortalidone / oxprenolol 27/09/1976 10 years 03/03/2035 01/06/2035 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00000720/203503 NAP 721 chlortalidone / reserpine 06/02/1962 10 years 03/05/2034 01/08/2034 No 03/10/2024 Updated & published on 23/10/2024 PSUSA/00000721/203405 NAP 723 chlortetracycline 01/04/1949 11 years 03/11/2036 01/02/2037 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00000723/203611 NAP 726 chlorzoxazone 28/06/1960 10 years 02/04/2034 01/07/2034 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00000726/203404 NAP 730 cholera vaccine (inactivated, oral) 28/04/2004 3 years 28/04/2026 27/07/2026 No 02/06/2026 PSUSA/00000730/202604 Karin Bolin Sweden CAP 733 chlorobutanol hemihydrate / choline salicylate / hexetidine Not available* 9 years 03/11/2029 01/02/2030 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00000733/202911 NAP 736 choriogonadotropin alfa, chorionic gonadotrophin 02/02/2001 3 years 19/09/2028 18/12/2028 No 27/05/2026 DLP was amended on 27/05/2026 PSUSA/00000736/202809 Bianca Mulder Netherlands CAP NAP 738 chrome alum Not available* 9 years 03/11/2029 01/02/2030 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00000738/202911 NAP 739 chromium (51 cr) edta 30/11/1975 10 years 03/03/2035 01/06/2035 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00000739/203503 NAP 742 ciclesonide 24/02/2004 5 years 23/08/2029 21/11/2029 No 02/06/2026 PSUSA/00000742/202908 Karin Bolin Sweden NAP 745 ciclosporin (systemic use) 15/12/1982 3 years 31/12/2027 30/03/2028 No 24/09/2025 DLP was amended on 24/09/2025 PSUSA/00000745/202712 Maia Uusküla Estonia NAP 748 cilastatin / imipenem 28/06/1984 5 years 27/06/2027 25/09/2027 No 01/03/2023 DLP was updated on 01/03/2023 PRAC Rapporteur name amended on 04/07/2018 PSUR Frequency amended and DLP updated on 28/02/2018 PRAC Representative name was amended on 17/10/2017 PRAC representative and Lead Member State were added on 18/11/2016 Transferred from the List of substances under PSUR Work Sharing scheme and other substances contained in Nationally Authorised Products with DLP synchronised on 06/03/2015 PSUSA/00000748/202706 Karen Pernille Harg Norway NAP 749 cilazapril, cilazapril / hydrochlorothiazide 21/02/1990 5 years 20/02/2029 21/05/2029 No 31/01/2024 PRAC representative updated on 31/01/2024 PSUSA/00000749/202902 Carla Torre Portugal NAP 753 cimetidine 09/11/1976 9 years 02/09/2028 01/12/2028 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00000753/202809 NAP 755 cimicifuga racemosa (L.) nutt., rhizoma Not available* 5 years 01/01/2028 31/03/2028 Yes 20/09/2023 DLP amended on 20/09/2023 PSUSA/00000755/202801 Jan Neuhauser Austria NAP 757 cinchocaine Not available* 8 years 01/12/2028 01/03/2029 Yes 27/05/2026 DLP was amended on 27/05/2026 PSUR frequency amended and DLP updated on 27/05/2026 Information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" was amended on 27/05/2026 PSUR frequency amended and DLP updated on 31/07/2024 PSUSA/00000757/202812 Dennis Lex Germany NAP 759 1,3-butanediol / cinchocaine hydrochloride / dexamethasone 23/09/1983 9 years 01/12/2028 01/03/2029 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00000759/202812 NAP 761 cinchocaine hydrochloride / hydrocortisone Not available* 7 years 03/08/2031 01/11/2031 No 02/04/2025 DLP was amended on 02/04/2025 PSUSA/00000761/203108 John Joseph Borg Malta NAP 762 cinchocaine hydrochloride / policresulen Not available* 9 years 03/11/2029 01/02/2030 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00000762/202911 NAP 766 cinnarizine 01/11/1961 10 years 03/05/2034 01/08/2034 No 03/10/2024 Updated & published on 23/10/2024 PSUSA/00000766/203405 NAP 767 cinnarizine / dimenhydrinate 19/03/1996 8 years 03/11/2033 01/02/2034 No 01/07/2026 DLP was amended on 01/07/2026 PSUSA/00000767/203311 Jan Neuhauser Austria NAP 768 cinnarizine / piracetam Not available* 9 years 03/11/2029 01/02/2030 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00000768/202911 NAP 769 cinolazepam 02/12/1994 8 years 01/12/2032 01/03/2033 Yes 30/07/2025 PSUR frequency amended and DLP updated on 30/07/2025 PSUSA/00000769/203212 Miroslava Gocova Slovakia NAP 771 ciprofibrate 09/12/1983 5 years 09/12/2026 09/03/2027 No 08/04/2026 DLP was updated on 27/07/2022 Lead MS and PRAC Rapporteur name amended on 19/12/2018 Next DLP was amended on 25/09/2017 Lead MS and PRAC Rapporteur name was added on 28/07/2016 PSUSA/00000771/202612 Jo Robays Belgium NAP 772 ciprofloxacin / fluocinolone acetonide 25/03/2002 7 years 02/04/2031 01/07/2031 No 18/12/2024 DLP was amended on 18/12/2024 PSUSA/00000772/203104 Maria del Pilar Rayon Spain NAP 774 ciprofloxacin hydrochloride / hydrocortisone Not available* 3 years 30/11/2026 28/02/2027 No 31/07/2024 DLP was amended on 31/07/2024 PSUSA/00000774/202611 Amelia Cupelli Italy NAP 775 ciprofloxacin (systemic use) 31/01/1987 5 years 02/04/2028 01/07/2028 No 20/12/2023 DLP was amended on 20/12/2023 PSUSA/00000775/202804 Karen Pernille Harg Norway NAP 776 ciprofloxacin (topical use) 31/01/1987 5 years 31/01/2028 30/04/2028 No 18/10/2023 Next DLP was updated on 18/10/2023 PSUSA/00000776/202801 Karen Pernille Harg Norway NAP 777 cisatracurium 07/08/1995 8 years 31/07/2033 29/10/2033 No 01/04/2026 PSUR frequency amended and DLP updated on 01/04/2026 PSUSA/00000777/203307 Veronika Macurová Czech Republic NAP 778 cisplatin 19/12/1978 5 years 18/12/2027 17/03/2028 No 20/09/2023 DLP amended on 20/09/2023 PSUSA/00000778/202712 Marie Louise Schougaard Christiansen Denmark NAP 779 citalopram 31/12/1989 5 years 31/12/2026 31/03/2027 No 21/09/2022 DLP was updated on 21/09/2022 PRAC Rapporteur name was amended on 31/07/2018 Next DLP was amended on 25/09/2017 Information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" was amended on 25/09/2017 Lead MS and PRAC Rapporteur name was added on 28/07/2016 PSUSA/00000779/202612 Karin Bolin Sweden NAP 780 citicoline 31/12/1966 10 years 03/07/2034 01/10/2034 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00000780/203407 NAP 781 citric acid Not available* 28 years 01/01/2040 31/03/2040 No 01/10/2012 PSUSA/00000781/204001 NAP 782 citric acid / magnesium / sodium, citric acid anhydrous / light magnesium oxide / sodium picosulfate Not available* 9 years 03/11/2029 01/02/2030 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00000782/202911 none NAP 783 citric acid / potassium salts, potassium citrate, potassium sodium hydrogen citrate, citric acid / potassium citrate / sodium citrate Not available* 6 years 03/11/2029 01/02/2030 No 02/04/2025 Active substance name was amended on 02/04/2025 DLP was amended on 03/07/2024 PSUSA/00000783/202911 Polona Golmajer Slovenia NAP 785 citric acid / sodium Not available* 28 years 01/01/2040 31/03/2040 No 01/10/2012 PSUSA/00000785/204001 NAP 786 citric acid / urea Not available* 28 years 01/01/2040 31/03/2040 No 01/10/2012 PSUSA/00000786/204001 NAP 787 cladribine (apart from products with multiple sclerosis indication) 26/02/1993 3 years 25/02/2027 26/05/2027 No 20/10/2021 DLP was updated on 20/10/2021 PRAC representative was updated on 31/03/2021 PRAC representative was updated on 25/09/2019 LMS and PRAC representative were updated on 05/06/2019 DLP was updated on 21/11/2018 Entry name amended on 19/12/2017 PRAC Representative was amended on 28/03/2017 next DLP was amended on 29/10/2015 PSUSA/00000787/202702 Marie Louise Schougaard Christiansen Denmark CAP NAP 788 clarithromycin 17/07/1989 3 years 01/04/2026 30/06/2026 No 20/12/2023 DLP was amended on 20/12/2023 PSUSA/00000788/202604 Eamon O'Murchu Ireland NAP 789 clebopride 22/02/1979 8 years 30/06/2032 28/09/2032 No 19/09/2025 PSUR frequency amended and DLP updated on 05/03/2025 PSUSA/00000789/203206 Maria Martinez Gonzalez Spain NAP 790 clebopride hydrogen maleate / simeticone Not available* 9 years 01/12/2029 01/03/2030 No 28/08/2024 PSUR frequency and DLP amended on 28/08/2024. PSUSA/00000790/202912 NAP 791 clemastine 11/10/1966 9 years 03/03/2028 01/06/2028 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00000791/202803 NAP 792 clemastine / dexamethasone Not available* 7 years 03/08/2031 01/11/2031 No 27/03/2024 PSUR frequency and DLP amended on 27/03/2024 PSUSA/00000792/203108 none NAP 794 clenbuterol 12/12/1980 5 years 30/09/2031 29/12/2031 Yes 01/07/2026 PSUR frequency amended and DLP updated on 01/07/2026 Next DLP was updated on 31/05/2023 PSUSA/00000794/203109 Amelia Cupelli Italy NAP 795 clindamycin 16/10/1969 3 years 15/10/2027 13/01/2028 No 25/06/2025 DLP was amended on 25/06/2025 PSUSA/00000795/202710 Sonja Hrabcik Austria NAP 796 benzoyl peroxide / clindamycin phosphate 26/01/1983 8 years 03/05/2033 01/08/2033 No 04/02/2026 DLP was amended on 04/02/2026 PSUSA/00000796/203305 Rugile Pilviniene Lithuania NAP 797 clioquinol Not available* 9 years 01/12/2029 01/03/2030 No 28/08/2024 PSUR frequency and DLP amended on 28/08/2024. PSUSA/00000797/202912 NAP 798 clobazam 06/02/1970 8 years 06/02/2028 06/05/2028 No 21/10/2020 DLP was updated on 21/10/2020 PRAC representative was updated on 23/09/2020 PRAC representative was added on 06/05/2020 LMS was added on 01/04/2020 PSUR frequency and DLP were updated on 25/09/2019 PSUSA/00000798/202802 Kimmo Jaakkola Finland NAP 799 clobetasol 21/02/1973 5 years 28/02/2030 29/05/2030 No 19/11/2025 DLP was amended on 19/11/2025 PSUSA/00000799/203002 Jo Robays Belgium NAP 800 clobetasone 17/09/1975 9 years 03/08/2028 01/11/2028 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00000800/202808 NAP 805 clofarabine 29/05/2006 3 years 28/12/2026 28/03/2027 Yes 25/09/2024 DLP was amended on 25/09/2024 Information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" was amended on 25/09/2024 PSUR frequency, DLP and PSURs required for products referred to in Articles 10(1), 10a, 16a of Directive 2001/83/EC as amended were updated on 28/07/2021 DLP and PRAC representative were updated on 29/07/2020 Reference to NAP added on 01/07/2020 New CAP authorised on 14/11/2019 DLP and Information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" were updated on 31/07/2019 PRAC representative was updated on 03/06/2020 PRAC representative was updated on 03/06/2020 DLP was updated on 31/07/2018 DLP updated and PRAC Rapporteur name amended on 21/07/2017 PRAC Rapporteur name was amended on 28/07/2016 Next DLP and PRAC Rapporteur name updated was amended on 28/07/2016 PRAC Rapporteur name updated on 03/06/2016 PSUSA/00000805/202612 Tiphaine Vaillant France CAP NAP 806 clofazimine 24/04/1969 9 years 03/05/2028 01/08/2028 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00000806/202805 none NAP 809 clomethiazole 01/11/1959 10 years 31/01/2034 01/05/2034 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00000809/203401 NAP 810 clomifene Not available* 8 years 01/12/2033 01/03/2034 No 29/07/2026 DLP was amended on 29/07/2026 PSUSA/00000810/203312 Eva Jirsová Czech Republic NAP 811 clomipramine 18/10/1965 8 years 03/03/2033 01/06/2033 No 19/11/2025 DLP was amended on 19/11/2025 PSUSA/00000811/203303 Dennis Lex Germany NAP 812 clonazepam 27/06/1973 5 years 26/06/2030 24/09/2030 Yes 04/03/2026 DLP was amended on 04/03/2026 PSUSA/00000812/203006 Maia Uusküla Estonia NAP 813 clonidine 16/08/1967 5 years 16/08/2030 14/11/2030 No 27/05/2026 DLP was corrected on 27/05/2026 PSUR frequency amended and DLP updated on 29/04/2026 PSUSA/00000813/203008 Carla Torre Portugal NAP 815 clonixin 28/02/1975 10 years 03/03/2035 01/06/2035 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00000815/203503 NAP 816 clopamide / dihydroegocrystine / reserpine 30/04/1966 10 years 03/07/2034 01/10/2034 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00000816/203407 NAP 819 cloperastine 12/08/1981 9 years 03/11/2028 01/02/2029 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00000819/202811 NAP 820 acetylsalicylic acid / clopidogrel, clopidogrel 15/07/1998 3 years 17/11/2028 15/02/2029 No 29/07/2026 DLP was amended on 29/07/2026 PSUSA/00000820/202811 Carla Torre Portugal CAP NAP 821 cloprednol Not available* 9 years 01/12/2029 01/03/2030 No 28/08/2024 PSUR frequency and DLP amended on 28/08/2024. PSUSA/00000821/202912 NAP 822 clorazepate 03/08/1966 9 years 03/03/2028 01/06/2028 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00000822/202803 NAP 824 clorazepate dipotassium Not available* 9 years 01/12/2029 01/03/2030 No 28/08/2024 PSUR frequency and DLP amended on 28/08/2024. PSUSA/00000824/202912 NAP 826 clotiapine Not available* 9 years 01/12/2029 01/03/2030 No 28/08/2024 PSUR frequency and DLP amended on 28/08/2024. PSUSA/00000826/202912 NAP 827 clotiazepam 18/05/1978 5 years 31/05/2030 29/08/2030 No 04/02/2026 DLP was amended on 04/02/2026 PSUSA/00000827/203005 Jo Robays Belgium NAP 828 clotrimazole / hexamidine diisetionate / prednisolone acetate 13/11/1991 9 years 31/01/2029 01/05/2029 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00000828/202901 NAP 829 clotrimazole 08/10/1975 8 years 03/03/2033 01/06/2033 No 19/11/2025 DLP was amended on 19/11/2025 PSUSA/00000829/203303 Melinda Palfi Hungary NAP 830 clotrimazole / dexamethasone Not available* 10 years 03/11/2034 01/02/2035 No 30/07/2025 PSUR frequency amended and DLP updated on 30/07/2025 PSUSA/00000830/203411 Carla Torre Portugal NAP 831 clotrimazole / hydrocortisone Not available* 10 years 03/11/2034 01/02/2035 No 30/07/2025 PSUR frequency amended and DLP updated on 30/07/2025 PSUSA/00000831/203411 Rhea Fitzgerald Ireland NAP 832 clotrimazole / metronidazole Not available* 7 years 03/11/2031 01/02/2032 No 30/07/2025 DLP was amended on 30/07/2025 PSUSA/00000832/203111 Roxana Dondera Romania NAP 834 clotrimazole / hexamidine diisetionate 13/11/1991 9 years 31/01/2029 01/05/2029 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00000834/202901 NAP 835 cloxacillin 05/01/1962 10 years 03/05/2034 01/08/2034 No 03/10/2024 Updated & published on 23/10/2024 PSUSA/00000835/203405 NAP 836 clozapine 24/10/1969 5 years 03/03/2030 01/06/2030 No 19/11/2025 PSUR frequency amended and DLP updated on 19/11/2025 PSUSA/00000836/203003 Amelia Cupelli Italy NAP 838 cobamamide, hydroxocobalamin (except for products for chemical poisoning), hydroxocobalamin / cobamamide 27/11/1969 10 years 02/09/2034 01/12/2034 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00000838/203409 NAP 843 codeine 06/09/1954 5 years 31/01/2030 01/05/2030 No 22/10/2025 PSUR frequency amended and DLP updated on 22/10/2025 PSUSA/00000843/203001 Petar Mas Croatia NAP 850 codeine / ibuprofen 05/03/1993 5 years 02/12/2028 02/03/2029 No 31/07/2024 PSUR frequency amended and DLP updated on 31/07/2024 PSUSA/00000850/202812 Tiphaine Vaillant France NAP 851 codeine / paracetamol 01/09/1972 5 years 03/03/2030 01/06/2030 No 19/11/2025 PSUR frequency amended and DLP updated on 19/11/2025 PSUSA/00000851/203003 Veronika Macurová Czech Republic NAP 858 colchicine 30/07/1947 5 years 30/07/2028 28/10/2028 No 26/08/2026 Reference to CAP added on 26/08/2026 New CAP authorised on 24/07/2026 DLP was amended on 27/03/2024 PSUSA/00000858/202807 Maria del Pilar Rayon Spain CAP NAP 863 sodium fluoride, colecalciferol / sodium fluoride, dectaflur / olaflur / sodium fluoride 22/01/1980 9 years 03/11/2028 01/02/2029 No 02/04/2025 Active substance name was amended on 02/04/2025 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00000863/202811 none NAP 864 colesevelam 10/03/2004 3 years 10/03/2027 08/06/2027 No 20/11/2024 DLP was amended on 20/11/2024 PSUSA/00000864/202703 Bianca Mulder Netherlands CAP NAP 865 colestipol 25/06/1976 9 years 03/08/2028 01/11/2028 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00000865/202808 NAP 866 colestyramine 02/04/1965 9 years 03/03/2028 01/06/2028 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00000866/202803 NAP 868 colistin sulphate 17/01/1962 10 years 03/05/2034 01/08/2034 No 03/10/2024 Updated & published on 23/10/2024 PSUSA/00000868/203405 NAP 873 conestat alfa 28/10/2010 6 months 28/04/2026 07/07/2026 28/10/2026 06/01/2027 No 01/07/2026 DLP was amended on 01/07/2026 PSUSA/00000873/202604 PSUSA/00000873/202610 Jan Neuhauser Austria CAP 875 corifollitropin alfa 25/01/2010 3 years 24/07/2026 22/10/2026 No 27/03/2024 DLP was amended on 27/03/2024 PSUSA/00000875/202607 Bianca Mulder Netherlands CAP 876 corticorelin 01/10/1988 5 years 31/10/2029 29/01/2030 No 25/06/2025 DLP was amended on 25/06/2025 PSUSA/00000876/202910 Jan Neuhauser Austria NAP 878 cortisone 18/06/1952 10 years 01/01/2034 01/04/2034 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00000878/203401 NAP 879 chloramphenicol / cortisone acetate / ethacridine lactate / zinc oxide 25/06/1949 11 years 03/05/2040 01/08/2040 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00000879/204005 NAP 883 cromoglicic acid 01/02/1969 5 years 01/02/2027 02/05/2027 No 19/10/2022 DLP was updated on 19/10/2022 PRAC Rapporteur name updated on 23/10/2018 Correction of DLP on 31/01/2018 DLP was amended on 15/11/2017 Lead MS was added on 22/09/2016 PSUSA/00000883/202702 Eamon O'Murchu Ireland NAP 884 crotamiton 14/11/1946 11 years 03/11/2036 01/02/2037 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00000884/203611 NAP 885 crotamiton / hydrocortisone 17/12/1963 10 years 03/06/2034 01/09/2034 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00000885/203406 NAP 886 cyamemazine 14/06/1971 8 years 03/03/2033 01/06/2033 No 19/11/2025 DLP was amended on 19/11/2025 PSUSA/00000886/203303 Tiphaine Vaillant France NAP 888 cyanocobalamin 22/02/1952 10 years 01/12/2032 01/03/2033 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00000888/203212 NAP 892 cyanocobalamin / folic acid, cyanocobalamin / folic acid / potassium iodide Not available* 7 years 03/11/2032 01/02/2033 Yes 01/07/2026 DLP was amended on 01/07/2026 PSUSA/00000892/203211 Ana Sofia Diniz Martins Portugal NAP 893 cyanocobalamin / folic acid / pyridoxine Not available* 7 years 03/11/2031 01/02/2032 No 30/07/2025 DLP was amended on 30/07/2025 PSUSA/00000893/203111 Dennis Lex Germany NAP 896 cyclizine 02/02/1956 6 years 01/02/2032 01/05/2032 No 31/01/2024 PSUR frequency amended and DLP updated on 31/01/2024 PSUSA/00000896/203202 none NAP 898 cyclobenzaprine Not available* 12 years 03/06/2040 01/09/2040 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00000898/204006 NAP 899 cyclopenthiazide 11/01/1961 11 years 03/06/2039 01/09/2039 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00000899/203906 NAP 900 cyclopentolate 19/02/1957 10 years 31/01/2034 01/05/2034 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00000900/203401 NAP 901 cyclophosphamide 13/10/1958 12 years 31/01/2037 01/05/2037 No 22/10/2025 PSUR frequency amended and DLP updated on 22/10/2025 PSUSA/00000901/203701 Dennis Lex Germany NAP 902 cyproheptadine 21/12/1961 5 years 31/12/2028 31/03/2029 No 25/09/2024 PSUR frequency amended and DLP updated on 25/09/2024 PSUSA/00000902/202812 Melinda Palfi Hungary NAP 905 cyproterone 22/11/2009 5 years 03/07/2028 01/10/2028 No 28/02/2024 DLP was amended on 28/02/2024 PSUSA/00000905/202807 Barbara Kovacic Bytyqi Croatia NAP 906 cyproterone / ethinylestradiol Not available* 3 years 31/05/2026 29/08/2026 No 31/01/2024 DLP was amended on 31/01/2024 PSUSA/00000906/202605 Bianca Mulder Netherlands NAP 907 cyproterone acetate / estradiol valerate Not available* 8 years 03/03/2026 01/06/2026 No 07/07/2026 PSUR frequency and DLP amended on 31/07/2024. PSUSA/00000907/202603 Zoubida Amimour France NAP 908 cystine Not available* 11 years 03/03/2040 01/06/2040 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00000908/204003 NAP 910 cystine / pyridoxine hydrochloride Not available* 8 years 03/03/2026 01/06/2026 No 01/07/2026 PSUR frequency and DLP amended on 31/07/2024. PSUSA/00000910/202603 Adam Przybylkowski Poland NAP 911 cytarabine 11/07/2001 5 years 31/03/2030 29/06/2030 No 17/12/2025 PSUR frequency amended and DLP updated on 17/12/2025 PSUSA/00000911/203003 Melinda Palfi Hungary NAP 913 cytisine, cytisinicline 25/02/2009 13 years 24/02/2031 25/05/2031 Yes 28/02/2024 Information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" was amended on 28/02/2024 DLP was amended on 28/02/2024 Active substance name was amended on 28/02/2024 PSUSA/00000913/203102 none NAP 914 cytomegalovirus immunoglobulin 29/12/1995 5 years 31/01/2026 01/05/2026 Yes 20/10/2021 PRAC representative was updated on 01/03/2023 DLP was updated on 20/10/2021 Next DLP was amended on 19/10/2016 The DLP was amended on 30/09/20145. Lead MS was added on 13/07/2015 PSUSA/00000914/202601 Dirk Mentzer Germany NAP 918 dabigatran 18/03/2008 3 years 18/03/2026 16/06/2026 No 01/04/2026 Reference to NAP added on 01/04/2026 PSUR frequency amended and DLP updated on 15/11/2023 PSUSA/00000918/202603 Marie Louise Schougaard Christiansen Denmark CAP NAP 919 dacarbazine 01/02/1978 5 years 01/02/2028 01/05/2028 No 18/10/2023 Next DLP was updated on 18/10/2023 PSUSA/00000919/202802 Jan Neuhauser Austria NAP 920 dactinomycin 01/07/1963 9 years 03/03/2028 01/06/2028 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00000920/202803 NAP 922 dalteparin sodium 26/08/1985 2 years 31/08/2026 29/11/2026 No 30/04/2025 DLP was amended on 30/04/2025 PSUSA/00000922/202608 Rugile Pilviniene Lithuania NAP 923 danaparoid 01/12/1992 5 years 01/12/2028 01/03/2029 No 31/07/2024 DLP was amended on 31/07/2024 PSUSA/00000923/202812 Eamon O'Murchu Ireland NAP 924 danazol 10/06/1974 9 years 03/08/2028 01/11/2028 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00000924/202808 NAP 925 dantrolene 31/01/1974 9 years 03/08/2028 01/11/2028 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00000925/202808 NAP 927 dapiprazole 06/08/1985 9 years 01/12/2028 01/03/2029 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00000927/202812 NAP 928 dapoxetine 17/12/2008 5 years 17/12/2028 17/03/2029 No 02/06/2026 PSUSA/00000928/202812 Jenny Jönsson Sweden NAP 929 dapsone Not available* 8 years 03/03/2034 01/06/2034 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024. PSUSA/00000929/203403 none NAP 930 dapsone / ferrous oxalate 01/01/1974 9 years 03/06/2028 01/09/2028 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00000930/202806 NAP 931 daptomycin 19/01/2006 5 years 11/09/2029 10/12/2029 No 25/05/2022 DLP was updated on 25/05/2022 Submission date corrected on 06/05/2020 DLP and PSUR frequency updated on 30/04/2019 PRAC Rapporteur name updated on 03/04/2018 Lead MS and PRAC Rapporteur name updated on 23/10/2018 DLP was updated on 07/05/2018 Next DLP was amended on 26/04/2017 Next DLP was amended on 03/05/2016 "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended? Yes/No" was amended on 16/07/2015 PSUSA/00000931/202909 Pernille Harg Norway CAP 932 darbepoetin alfa 08/06/2001 3 years 31/10/2026 29/01/2027 No 03/07/2024 DLP was amended on 03/07/2024 PSUSA/00000932/202610 Dennis Lex Germany CAP 933 darifenacin 22/10/2004 5 years 31/10/2029 29/01/2030 No 25/06/2025 PSUR frequency amended and DLP updated on 25/06/2025 PSUSA/00000933/202910 Maria del Pilar Rayon Spain CAP 934 darunavir 12/02/2007 5 years 23/12/2028 23/03/2029 No 25/09/2024 PSUR frequency amended and DLP updated on 25/09/2024 PSUSA/00000934/202812 Liana Martirosyan Netherlands CAP 935 dasatinib 20/11/2006 3 years 27/06/2028 25/09/2028 No 04/03/2026 DLP was amended on 04/03/2026 PSUSA/00000935/202806 Marie Louise Schougaard Christiansen Denmark CAP NAP 936 daunorubicin 08/06/1966 3 years 07/06/2027 05/09/2027 No 05/02/2025 DLP was amended on 05/02/2025 PSUSA/00000936/202706 Sonja Hrabcik Austria NAP 939 deferasirox 28/08/2006 5 years 31/10/2030 29/01/2031 Yes 01/07/2026 PSUR frequency amended and DLP updated on 01/07/2026 DLP was amended on 28/06/2023 PSUSA/00000939/203010 Tiphaine Vaillant France CAP NAP 940 deferiprone 25/08/1999 5 years 31/08/2029 29/11/2029 No 30/04/2025 PSUR frequency amended and DLP updated on 30/04/2025 PSUSA/00000940/202908 Tiphaine Vaillant France CAP 941 deferoxamine 01/12/1962 9 years 03/03/2028 01/06/2028 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00000941/202803 NAP 943 deflazacort 26/03/1982 9 years 03/11/2028 01/02/2029 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00000943/202811 NAP 944 degarelix 17/02/2009 5 years 17/02/2027 18/05/2027 No 19/10/2022 PSUR frequency and DLP were updated on 19/10/2022 PRAC representative was updated on 29/07/2020 PRAC representative was updated on 03/06/2020 DLP was updated on 23/10/2019 PRAC Rapporteur name updated on 21/07/2017 PSUR Frequency amended and DLP updated on 22/09/2016 PRAC Rapporteur name was amended on 28/07/2016 PRAC Rapporteur name updated on 03/06/2016 Next DLP was amended on 30/09/2015. DLP was amended on 01/04/2015. PSUSA/00000944/202702 Tiphaine Vaillant France CAP 945 dehydrocholic acid Not available* 9 years 03/11/2026 01/02/2027 Yes 27/01/2026 Information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" was amended on 05/03/2025 PSUR frequency amended and DLP updated on 05/03/2025 PSUR frequency and DLP amended on 27/03/2024 PSUSA/00000945/202611 Roxana Stefania Udrescu Romania NAP 949 delorazepam 24/02/1978 9 years 03/11/2028 01/02/2029 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00000949/202811 NAP 951 demeclocycline 23/08/1967 10 years 03/08/2034 01/11/2034 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00000951/203408 NAP 954 denosumab (indicated for osteoporosis and for bone loss associated with hormone ablation in prostate cancer) 26/05/2010 3 years 26/09/2027 25/12/2027 No 02/06/2026 PSUSA/00000954/202709 Karin Bolin Sweden CAP 957 dermatan sulfate Not available* 7 years 03/11/2031 01/02/2032 No 30/07/2025 DLP was amended on 30/07/2025 PSUSA/00000957/203111 Amelia Cupelli Italy NAP 958 desflurane 18/09/1992 3 years 30/09/2026 29/12/2026 Yes 05/06/2024 DLP was amended on 05/06/2024 PSUSA/00000958/202609 Melinda Palfi Hungary NAP 962 desloratadine 15/01/2001 5 years 15/07/2026 13/10/2026 No 25/06/2025 Information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" was amended on 25/06/2025 PRAC representative was updated on 19/10/2022 PRAC Representative amended on 28/04/2022 DLP was updated on 30/03/2022 DLP was updated on 28/03/2017 PRAC Representative amended on 18/11/2016 PSUSA/00000962/202607 Jo Robays Belgium CAP NAP 963 desloratadine / pseudoephedrine 30/07/2007 5 years 15/07/2026 13/10/2026 No 28/04/2022 PRAC representative was updated on 19/10/2022 Information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" was amended on 27/07/2022 PRAC Representative amended on 28/04/2022 DLP was updated on 30/03/2022 DLP was updated on 28/03/2017 PRAC Representative amended on 18/11/2016 PSUSA/00000963/202607 Jo Robays Belgium CAP 964 desmopressin 01/12/1972 3 years 31/12/2026 31/03/2027 No 25/09/2024 DLP was amended on 25/09/2024 PSUSA/00000964/202612 Jan Neuhauser Austria NAP 966 desogestrel 01/07/1998 5 years 01/07/2026 29/09/2026 No 02/06/2026 PSUSA/00000966/202607 Jenny Jönsson Sweden NAP 967 desogestrel / ethinylestradiol 01/10/1994 5 years 30/09/2030 29/12/2030 No 01/07/2026 DLP was amended on 01/07/2026 PSUSA/00000967/203009 Kimmo Jaakkola Finland NAP 968 desonide 31/08/1985 9 years 01/12/2028 01/03/2029 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00000968/202812 NAP 969 desoximetasone 23/01/1968 10 years 03/08/2034 01/11/2034 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00000969/203408 NAP 973 dexamethasone (apart from centrally authorised products) 01/01/1952 5 years 31/01/2026 01/05/2026 No 19/10/2022 PRAC representative was updated on 19/10/2022 PRAC representative was updated on 27/07/2022 DLP was updated on 20/10/2021 PRAC representative was updated on 30/06/2021 Next DLP was amended on 19/10/2016 Entry name amended on 03/05/2016 Rapporteur's name was amended on 27/11/2015. Lead MS added on 31/07/2015. PSUSA/00000973/202601 Amelia Cupelli Italy NAP 974 dexamethasone / framycetin / gramicidin 10/08/1954 11 years 01/12/2036 01/03/2037 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00000974/203612 NAP 977 dexamethasone / neomycin / polymyxin b, dexamethasone / neomycin 01/01/1952 10 years 01/12/2032 01/03/2033 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00000977/203212 none NAP 978 dexamethasone / polymyxin b / trimethoprim 01/01/1952 12 years 03/06/2040 01/09/2040 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00000978/204006 NAP 979 dexamethasone / tobramycin (topical and ophtalmic use, except systemic formulations) Not available* 5 years 31/03/2026 29/06/2026 No 27/07/2022 PRAC representative was updated on 27/07/2022 DLP and active substance name updated on 22/12/2021 PRAC representative was updated on 30/06/2021 LMS and PRAC representative were added on 23/06/2020 PSUR Frequency amended and next DLP updated on 25/09/2017 PSUSA/00000979/202603 Amelia Cupelli Italy NAP 980 dexamethasone / lidocaine Not available* 8 years 11/05/2032 09/08/2032 Yes 05/06/2024 PSUR frequency amended and DLP updated on 05/06/2024 Information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" was amended on 05/06/2024 Active substance name was amended on 05/06/2024 PSUSA/00000980/203205 none NAP 982 dexamethasone isonicotinate / tramazoline hydrochloride monohydrate 01/01/1963 11 years 03/07/2039 01/10/2039 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00000982/203907 NAP 983 dexamethasone / framycetin sulfate / polymyxin b sulfate Not available* 10 years 01/12/2032 01/03/2033 Yes 05/06/2024 PSUR frequency amended and DLP updated on 05/06/2024 Information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" was amended on 05/06/2024 Entry re-activated on 05/06/2024 Name of active substance was amended on 28/02/2013 PSUSA/00000983/203212 none NAP 984 dexamethasone sodium phosphate / gentamicin sulfate Not available* 9 years 03/08/2030 01/11/2030 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00000984/203008 NAP 985 dexamethasone (centrally authorised product indicated in uveitis and macular oedema) 27/07/2010 5 years 27/01/2030 27/04/2030 No 22/10/2025 PSUR frequency amended and DLP updated on 22/10/2025 PSUSA/00000985/203001 Maria del Pilar Rayon Spain CAP 986 dexamfetamine Not available* 3 years 11/09/2027 10/12/2027 Yes 30/04/2025 PSUR frequency amended and DLP updated on 30/04/2025 PSUSA/00000986/202709 Ana Sofia Diniz Martins Portugal NAP 989 dexchlorpheniramine 18/02/1962 3 years 30/06/2027 28/09/2027 No 05/03/2025 DLP was amended on 05/03/2025 PSUSA/00000989/202706 Ana Sofia Diniz Martins Portugal NAP 996 dexibuprofen 25/07/2000 3 years 31/08/2026 29/11/2026 No 30/04/2024 DLP was amended on 30/04/2024 PSUSA/00000996/202608 Jan Neuhauser Austria NAP 997 dexketoprofen, dexketoprofen / tramadol 07/07/2002 5 years 31/10/2029 29/01/2030 No 19/09/2025 Entry name updated on 24/09/2025 PSUR frequency amended and DLP updated on 25/06/2025 PSUSA/00000997/202910 Maria Martinez Gonzalez Spain NAP 998 dexmedetomidine 16/09/2011 3 years 15/03/2027 13/06/2027 No 20/11/2024 DLP was amended on 20/11/2024 PSUSA/00000998/202703 Karin Bolin Sweden CAP NAP 999 dexpanthenol 03/03/1999 10 years 02/01/2034 02/04/2034 No 25/09/2024 PSUR frequency amended and DLP updated on 25/09/2024 PSUSA/00000999/203401 Terhi Lehtinen Finland NAP 1000 dexpanthenol / dimethyl sulfoxide / heparin Not available* 8 years 03/03/2034 01/06/2034 No 05/08/2025 PSUR frequency and DLP amended on 31/07/2024. PSUSA/00001000/203403 Jan Neuhauser Austria NAP 1001 dexrazoxane 17/02/1992 3 years 28/02/2028 28/05/2028 No 22/10/2025 PSUR frequency amended and DLP updated on 22/10/2025 PSUSA/00001001/202802 Tiphaine Vaillant France CAP NAP 1002 dextran Not available* 10 years 03/06/2035 01/09/2035 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00001002/203506 NAP 1006 dextran 70 / sodium chloride Not available* 11 years 03/03/2040 01/06/2040 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00001006/204003 NAP 1009 dextromethorphan, dextromethorphan / guaifenesin 01/01/1966 5 years 01/11/2026 30/01/2027 No 20/05/2026 Lead MS and PRAC Rapporteur name updated on 27/05/2026 Entry amended following merge on 28/05/2025 Information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" was amended on 26/07/2023 PSUR frequency and DLP were updated on 28/06/2022 PRAC Representative was amended on 28/04/2022 DLP was updated on 03/07/2019 PRAC Representative was amended on 18/11/2016 Next DLP was amended on 28/07/2016 Lead MS added on 16/06/2015 PSUSA/00001009/202611 Maria del Pilar Rayon Spain NAP 1013 dextromethorphan hydrobromide / diphenhydramine hydrochloride / levomenthol Not available* 7 years 03/11/2031 01/02/2032 No 30/07/2025 DLP was amended on 30/07/2025 PSUSA/00001013/203111 John Joseph Borg Malta NAP 1015 dextromethorphan hydrobromide / paracetamol / phenylpropanolamine hydrochloride Not available* 9 years 03/08/2030 01/11/2030 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00001015/203008 NAP 1021 dextromethorphan hydrobromide / pseudoephedrine hydrochloride / triprolidine hydrochloride Not available* 10 years 03/11/2034 01/02/2035 No 19/09/2025 PSUR frequency amended and DLP updated on 30/07/2025 PSUSA/00001021/203411 Maria Martinez Gonzalez Spain NAP 1026 diacerein 12/08/2007 5 years 15/12/2025 15/03/2026 Yes 22/09/2021 PSUR frequency and DLP were updated on 22/09/2021 PRAC representative was updated on 26/05/2021 PRAC Representative updated on 26/09/2018 DLP was updated on 31/07/2018 PSUR Frequency amended and next DLP updated on 25/09/2017 'PRAC Rapporteur name updated on 21/07/2017 Next DLP and PRAC Rapporteur name were amended on 28/07/2016 DLP amended on 31/07/2015 'Lead MS was added on 22/12/2014 Information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" was amended on 28/05/2014 PSUSA/00001026/202512 Tiphaine Vaillant France NAP 1028 diamorphine Not available* 7 years 03/11/2031 01/02/2032 No 30/07/2025 DLP was amended on 30/07/2025 PSUSA/00001028/203111 Liana Martirosyan Netherlands NAP 1029 diazepam 29/11/1963 8 years 03/03/2033 01/06/2033 No 19/11/2025 DLP was amended on 19/11/2025 PSUSA/00001029/203303 Karin Erneholm Denmark NAP 1030 diazepam / pyridoxine 04/04/1966 11 years 02/12/2039 01/03/2040 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00001030/203912 NAP 1032 diazoxide 29/12/1972 9 years 03/06/2028 01/09/2028 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00001032/202806 NAP 1034 dibotermin alfa 09/09/2002 5 years 08/09/2030 07/12/2030 No 27/05/2026 DLP was amended on 27/05/2026 PSUSA/00001034/203009 Bianca Mulder Netherlands CAP 1040 diclofenac / misoprostol Not available* 3 years 17/07/2028 15/10/2028 No 01/04/2026 PSUR frequency amended and DLP updated on 01/04/2026 PSUSA/00001040/202807 Karin Erneholm Denmark NAP 1041 cyanocobalamin / diclofenac / pyridoxine / thiamine Not available* 5 years 01/01/2030 01/04/2030 Yes 24/09/2025 DLP was amended on 24/09/2025 PSUSA/00001041/203001 Adam Przybylkowski Poland NAP 1044 diclofenac / lidocaine 11/11/2009 5 years 11/11/2029 09/02/2030 Yes 17/12/2025 Entry re-activated on 17/12/2025 PSUSA/00001044/202911 to be assigned none NAP 1045 diclofenac sodium / orphenadrine citrate Not available* 8 years 03/03/2026 01/06/2026 No 27/01/2026 PSUR frequency and DLP amended on 31/07/2024. PSUSA/00001045/202603 Roxana Stefania Udrescu Romania NAP 1048 diclofenac (systemic formulations) 11/05/1977 5 years 30/09/2029 29/12/2029 No 16/10/2023 PRAC Rapporteur name was amended on 18/10/2023 PSUSA/00001048/202909 Karin Erneholm Denmark NAP 1050 dicloxacillin 24/02/1961 10 years 02/04/2034 01/07/2034 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00001050/203404 NAP 1051 dicycloverine, dicyloverine/ paracetamol, dicycloverine/ doxylamine 11/05/1950 11 years 03/05/2040 01/08/2040 Yes 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00001051/204005 NAP 1057 dienogest / ethinylestradiol 14/02/1995 5 years 15/03/2028 13/06/2028 No 15/11/2023 DLP was amended on 15/11/2023 PSUSA/00001057/202803 Dennis Lex Germany NAP 1058 diethylamine salicylate Not available* 11 years 03/03/2040 01/06/2040 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00001058/204003 NAP 1059 diethylcarbamazine 09/01/1974 9 years 03/06/2028 01/09/2028 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00001059/202806 NAP 1061 diflucortolone Not available* 9 years 03/08/2030 01/11/2030 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00001061/203008 NAP 1062 diflucortolone valerate / isoconazole nitrate Not available* 9 years 03/08/2030 01/11/2030 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00001062/203008 NAP 1063 diflunisal (for nationally authorised products) Not available* 9 years 03/11/2030 01/02/2031 No 24/09/2025 Entry name updated on 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00001063/203011 none NAP 1064 digitoxin 11/09/1952 10 years 01/01/2034 01/04/2034 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00001064/203401 NAP 1065 digoxin, metildigoxin 01/11/1930 10 years 03/11/2032 01/02/2033 No 18/10/2023 PSUR frequency amended and DLP updated on 18/10/2023 PSUSA/00001065/203211 none NAP 1066 digoxin specific antibody fragments 05/10/1983 9 years 01/12/2028 01/03/2029 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00001066/202812 NAP 1069 artenimol / piperaquine tetraphosphate 27/10/2011 5 years 27/10/2030 25/01/2031 No 01/07/2026 PSUR frequency amended and DLP updated on 01/07/2026 DLP was amended on 28/06/2023 PSUSA/00001069/203010 Dennis Lex Germany CAP 1070 dihydrocodeine 11/11/1921 11 years 03/11/2036 01/02/2037 No 18/10/2023 Information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" , PSUR frequency and DLP wereamended on 18/10/2023 PSUSA/00001070/203611 none NAP 1075 dihydroergotamine 01/07/1946 3 years 01/04/2027 30/06/2027 Yes 18/12/2024 DLP was amended on 18/12/2024 PSUSA/00001075/202704 Adam Przybylkowski Poland NAP 1080 dihydrotachysterol 01/04/1959 10 years 31/01/2034 01/05/2034 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00001080/203401 NAP 1082 diiodohydroxyquinoline Not available* 9 years 03/11/2030 01/02/2031 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00001082/203011 NAP 1083 diisopropylamine Not available* 9 years 03/11/2030 01/02/2031 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00001083/203011 NAP 1084 diltiazem 02/05/1979 5 years 02/05/2027 31/07/2027 No 16/10/2023 PRAC Rapporteur name was amended on 18/10/2023 PSUSA/00001084/202705 Karin Erneholm Denmark NAP 1088 caffeine / dimenhydrinate, dimenhydrinate 10/02/1950 8 years 01/12/2033 01/03/2034 No 29/07/2026 DLP was amended on 29/07/2026 PSUSA/00001088/203312 Maria Martinez Gonzalez Spain NAP 1089 dimercaptosuccinic acid (dmsa) 31/05/1982 9 years 01/12/2028 01/03/2029 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00001089/202812 NAP 1094 dimeticone 17/11/1965 10 years 03/06/2034 01/09/2034 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00001094/203406 NAP 1095 aluminium hydroxide gel / dimeticone / magnesium hydroxide Not available* 9 years 03/03/2029 01/06/2029 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00001095/202903 NAP 1097 clebopride / dimeticone Not available* 9 years 01/12/2029 01/03/2030 No 28/08/2024 PSUR frequency and DLP amended on 28/08/2024. PSUSA/00001097/202912 NAP 1098 dihydroxyaluminum sodium carbonate, dihydroxyaluminum sodium carbonate / dimeticone Not available* 10 years 03/11/2034 01/02/2035 No 30/07/2025 PSUR frequency amended and DLP updated on 30/07/2025 PSUSA/00001098/203411 Ana Sofia Diniz Martins Portugal NAP 1099 dimeticone / guaiazulene Not available* 8 years 03/03/2026 01/06/2026 No 07/07/2026 PSUR frequency and DLP amended on 31/07/2024. PSUSA/00001099/202603 Thiphaine Vaillant France NAP 1100 dimeticone / metoclopramide / oxazepam hemisuccinate / polyenzymes Not available* 10 years 03/06/2035 01/09/2035 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00001100/203506 NAP 1101 dimetindene 01/08/1961 10 years 03/05/2034 01/08/2034 No 03/10/2024 Updated & published on 23/10/2024 PSUSA/00001101/203405 NAP 1102 dimetindene / phenylephrine 29/09/1965 5 years 15/07/2030 13/10/2030 No 01/04/2026 DLP was amended on 01/04/2026 PSUSA/00001102/203007 Jana Pecherova Slovakia NAP 1103 dinoprost trometamol 08/05/1973 9 years 03/06/2028 01/09/2028 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00001103/202806 NAP 1104 dinoprostone 26/09/1972 3 years 30/09/2028 29/12/2028 No 01/07/2026 DLP was amended on 01/07/2026 PSUSA/00001104/202809 Jenny Jönsson Sweden NAP 1105 diosmectite 12/11/1975 9 years 03/08/2028 01/11/2028 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00001105/202808 NAP 1106 diosmin Not available* 9 years 03/11/2030 01/02/2031 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00001106/203011 NAP 1107 diosmin / hesperidin, ascorbic acid/ dry Ruscus extract titrated in sterolic heterosides/ Hesperidin methyl chalcone Not available* 9 years 03/11/2030 01/02/2031 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00001107/203011 Polona Golmajer Slovenia NAP 1110 diphenhydramine / paracetamol Not available* 7 years 03/11/2031 01/02/2032 No 30/07/2025 DLP was amended on 30/07/2025 PSUSA/00001110/203111 Rhea Fitzgerald Ireland NAP 1112 dexamethasone / diphenhydramine hydrochloride Not available* 9 years 03/03/2030 01/06/2030 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00001112/203003 NAP 1113 allantoin / dexpanthenol / diphenhydramine hydrochloride Not available* 9 years 03/03/2029 01/06/2029 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00001113/202903 NAP 1115 codeine phosphate / diphenhydramine hydrochloride / levomenthol Not available* 9 years 03/03/2030 01/06/2030 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00001115/203003 NAP 1116 diphenhydramine hydrochloride / lorazepam Not available* 9 years 03/11/2030 01/02/2031 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00001116/203011 NAP 1117 anhydrous caffeine / codeine phosphate / diphenhydramine hydrochloride / paracetamol, caffeine / codeine phosphate / diphenhydramine hydrochloride / paracetamol / phenylephrine hydrochloride / ascorbic acid, caffeine / codeine phosphate / diphenhydramine hydrochloride / paracetamol / phenylephrine hydrochloride Not available* 9 years 03/03/2029 01/06/2029 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00001117/202903 NAP 1118 diphenhydramine hydrochloride / paracetamol / pseudoephedrine hydrochloride Not available* 9 years 03/11/2030 01/02/2031 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00001118/203011 NAP 1119 ammonium chloride / diphenhydramine hydrochloride / sodium citrate Not available* 9 years 03/03/2029 01/06/2029 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00001119/202903 NAP 1122 diphtheria / tetanus / pertussis antigens (pertussis toxoid, filamentous haemagglutinin, pertactin) (acellular, component) / hepatitis b (rdna) / poliomyelitis (inactivated) / haemophilus type b conjugate vaccines (adsorbed) 23/10/2000 3 years 22/10/2026 20/01/2027 No 03/07/2024 DLP was amended on 03/07/2024 PSUSA/00001122/202610 Jean-Michel Dogné Belgium CAP 1124 diphtheria / tetanus / pertussis (acellular, component) / poliomyelitis (inactivated) / haemophilus type b conjugate vaccine (adsorbed) 27/06/1997 3 years 13/11/2026 11/02/2027 No 06/10/2025 DLP was amended on 31/07/2024 PSUSA/00001124/202611 Dirk Mentzer Germany NAP 1125 diphtheria / tetanus / pertussis (acellular, component) vaccine (adsorbed), diphtheria / tetanus / pertussis (acellular, component) vaccine (adsorbed) reduced antigens contents 17/03/1995 5 years 16/03/2027 14/06/2027 No 06/10/2025 PRAC representative was updated on 01/03/2023 DLP was updated on 16/11/2022 DLP was updated on 19/12/2017 Lead MS and PRAC Rapporteur name was added on 19/10/2016 The DLP was amended on 30/09/2015 Name of active substance was amended on 28/03/2013 PSUSA/00001125/202703 Dirk Mentzer Germany NAP 1126 diphtheria / tetanus / pertussis (acellular, component) and poliomyelitis (inactivated) vaccine (adsorbed), diphtheria / tetanus / pertussis (acellular, component) and poliomyelitis (inactivated) vaccine (adsorbed, reduced antigen(s) content) 08/07/1991 5 years 08/07/2030 06/10/2030 No 04/03/2026 DLP was amended on 04/03/2026 PSUSA/00001126/203007 Marie Louise Schougaard Christiansen Denmark NAP 1127 diphtheria / tetanus / poliomyelitis (inactivated) vaccine (adsorbed, reduced antigens(s) content) 05/02/1999 5 years 04/08/2027 02/11/2027 No 06/10/2025 DLP was updated on 05/04/2023 PRAC representative was updated on 01/03/2023 DLP was updated on 07/05/2018 PRAC representative and Lead Member State were added on 30/01/2017 PSUSA/00001127/202708 Dirk Mentzer Germany NAP 1128 diphtheria / tetanus vaccines (adsorbed), diphtheria vaccines (adsorbed) 10/05/1990 5 years 09/05/2030 07/08/2030 No 04/02/2026 DLP was amended on 04/02/2026 PSUSA/00001128/203005 Dirk Mentzer Germany NAP 1135 diprophylline, diprophylline / turpentine oil Not available* 11 years 02/04/2040 01/07/2040 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00001135/204004 Amelia Cupelli Italy NAP 1138 dipyridamole 11/11/1959 9 years 02/12/2027 01/03/2028 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00001138/202712 NAP 1143 disopyramide 18/04/1967 9 years 02/04/2028 01/07/2028 No 15/01/2025 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00001143/202804 Jean-Michel Dogné Belgium NAP 1144 distigmine 01/04/1979 9 years 03/11/2028 01/02/2029 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00001144/202811 NAP 1145 disulfiram 04/03/1971 9 years 03/06/2028 01/09/2028 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00001145/202806 NAP 1150 dobesilate calcium 13/10/1970 9 years 03/05/2028 01/08/2028 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00001150/202805 NAP 1151 dobutamine 21/03/1977 3 years 01/03/2027 30/05/2027 No 19/09/2024 PSUSA/00001151/202703 Zoubida Amimour France NAP 1152 docetaxel 25/11/1995 5 years 30/11/2027 28/02/2028 No 26/07/2023 PSUR frequency amended and DLP updated on 26/07/2023 PSUSA/00001152/202711 Tiphaine Vaillant France CAP NAP 1158 domperidone 01/03/1978 5 years 19/11/2029 17/02/2030 No 30/07/2025 DLP was amended on 30/07/2025 PSUSA/00001158/202911 Jo Robays Belgium NAP 1160 donepezil 25/11/1996 5 years 25/11/2026 23/02/2027 No 27/07/2022 DLP was updated on 27/07/2022 Lead MS and PRAC Rapporteur name amended on 19/12/2018 Next DLP was amended on 25/09/2017 Lead MS and PRAC Rapporteur name was added on 28/07/2016 Information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" was amended on 30/11/2012 PSUSA/00001160/202611 Dennis Lex Germany NAP 1161 dopamine 09/10/1975 9 years 03/08/2028 01/11/2028 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00001161/202808 NAP 1162 dopexamine 13/11/1989 9 years 31/01/2029 01/05/2029 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00001162/202901 NAP 1164 dornase alfa 03/09/1993 5 years 02/09/2027 01/12/2027 No 12/09/2025 DLP was amended on 03/05/2023 Lead MS and PRAC Rapporteur name amended on 19/12/2018 DLP was updated on 06/06/2018 Lead MS and PRAC Rapporteur name was added on 28/02/2017 PSUSA/00001164/202709 Veronika Macurová Czech Republic NAP 1166 dorzolamide / timolol 06/03/1998 5 years 18/02/2029 19/05/2029 No 16/10/2023 PRAC Rapporteur name was amended on 18/10/2023 PSUSA/00001166/202902 Karin Erneholm Denmark NAP 1167 dosulepin 17/04/1973 9 years 03/06/2028 01/09/2028 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00001167/202806 NAP 1168 doxapram hydrochloride 18/12/1967 10 years 03/08/2034 01/11/2034 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00001168/203408 NAP 1169 doxazosin 18/12/1986 7 years 17/12/2030 17/03/2031 No 25/09/2024 PSUR frequency amended and DLP updated on 25/09/2024 PSUSA/00001169/203012 Karin Erneholm Denmark NAP 1170 doxepin 01/08/1969 9 years 03/05/2028 01/08/2028 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00001170/202805 NAP 1172 doxorubicin 21/06/1996 5 years 12/11/2027 10/02/2028 No 28/06/2022 PSUR frequency amended and DLP updated on 28/06/2023 PSUSA/00001172/202711 Eva Jirsová Czech Republic CAP NAP 1173 doxycycline 05/05/1967 8 years 03/03/2033 01/06/2033 No 19/11/2025 DLP was amended on 19/11/2025 PSUSA/00001173/203303 Liana Martirosyan Netherlands NAP 1174 doxylamine 07/04/1948 5 years 06/04/2028 05/07/2028 No 20/12/2023 PSUR frequency amended and DLP updated on 20/12/2023 PSUSA/00001174/202804 Ana Sofia Diniz Martins Portugal NAP 1176 doxylamine succinate / pyridoxine hydrochloride 07/04/1948 10 years 03/11/2032 01/02/2033 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00001176/203211 NAP 1178 bemotrizinol / butyl methoxydibenzoylmethane / drometrizole Not available* 9 years 03/05/2029 01/08/2029 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00001178/202905 NAP 1180 dronedarone 26/11/2009 5 years 31/07/2030 29/10/2030 No 01/04/2026 PSUR frequency amended and DLP updated on 01/04/2026 PSUSA/00001180/203007 Bianca Mulder Netherlands CAP 1181 droperidol 20/04/1963 9 years 03/03/2028 01/06/2028 No 26/07/2023 Information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" was amended on 26/07/2023 Update of PSUR frequency & DLP resulting from PRAC re-allocation exercise for entries with DLPs in 2025 on 26/07/2023 PSUSA/00001181/202803 none NAP 1182 droperidol / fentanyl 14/08/1974 10 years 03/03/2035 01/06/2035 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00001182/203503 NAP 1184 drospirenone / estradiol 07/03/2000 5 years 10/12/2029 10/03/2030 No 30/07/2025 DLP was amended on 30/07/2025 PSUSA/00001184/202912 Bianca Mulder Netherlands NAP 1186 drotaverine Not available* 9 years 03/11/2030 01/02/2031 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00001186/203011 none NAP 1187 duloxetine 11/08/2004 5 years 03/08/2028 01/11/2028 No 30/04/2024 PSUR frequency amended and DLP updated on 30/04/2024 PSUSA/00001187/202808 Maria del Pilar Rayon Spain CAP NAP 1188 ossein hydroxyapatite compound Not available* 8 years 03/11/2026 01/02/2027 No 11/06/2025 Correction of DLP on 20/11/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00001188/202611 Guðrún Stefánsdóttir Iceland NAP 1190 dydrogesterone 22/04/1960 9 years 01/02/2028 01/05/2028 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00001190/202802 NAP 1191 ebastine 01/01/1996 5 years 31/05/2028 29/08/2028 No 31/01/2024 Next DLP was updated on 31/01/2024 PSUSA/00001191/202805 Marie Louise Schougaard Christiansen Denmark NAP 1195 econazole, econazole nitrate / triamcinolone acetonide 04/01/1974 5 years 16/11/2027 14/02/2028 No 26/07/2023 Next DLP was updated on 26/07/2023 PSUSA/00001195/202711 Melinda Palfi Hungary NAP 1198 eculizumab 20/06/2007 2 years 01/10/2027 30/12/2027 No 01/07/2026 DLP was amended on 01/07/2026 PSUSA/00001198/202710 Maria Martinez Gonzalez Spain CAP 1200 efavirenz 28/05/1999 5 years 16/04/2027 15/07/2027 Yes 22/10/2025 Information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" was amended on 22/10/2025 Entry re-activated on 22/10/2025 PSUR frequency and DLP were updated on 21/12/2022 PSUR frequency and DLP were updated on 18/12/2019 DLP was updated on 19/12/2018 DLP was updated on 19/12/2017 Reference to NAP added on 23/05/2017 Correction of PRAC Rapporteur name on 28/02/2017 Next DLP was updated on 18/11/2016 PSUR Frequency and Next DLP was amended on 21/12/2015. "Are PSURs required for products referred to in Articles 10(1), 10a, 14 and 16a of Directive 2001/83/EC as amended?Yes/No" was amended on 06/03/2015 PSUSA/00001200/202704 Ana Sofia Diniz Martins Portugal NAP 1201 efavirenz / emtricitabine / tenofovir 13/12/2007 5 years 12/07/2026 10/10/2026 Yes 23/02/2026 Entry re-introduced and reference to NAP added on 27/03/2024 Information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" and PSUR frequency amended on 28/04/2022 Next DLP was updated on 06/03/2019 Next DLP updated on 04/03/2016 PSUSA/00001201/202607 Martin Huber Germany CAP NAP 1202 eflornithine (topical use) 20/03/2001 5 years 26/07/2028 24/10/2028 No 27/03/2024 DLP was amended on 27/03/2024 PSUSA/00001202/202807 Rhea Fitzgerald Ireland CAP 1204 eletriptan 20/01/2000 5 years 19/02/2026 20/05/2026 No 20/10/2021 DLP was updated on 20/10/2021 PRAC Rapporteur name updated on 27/06/2017 Next DLP was updated on 18/11/2016 The DLP amended on 30/09/2015 Lead MS was added on 13/07/2015 PSUSA/00001204/202602 Eva Jirsová Czech Republic NAP 1205 eltrombopag 11/03/2010 3 years 30/09/2027 29/12/2027 No 19/09/2025 DLP was updated on 25/05/2022 PSUR frequency and DLP were updated on 30/04/2019 DLP was updated on 07/05/2018 DLP was updated on 23/05/2017 PRAC Representative amended on 28/06/2016 Next DLP was amended on 03/05/2016 PSUSA/00001205/202709 Maria Martinez Gonzalez Spain CAP 1207 emedastine 27/01/1999 3 years 31/05/2026 29/08/2026 No 19/09/2024 PSUSA/00001207/202605 Zoubida Amimour France CAP 1209 emtricitabine 24/10/2003 3 years 02/04/2026 01/07/2026 No 20/12/2023 DLP was amended on 20/12/2023 PSUSA/00001209/202604 Ana Sofia Diniz Martins Portugal CAP 1210 emtricitabine / tenofovir disoproxil 21/02/2005 3 years 02/04/2026 01/07/2026 No 20/12/2023 DLP was amended on 20/12/2023 PSUSA/00001210/202604 Ana Sofia Diniz Martins Portugal CAP 1211 enalapril 01/11/2004 5 years 31/03/2028 29/06/2028 No 02/06/2026 PSUSA/00001211/202803 Karin Bolin Sweden NAP 1212 enalapril / hydrochlorothiazide 24/03/2002 5 years 26/07/2027 24/10/2027 No 16/10/2023 PRAC Rapporteur name was amended on 18/10/2023 PSUSA/00001212/202707 Karin Erneholm Denmark NAP 1213 enalapril / nitrendipine 08/01/2002 7 years 08/01/2030 08/04/2030 No 20/09/2023 DLP and PSUR frequency amended on 20/09/2023 PSUSA/00001213/203001 Maria del Pilar Rayon Spain NAP 1214 enalapril maleate / felodipine Not available* 9 years 03/11/2030 01/02/2031 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00001214/203011 NAP 1215 enalapril maleate / lercanidipine 26/07/2006 7 years 03/06/2031 01/09/2031 No 05/02/2025 DLP was amended on 05/02/2025 PSUSA/00001215/203106 Carla Torre Portugal NAP 1217 enfuvirtide 27/05/2003 5 years 12/03/2026 10/06/2026 No 02/06/2026 PSUSA/00001217/202603 Karin Bolin Sweden CAP 1220 enoximone 27/10/1987 9 years 01/01/2029 01/04/2029 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00001220/202901 NAP 1221 enoxolone 28/09/1988 9 years 01/01/2029 01/04/2029 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00001221/202901 NAP 1223 entacapone 16/09/1998 3 years 16/01/2028 15/04/2028 No 24/09/2025 DLP was amended on 24/09/2025 PSUSA/00001223/202801 Terhi Lehtinen Finland CAP 1224 entecavir 26/06/2006 5 years 28/03/2027 26/06/2027 No 02/06/2026 PSUSA/00001224/202703 Karin Bolin Sweden CAP 1225 eosine Not available* 8 years 03/03/2034 01/06/2034 No 05/08/2025 PSUR frequency and DLP amended on 31/07/2024. PSUSA/00001225/203403 Amelia Cupelli Italy NAP 1228 ephedrine 15/05/1952 10 years 01/12/2032 01/03/2033 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00001228/203212 NAP 1229 ephedrine hydrochloride / glaucine hydrobromide Not available* 9 years 03/11/2030 01/02/2031 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00001229/203011 NAP 1231 epinastine 18/10/2002 5 years 31/10/2027 29/01/2028 No 28/06/2023 Next DLP was updated on 28/06/2023 DLP was updated on 04/07/2018 PRAC representative and Lead Member State were added on 28/03/2017 PSUSA/00001231/202710 Karin Bolin Sweden NAP 1232 epinephrine (except for nasal use) 15/05/1952 5 years 15/07/2030 13/10/2030 No 01/04/2026 DLP was amended on 01/04/2026 PSUSA/00001232/203007 Zoubida Amimour France NAP 1233 epinephrine / lidocaine 01/10/1948 8 years 30/09/2028 29/12/2028 No 30/06/2021 DLP was updated on 30/06/2021 PRAC representative was added on 06/05/2020 LMS was added on 01/04/2020 The DLP was amended on 03/03/2014 PSUSA/00001233/202809 Eamon O'Murchu Ireland NAP 1234 epirubicin 28/06/1982 5 years 30/06/2028 28/09/2028 No 28/02/2024 PSUR frequency amended and DLP updated on 28/02/2024 PSUSA/00001234/202806 Marie Louise Schougaard Christiansen Denmark NAP 1236 eplerenone 16/03/2004 7 years 15/03/2029 13/06/2029 No 31/01/2024 PRAC representative updated on 31/01/2024 PSUSA/00001236/202903 Bianca Mulder Netherlands NAP 1237 epoetin alfa 04/08/1988 3 years 31/08/2027 29/11/2027 No 30/04/2025 DLP was amended on 30/04/2025 PSUSA/00001237/202708 Tiphaine Vaillant France CAP NAP 1239 epoetin beta 16/07/1997 3 years 13/02/2026 14/05/2026 No 18/10/2023 Next DLP was updated on 18/10/2023 PSUSA/00001239/202602 Dennis Lex Germany CAP 1240 epoetin theta 23/10/2009 5 years 20/04/2029 19/07/2029 No 18/12/2024 PSUR frequency amended and DLP updated on 18/12/2024 PSUSA/00001240/202904 Tiphaine Vaillant France CAP 1241 epoetin zeta 18/12/2007 3 years 18/12/2026 18/03/2027 No 25/09/2024 Reference to NAP removed on 25/09/2024 Next DLP was updated on 25/09/2024 DLP was updated and reference to NAP added on 22/09/2021 PRAC Rapporteur name was amended on 31/07/2018 DLP was updated on 31/07/2018 Next DLP updated on 30/09/2015 PSUSA/00001241/202612 Dennis Lex Germany CAP 1242 epoprostenol 18/03/1981 5 years 31/03/2027 29/06/2027 No 21/12/2022 DLP was updated on 21/12/2022 PRAC Rapporteur name updated on 23/10/2018 DLP was updated on 19/12/2017 Lead MS and PRAC Rapporteur name was added on 19/10/2016 PSUSA/00001242/202703 Eamon O'Murchu Ireland NAP 1243 eprosartan 30/04/1997 5 years 30/04/2027 29/07/2027 No 01/02/2023 DLP was updated on 01/02/2023 PRAC Rapporteur name was amended on 31/07/2018 DLP was amended on 31/01/2018 Lead MS and PRAC Rapporteur name was added on 19/10/2016 PSUSA/00001243/202704 Dennis Lex Germany NAP 1244 eprosartan / hydrochlorothiazide 30/04/1997 5 years 30/04/2027 29/07/2027 No 01/02/2023 DLP was updated on 01/02/2023 PRAC Rapporteur name was amended on 31/07/2018 DLP was amended on 31/01/2018 Lead MS and PRAC Rapporteur name was added on 19/10/2016 PSUSA/00001244/202704 Dennis Lex Germany NAP 1245 eptacog alfa 23/02/1996 5 years 31/12/2025 31/03/2026 No 22/09/2021 PSUR frequency, DLP and active substance name were updated on 22/09/2021 PRAC Representative updated on 26/09/2018 DLP was updated on 31/07/2018 Reference to NAP products removed on 19/12/2017 Reference to NAP products added on 17/10/2017 PSUR Frequency amended on 31/07/2015 PSUSA/00001245/202512 Bianca Mulder Netherlands CAP 1248 erdosteine Not available* 10 years 01/02/2026 02/05/2026 No 19/10/2016 PRAC Rapporteur name was amended on 28/04/2022 PRAC Rapporteur name was amended on 03/04/2019 PSUR Frequency amended and DLP updated on 19/10/2016 Lead MS added on 31/07/2015. PSUSA/00001248/202602 Marie Louise Schougaard Christiansen Denmark NAP 1251 ergometrine / oxytocin 15/06/1960 10 years 02/04/2034 01/07/2034 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00001251/203404 NAP 1252 belladonna alkaloids / caffeine / ergotamine tartrate / paracetamol Not available* 9 years 03/05/2029 01/08/2029 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00001252/202905 NAP 1253 belladonna alkaloids / ergotamine tartrate / phenobarbital Not available* 9 years 03/05/2029 01/08/2029 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00001253/202905 NAP 1254 eribulin 15/11/2010 5 years 14/11/2028 12/02/2029 No 02/06/2026 PSUSA/00001254/202811 Jenny-Maria Jönsson Sweden CAP 1255 erlotinib 19/09/2005 3 years 17/11/2026 15/02/2027 No 31/07/2024 PSUR frequency amended and DLP updated on 31/07/2024 PSUSA/00001255/202611 Marie Louise Schougaard Christiansen Denmark CAP NAP 1256 ertapenem 18/04/2002 5 years 29/03/2030 27/06/2030 No 16/12/2020 New CAP authorised on 15/07/2022 PSUR frequency, DLP and Information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" were updated on 16/12/2020 Reference to NAP added on 25/09/2019 LMS and PRAC representative updated 05/06/2019 DLP was amended on 15/11/2017 PRAC Representative was amended on 28/03/2017 PRAC Rapporteur name updated on 30/09/2015 The next DLP was amended on 01/12/2014 PSUSA/00001256/203003 Ana Sofia Diniz Martins Portugal CAP NAP 1258 benzoyl peroxide / erythromycin Not available* 9 years 03/06/2029 01/09/2029 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00001258/202906 NAP 1259 erythromycin / tretinoin, isotretinoin, erythromycin / isotretinoin 24/10/2001 5 years 24/10/2026 22/01/2027 No 17/02/2026 Active substance name was amended on 30/07/2025 DLP was updated on 29/06/2022 PRAC representative was updated on 22/12/2021 PRAC representative was udpated on 06/05/2020 Next DLP was amended on 27/06/2017 PRAC representative and Lead Member State were added on 03/05/2016 PSUSA/00001259/202610 Jana Pecherova Slovakia NAP 1260 erythromycin / zinc acetate Not available* 9 years 03/11/2030 01/02/2031 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00001260/203011 NAP 1263 escherichia coli lysate 11/12/1987 5 years 31/07/2030 29/10/2030 No 01/04/2026 DLP was amended on 01/04/2026 PSUSA/00001263/203007 Dirk Mentzer Germany NAP 1264 escherichia coli (living cells) Not available* 15 years 31/12/2026 31/03/2027 No 19/12/2018 Entry name amended on 19/12/2018 PSUSA/00001264/202612 NAP 1265 escitalopram 31/12/2001 5 years 31/12/2026 31/03/2027 No 21/09/2022 DLP was updated on 21/09/2022 PRAC Rapporteur name was amended on 31/07/2018 Next DLP was amended on 25/09/2017 Lead MS and PRAC Rapporteur name was added on 28/07/2016 PSUSA/00001265/202612 Karin Bolin Sweden NAP 1266 esketamine (except for centrally authorised products) 01/08/1997 5 years 31/08/2026 29/11/2026 No 28/04/2022 DLP was updated on 28/04/2022 Entry name updated on 05/02/2020 DLP was updated and information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" was amended on 23/05/2017 Lead MS and PRAC Rapporteur name was added on 07/04/2016 PSUSA/00001266/202608 Terhi Lehtinen Finland NAP 1267 eslicarbazepine acetate 21/04/2009 3 years 21/04/2027 20/07/2027 No 18/12/2024 DLP was amended on 18/12/2024 PSUSA/00001267/202704 Dennis Lex Germany CAP NAP 1268 esmolol 13/12/1986 9 years 01/12/2028 01/03/2029 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00001268/202812 NAP 1269 esomeprazole 10/03/2000 5 years 10/03/2029 08/06/2029 No 20/11/2024 PSUR frequency amended and DLP updated on 20/11/2024 PSUSA/00001269/202903 Rugile Pilviniene Lithuania CAP NAP 1270 esomeprazole / naproxen Not available* 5 years 30/04/2027 29/07/2027 No 01/02/2023 DLP was updated on 01/02/2023 PRAC Rapporteur name updated on 23/10/2018 PRAC Representative updated on 26/09/2018 DLP was amended on 31/01/2018 Lead MS and PRAC Rapporteur name was added on 19/10/2016 PSUSA/00001270/202704 Liana Martirosyan Netherlands NAP 1271 estazolam 30/04/1975 9 years 03/08/2028 01/11/2028 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00001271/202808 NAP 1276 dydrogesterone / estradiol 22/02/1995 7 years 02/12/2030 02/03/2031 No 19/09/2024 PSUSA/00001276/203012 Zoubida Amimour France NAP 1277 estradiol / levonorgestrel Not available* 8 years 03/05/2026 01/08/2026 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00001277/202605 NAP 1278 estradiol / norethisterone 22/06/1996 5 years 31/03/2027 29/06/2027 No 02/06/2026 PSUSA/00001278/202703 Jenny Jönsson Sweden NAP 1279 estradiol / testosterone 01/03/1976 10 years 03/03/2035 01/06/2035 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00001279/203503 NAP 1280 estradiol valerate / norgestrel Not available* 8 years 03/05/2026 01/08/2026 No 23/09/2025 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00001280/202605 Adam Przybylkowski Poland NAP 1281 estramustine 02/09/1971 10 years 01/12/2034 01/03/2035 No 05/01/2025 Correction of DLP on 20/11/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00001281/203412 Tiphaine Vaillant France NAP 1282 estriol 01/01/1957 15 years 31/12/2025 31/03/2026 No 26/05/2025 PSUSA/00001282/202512 Terhi Lehtinen Finland NAP 1283 estradiol / estriol Not available* 9 years 03/11/2030 01/02/2031 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00001283/203011 NAP 1284 estradiol / estriol / levonorgestrel Not available* 9 years 03/11/2030 01/02/2031 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00001284/203011 NAP 1293 etacrynic acid 14/05/1965 11 years 02/12/2039 01/03/2040 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00001293/203912 NAP 1294 etamsylate 22/04/1987 15 years 03/06/2040 01/09/2040 No 04/02/2026 PSUR frequency amended and DLP updated on 04/02/2026 PSUSA/00001294/204006 Veronika Macurová Czech Republic NAP 1296 ethacridine Not available* 9 years 03/11/2030 01/02/2031 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00001296/203011 NAP 1297 albumin tannate / ethacridine lactate monohydrate Not available* 9 years 03/03/2029 01/06/2029 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00001297/202903 NAP 1298 ethambutol 17/10/1958 9 years 02/12/2027 01/03/2028 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00001298/202712 NAP 1304 ethanol / povidone iodinated, povidone iodinated / isopropyl alcohol (covers other synonymous terms such as 2-propanol) 22/02/1974 9 years 03/08/2028 01/11/2028 No 04/02/2026 Active substance name was amended on 04/02/2026 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00001304/202808 Zoubida Amimour France NAP 1305 ethanolamine Not available* 8 years 03/06/2027 01/09/2027 Yes 29/07/2026 Information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" was amended on 29/07/2026 DLP was amended on 29/07/2026 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00001305/202706 Tiphaine Vaillant France NAP 1306 ethinylestradiol 01/06/1976 8 years 03/03/2033 01/06/2033 No 19/11/2025 DLP was amended on 19/11/2025 PSUSA/00001306/203303 Amelia Cupelli Italy NAP 1307 ethinylestradiol / etonogestrel 12/06/2001 5 years 01/07/2030 29/09/2030 No 04/03/2026 DLP was amended on 04/03/2026 PSUSA/00001307/203007 Bianca Mulder Netherlands NAP 1308 ethinylestradiol / gestodene 09/07/1986 5 years 16/03/2026 14/06/2026 No 17/11/2021 PRAC Rapporteur name was amended on 28/04/2022 DLP was updated on 17/11/2021 Active substance name was amended on 05/06/2019 PRAC Rapporteur name was amended on 03/04/2019 Next DLP was updated on 18/11/2016 Lead MS was added on 30/09/2015 Name of entry was amended on 28/05/2014 Information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" was amended on 30/11/2012 PSUSA/00001308/202603 Marie Louise Schougaard Christiansen Denmark NAP 1309 ethinylestradiol / levonorgestrel 22/04/1965 5 years 13/04/2030 12/07/2030 No 17/12/2025 PSUR frequency amended and DLP updated on 17/12/2025 PSUSA/00001309/203004 Marie Louise Schougaard Christiansen Denmark NAP 1311 ethinylestradiol / norelgestromin 20/11/2001 5 years 19/11/2029 17/02/2030 No 30/07/2025 DLP was amended on 30/07/2025 PSUSA/00001311/202911 Bianca Mulder Netherlands CAP 1312 ethinylestradiol / norethisterone 07/08/1974 5 years 06/08/2027 04/11/2027 No 31/01/2024 PRAC representative updated on 31/01/2024 PSUSA/00001312/202708 Bianca Mulder Netherlands NAP 1313 ethinylestradiol / norgestimate 29/10/1986 5 years 30/10/2026 28/01/2027 No 29/06/2022 DLP was updated on 29/06/2022 PRAC Rapporteur name was amended on 28/04/2022 PRAC representative and LMS were added on 31/03/2021 Lead MS and PRAC Rapporteur name removed on 05/02/2020 DLP was updated on 21/07/2017 Lead MS and PRAC Rapporteur name was added on 03/06/2016 PSUSA/00001313/202610 Marie Louise Schougaard Christiansen Denmark NAP 1316 ethosuximide 09/03/1961 3 years 09/03/2026 07/06/2026 No 15/11/2023 DLP was amended on 15/11/2023 PSUSA/00001316/202603 Karin Erneholm Denmark NAP 1317 ethyl loflazepate 03/11/1980 8 years 03/03/2033 01/06/2033 No 19/11/2025 DLP was amended on 19/11/2025 PSUSA/00001317/203303 Jo Robays Belgium NAP 1318 ethyl nicotinate / hydroxyethyl salicylate / nonylic acid vanillylamide Not available* 9 years 03/11/2030 01/02/2031 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00001318/203011 NAP 1319 ethylmorphine 19/07/1944 11 years 03/05/2040 01/08/2040 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00001319/204005 NAP 1320 etidronate 30/09/1977 5 years 30/09/2027 29/12/2027 Yes 19/12/2018 Next DLP was updated on 31/05/2023 PSUSA/00001320/202709 Rugile Pilviniene Lithuania NAP 1321 etifoxine Not available* 3 years 19/10/2026 17/01/2027 No 03/07/2024 DLP was amended on 03/07/2024 PSUSA/00001321/202610 Maria Popova-Kiradjieva Bulgaria NAP 1322 etilefrine (except for treatment of priapism) 17/04/1952 12 years 03/06/2040 01/09/2040 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00001322/204006 Terhi Lehtinen Finland NAP 1324 etodolac 02/08/1984 8 years 03/05/2033 01/08/2033 No 04/02/2026 DLP was amended on 04/02/2026 PSUSA/00001324/203305 Karin Erneholm Denmark NAP 1325 etofenamate Not available* 9 years 03/11/2030 01/02/2031 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00001325/203011 NAP 1326 benzyl nicotinate / etofenamate Not available* 8 years 01/12/2033 01/03/2034 No 31/07/2024 PSUR frequency amended and DLP updated on 31/07/2024 PSUSA/00001326/203312 none NAP 1329 etofylline, etofylline / theophylline Not available* 8 years 03/06/2027 01/09/2027 Yes 22/10/2025 Information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" was amended on 22/10/2025 DLP was amended on 22/10/2025 Active substance name was amended on 22/10/2025 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00001329/202706 none NAP 1330 etomidate Not available* 5 years 30/09/2027 29/12/2027 No 06/06/2018 Next DLP was updated on 31/05/2023 PSUSA/00001330/202709 Dennis Lex Germany NAP 1331 etonogestrel 25/08/1998 3 years 01/09/2027 30/11/2027 No 30/04/2025 DLP was amended on 30/04/2025 PSUSA/00001331/202709 Bianca Mulder Netherlands NAP 1333 etoposide 09/07/1980 3 years 16/02/2026 17/05/2026 No 18/10/2023 Next DLP was updated on 18/10/2023 PSUSA/00001333/202602 Dennis Lex Germany NAP 1334 etoricoxib 13/02/2002 5 years 31/03/2027 29/06/2027 No 31/01/2024 PRAC representative updated on 31/01/2024 PSUSA/00001334/202703 Carla Torre Portugal NAP 1335 etravirine 28/08/2008 3 years 27/09/2026 26/12/2026 No 19/09/2024 PSUSA/00001335/202609 Zoubida Amimour France CAP 1342 eugenol Not available* 9 years 03/11/2030 01/02/2031 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00001342/203011 NAP 1343 everolimus (indicated for astrocytoma (SEGA), renal angiomyolipoma, refractory seizures) 02/09/2011 5 years 31/03/2029 29/06/2029 No 25/06/2025 Information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" was amended on 25/06/2025 Information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" was amended on 18/12/2024 PSUR frequency amended and DLP updated on 18/12/2024 DLP updated on 22/12/2021 Active substance name was updated on 03/02/2021 DLP was updated on 21/11/2018 PSUR submission frequency and next DLP were amended on 29/10/2015 Correction of DLP was done on 28/05/2014 Conditional approval PSUSA/00001343/202903 Dennis Lex Germany CAP 1344 technetium (99mTc) exametazime 01/02/1986 15 years 31/01/2031 01/05/2031 No 16/10/2023 PRAC Rapporteur name was amended on 18/10/2023 PSUSA/00001344/203101 Karin Erneholm Denmark NAP 1345 exemestane 16/12/1998 5 years 15/12/2025 15/03/2026 No 15/11/2023 PRAC Rapporteur updated on 15/11/2023 PSUSA/00001345/202512 Barbara Kovacic Bytyqi Croatia NAP 1346 ezetimibe 17/10/2002 5 years 31/10/2027 29/01/2028 No 28/06/2023 Next DLP was updated on 28/06/2023 PRAC Rapporteur name was amended on 31/07/2018 DLP was updated on 04/07/2018 Lead MS added on 16/06/2015 PSUSA/00001346/202710 Dennis Lex Germany NAP 1347 ezetimibe / simvastatin 02/04/2004 5 years 10/03/2029 08/06/2029 No 20/11/2024 DLP was amended on 20/11/2024 PSUSA/00001347/202903 Dennis Lex Germany NAP 1349 famciclovir 10/12/1993 5 years 31/12/2025 31/03/2026 No 12/09/2025 PSUR frequency and DLP were updated on 22/09/2021 Lead MS and PRAC Rapporteur name amended on 19/12/2018 DLP was updated on 26/09/2018 PRAC representative and Lead Member State were added on 23/05/2017 PSUSA/00001349/202512 Veronika Macurová Czech Republic NAP 1350 famotidine 21/09/1984 5 years 30/09/2027 29/12/2027 No 27/07/2022 Next DLP was updated on 31/05/2023 PSUSA/00001350/202709 Amelia Cupelli Italy NAP 1351 calcium carbonate / famotidine / magnesium hydroxide Not available* 5 years 30/09/2028 29/12/2028 No 19/09/2024 PSUSA/00001351/202809 Zoubida Amimour France NAP 1352 fampridine 20/07/2011 5 years 21/01/2028 20/04/2028 No 23/09/2020 New CAP authorised on 24/09/2020 DLP was updated on 23/09/2020 PRAC Rapporteur name updated on 23/10/2018 PRAC Representative updated on 26/09/2018 PSUR Frequency amended and next DLP updated on 25/09/2017 Next DLP was updated on 22/09/2016 Next DLP was updated on 30/09/2105. Next DLP was amended on 06/10/2014 Next DLP was amended on 03/03/2014 Conditional approval PSUSA/00001352/202801 Liana Martirosyan Netherlands CAP 1353 febuxostat 21/04/2008 1 year 20/04/2026 29/06/2026 20/04/2027 29/06/2027 No 18/12/2024 DLP was amended on 18/12/2024 PSUSA/00001353/202604 PSUSA/00001353/202704 Jan Neuhauser Austria CAP 1355 felbinac 25/09/1986 9 years 01/12/2028 01/03/2029 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00001355/202812 NAP 1356 felodipine 31/12/1987 5 years 31/12/2027 30/03/2028 No 20/09/2023 DLP amended on 20/09/2023 PSUSA/00001356/202712 Miroslava Gocova Slovakia NAP 1357 felodipine / metoprolol 31/12/1992 10 years 31/12/2027 30/03/2028 No 18/10/2023 PRAC Rapporteur name was amended on 18/10/2023 PSUSA/00001357/202712 Karin Erneholm Denmark NAP 1358 felodipine / ramipril 19/09/1997 5 years 19/09/2028 18/12/2028 No 05/06/2024 DLP was amended on 05/06/2024 PSUSA/00001358/202809 Dennis Lex Germany NAP 1361 fenipentol Not available* 7 years 01/12/2031 29/02/2032 No 27/03/2024 PSUR frequency and DLP amended on 27/03/2024 PSUSA/00001361/203112 Miroslava Gocova Slovakia NAP 1362 fenofibrate 04/11/1974 3 years 31/07/2026 29/10/2026 No 27/03/2024 DLP was amended on 27/03/2024 PSUSA/00001362/202607 Jo Robays Belgium NAP 1363 fenofibrate / pravastatin 14/04/2011 3 years 14/04/2026 13/07/2026 No 19/09/2024 PSUSA/00001363/202604 Zoubida Amimour France CAP 1366 fenoterol (respiratory indications) 27/09/1965 5 years 27/09/2027 26/12/2027 No 06/06/2018 Next DLP was updated on 31/05/2023 PSUSA/00001366/202709 Barbara Kovacic Bytyqi Croatia NAP 1367 fenoterol / ipratropium 28/05/1980 5 years 02/02/2028 02/05/2028 No 31/01/2024 PRAC representative updated on 31/01/2024 PSUSA/00001367/202802 Bianca Mulder Netherlands NAP 1369 fentanyl (transmucosal route of administration) 04/04/2008 3 years 30/04/2026 29/07/2026 No 31/01/2024 Next DLP was updated on 31/01/2024 PSUSA/00001369/202604 Tiphaine Vaillant France CAP NAP 1370 fentanyl (transdermal patches, solution for injection - nationally authorised product only) 07/03/1995 3 years 30/04/2027 29/07/2027 No 18/12/2024 PSUR frequency amended and DLP updated on 18/12/2024 PSUSA/00001370/202704 Liana Martirosyan Netherlands NAP 1371 fenticonazole 16/04/1986 8 years 03/06/2033 01/09/2033 No 04/02/2026 DLP was amended on 04/02/2026 PSUSA/00001371/203306 Marie Louise Schougaard Christiansen Denmark NAP 1382 ferucarbotran 01/07/2022 2 years 30/06/2027 28/09/2027 No 02/06/2026 PSUSA/00001382/202706 Jenny Jönsson Sweden NAP 1387 fesoterodine, desfesoterodine 20/04/2007 5 years 19/04/2030 18/07/2030 No 16/12/2020 PSUR frequency, DLP and reference to NAP were updated on 16/12/2020 PRAC Representative name was corrected on 29/07/2020 PRAC Representative updated on 26/09/2018 Entry name was amended on 06/06/2018 DLP was updated on 19/12/2017 PRAC Rapporteur name updated on 03/06/2016 PSUSA/00001387/203004 Maria del Pilar Rayon Spain CAP NAP 1388 fexofenadine 11/03/1996 5 years 11/03/2027 09/06/2027 No 16/11/2022 DLP was updated on 16/11/2022 PRAC Rapporteur name was amended on 28/04/2022 PRAC Rapporteur name was amended on 21/11/2018 DLP was amended on 15/11/2017 Lead MS was added on 22/09/2016 PRAC Rapporteur name updated on 05/11/2018 PSUSA/00001388/202703 Marie Louise Schougaard Christiansen Denmark NAP 1390 fidaxomicin 27/05/2011 3 years 26/05/2026 24/08/2026 No 02/06/2026 PSUSA/00001390/202605 Karin Bolin Sweden CAP 1391 filgrastim 15/03/1991 3 years 15/09/2027 14/12/2027 No 25/05/2022 New CAP authorised on 12/02/2025 DLP was updated on 25/05/2022 DLP was updated on 05/06/2019 Next DLP was amended on 03/06/2016 EURD was amended on 01/10/2013 PSUSA/00001391/202709 Terhi Lehtinen Finland CAP NAP 1392 finasteride, finasteride / doxazosin 17/04/1998 3 years 31/08/2028 29/11/2028 No 02/06/2026 PSUSA/00001392/202808 Jenny Jönsson Sweden NAP 1393 fingolimod 17/03/2011 3 years 28/02/2028 28/05/2028 No 19/11/2025 PSUR frequency amended and DLP updated on 19/11/2025 PSUSA/00001393/202802 Tiphaine Vaillant France CAP 1395 flavoxate 04/08/1967 11 years 02/12/2039 01/03/2040 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00001395/203912 NAP 1396 flecainide 25/06/1982 5 years 30/06/2027 28/09/2027 No 01/03/2023 DLP was updated on 01/03/2023 PRAC Rapporteur name amended on 04/07/2018 DLP was updated on 27/03/2018 PRAC Representative name was amended on 17/10/2017 Lead MS and PRAC Rapporteur name was added on 20/12/2016 PSUSA/00001396/202706 Karen Pernille Harg Norway NAP 1398 flopropione Not available* 9 years 01/12/2030 01/03/2031 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00001398/203012 NAP 1399 fluanisone 01/10/1986 9 years 01/12/2028 01/03/2029 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00001399/202812 NAP 1400 flubendazole 10/03/1980 5 years 04/02/2029 05/05/2029 Yes 03/05/2023 Lead MS and PRAC Rapporteur name added on 26/07/2023 Entry re-activated on 03/05/2023 Entry re-activated on 21/10/2022 Information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" was amended on 21/10/2022 DLP was updated on 17/10/2017 Correction of PRAC Rapporteur name on 28/02/2017 PRAC Rapporteur name was amended on 20/12/2016 Lead MS and PRAC Rapporteur name was added on 28/07/2016 PSUSA/00001400/202902 Ana Sofia Diniz Martins Portugal NAP 1402 flucloxacillin 14/01/1971 8 years 03/03/2028 01/06/2028 No 16/12/2020 Information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended" was amended on 16/12/2020 DLP was updated on 18/11/2020 PRAC representative was added on 06/05/2020 EURD updated on 25/09/2019 LMS was added on 31/07/2019 PSUSA/00001402/202803 Ana Sofia Diniz Martins Portugal NAP 1404 fluconazole 08/03/1988 3 years 02/03/2026 31/05/2026 No 15/11/2023 DLP was amended on 15/11/2023 PSUSA/00001404/202603 Marie Louise Schougaard Christiansen Denmark NAP 1405 flucytosine 01/10/1975 8 years 03/03/2033 01/06/2033 No 19/11/2025 DLP was amended on 19/11/2025 PSUSA/00001405/203303 Zoubida Amimour France NAP 1406 fludarabine 11/08/1994 5 years 11/08/2027 09/11/2027 No 05/04/2023 DLP was updated on 05/04/2023 Lead MS and PRAC Rapporteur name amended on 19/12/2018 DLP was updated on 07/05/2018 PRAC Rapporteur name was amended on 27/03/2018 DLP was corrected on 28/03/2017 PRAC representative and Lead Member State were added on 30/01/2017 PSUSA/00001406/202708 Terhi Lehtinen Finland NAP 1408 fludrocortisone 28/10/1954 12 years 03/06/2040 01/09/2040 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00001408/204006 NAP 1411 fludroxycortide Not available* 9 years 01/12/2030 01/03/2031 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00001411/203012 NAP 1412 fluindione 02/09/1969 9 years 03/05/2028 01/08/2028 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00001412/202805 NAP 1413 flumazenil 30/12/1986 5 years 29/12/2029 29/03/2030 No 24/09/2025 PSUR frequency amended and DLP updated on 24/09/2025 PSUSA/00001413/202912 Liana Martirosyan Netherlands NAP 1414 flumetasone 01/01/1964 11 years 03/07/2039 01/10/2039 No 15/01/2025 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00001414/203907 Liana Martirosyan Netherlands NAP 1415 clioquinol / flumetasone 15/02/1966 10 years 03/07/2034 01/10/2034 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00001415/203407 NAP 1416 flunarizine 01/06/1977 5 years 31/05/2029 29/08/2029 No 05/02/2025 PSUR frequency amended and DLP updated on 05/02/2025 PSUSA/00001416/202905 Ana Sofia Diniz Martins Portugal NAP 1417 flunisolide 25/08/1982 10 years 03/05/2035 01/08/2035 No 04/02/2026 PSUR frequency amended and DLP updated on 04/02/2026 PSUSA/00001417/203505 Dennis Lex Germany NAP 1418 flunitrazepam 01/01/2000 3 years 01/01/2028 31/03/2028 No 24/09/2025 DLP was amended on 24/09/2025 PSUSA/00001418/202801 Jan Neuhauser Austria NAP 1419 fluocinolone acetonide (all routes of administration apart from intravitreal implant in applicator) 26/02/1965 10 years 03/06/2034 01/09/2034 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00001419/203406 NAP 1420 fluocinolone / metronidazole / nystatin Not available* 9 years 01/12/2030 01/03/2031 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00001420/203012 NAP 1421 clioquinol / fluocinolone acetonide Not available* 9 years 01/12/2029 01/03/2030 No 28/08/2024 PSUR frequency and DLP amended on 28/08/2024. PSUSA/00001421/202912 NAP 1423 fluocinolone acetonide / lidocaine Not available* 9 years 01/12/2030 01/03/2031 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00001423/203012 NAP 1424 bismuth subgallate / fluocinolone acetonide / lidocaine / menthol Not available* 9 years 03/06/2029 01/09/2029 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00001424/202906 NAP 1425 fluocinonide Not available* 8 years 03/06/2026 01/09/2026 No 23/09/2025 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00001425/202606 Zane Neikena Latvia NAP 1426 fluocinonide / hexetidine / ruscogenin Not available* 9 years 01/12/2030 01/03/2031 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00001426/203012 NAP 1427 fluocinonide / lidocaine Not available* 9 years 01/12/2030 01/03/2031 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00001427/203012 NAP 1430 fluocortolone pivalate / lidocaine hydrochloride Not available* 9 years 01/12/2030 01/03/2031 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00001430/203012 NAP 1431 fluorescein (topical ophthalmic use) 12/04/1961 11 years 03/06/2039 01/09/2039 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00001431/203906 NAP 1432 fluorescein / oxybuprocaine 12/04/1961 11 years 03/06/2039 01/09/2039 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00001432/203906 NAP 1433 fluoride (except sodium fluoride) Not available* 9 years 01/12/2030 01/03/2031 No 25/06/2025 Active substance name was amended on 25/06/2025 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00001433/203012 none NAP 1434 fluoride / malic acid Not available* 9 years 31/01/2031 01/05/2031 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00001434/203101 NAP 1435 fluoride / monofluorophosphate Not available* 9 years 31/01/2031 01/05/2031 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00001435/203101 NAP 1437 fludeoxyglucose (18F) 14/11/1994 10 years 30/11/2027 28/02/2028 No 19/12/2018 PRAC representative was updated on 29/07/2020 PRAC representative was updated on 03/06/2020 PSUR Frequency and DLP updated on 19/12/2018 DLP was updated on 31/07/2018 Active substance name was amended on 06/06/2018 Entry name was corrected and PRAC Rapporteur amended on 21/07/2017 PRAC Rapporteur name was amended on 28/07/2016 PRAC Rapporteur name updated on 07/04/2016 PRAC Rapporteur name updated on 04/02/2016 Lead MS was added on 22/12/2014 PSUSA/00001437/202711 Tiphaine Vaillant France NAP 1438 fluorometholone 14/04/1972 9 years 03/06/2028 01/09/2028 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00001438/202806 NAP 1442 fluoxetine 07/09/1986 5 years 07/09/2027 06/12/2027 No 03/05/2023 DLP was amended on 03/05/2023 PRAC representative was updated on 29/07/2020 PRAC representative was updated on 03/06/2020 DLP was updated on 06/06/2018 Information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" was amended on 06/06/2018 PRAC Rapporteur name updated on 21/07/2017 Lead MS and PRAC Rapporteur name was added on 28/02/2017 PSUSA/00001442/202709 Tiphaine Vaillant France NAP 1443 fluoxetine / olanzapine Not available* 9 years 31/01/2031 01/05/2031 No 24/09/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00001443/203101 NAP 1444 flupentixol 30/11/1965 5 years 30/11/2028 28/02/2029 No 19/11/2025 PSUR frequency amended and DLP updated on 19/11/2025 DLP was amended on 31/07/2024 PSUSA/00001444/202811 Veronika Macurová Czech Republic NAP 1445 flupentixol / melitracene 31/01/1971 13 years 30/11/2036 28/02/2037 No 12/09/2025 DLP was amended on 31/07/2024 PSUSA/00001445/203611 Veronika Macurová Czech Republic NAP 1446 fluphenazine 18/12/1959 11 years 03/05/2039 01/08/2039 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00001446/203905 NAP 1448 fluprednidene / miconazole Not available* 8 years 03/06/2026 01/09/2026 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00001448/202606 NAP 1449 flurazepam 02/03/1973 9 years 03/06/2028 01/09/2028 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00001449/202806 NAP 1450 flurbiprofen 10/11/1976 5 years 30/11/2027 28/02/2028 No 26/07/2023 PSUR frequency amended and DLP updated on 26/07/2023 PSUSA/00001450/202711 Amelia Cupelli Italy NAP 1452 fluspirilene 01/09/1977 9 years 03/11/2028 01/02/2029 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00001452/202811 NAP 1453 flutamide 24/03/1982 5 years 23/10/2028 21/01/2029 Yes 03/07/2024 DLP was amended on 03/07/2024 PSUSA/00001453/202810 Dennis Lex Germany NAP 1454 fluticasone propionate 08/03/1990 5 years 28/02/2027 29/05/2027 No 16/11/2022 DLP was updated on 16/11/2022 PRAC representative was updated on 28/07/2021 PRAC representative was updated on 28/04/2021 Lead MS and PRAC Rapporteur name amended on 19/12/2018 DLP was amended on 15/11/2017 Lead MS was added on 22/09/2016 PSUSA/00001454/202702 Polona Golmajer Slovenia NAP 1455 fluticasone / salmeterol (for nationally authorised products) 25/10/1990 8 years 31/10/2032 29/01/2033 No 02/06/2026 PSUSA/00001455/203210 Karin Bolin Sweden NAP 1456 flutrimazole 01/12/1994 8 years 03/08/2033 01/11/2033 No 01/04/2026 DLP was amended on 01/04/2026 PSUSA/00001456/203308 Maria Martinez Gonzalez Spain NAP 1457 fluvastatin 23/08/1993 5 years 31/08/2027 29/11/2027 No 03/05/2023 DLP was amended on 03/05/2023 DLP was updated on 06/06/2018 Lead MS and PRAC Rapporteur name was added on 28/02/2017 PSUSA/00001457/202708 Eva Jirsová Czech Republic NAP 1458 fluvoxamine 13/07/1983 5 years 31/07/2027 29/10/2027 No 05/04/2023 DLP was updated on 05/04/2023 PRAC Rapporteur name was amended on 06/03/2019 Lead MS and PRAC Rapporteur name amended on 19/12/2018 DLP was updated on 07/05/2018 PRAC representative and Lead Member State were added on 30/01/2017 PSUSA/00001458/202707 Rugile Pilviniene Lithuania NAP 1459 folic acid 13/12/1947 10 years 13/12/2027 12/03/2028 No 31/01/2018 PRAC Rapporteur name was amended on 28/04/2022 PRAC Rapporteur name was amended on 03/04/2019 PSUR frequency amended and DLP updated on 31/01/2018 Lead MS and PRAC Rapporteur name was added on 19/10/2016 Information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" was amended on 30/11/2012 PSUSA/00001459/202712 Marie Louise Schougaard Christiansen Denmark NAP 1461 folic acid / nicotinamide Not available* 28 years 01/01/2040 31/03/2040 No 01/10/2012 PSUSA/00001461/204001 NAP 1463 follitropin alfa 20/10/1995 5 years 19/10/2029 17/01/2030 No 25/06/2025 PSUR frequency amended and DLP updated on 25/06/2025 PSUSA/00001463/202910 Bianca Mulder Netherlands CAP 1464 follitropin alfa / lutropin alfa 25/06/2007 5 years 19/10/2029 17/01/2030 No 25/06/2025 PSUR frequency amended and DLP updated on 25/06/2025 PSUSA/00001464/202910 Marie Louise Schougaard Christiansen Denmark CAP 1465 follitropin beta 03/05/1996 3 years 01/05/2026 30/07/2026 No 31/01/2024 Next DLP was updated on 31/01/2024 PSUSA/00001465/202605 Rhea Fitzgerald Ireland CAP 1466 fomepizole 21/09/2000 7 years 03/03/2032 01/06/2032 Yes 19/11/2025 DLP was amended on 19/11/2025 PSUSA/00001466/203203 Zoubida Amimour France NAP 1467 fondaparinux 21/03/2002 3 years 06/12/2027 05/03/2028 No 02/06/2026 PSUSA/00001467/202712 Karin Bolin Sweden CAP NAP 1469 formoterol 29/06/1990 5 years 31/05/2030 29/08/2030 No 02/06/2026 PSUSA/00001469/203005 Karin Bolin Sweden NAP 1470 fosamprenavir 12/07/2004 5 years 20/10/2028 18/01/2029 No 19/09/2024 PSUSA/00001470/202810 Zoubida Amimour France CAP 1471 fosaprepitant 11/01/2008 5 years 25/03/2029 23/06/2029 No 02/06/2026 PSUSA/00001471/202903 Jenny-Maria Jönsson Sweden CAP 1472 foscarnet 31/03/1989 8 years 31/03/2031 29/06/2031 No 20/12/2023 PSUR frequency amended and DLP updated on 20/12/2023 PSUSA/00001472/203103 Liana Martirosyan Netherlands NAP 1476 fosphenytoin 05/08/1996 5 years 05/08/2030 03/11/2030 No 01/04/2026 DLP was amended on 01/04/2026 PSUSA/00001476/203008 Eamon O'Murchu Ireland NAP 1477 fotemustine 14/04/1989 8 years 03/06/2033 01/09/2033 No 04/02/2026 DLP was amended on 04/02/2026 PSUSA/00001477/203306 Amelia Cupelli Italy NAP 1478 framycetin Not available* 11 years 02/04/2040 01/07/2040 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00001478/204004 NAP 1479 framycetin sulfate / lidocaine hydrochloride Not available* 9 years 31/01/2031 01/05/2031 No 24/09/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00001479/203101 NAP 1482 framycetin sulfate / triamcinolone acetonide Not available* 9 years 31/01/2031 01/05/2031 No 24/09/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00001482/203101 NAP 1484 frovatriptan 31/10/2001 5 years 01/03/2027 30/05/2027 No 16/11/2022 DLP was updated on 16/11/2022 DLP was amended on 15/11/2017 PRAC Rapporteur name updated on 27/06/2017 Lead MS was added on 22/09/2016 PSUSA/00001484/202703 Eva Jirsová Czech Republic NAP 1486 fructose / glucose / xylitol Not available* 9 years 31/01/2031 01/05/2031 No 24/09/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00001486/203101 NAP 1489 fulvestrant 10/03/2004 5 years 25/04/2028 24/07/2028 No 02/06/2026 PSUSA/00001489/202804 Jenny-Maria Jönsson Sweden CAP 1491 furosemide 01/01/1955 5 years 01/01/2028 31/03/2028 No 29/07/2026 Reference to CAP added on 29/07/2026 New CAP authorised on 29/05/2026 PRAC representative updated on 31/01/2024 PSUSA/00001491/202801 Carla Torre Portugal CAP NAP 1493 furosemide / spironolactone 11/01/1961 5 years 17/03/2028 15/06/2028 No 15/11/2023 DLP was amended on 15/11/2023 PSUSA/00001493/202803 Karin Erneholm Denmark NAP 1494 furosemide / triamterene Not available* 9 years 31/01/2031 01/05/2031 No 24/09/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00001494/203101 NAP 1498 fusidic acid / hydrocortisone acetate Not available* 9 years 31/01/2031 01/05/2031 No 24/09/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00001498/203101 NAP 1499 gabapentin 05/02/1993 3 years 01/02/2028 01/05/2028 No 22/10/2025 DLP was amended on 22/10/2025 PSUSA/00001499/202802 Dennis Lex Germany NAP 1500 gadobenic acid 22/07/1997 2 years 30/04/2027 29/07/2027 Yes 04/02/2026 DLP was amended on 04/02/2026 PSUSA/00001500/202704 Dennis Lex Germany NAP 1502 gadobutrol 20/08/1998 2 years 30/04/2027 29/07/2027 Yes 04/02/2026 DLP was amended on 04/02/2026 PSUSA/00001502/202704 Dennis Lex Germany NAP 1503 gadodiamide 01/02/1993 2 years 30/04/2027 29/07/2027 No 02/06/2026 PSUSA/00001503/202704 Karin Bolin Sweden NAP 1504 gadopentetic acid Not available* 2 years 30/04/2027 29/07/2027 Yes 04/02/2026 DLP was amended on 04/02/2026 PSUSA/00001504/202704 Dennis Lex Germany NAP 1505 gadoteric acid (intra articular formulation) 31/01/2002 2 years 30/04/2027 29/07/2027 Yes 30/04/2026 PSUR frequency amended and DLP updated on 04/02/2026 PSUSA/00001505/202704 Bianca Mulder Netherlands NAP 1506 gadoteric acid (IV and intravascular formulations) 08/03/1989 2 years 30/04/2027 29/07/2027 Yes 30/04/2026 DLP was amended on 04/02/2026 PSUSA/00001506/202704 Bianca Mulder Netherlands NAP 1507 gadoteridol 29/10/1992 2 years 30/04/2027 29/07/2027 Yes 04/02/2026 DLP was amended on 04/02/2026 PSUSA/00001507/202704 Karin Erneholm Denmark NAP 1509 gadoxetic acid disodium 20/08/1998 2 years 30/04/2027 29/07/2027 No 03/06/2026 Correction of Lead Member State and PRAC rapporteur name on 29/04/2026 DLP was amended on 04/02/2026 PSUSA/00001509/202704 Karin Bolin Sweden NAP 1511 galactose / palmitic acid 21/06/1995 8 years 03/08/2033 01/11/2033 No 01/04/2026 DLP was amended on 01/04/2026 PSUSA/00001511/203308 NAP 1512 galantamine 01/03/2000 5 years 01/03/2029 30/05/2029 No 18/11/2020 DLP was updated on 18/11/2020 PRAC Rapporteur name was amended on 31/07/2018 Next DLP was updated and information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" was amended on 18/11/2016 PRAC Rapporteur name amended on 29/10/2015 Lead MS was added on 30/09/2015 PSUSA/00001512/202903 Karin Bolin Sweden NAP 1513 gallium (67ga) citrate 31/03/1972 10 years 01/12/2034 01/03/2035 Yes 02/04/2025 Information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" was amended on 02/04/2025 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00001513/203412 Eva Jirsova Czech Republic NAP 1514 gallopamil 30/12/1986 9 years 01/01/2029 01/04/2029 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00001514/202901 NAP 1515 galsulfase 31/05/2005 3 years 31/05/2027 29/08/2027 No 05/02/2025 PSUR frequency amended and DLP updated on 05/02/2025 PSUSA/00001515/202705 Ana Sofia Diniz Martins Portugal CAP 1516 ganciclovir 15/06/1988 6 years 14/06/2031 12/09/2031 No 04/03/2026 PSUR frequency amended and DLP updated on 04/03/2026 PSUSA/00001516/203106 Liana Martirosyan Netherlands NAP 1517 ganirelix 17/05/2000 5 years 28/02/2027 29/05/2027 No 16/11/2022 DLP was updated on 16/11/2022 New CAP authorised on 15/07/2022 DLP was updated on 17/10/2017 PRAC Rapporteur name amended on 29/10/2015. PSUSA/00001517/202702 Kimmo Jaakkola Finland CAP 1518 gefitinib 24/06/2009 5 years 05/07/2026 03/10/2026 No 02/06/2026 PSUSA/00001518/202607 Jenny-Maria Jönsson Sweden CAP 1519 gemcitabine 12/01/1995 5 years 12/01/2028 11/04/2028 No 02/06/2026 PSUSA/00001519/202801 Jenny Jönsson Sweden NAP 1521 gemfibrozil 01/06/1981 8 years 03/05/2033 01/08/2033 No 04/02/2026 DLP was amended on 04/02/2026 PSUSA/00001521/203305 Karin Erneholm Denmark NAP 1522 gentamicin (topical use) 28/02/1973 11 years 03/03/2036 01/06/2036 No 19/11/2025 PSUR frequency amended and DLP updated on 19/11/2025 PSUSA/00001522/203603 Amelia Cupelli Italy NAP 1523 betamethasone / gentamicin Not available* 9 years 03/06/2029 01/09/2029 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00001523/202906 NAP 1524 dexamethasone / gentamicin / tetryzoline Not available* 9 years 03/03/2030 01/06/2030 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00001524/203003 NAP 1525 gestrinone 21/01/1983 9 years 01/12/2028 01/03/2029 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00001525/202812 NAP 1529 glatiramer 23/12/1996 3 years 30/11/2026 28/02/2027 Yes 31/07/2024 DLP was amended on 31/07/2024 PSUSA/00001529/202611 Karin Erneholm Denmark NAP 1530 glibenclamide (for nationally authorised products only) 01/01/1969 9 years 03/05/2028 01/08/2028 No 18/10/2023 Information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?", PSUR frequency and DLP were amended on 18/10/2023 Active substance name updated on 04/07/2018 PSUSA/00001530/202805 none NAP 1532 gliclazide 26/04/1971 5 years 28/02/2026 29/05/2026 No 05/08/2025 DLP updated on 17/11/2021 Correction to the PRAC representative name on 05/02/2020 Lead MS and PRAC Rapporteur name amended on 19/12/2018 Next DLP was updated and information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" was amended on 18/11/2016 European Union reference date (EURD) was amended on 28/06/2016 Lead MS was added on 30/09/2015 PSUSA/00001532/202602 Guðrún Stefánsdóttir Iceland NAP 1533 glicofosfopeptical 07/12/1987 9 years 01/01/2029 01/04/2029 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00001533/202901 NAP 1534 glimepiride 20/06/1995 5 years 20/06/2027 18/09/2027 No 31/01/2024 PRAC representative updated on 31/01/2024 PSUSA/00001534/202706 Bianca Mulder Netherlands NAP 1535 glipizide 20/11/1971 5 years 31/01/2030 01/05/2030 Yes 22/10/2025 PSUR frequency amended and DLP updated on 22/10/2025 PSUSA/00001535/203001 Petar Mas Croatia NAP 1536 glipizide / metformin Not available* 9 years 03/03/2031 01/06/2031 Yes 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00001536/203103 NAP 1537 gliquidone 16/09/1969 11 years 03/03/2040 01/06/2040 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00001537/204003 none NAP 1538 glucagon (except for centrally authorised products) Not available* 8 years 30/06/2026 28/09/2026 No 31/07/2024 DLP amended on 20/11/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00001538/202606 Terhi Lehtinen Finland NAP 1539 glucosamine 31/07/1996 5 years 31/03/2027 29/06/2027 No 16/10/2023 PRAC Rapporteur name was amended on 18/10/2023 PSUSA/00001539/202703 Karin Erneholm Denmark NAP 1541 calcium / glucose / glutathione disulphide / magnesium / potassium / sodium / sodium bicarbonate Not available* 9 years 03/06/2029 01/09/2029 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00001541/202906 NAP 1544 benfotiamine / glutamate sodium / inositol Not available* 9 years 03/05/2029 01/08/2029 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00001544/202905 NAP 1546 glutethimide 15/04/1974 10 years 03/03/2035 01/06/2035 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00001546/203503 NAP 1548 glycerol Not available* 8 years 03/06/2026 01/09/2026 No 23/09/2025 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00001548/202606 Jan Neuhauser Austria NAP 1550 glycerol / sucrose Not available* 9 years 03/03/2031 01/06/2031 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00001550/203103 NAP 1551 glycerol / lecithin / soybean oil / triglycerides medium-chain Not available* 9 years 03/03/2031 01/06/2031 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00001551/203103 NAP 1552 glyceryl trinitrate 19/10/1981 5 years 15/07/2030 13/10/2030 No 01/04/2026 DLP was amended on 01/04/2026 PSUSA/00001552/203007 Polona Golmajer Slovenia NAP 1553 glycine Not available* 8 years 03/08/2026 01/11/2026 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00001553/202608 NAP 1556 glycopyrronium (all indications except for the treatment of severe sialorhoea or for the treatment of chronic obstructive pulmonary disease) Not available* 15 years 30/09/2030 29/12/2030 No 22/09/2021 Active substance name amended on 22/09/2021 PRAC Rapporteur name was amended on 23/10/2018 The name of the active substance was amended on 22/09/2016 PSUR Frequency amended and DLP updated on 03/06/2016 Lead MS added on 12/05/2015 Name of active substance was amended on 30/11/2012 PSUSA/00001556/203009 Eamon O'Murchu Ireland NAP 1557 neostigmine, glycopyrronium / neostigmine 06/03/1992 15 years 30/09/2030 29/12/2030 No 20/12/2023 Active substance name was amended on 20/12/2023 PRAC Rapporteur name was amended on 23/10/2018 PSUR Frequency amended and DLP updated on 03/06/2016 Lead MS added on 12/05/2015 PSUSA/00001557/203009 Eamon O'Murchu Ireland NAP 1558 glycosaminoglycan polysulphate / salicylic acid / suprarenal gland extract Not available* 9 years 03/03/2031 01/06/2031 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00001558/203103 NAP 1560 golimumab 01/10/2009 3 years 06/04/2026 05/07/2026 No 04/03/2026 New CAP authorised on 10/02/2026 New CAP authorised on 17/11/2025 DLP was amended on 20/12/2023 PSUSA/00001560/202604 Karin Bolin Sweden CAP 1561 gonadorelin 29/08/1973 10 years 03/03/2035 01/06/2035 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00001561/203503 NAP 1562 goserelin 12/05/1987 5 years 12/05/2026 10/08/2026 No 02/02/2022 DLP was updated on 02/02/2022 Next DLP was amended on 30/01/2017 PRAC Rapporteur and Lead Member State added on 27/11/2015. PSUSA/00001562/202605 Dennis Lex Germany NAP 1563 gramicidin Not available* 9 years 03/03/2031 01/06/2031 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00001563/203103 NAP 1564 benzocaine / cetylpyridinium chloride / dichlorobenzyl alcohol / gramicidin Not available* 8 years 01/12/2033 01/03/2034 No 30/10/2024 PSUR frequency amended and DLP updated on 31/07/2024 PSUSA/00001564/203312 Terhi Lehtinen Finland NAP 1567 gramicidin / neomycin sulfate / polymyxin b sulphate Not available* 8 years 03/08/2026 01/11/2026 No 18/11/2025 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00001567/202608 Petar Mas Croatia NAP 1568 granisetron (all formulations except transdermal patch) 19/02/1991 5 years 18/02/2026 19/05/2026 No 17/02/2026 Name of active substance was amended on 25/05/2022 PRAC representative was updated on 22/12/2021 DLP was updated on 20/10/2021 PRAC representative was updated on 06/05/2020 Next DLP was updated on 18/11/2016 PRAC Rapporteur name and country updated on 29/10/2015. Name of active substance was amended on 31/05/2013 PSUSA/00001568/202602 Jana Pecherova Slovakia NAP 1572 griseofulvin 16/07/1959 10 years 31/01/2034 01/05/2034 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00001572/203401 NAP 1573 guaiazulene Not available* 9 years 03/03/2031 01/06/2031 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00001573/203103 NAP 1574 guaifenesin 31/05/1949 10 years 03/11/2032 01/02/2033 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00001574/203211 NAP 1576 codeine / guaifenesin, ammonium chloride / codeine phosphate hemihydrate / guaifenesin / thyme oil Not available* 7 years 03/11/2026 01/02/2027 Yes 01/04/2026 Active substance name was amended on 01/04/2026 DLP was amended on 28/05/2025 Active substance name was amended on 28/05/2025 Information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" was amended on 28/05/2025 PSUR frequency and DLP amended on 27/03/2024 PSUSA/00001576/202611 Jan Neuhauser Austria NAP 1580 guaifenesin / pseudoephedrine / triprolidine, guaifenesin / pseudoephedrine Not available* 8 years 03/08/2026 01/11/2026 No 18/11/2025 Active substance name was amended on 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00001580/202608 Miroslava Gocova Slovakia NAP 1582 haemophilus influenzae / klebsiella ozaenae / klebsiella pneumoniae / moraxella catarrhalis / staphylococcus aureus / streptococcus pneumoniae / streptococcus pyogenes / streptococcus viridans vaccine 26/09/1983 5 years 31/12/2027 30/03/2028 No 06/10/2025 DLP amended on 20/09/2023 PSUSA/00001582/202712 Dirk Mentzer Germany NAP 1583 haemophilus type b and meningococcal group C conjugate vaccine 19/12/2005 3 years 01/02/2026 02/05/2026 No 18/10/2023 Next DLP was updated on 18/10/2023 PSUSA/00001583/202602 Jean-Michel Dogné Belgium NAP 1584 haemophilus type b conjugate vaccines 06/02/1992 3 years 06/02/2026 07/05/2026 No 18/10/2023 Next DLP was updated on 18/10/2023 PSUSA/00001584/202602 Jean-Michel Dogné Belgium NAP 1587 haloperidol 25/04/1960 5 years 24/01/2030 24/04/2030 No 24/09/2025 PSUR frequency amended and DLP updated on 24/09/2025 PSUSA/00001587/203001 Maia Uusküla Estonia NAP 1588 halothane Not available* 8 years 03/08/2026 01/11/2026 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00001588/202608 NAP 1589 heparin 31/03/1939 9 years 08/11/2027 06/02/2028 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00001589/202711 none NAP 1591 heparinoid 01/05/1964 10 years 03/06/2034 01/09/2034 No 15/01/2025 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00001591/203406 Miroslava Gocova Slovakia NAP 1592 heparinoid / ibuprofen Not available* 8 years 03/11/2026 01/02/2027 No 27/02/2026 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00001592/202611 Miroslava Gocova Slovakia NAP 1593 hepatitis a (inactivated) / hepatitis b (rdna) vaccines (adsorbed) 20/09/1996 3 years 20/09/2027 19/12/2027 No 25/05/2022 DLP was updated on 25/05/2022 DLP was updated on 05/06/2019 Lead MS and PRAC Rapporteur name added on 21/11/2018 PRAC Representative amended on 28/03/2017 PSUR Frequency amended and DLP updated on 03/05/2016 PSUSA/00001593/202709 Jean-Michel Dogné Belgium CAP 1594 hepatitis a (inactivated) / typhoid polysaccharide vaccine (adsorbed) 22/06/1999 3 years 22/06/2026 20/09/2026 No 06/10/2025 DLP was amended on 28/02/2024 PSUSA/00001594/202606 Dirk Mentzer Germany NAP 1596 hepatitis A vaccines (inactivated, adsorbed) 01/01/1992 5 years 01/01/2029 01/04/2029 No 06/10/2025 DLP was amended on 25/09/2024 PSUSA/00001596/202901 Dirk Mentzer Germany NAP 1597 hepatitis B vaccine (rDNA) 14/11/1986 5 years 28/02/2030 29/05/2030 No 19/11/2025 DLP was amended on 19/11/2025 PSUSA/00001597/203002 Dirk Mentzer Germany CAP NAP 1598 hepatitis B (rDNA) vaccine (adjuvanted, adsorbed) 02/02/2005 3 years 01/02/2027 02/05/2027 No 19/10/2022 DLP was updated on 19/10/2022 DLP was updated on 21/10/2020 PRAC representative was updated on 23/09/2020 Reference to NAP removed on 01/07/2020 Reference to NAP added on 25/09/2019 DLP was updated on 26/09/2018 PRAC Representative amended on 18/11/2016 Next DLP was updated on 22/09/2016 DLP was corrected on 13/03/2015 PSUR submission frequency was corrected on 06/03/2015 Name of active substance was amended on 31/05/2013 PSUSA/00001598/202702 Jean-Michel Dogné Belgium CAP 1601 deanol and all combinations with deanol except for diclofenac deanol Not available* 9 years 03/03/2030 01/06/2030 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00001601/203003 Ana Sofia Diniz Martins Portugal NAP 1602 hexamidine 29/03/1951 11 years 01/12/2036 01/03/2037 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00001602/203612 NAP 1603 chlorocresol / chlorhexidine / hexamidine Not available* 7 years 03/08/2031 01/11/2031 No 02/04/2025 DLP was amended on 02/04/2025 PSUSA/00001603/203108 Zoubida Amimour France NAP 1604 hexamidine / lidocaine 29/03/1951 11 years 01/12/2036 01/03/2037 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00001604/203612 Zoubida Amimour France NAP 1606 hexaminolevulinate hydrochloride 17/09/2004 5 years 16/09/2029 15/12/2029 No 02/06/2026 PSUSA/00001606/202909 Karin Bolin Sweden NAP 1607 hexetidine Not available* 10 years 12/02/2035 13/05/2035 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00001607/203502 NAP 1608 hexylresorcinol Not available* 9 years 03/06/2031 01/09/2031 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00001608/203106 NAP 1609 hidrosmin Not available* 9 years 03/06/2031 01/09/2031 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00001609/203106 NAP 1610 histamine (indicated for acute myeloid leukemia) 07/10/2008 1 year 06/10/2026 15/12/2026 06/10/2027 15/12/2027 No 27/05/2026 DLP was amended on 27/05/2026 PSUSA/00001610/202610 PSUSA/00001610/202710 Eamon O Murchu Ireland CAP 1614 human anti-d immunoglobulin 28/03/1969 3 years 28/03/2027 26/06/2027 No 06/10/2025 DLP was amended on 20/11/2024 PSUSA/00001614/202703 Dirk Mentzer Germany NAP 1617 human coagulation factor IX 12/07/1985 5 years 12/07/2027 10/10/2027 No 06/10/2025 PRAC representative was updated on 01/03/2023 Lead MS and PRAC Representative name added on 19/10/2022 DLP was updated on 01/04/2020 Reference to centrally authorised products removed on 23/10/2019 PRAC Representative updated on 26/09/2018 DLP was updated on 28/03/2017 The DLP was amended on 01/04/2014 PSUSA/00001617/202707 Dirk Mentzer Germany NAP 1619 human coagulation factor VII 01/11/1975 3 years 31/10/2028 29/01/2029 No 01/07/2026 DLP was amended on 01/07/2026 PSUSA/00001619/202810 Sonja Hrabcik Austria NAP 1620 human coagulation factor VIII (antihemophilic factor A) 30/11/1989 5 years 30/11/2029 28/02/2030 No 06/10/2025 DLP was amended on 30/07/2025 PSUSA/00001620/202911 Dirk Mentzer Germany NAP 1621 human coagulation factor viii / human von willebrand factor 07/06/1982 5 years 07/10/2026 05/01/2027 No 06/10/2025 PRAC representative was updated on 01/03/2023 PSUR frequency and DLP were updated on 28/06/2022 DLP was updated on 03/07/2019 Next DLP was updated on 28/06/2016 Lead MS added on 16/06/2015 PSUSA/00001621/202610 Dirk Mentzer Germany NAP 1622 human coagulation factor XIII Not available* 5 years 30/06/2027 28/09/2027 No 06/10/2025 DLP was amended on 03/05/2023 PRAC representative was updated on 01/03/2023 DLP was updated on 27/03/2018 Lead MS and PRAC Rapporteur name was added on 20/12/2016 PSUSA/00001622/202706 Dirk Mentzer Germany NAP 1624 human fibrinogen 04/01/1966 5 years 30/06/2029 28/09/2029 No 06/10/2025 PSUR frequency amended and DLP updated on 05/03/2025 PSUSA/00001624/202906 Dirk Mentzer Germany NAP 1629 human hemin 05/05/1995 3 years 31/05/2027 29/08/2027 No 05/02/2025 DLP was amended on 05/02/2025 PSUSA/00001629/202705 Tiphaine Vaillant France NAP 1631 human hepatitis B immunoglobulin 02/06/1979 5 years 30/11/2028 28/02/2029 Yes 06/10/2025 Information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" was amended on 23/10/2024 PSUR frequency amended and DLP updated on 31/07/2024 PSUSA/00001631/202811 Dirk Mentzer Germany CAP NAP 1633 human normal immunoglobulin (IgG) 25/01/1985 5 years 31/05/2030 29/08/2030 No 04/02/2026 DLP was amended on 04/02/2026 PSUSA/00001633/203005 Dirk Mentzer Germany CAP NAP 1634 human papillomavirus vaccine (rDNA) - 4-valent 20/09/2006 5 years 31/05/2030 29/08/2030 No 02/06/2026 PSUSA/00001634/203005 Jenny Jönsson Sweden CAP 1635 human plasma (pooled and treated for virus inactivation) 31/05/2006 3 years 28/02/2026 29/05/2026 No 06/10/2025 DLP was amended on 15/11/2023 PSUSA/00001635/202602 Dirk Mentzer Germany NAP 1638 human prothrombin complex Not available* 5 years 30/04/2026 29/07/2026 Yes 06/10/2025 PRAC representative was updated on 01/03/2023 DLP and Information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" were amended on 22/12/2021 Next DLP was amended on 30/01/2017 Lead MS was amended on 22/09/2016 PRAC Rapporteur and Lead Member State added on 27/11/2015. PSUSA/00001638/202604 Dirk Mentzer Germany NAP 1639 human rabies immunoglobulin 27/04/1984 5 years 26/04/2027 25/07/2027 No 06/10/2025 PRAC representative was updated on 01/03/2023 DLP was updated on 21/12/2022 PSUR frequency amended and DLP updated on 31/01/2018 Lead MS and PRAC Rapporteur name was added on 19/10/2016 PSUSA/00001639/202704 Dirk Mentzer Germany NAP 1642 human von willebrand factor 30/09/2003 5 years 30/09/2028 29/12/2028 No 06/10/2025 PSUR frequency amended and DLP updated on 05/06/2024 PSUSA/00001642/202809 Dirk Mentzer Germany NAP 1644 hyaluronic acid Not available* 9 years 03/06/2031 01/09/2031 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00001644/203106 NAP 1645 hyaluronidase 31/05/1960 10 years 02/04/2034 01/07/2034 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00001645/203404 NAP 1646 hydralazine, dihydralazine 13/03/1952 9 years 02/12/2027 01/03/2028 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00001646/202712 none NAP 1650 hydrochlorothiazide 22/12/1958 9 years 02/12/2027 01/03/2028 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00001650/202712 NAP 1655 hydrochlorothiazide / losartan 15/02/1995 5 years 15/02/2028 15/05/2028 No 31/01/2024 PRAC representative updated on 31/01/2024 PSUSA/00001655/202802 Bianca Mulder Netherlands NAP 1657 hydrochlorothiazide / metoprolol 11/05/1978 8 years 11/05/2026 09/08/2026 Yes 22/10/2025 DLP was amended on 22/10/2025 Information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" was amended on 22/10/2025 PSUSA/00001657/202605 Dennis Lex Germany NAP 1658 hydrochlorothiazide / nebivolol 20/09/2009 6 years 03/11/2029 01/02/2030 No 03/07/2024 DLP was amended on 03/07/2024 PSUSA/00001658/202911 Amelia Cupelli Italy NAP 1662 hydrochlorothiazide / spironolactone Not available* 5 years 01/01/2029 01/04/2029 No 25/09/2024 PSUR frequency amended and DLP updated on 25/09/2024 PSUSA/00001662/202901 Barbara Kovacic Bytyqi Croatia NAP 1664 hydrochlorothiazide / triamterene, hydrochlorothiazide / propranolol / triamterene Not available* 9 years 03/06/2031 01/09/2031 No 19/10/2023 Active substance name, PSUR frequency and DLP were amended on 19/10/2023 PSUSA/00001664/203106 none NAP 1672 hydrocortisone / natamycin / neomycine sulphate 20/06/1995 8 years 03/08/2033 01/11/2033 No 01/04/2026 DLP was amended on 01/04/2026 PSUSA/00001672/203308 Terhi Lehtinen Finland NAP 1675 hydrocortisone / urea 31/12/1986 9 years 01/01/2029 01/04/2029 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00001675/202901 NAP 1676 benzocaine / hydrocortisone acetate Not available* 9 years 03/06/2029 01/09/2029 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00001676/202906 NAP 1678 gentamicin sulphate / hydrocortisone acetate Not available* 10 years 12/02/2035 13/05/2035 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00001678/203502 NAP 1679 lidocaine / hydrocortisone Not available* 10 years 12/02/2035 13/05/2035 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00001679/203502 NAP 1680 hydrocortisone acetate / lidocaine hydrochloride / mefenidramium metilsulfate Not available* 10 years 12/02/2035 13/05/2035 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00001680/203502 NAP 1684 hydrocortisone acetate / zinc sulfate Not available* 8 years 03/11/2026 01/02/2027 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00001684/202611 NAP 1686 hydromorphone 25/11/1998 3 years 30/11/2027 28/02/2028 No 30/07/2025 DLP was amended on 30/07/2025 PSUSA/00001686/202711 Polona Golmajer Slovenia NAP 1688 quinidine, hydroquinidine 02/07/1973 5 years 02/07/2027 30/09/2027 No 23/10/2024 Active substance name was amended on 23/10/2024 DLP was updated on 01/03/2023 PRAC Representative updated on 16/11/2022 PRAC representative was updated on 20/10/2021 European Union reference date, DLP and submission dates updated on 07/05/2018 PSUR frequency amended and DLP updated on 15/11/2017 Lead MS was added on 22/09/2016 Transferred from the List of substances under PSUR Work Sharing scheme and other substances contained in Nationally Authorised Products with DLP synchronised on 06/03/2015 PSUSA/00001688/202707 Maria del Pilar Rayon Spain NAP 1689 hydroquinone Not available* 8 years 03/11/2026 01/02/2027 No 27/02/2026 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00001689/202611 María Martínez González Spain NAP 1692 hydroxycarbamide (for centrally authorised product only) 29/06/2007 1 year 28/06/2026 06/09/2026 28/06/2027 06/09/2027 No 04/02/2026 DLP was amended on 04/02/2026 PSUSA/00001692/202606 PSUSA/00001692/202706 Jo Robays Belgium CAP 1693 hydroxychloroquine 18/04/1955 5 years 18/04/2026 17/07/2026 No 22/12/2021 PSUR frequency and DLP were updated on 22/12/2021 LMS and PRAC representative were added on 23/09/2020 DLP was updated on 03/06/2020 PSUSA/00001693/202604 Marie Louise Schougaard Christiansen Denmark NAP 1694 hydroxyethyl starch, hydroxyethyl starch combinations Not available* 1 year 01/03/2026 10/05/2026 01/03/2027 10/05/2027 No 04/03/2026 Active substance name was amended on 04/03/2026 DLP was amended on 22/10/2025 PSUSA/00001694/202603 PSUSA/00001694/202703 Dennis Lex Germany NAP 1696 hydroxyzine, hydroxyzine combination 14/12/1955 5 years 01/11/2028 30/01/2029 No 03/07/2024 PSUR frequency amended and DLP updated on 03/07/2024 PSUSA/00001696/202811 Tiphaine Vaillant France NAP 1697 hymecromone 27/07/1965 10 years 03/06/2034 01/09/2034 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00001697/203406 NAP 1698 hyoscine 01/01/1952 10 years 01/12/2032 01/03/2033 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00001698/203212 NAP 1699 hyoscyamine 01/02/1966 10 years 03/06/2034 01/09/2034 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00001699/203406 NAP 1701 hypericum perforatum L., herba 07/04/1998 5 years 01/01/2028 31/03/2028 Yes 20/09/2023 DLP amended on 20/09/2023 PSUSA/00001701/202801 Melinda Palfi Hungary NAP 1702 ibandronic acid 25/06/1996 5 years 24/06/2029 22/09/2029 No 05/03/2025 PSUR frequency amended and DLP updated on 05/03/2025 PSUSA/00001702/202906 Karin Erneholm Denmark CAP NAP 1708 ibuprofen / levomenthol Not available* 8 years 15/07/2028 13/10/2028 No 13/08/2025 DLP was updated on 31/03/2021 LMS and PRAC representative were added on 18/12/2019 DLP was updated on 05/06/2019 PSUSA/00001708/202807 Veronika Macurová Czech Republic NAP 1711 ibuprofen / pseudoephedrine Not available* 3 years 18/07/2026 16/10/2026 Yes 18/11/2025 PSUSA/00001711/202607 Tiphaine Vaillant France NAP 1712 ibuprofen (indicated in ductus arteriosus) 29/07/2004 3 years 29/07/2026 27/10/2026 No 27/03/2024 DLP was amended on 27/03/2024 PSUSA/00001712/202607 Rhea Fitzgerald Ireland CAP 1713 ibutilide 28/12/1995 5 years 31/12/2027 30/03/2028 No 20/09/2023 DLP amended on 20/09/2023 PSUSA/00001713/202712 Georgia Gkegka Greece NAP 1714 icatibant 11/07/2008 3 years 11/07/2027 09/10/2027 No 02/06/2026 PSUSA/00001714/202707 Karin Bolin Sweden CAP 1718 calcium oxide / ichthammol / potassium aluminium sulfate / sodium perborate Not available* 9 years 03/06/2029 01/09/2029 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00001718/202906 NAP 1720 idarubicin 29/11/1989 3 years 30/11/2028 28/02/2029 No 29/07/2026 DLP was amended on 29/07/2026 PSUSA/00001720/202811 Jan Neuhauser Austria NAP 1722 idursulfase 08/01/2007 3 years 23/07/2027 21/10/2027 No 02/04/2025 DLP was amended on 02/04/2025 PSUSA/00001722/202707 Liana Martirosyan Netherlands CAP 1723 ifosfamide 13/07/1976 8 years 31/07/2028 29/10/2028 No 02/06/2026 PSUSA/00001723/202807 Jenny Jönsson Sweden NAP 1724 iloprost (nebuliser solution only) 27/04/1994 5 years 15/09/2028 14/12/2028 No 19/09/2024 PSUSA/00001724/202809 Zoubida Amimour France CAP NAP 1725 imatinib 07/11/2001 3 years 10/05/2027 08/08/2027 No 19/09/2025 DLP was amended on 05/02/2025 PSUSA/00001725/202705 Maria Martinez Gonzalez Spain CAP NAP 1726 imidapril 10/10/1993 7 years 02/12/2030 02/03/2031 No 31/07/2024 DLP was amended on 31/07/2024 PSUSA/00001726/203012 John Joseph Borg Malta NAP 1727 imiglucerase 23/05/1994 3 years 23/05/2026 21/08/2026 No 31/01/2024 PSUR frequency amended and DLP updated on 31/01/2024 PSUSA/00001727/202605 Liana Martirosyan Netherlands CAP 1728 imipramine 13/03/1958 8 years 15/07/2028 13/10/2028 No 31/03/2021 PSUR frequency and DLP were updated on 31/03/2021 LMS and PRAC representative were added on 04/03/2020 PSUR frequency and DLP were updated on 05/06/2019 PSUSA/00001728/202807 Dennis Lex Germany NAP 1729 imiquimod 18/09/1998 3 years 26/01/2026 26/04/2026 No 25/06/2025 Information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" was amended on 25/06/2025 Next DLP was updated on 18/10/2023 PSUSA/00001729/202601 Adam Przybylkowski Poland CAP NAP 1730 indacaterol 30/11/2009 5 years 30/11/2027 28/02/2028 No 26/07/2023 PSUR frequency amended and DLP updated on 26/07/2023 PSUSA/00001730/202711 Marie Louise Schougaard Christiansen Denmark CAP 1731 indapamide 25/02/2002 7 years 25/11/2032 23/02/2033 No 29/07/2026 PSUR frequency amended and DLP updated on 29/07/2026 PSUSA/00001731/203211 Dennis Lex Germany NAP 1734 indium (111In) chloride, indium (111In) oxine Not available* 8 years 15/07/2029 13/10/2029 Yes 28/04/2022 PRAC representative was updated on 19/10/2022 PRAC Representative was amended on 28/04/2022 DLP was updated on 30/03/2022 Information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" and DLP were updated on 03/02/2021 LMS and PRAC representative were added on 18/12/2019 DLP was updated on 05/06/2019 PSUSA/00001734/202907 Jo Robays Belgium NAP 1736 indobufen 05/05/1984 8 years 04/05/2033 02/08/2033 No 04/02/2026 PSUR frequency amended and DLP updated on 04/02/2026 PSUSA/00001736/203305 Amelia Cupelli Italy NAP 1737 indocyanine green 16/04/2003 7 years 03/05/2031 01/08/2031 No 05/02/2025 DLP was amended on 05/02/2025 PSUSA/00001737/203105 Jean-Michel Dogné Belgium NAP 1738 indometacin Not available* 3 years 15/07/2026 13/10/2026 No 19/09/2025 DLP was amended on 27/03/2024 PSUSA/00001738/202607 Maria Martinez Gonzalez Spain NAP 1742 influenza vaccine (live, nasal) 27/01/2011 1 year 31/08/2026 09/11/2026 31/08/2027 09/11/2027 No 29/04/2026 DLP was amended on 29/04/2026 PSUSA/00001742/202608 PSUSA/00001742/202708 Jean-Michel Dogné Belgium CAP 1744 influenza vaccine (surface antigen, inactivated) 16/02/1998 1 year 15/03/2026 24/05/2026 15/03/2027 24/05/2027 No 22/10/2025 DLP was amended on 22/10/2025 PSUSA/00001744/202603 PSUSA/00001744/202703 Amelia Cupelli Italy NAP 1749 insulin aspart 07/09/1999 3 years 30/09/2026 29/12/2026 No 02/06/2026 PSUSA/00001749/202609 Karin Bolin Sweden CAP 1750 insulin detemir 01/06/2004 5 years 31/10/2029 29/01/2030 No 25/06/2025 PSUR frequency amended and DLP updated on 25/06/2025 PSUSA/00001750/202910 Marie Louise Schougaard Christiansen Denmark CAP 1751 insulin glargine 21/04/2000 3 years 21/04/2028 20/07/2028 No 31/01/2024 New CAP authorised on 09/01/2026 PRAC representative updated on 31/01/2024 PSUSA/00001751/202804 Bianca Mulder Netherlands CAP 1752 insulin glulisine 16/04/2004 3 years 16/04/2026 15/07/2026 No 20/12/2023 DLP was amended on 20/12/2023 PSUSA/00001752/202604 Marie Louise Schougaard Christiansen Denmark CAP 1753 insulin human, insulin human / insulin isophane (subcutaneous and intravenous routes of administration) 26/10/1980 5 years 26/10/2028 24/01/2029 No 03/07/2024 PSUR frequency amended and DLP updated on 03/07/2024 PSUSA/00001753/202810 Marie Louise Schougaard Christiansen Denmark CAP NAP 1755 insulin lispro 30/04/1995 3 years 30/04/2027 29/07/2027 No 02/06/2026 PSUSA/00001755/202704 Karin Bolin Sweden CAP 1759 interferon beta-1b 30/11/1995 5 years 23/07/2029 21/10/2029 No 02/04/2025 PSUR frequency amended and DLP updated on 02/04/2025 PSUSA/00001759/202907 Dennis Lex Germany CAP 1760 interferon gamma 28/09/1992 8 years 31/01/2033 01/05/2033 No 22/10/2025 PSUR frequency amended and DLP updated on 22/10/2025 PSUSA/00001760/203301 Liana Martirosyan Netherlands NAP 1761 iobitridol 24/08/1994 5 years 30/04/2029 29/07/2029 No 05/02/2025 DLP was amended on 05/02/2025 PSUSA/00001761/202904 Eamon O'Murchu Ireland NAP 1763 iodine (123i) iobenguane 31/01/1995 8 years 03/08/2033 01/11/2033 No 01/04/2026 DLP was amended on 01/04/2026 PSUSA/00001763/203308 Adam Przybylkowski Poland NAP 1764 iodine (131i) iobenguane 01/06/1991 5 years 01/05/2029 30/07/2029 No 05/02/2025 PSUR frequency amended and DLP updated on 05/02/2025 PSUSA/00001764/202905 Karin Erneholm Denmark NAP 1766 iodixanol 01/05/1993 8 years 30/04/2028 29/07/2028 No 03/02/2021 DLP was updated on 03/02/2021 PRAC representative was added on 06/05/2020 LMS was added on 25/09/2019 PSUSA/00001766/202804 Karen Pernille Harg Norway NAP 1767 ioflupane (123i) 27/07/2000 5 years 27/07/2027 25/10/2027 No 05/04/2023 DLP was updated on 05/04/2023 New CAP authorised on 17/06/2021 PRAC representative was updated on 29/07/2020 PRAC representative was updated on 03/06/2020 New CAP authorised on 25/06/2019 LMS and PRAC representative updated 05/06/2019 DLP was updated on 27/03/2018 PSUSA/00001767/202707 Tiphaine Vaillant France CAP 1768 iohexol 04/06/1982 8 years 30/06/2028 28/09/2028 No 03/03/2021 DLP was updated on 03/03/2021 PRAC representative was added on 06/05/2020 LMS was added on 01/04/2020 PSUSA/00001768/202806 Karen Pernille Harg Norway NAP 1769 iomeprol 11/12/1992 8 years 30/04/2028 29/07/2028 No 03/02/2021 DLP was updated on 03/02/2021 PRAC representative was added on 06/05/2020 LMS was added on 25/09/2019 PSUSA/00001769/202804 Karen Pernille Harg Norway NAP 1771 iopamidol 18/05/1981 8 years 31/12/2027 30/03/2028 No 23/09/2020 DLP was updated on 23/09/2020 LMS and PRAC representatives were added on 31/07/2019 PSUSA/00001771/202712 Eamon O'Murchu Ireland NAP 1773 iopromide 28/02/1985 8 years 30/06/2028 28/09/2028 No 03/03/2021 DLP was updated on 03/03/2021 PRAC representative was added on 06/05/2020 LMS was added on 01/04/2020 PSUSA/00001773/202806 Karen Pernille Harg Norway NAP 1775 ioversol 01/06/1989 8 years 03/06/2033 01/09/2033 No 04/02/2026 DLP was amended on 04/02/2026 PSUSA/00001775/203306 Rhea Fitzgerald Ireland NAP 1779 ioxitalamate 11/03/2003 8 years 10/03/2036 08/06/2036 No 30/04/2024 EURD, PSUR frequency and DLP updated on 30/04/2024 Active substance name was amended on 30/04/2024 PSUSA/00001779/203603 none NAP 1780 ipratropium 14/08/1974 3 years 31/01/2026 01/05/2026 No 18/10/2023 Next DLP was updated on 18/10/2023 PSUSA/00001780/202601 Melinda Palfi Hungary NAP 1781 ipratropium / salbutamol 22/03/1994 3 years 31/01/2026 01/05/2026 No 15/11/2023 PRAC Rapporteur updated on 15/11/2023 PSUSA/00001781/202601 Petar Mas Croatia NAP 1783 irinotecan (except for liposomal formulations) 05/05/1995 5 years 04/05/2028 02/08/2028 No 31/01/2024 PSUR frequency amended and DLP updated on 31/01/2024 PSUSA/00001783/202805 Tiphaine Vaillant France NAP 1784 isocarboxazid Not available* 11 years 03/05/2040 01/08/2040 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00001784/204005 NAP 1785 isoconazole Not available* 9 years 03/07/2031 01/10/2031 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00001785/203107 NAP 1786 isoflurane 07/10/1981 3 years 31/10/2028 29/01/2029 No 01/07/2026 DLP was amended on 01/07/2026 PSUSA/00001786/202810 Melinda Palfi Hungary NAP 1788 dichloralphenazone / isometheptene mucate / paracetamol Not available* 9 years 03/08/2030 01/11/2030 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00001788/203008 NAP 1789 isoniazid, isoniazid / pyridoxine hydrochloride, isoniazid / rifampicin, isoniazid / pyrazinamide / rifampicin, ethambutol / isoniazid / pyrazinamide / rifampicin 28/02/1973 5 years 01/11/2029 30/01/2030 No 02/06/2026 PSUSA/00001789/202911 Jenny Jönsson Sweden NAP 1793 isoprenaline 04/04/1977 13 years 03/04/2034 02/07/2034 No 05/01/2025 DLP was amended on 18/12/2024 PSUSA/00001793/203404 Pernille Harg Norway NAP 1794 isosorbide 01/05/1980 13 years 30/04/2034 29/07/2034 No 05/01/2025 DLP was amended on 18/12/2024 PSUSA/00001794/203404 Dennis Lex Germany NAP 1797 isradipine 03/01/1989 15 years 03/06/2040 01/09/2040 No 01/04/2026 PSUR frequency amended and DLP updated on 01/04/2026 DLP was amended on 04/02/2026 PSUSA/00001797/204006 Veronika Macurová Czech Republic NAP 1798 itraconazole 31/08/1974 5 years 31/03/2027 29/06/2027 No 21/12/2022 DLP was updated on 21/12/2022 PRAC Rapporteur name was amended on 28/04/2022 PRAC Rapporteur name was amended on 03/04/2019 Lead MS and PRAC Rapporteur name amended on 19/12/2018 DLP was updated on 19/12/2017 Lead MS and PRAC Rapporteur name was added on 19/10/2016 Information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" was amended on 30/11/2012 PSUSA/00001798/202703 Marie Louise Schougaard Christiansen Denmark NAP 1799 ivabradine 25/04/2005 3 years 25/04/2026 24/07/2026 No 31/01/2024 PRAC representative updated on 31/01/2024 PSUSA/00001799/202604 Bianca Mulder Netherlands CAP NAP 1801 japanese encephalitis virus (inactivated) 31/03/2009 3 years 31/03/2027 29/06/2027 No 06/10/2025 DLP was amended on 18/12/2024 PSUSA/00001801/202703 Dirk Mentzer Germany CAP 1803 kanamycin Not available* 10 years 12/02/2035 13/05/2035 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00001803/203502 NAP 1804 ketamine 10/12/1968 3 years 09/12/2027 08/03/2028 No 30/07/2025 DLP was amended on 30/07/2025 PSUSA/00001804/202712 Jean-Michel Dogné Belgium NAP 1806 ketazolam Not available* 9 years 03/07/2031 01/10/2031 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00001806/203107 NAP 1807 ketobemidone, ketobemidone/dimethylaminodiphenylbutene hydrochloride 07/05/1993 9 years 31/05/2029 29/08/2029 No 03/02/2021 DLP and Name of active substance were updated on 03/02/2021 PSUR Frequency was amended on 03/06/2020 PRAC representative was added on 06/05/2020 LMS was added on 25/09/2019 PSUSA/00001807/202905 Karen Pernille Harg Norway NAP 1808 ketoconazole 01/06/1980 7 years 31/05/2031 29/08/2031 No 31/07/2024 DLP was amended on 31/07/2024 PSUSA/00001808/203105 Guðrún Stefánsdóttir Iceland NAP 1809 ketoprofen (all formulations except topical) 27/07/1972 5 years 23/01/2027 23/04/2027 No 09/07/2026 DLP was updated on 19/10/2022 DLP was updated on 07/05/2018 PRAC representative and Lead Member State were added on 30/01/2017 PSUSA/00001809/202701 Amelia Cupelli Italy NAP 1810 ketorolac (ophtalmic formulations) 20/07/1989 5 years 31/07/2027 29/10/2027 No 16/10/2023 PRAC Rapporteur name was amended on 18/10/2023 PSUSA/00001810/202707 Karin Erneholm Denmark NAP 1811 ketorolac (systemic formulations) 20/07/1989 5 years 19/07/2027 17/10/2027 No 16/10/2023 PRAC Rapporteur name was amended on 18/10/2023 PSUSA/00001811/202707 Karin Erneholm Denmark NAP 1812 ketotifen (ophtalmic formulations) 15/10/1977 10 years 30/06/2032 28/09/2032 No 01/03/2023 PSUR frequency and DLP were updated on 01/03/2023 DLP was updated on 27/03/2018 Lead MS and PRAC Rapporteur name was added on 20/12/2016 PSUSA/00001812/203206 Karin Bolin Sweden NAP 1813 ketotifen (oral formulations) 15/10/1977 5 years 31/10/2028 29/01/2029 No 03/07/2024 PSUR frequency amended and DLP updated on 03/07/2024 PSUSA/00001813/202810 Amelia Cupelli Italy NAP 1814 labetalol 04/03/1977 8 years 28/02/2028 28/05/2028 No 21/10/2020 DLP was updated on 21/10/2020 PRAC representative was added on 06/05/2020 LMS was added on 31/07/2019 PSUSA/00001814/202802 Karen Pernille Harg Norway NAP 1815 lacidipine 07/11/1990 5 years 31/10/2026 29/01/2027 No 29/06/2022 DLP was updated on 29/06/2022 DLP was updated on 21/07/2017 Lead MS and PRAC Rapporteur name was added on 03/06/2016 PSUSA/00001815/202610 Maia Uusküla Estonia NAP 1816 lacosamide 29/08/2008 3 years 31/08/2027 29/11/2027 No 30/04/2025 DLP was amended on 30/04/2025 PSUSA/00001816/202708 Karin Bolin Sweden CAP 1817 lactic acid Not available* 18 years 01/01/2030 01/04/2030 No 01/10/2012 PSUSA/00001817/203001 NAP 1818 lactic acid / salicylic acid 25/04/1977 9 years 03/11/2028 01/02/2029 No 24/09/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00001818/202811 Adam Przybylkowski Poland NAP 1819 lactitol 03/09/1985 5 years 23/09/2030 22/12/2030 No 27/05/2026 DLP was amended on 27/05/2026 PSUSA/00001819/203009 Jan Neuhauser Austria NAP 1821 lactulose 21/05/1964 5 years 31/05/2026 29/08/2026 No 27/07/2022 PRAC representative was updated on 27/07/2022 DLP was updated on 02/02/2022 PRAC representative was updated on 30/06/2021 Next DLP was updated on 30/01/2017 PRAC Rapporteur name updated on 04/02/2016 PRAC Rapporteur and Lead Member State added on 27/11/2015 PSUSA/00001821/202605 Amelia Cupelli Italy NAP 1822 lactose monohydrate / lactulose Not available* 18 years 01/01/2030 01/04/2030 No 01/10/2012 PSUSA/00001822/203001 NAP 1823 lactulose / paraffin liquid / vaseline Not available* 18 years 01/01/2030 01/04/2030 No 01/10/2012 PSUSA/00001823/203001 NAP 1824 lamivudine (chronic hepatitis B) 29/07/1999 5 years 31/07/2030 29/10/2030 No 01/04/2026 DLP was amended on 01/04/2026 PSUSA/00001824/203007 Zoubida Amimour France CAP NAP 1825 lamotrigine 05/11/1990 5 years 30/11/2027 28/02/2028 No 26/07/2023 Next DLP was updated on 26/07/2023 PSUSA/00001825/202711 Liana Martirosyan Netherlands NAP 1826 lanreotide 16/05/1994 3 years 31/05/2026 29/08/2026 No 31/01/2024 PSUR frequency amended and DLP updated on 31/01/2024 PSUSA/00001826/202605 Zane Neikena Latvia NAP 1827 dexlansoprazole, lansoprazole 31/12/1990 5 years 31/12/2026 31/03/2027 No 21/09/2022 DLP was updated on 21/09/2022 Next DLP was amended on 25/09/2017 Correction of PRAC Rapporteur name on 28/02/2017 PRAC Rapporteur name was amended on 20/12/2016 Lead MS and PRAC Rapporteur name was added on 28/07/2016 Name of active substance was amended on 08/01/2014 Information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" was amended on 30/11/2012 PSUSA/00001827/202612 Ana Sofia Diniz Martins Portugal NAP 1829 lapatinib 10/06/2008 5 years 12/03/2030 10/06/2030 No 02/06/2026 PSUSA/00001829/203003 Jenny-Maria Jönsson Sweden CAP 1830 laronidase 10/06/2003 3 years 30/04/2027 29/07/2027 No 05/02/2025 DLP was amended on 05/02/2025 PSUSA/00001830/202704 Zoubida Amimour France CAP 1832 latanoprost 05/06/1996 5 years 30/04/2028 29/07/2028 No 19/11/2025 Correction of DLP on 19/11/2025 Active substance name was amended on 05/03/2025 PRAC Representative amended on 28/04/2022 DLP was updated on 22/12/2021 Next DLP and typo in the name amended on 30/01/2017 PRAC Representative amended on 18/11/2016 Lead Member State was added on 21/12/2015. Name of entry amended on 03/03/2014 PSUSA/00001832/202804 Jean-Michel Dogné Belgium NAP 1833 latanoprost / timolol 05/06/1996 5 years 04/06/2027 02/09/2027 No 01/02/2023 DLP was updated on 01/02/2023 PSUR Frequency amended and DLP updated on 28/02/2018 PRAC representative and Lead Member State were added on 18/11/2016 Transferred from the List of substances under PSUR Work Sharing scheme and other substances contained in Nationally Authorised Products with DLP synchronised on 06/03/2015 PSUSA/00001833/202706 Karin Bolin Sweden NAP 1835 lauromacrogol 400 25/05/1966 18 years 25/05/2030 23/08/2030 No 01/10/2012 PSUSA/00001835/203005 NAP 1836 lauromacrogols combinations Not available* 18 years 01/01/2030 01/04/2030 No 01/10/2012 PSUSA/00001836/203001 NAP 1837 leflunomide 10/09/1998 3 years 10/09/2026 09/12/2026 No 05/06/2024 DLP was amended on 05/06/2024 PSUSA/00001837/202609 Liana Martirosyan Netherlands CAP NAP 1838 lenalidomide 14/06/2007 3 years 26/12/2025 26/03/2026 Yes 20/09/2023 DLP and PSUR frequency amended on 20/09/2023 PSUSA/00001838/202512 Tiphaine Vaillant France CAP NAP 1839 lenograstim 11/10/1991 5 years 31/10/2027 29/01/2028 No 28/06/2023 PSUR frequency amended and DLP updated on 28/06/2023 PRAC representative was updated on 29/07/2020 DLP was updated on 01/07/2020 PRAC representative was updated on 03/06/2020 DLP updated and PRAC Rapporteur name amended on 21/07/2017 PRAC Rapporteur name was amended on 28/07/2016 Lead MS and PRAC Rapporteur name was added on 03/06/2016 Transferred from the List of substances under PSUR Work Sharing scheme and other substances contained in Nationally Authorised Products with DLP synchronised on 06/03/2015 PSUSA/00001839/202710 Tiphaine Vaillant France NAP 1841 lercanidipine 22/03/1996 5 years 31/08/2029 29/11/2029 No 30/04/2025 DLP was amended on 30/04/2025 PSUSA/00001841/202908 Kimmo Jaakkola Finland NAP 1842 letrozole 24/07/1996 3 years 31/10/2027 29/01/2028 No 25/06/2025 DLP was amended on 25/06/2025 PSUSA/00001842/202710 Tiphaine Vaillant France NAP 1846 levetiracetam 29/09/2000 3 years 30/11/2027 28/02/2028 No 30/07/2025 DLP was amended on 30/07/2025 PSUSA/00001846/202711 Jo Robays Belgium CAP NAP 1848 levobupivacaine 01/01/1999 5 years 31/12/2027 30/03/2028 No 20/09/2023 DLP amended on 20/09/2023 PSUSA/00001848/202712 Karin Bolin Sweden NAP 1849 levocabastine 22/02/1993 5 years 14/11/2027 12/02/2028 No 16/10/2023 PRAC Rapporteur name was amended on 18/10/2023 PSUSA/00001849/202711 Karin Erneholm Denmark NAP 1850 levocetirizine 03/01/2001 6 years 02/07/2029 30/09/2029 No 28/02/2024 DLP was amended on 28/02/2024 PSUSA/00001850/202907 Dennis Lex Germany NAP 1853 levodropropizine 08/05/1997 7 years 02/01/2031 02/04/2031 No 25/09/2024 DLP was amended on 25/09/2024 PSUSA/00001853/203101 Melinda Palfi Hungary NAP 1855 levomethadone 22/03/1969 5 years 01/05/2030 30/07/2030 No 04/02/2026 PSUR frequency amended and DLP updated on 04/02/2026 PSUSA/00001855/203005 Jan Neuhauser Austria NAP 1858 levosimendan 22/09/2000 5 years 22/09/2029 21/12/2029 No 03/06/2020 PRAC Rapporteur name was amended on 01/02/2023 PRAC Rapporteur name was amended on 22/09/2022 PSUR frequency and DLP were updated on 03/06/2020 PRAC Rapporteur name updated on 23/10/2018 PRAC Rapporteur name was amended on 31/07/2018 Next DLP was amended on 27/06/2017 PRAC representative and Lead Member State were added on 03/05/2016 PSUSA number was amended on 06/10/2014 PSUSA/00001858/202909 Karin Bolin Sweden NAP 1859 levosulpiride, sulpiride 01/04/1986 8 years 03/06/2033 01/09/2033 No 04/02/2026 DLP was amended on 04/02/2026 PSUSA/00001859/203306 Amelia Cupelli Italy NAP 1860 levothyroxine 01/01/1952 5 years 31/01/2027 01/05/2027 No 19/09/2024 PSUSA/00001860/202701 Zoubida Amimour France NAP 1867 lidocaine / prilocaine (not centrally authorised product) 01/04/1985 5 years 31/03/2027 29/06/2027 No 16/10/2023 PRAC Rapporteur name was amended on 18/10/2023 PSUSA/00001867/202703 Karin Erneholm Denmark NAP 1868 lidocaine / tetracaine 29/06/2006 8 years 30/06/2028 28/09/2028 No 03/03/2021 DLP was updated on 03/03/2021 PRAC representative was added on 06/05/2020 LMS was added on 01/04/2020 PSUSA/00001868/202806 Jean-Michel Dogné Belgium NAP 1869 carrageenin / titanium dioxide / zinc oxide, carrageenin / lidocaine / titanium dioxide / zinc oxide, titanium dioxide / zinc oxide / tetracaine hydrochloride, carrageenin / lidocaine / titanium dioxide Not available* 8 years 15/06/2028 13/09/2028 No 02/04/2025 Active substance name was amended on 02/04/2025 DLP was updated on 03/03/2021 PRAC representative was added on 06/05/2020 LMS was added on 01/04/2020 DLP was updated on 05/06/2019 The active substance name was amended on 01/04/2015 The active substance name was amended on 01/12/2014 PSUSA/00001869/202806 none NAP 1879 lidocaine hydrochloride / methylprednisolone acetate Not available* 8 years 01/08/2028 30/10/2028 No 31/03/2021 DLP was updated on 31/03/2021 PRAC representative and LMS were added on 04/03/2020 DLP was updated on 05/06/2019 PSUSA/00001879/202808 Zane Neikena Latvia NAP 1887 lincomycin 01/01/1960 10 years 03/03/2034 01/06/2034 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00001887/203403 NAP 1888 linezolid 18/04/2000 3 years 17/04/2028 16/07/2028 No 17/02/2026 Information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" was amended on 17/12/2025 DLP was amended on 17/12/2025 PSUR frequency and DLP were updated on 21/12/2022 PRAC representative was updated on 27/07/2022 PRAC representative was updated on 06/05/2020 Lead MS and PRAC Rapporteur name amended on 19/12/2018 DLP was updated on 19/12/2017 Lead MS and PRAC Rapporteur name was added on 19/10/2016 PSUSA/00001888/202804 Jana Pecherova Slovakia NAP 1890 liothyronine 16/12/1997 7 years 02/01/2031 02/04/2031 No 25/09/2024 DLP was amended on 25/09/2024 PSUSA/00001890/203101 Dennis Lex Germany NAP 1891 levothyroxine sodium / liothyronine sodium Not available* 9 years 02/09/2031 01/12/2031 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00001891/203109 NAP 1892 liraglutide, insulin degludec / liraglutide 30/06/2009 3 years 31/12/2026 31/03/2027 No 01/07/2026 New CAP authorised on 15/07/2026 Active substance name was amended on 01/07/2026 DLP was amended on 25/09/2024 PSUSA/00001892/202612 Bianca Mulder Netherlands CAP 1897 lithium 20/02/1967 6 years 03/08/2029 01/11/2029 No 30/04/2024 DLP was amended on 30/04/2024 PSUSA/00001897/202908 Dennis Lex Germany NAP 1898 lodoxamide 02/07/1990 8 years 03/06/2033 01/09/2033 No 04/02/2026 DLP was amended on 04/02/2026 PSUSA/00001898/203306 Terhi Lehtinen Finland NAP 1899 lofepramine 27/02/1976 9 years 03/08/2028 01/11/2028 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00001899/202808 NAP 1902 lomustine 26/01/1976 5 years 26/01/2028 25/04/2028 No 18/10/2023 Next DLP was updated on 18/10/2023 PSUSA/00001902/202801 Miroslava Gocova Slovakia NAP 1905 lopinavir / ritonavir 20/03/2001 5 years 30/09/2029 29/12/2029 No 19/09/2024 PSUSA/00001905/202909 Zoubida Amimour France CAP 1906 loprazolam 10/07/1981 9 years 03/11/2028 01/02/2029 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00001906/202811 NAP 1907 loratadine 01/10/1991 5 years 02/02/2027 03/05/2027 No 09/07/2026 DLP was updated on 19/10/2022 PRAC Representative amended on 28/04/2022 DLP was updated on 17/10/2017 PRAC Representative amended on 18/11/2016 Lead MS and PRAC Rapporteur name was added on 28/07/2016 PSUSA/00001907/202702 Jo Robays Belgium NAP 1908 loratadine / pseudoephedrine 01/10/1991 5 years 02/02/2027 03/05/2027 No 09/07/2026 DLP was updated on 19/10/2022 PRAC Representative amended on 28/04/2022 DLP was updated on 17/10/2017 PRAC Representative amended on 18/11/2016 Lead MS and PRAC Rapporteur name was added on 28/07/2016 PSUSA/00001908/202702 Jo Robays Belgium NAP 1909 lorazepam 31/12/1963 3 years 31/01/2028 30/04/2028 No 22/10/2025 DLP was amended on 22/10/2025 PSUSA/00001909/202801 Karin Erneholm Denmark NAP 1910 lormetazepam 07/12/1980 3 years 31/12/2026 31/03/2027 No 25/09/2024 DLP was amended on 25/09/2024 PSUSA/00001910/202612 Sonja Hrabcik Austria NAP 1911 lornoxicam Not available* 7 years 01/12/2031 29/02/2032 No 19/09/2025 DLP was amended on 30/07/2025 PSUSA/00001911/203112 Maria Martinez Gonzalez Spain NAP 1912 losartan 02/09/1994 8 years 01/09/2033 30/11/2033 No 29/04/2026 DLP was amended on 29/04/2026 PSUSA/00001912/203309 Bianca Mulder Netherlands NAP 1913 loteprednol 31/03/2003 7 years 03/05/2031 01/08/2031 No 05/02/2025 DLP was amended on 05/02/2025 PSUSA/00001913/203105 Amelia Cupelli Italy NAP 1916 loxapine 20/12/1961 9 years 01/02/2028 01/05/2028 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00001916/202802 NAP 1918 lutropin alfa 29/11/2000 5 years 28/11/2027 26/02/2028 No 26/07/2023 PSUR frequency amended and DLP updated on 26/07/2023 PSUSA/00001918/202711 Marie Louise Schougaard Christiansen Denmark CAP 1919 lymecycline 31/01/1961 9 years 01/02/2028 01/05/2028 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00001919/202802 NAP 1920 lynestrenol 20/03/1973 9 years 03/06/2028 01/09/2028 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00001920/202806 NAP 1924 macrogol 3350, macrogol 3350 combinations (oral use) 15/04/1991 5 years 31/05/2027 29/08/2027 No 25/06/2025 Active substance name was amended on 25/06/2025 PSUR frequency and DLP were updated on 01/02/2023 PRAC representative was updated on 27/07/2022 DLP was updated on 05/02/2020 PRAC representative was updated on 25/09/2019 Lead MS and PRAC Rapporteur name amended on 19/12/2018 Next DLP amended on 30/01/2017 PRAC Rappoerteur and Lead Member State added on 27/11/2015. PSUSA number was amended on 06/10/2014 PSUSA/00001924/202705 Amelia Cupelli Italy NAP 1926 magnesium hydroxide 09/11/1970 5 years 31/10/2026 29/01/2027 No 27/02/2026 DLP was updated on 29/06/2022 DLP was updated on 21/07/2017 Lead MS and PRAC Rapporteur name was added on 03/06/2016 PSUSA/00001926/202610 Polona Golmajer Slovenia NAP 1928 magnesium orotate, magnesium lactate Not available* 8 years 03/11/2026 01/02/2027 No 27/02/2026 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00001928/202611 Melinda Palfi Hungary NAP 1929 ascorbic acid / magnesium oxide, magnesium oxide Not available* 7 years 03/06/2031 01/09/2031 Yes 18/12/2024 Active substance name was amended on 18/12/2024 PSUR frequency and DLP amended on 28/02/2024 PSUSA/00001929/203106 Adam Przybylkowski Poland NAP 1930 malathion 04/03/1992 18 years 04/03/2030 02/06/2030 No 01/10/2012 PSUSA/00001930/203003 NAP 1932 manidipine 29/06/1990 5 years 29/06/2029 27/09/2029 No 05/03/2025 PSUR frequency amended and DLP updated on 05/03/2025 PSUSA/00001932/202906 Amelia Cupelli Italy NAP 1933 maprotiline 23/09/1970 9 years 03/05/2028 01/08/2028 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00001933/202805 NAP 1934 maraviroc 18/09/2007 5 years 05/08/2026 03/11/2026 No 02/06/2026 PSUSA/00001934/202608 Karin Bolin Sweden CAP 1936 measles / mumps / rubella / varicella vaccines (live) 26/07/2006 3 years 05/09/2027 04/12/2027 No 06/10/2025 DLP was amended on 30/04/2025 PSUSA/00001936/202709 Dirk Mentzer Germany CAP NAP 1937 measles / mumps / rubella vaccines (live, attenuated) 28/11/1997 3 years 04/05/2027 02/08/2027 No 06/10/2025 DLP was amended on 05/02/2025 PSUSA/00001937/202705 Dirk Mentzer Germany CAP NAP 1939 mebendazole 03/05/1971 15 years 03/05/2040 01/08/2040 No 04/02/2026 DLP was amended on 04/02/2026 PSUSA/00001939/204005 Amelia Cupelli Italy NAP 1940 mebeverine 10/11/1964 9 years 03/03/2028 01/06/2028 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00001940/202803 NAP 1942 mecasermin 03/08/2007 1 year 31/08/2026 09/11/2026 31/08/2027 09/11/2027 No 29/04/2026 DLP was amended on 29/04/2026 PSUSA/00001942/202608 PSUSA/00001942/202708 Terhi Lehtinen Finland CAP 1943 mecillinam 31/05/1977 9 years 03/11/2028 01/02/2029 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00001943/202811 NAP 1945 meclozine 08/05/1953 15 years 31/08/2040 29/11/2040 No 29/04/2026 DLP was amended on 29/04/2026 PSUSA/00001945/204008 Jo Robays Belgium NAP 1946 meclozine hydrochloride / pyridoxine hydrochloride Not available* 10 years 12/02/2035 13/05/2035 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00001946/203502 NAP 1947 mecobalamin 22/02/1952 10 years 01/12/2032 01/03/2033 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00001947/203212 NAP 1948 medazepam Not available* 9 years 02/09/2031 01/12/2031 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00001948/203109 NAP 1949 medrogestone Not available* 8 years 03/11/2026 01/02/2027 No 27/02/2026 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00001949/202611 Tiphaine Vaillant France NAP 1950 conjugated estrogens / medrogestone Not available* 9 years 03/03/2030 01/06/2030 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00001950/203003 NAP 1951 medroxyprogesterone 20/08/1959 5 years 19/08/2026 17/11/2026 No 31/01/2024 PSUR frequency amended and DLP updated on 31/01/2024 PSUSA/00001951/202608 none NAP 1954 mefenamic acid 28/03/1962 9 years 01/02/2028 01/05/2028 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00001954/202802 NAP 1955 mefloquine 20/02/1984 3 years 19/02/2026 20/05/2026 No 18/10/2023 Next DLP was updated on 18/10/2023 PSUSA/00001955/202602 Karen Pernille Harg Norway NAP 1956 mefruside / nifedipine 10/07/1984 9 years 01/12/2028 01/03/2029 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00001956/202812 NAP 1957 megestrol 18/08/1971 9 years 03/06/2028 01/09/2028 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00001957/202806 NAP 1959 meglumine antimonate 22/01/1947 11 years 03/11/2036 01/02/2037 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00001959/203611 NAP 1963 melatonin 29/06/2007 3 years 28/09/2026 27/12/2026 No 05/06/2024 DLP was amended on 05/06/2024 PSUSA/00001963/202609 Ana Sofia Diniz Martins Portugal CAP NAP 1965 melperone 17/01/1968 9 years 02/04/2028 01/07/2028 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00001965/202804 NAP 1967 memantine 15/05/2002 5 years 15/09/2028 14/12/2028 No 05/06/2024 DLP was amended on 05/06/2024 PSUSA/00001967/202809 Maria del Pilar Rayon Spain CAP NAP 1969 meningococcal group a, c, w135, y conjugate vaccine (conjugated to Corynebacterium diphtheriae CRM197 protein) 15/03/2010 5 years 14/03/2030 12/06/2030 No 19/11/2025 DLP was amended on 19/11/2025 PSUSA/00001969/203003 Liana Martirosyan Netherlands CAP 1971 meningococcal group c polysaccharide conjugate vaccine 15/10/1999 3 years 15/10/2027 13/01/2028 No 25/06/2025 DLP was amended on 25/06/2025 PSUSA/00001971/202710 Jean-Michel Dogné Belgium NAP 1972 menotrophin Not available* 7 years 31/12/2031 30/03/2032 No 24/09/2025 DLP was amended on 24/09/2025 PSUSA/00001972/203112 Veronika Macurová Czech Republic NAP 1974 mepartricin 28/02/1974 10 years 03/03/2035 01/06/2035 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00001974/203503 NAP 1978 mephenoxalone Not available* 8 years 03/11/2026 01/02/2027 No 27/02/2026 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00001978/202611 Eva Jirsová Czech Republic NAP 1979 epinephrine / mepivacaine hydrochloride, mepivacaine / norepinephrine, mepivacaine 01/04/1956 7 years 31/03/2030 29/06/2030 No 20/12/2023 PSUR frequency amended and DLP updated on 20/12/2023 PSUSA/00001979/203003 Karin Erneholm Denmark NAP 1982 mepivacaine hydrochloride / polyestradiol phosphate Not available* 11 years 03/05/2040 01/08/2040 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00001982/204005 NAP 1984 meptazinol Not available* 9 years 02/09/2031 01/12/2031 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00001984/203109 NAP 1985 mepyramine 31/12/1969 9 years 31/12/2031 30/03/2032 No 18/12/2024 PSUSA/00001985/203112 none NAP 1988 mercaptopurine 11/09/1953 3 years 01/09/2026 30/11/2026 No 02/06/2026 PSUSA/00001988/202609 Jenny-Maria Jönsson Sweden CAP NAP 1989 meropenem 31/08/1994 3 years 31/08/2027 29/11/2027 No 30/04/2025 DLP was amended on 30/04/2025 PSUSA/00001989/202708 Jan Neuhauser Austria NAP 1990 mesalazine 20/02/1984 2 years 19/02/2026 20/05/2026 Yes 19/10/2022 DLP was updated on 19/10/2022 PRAC Rapporteur name was amended on 28/04/2022 LMS and PRAC representative and 'Are PSURs required for products referred to in Articles 10(1), 10a, 16a of Directive 2001/83/EC as amended' were updated on 28/07/2021 PSUR frequency and DLP were updated on 21/10/2020 Lead MS and PRAC Rapporteur name amended on 19/12/2018 The Next DLP was amended on 29/10/2015 Lead MS was added on 04/02/2015 PSUSA/00001990/202602 Marie Louise Schougaard Christiansen Denmark NAP 1991 mesna Not available* 8 years 03/11/2026 01/02/2027 No 27/02/2026 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00001991/202611 Adam Przybylkowski Poland NAP 1994 metacycline Not available* 10 years 03/08/2036 01/11/2036 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00001994/203608 NAP 1995 metadoxine Not available* 9 years 02/12/2031 01/03/2032 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00001995/203112 NAP 1996 caffeine / drotaverine hydrochloride / metamizole sodium 24/11/1992 4 years 07/01/2028 06/04/2028 No 25/09/2024 PSUR frequency amended and DLP updated on 25/09/2024 PSUSA/00001996/202801 Miroslava Gocova Slovakia NAP 1997 metamizole 24/03/1923 3 years 24/03/2027 22/06/2027 No 20/11/2024 DLP was amended on 20/11/2024 PSUSA/00001997/202703 Melinda Palfi Hungary NAP 1998 hyoscine butylbromide / metamizole 03/11/1965 10 years 03/06/2034 01/09/2034 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00001998/203406 NAP 1999 metamizole sodium / triacetonamine tosilate Not available* 5 years 01/01/2030 01/04/2030 Yes 24/09/2025 DLP was amended on 24/09/2025 PSUSA/00001999/203001 Maria Popova-Kiradjieva Bulgaria NAP 2001 metformin 19/03/1959 3 years 01/04/2027 30/06/2027 No 18/12/2024 DLP was amended on 18/12/2024 PSUSA/00002001/202704 Amimour Zoubida France NAP 2002 glibenclamide / metformin hydrochloride 18/06/1993 4 years 18/06/2028 16/09/2028 No 05/03/2025 PSUR frequency amended and DLP updated on 05/03/2025 PSUSA/00002002/202806 Zoubida Amimour France NAP 2004 methadone 01/01/1930 5 years 01/05/2030 30/07/2030 No 04/02/2026 PSUR frequency amended and DLP updated on 04/02/2026 PSUSA/00002004/203005 Eamon O'Murchu Ireland NAP 2005 methenamine 02/08/1956 11 years 03/10/2037 01/01/2038 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00002005/203710 NAP 2006 boric acid / calcium thiocyanate / camphor / menthol / methenamine Not available* 9 years 03/06/2029 01/09/2029 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00002006/202906 NAP 2007 calcium thiocyanate / methenamine Not available* 9 years 03/06/2029 01/09/2029 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00002007/202906 NAP 2011 methocarbamol, methocarbamol / paracetamol Not available* 10 years 01/12/2034 01/03/2035 No 30/07/2025 Active substance name was amended on 30/07/2025 PSUR frequency amended and DLP updated on 30/07/2025 PSUR frequency and DLP amended on 27/03/2024 PSUSA/00002011/203412 Dennis Lex Germany NAP 2014 methotrexate 01/01/1962 5 years 31/10/2030 29/01/2031 Yes 01/07/2026 PSUR frequency amended and DLP updated on 01/07/2026 DLP was amended on 03/07/2024 PSUSA/00002014/203010 Dennis Lex Germany CAP NAP 2016 methoxsalen 31/03/1958 10 years 31/01/2034 01/05/2034 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00002016/203401 NAP 2017 methoxy polyethylene glycol-epoetin beta 20/07/2007 3 years 19/07/2026 17/10/2026 No 19/09/2025 DLP was amended on 27/03/2024 PSUSA/00002017/202607 Maria Martinez Gonzalez Spain CAP 2019 methylaminolevulinate 15/06/2001 5 years 30/06/2027 28/09/2027 No 02/06/2026 PSUSA/00002019/202706 Jenny Jönsson Sweden NAP 2021 methyldopa 01/01/1960 9 years 01/02/2028 01/05/2028 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00002021/202802 NAP 2022 methylergometrine Not available* 9 years 02/12/2031 01/03/2032 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00002022/203112 NAP 2023 methylnaltrexone bromide 02/07/2008 3 years 27/03/2028 25/06/2028 No 19/11/2025 DLP was amended on 19/11/2025 PSUSA/00002023/202803 Dennis Lex Germany CAP 2024 methylphenidate 06/10/1954 5 years 31/10/2029 29/01/2030 No 25/06/2025 PSUR frequency amended and DLP updated on 25/06/2025 PSUSA/00002024/202910 Dennis Lex Germany CAP NAP 2025 methylphenobarbital Not available* 5 years 31/03/2028 29/06/2028 Yes 20/12/2023 DLP was amended on 20/12/2023 PSUSA/00002025/202803 Benjamin Micallef Malta NAP 2026 methylprednisolone (systemic use) 18/12/1957 3 years 30/11/2026 28/02/2027 No 30/04/2025 DLP was corrected on 30/04/2025 PSUR frequency amended and DLP updated on 25/09/2024 Entry name updated on 25/09/2024 DLP was amended on 31/07/2024 PSUSA/00002026/202611 Jan Neuhauser Austria NAP 2029 methylthioninium chloride 03/11/1987 3 years 05/05/2026 03/08/2026 No 02/06/2026 PSUSA/00002029/202605 Karin Bolin Sweden CAP 2036 metoclopramide 17/11/1964 5 years 17/11/2029 15/02/2030 No 30/07/2025 PSUR frequency amended and DLP updated on 30/07/2025 PSUSA/00002036/202911 Karen Pernille Harg Norway NAP 2037 metolazone 01/01/1991 8 years 03/06/2033 01/09/2033 No 02/06/2026 PSUSA/00002037/203306 Karin Bolin Sweden NAP 2039 metoprolol 28/02/1975 8 years 03/03/2033 01/06/2033 No 19/11/2025 DLP was amended on 19/11/2025 PSUSA/00002039/203303 Dennis Lex Germany NAP 2041 metronidazole 29/07/1959 9 years 02/12/2027 01/03/2028 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00002041/202712 NAP 2042 metronidazole / miconazole, chlorquinaldol / metronidazole 18/12/1992 8 years 03/07/2033 01/10/2033 No 04/03/2026 DLP was amended on 04/03/2026 PSUSA/00002042/203307 Eva Jirsová Czech Republic NAP 2045 metronidazole / spiramycin 29/07/1959 10 years 31/01/2034 01/05/2034 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00002045/203401 NAP 2046 metyrapone 14/06/1961 6 years 14/06/2030 12/09/2030 Yes 05/02/2025 DLP was amended on 05/02/2025 PSUSA/00002046/203006 Kimmo Jaakkola Finland NAP 2047 mexazolam Not available* 7 years 01/12/2031 29/02/2032 No 30/07/2025 DLP was amended on 30/07/2025 PSUSA/00002047/203112 John Joseph Borg Malta NAP 2048 mexiletine (nationally authorised products only) 06/10/1975 9 years 03/08/2028 01/11/2028 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00002048/202808 NAP 2050 mianserin 01/01/1974 9 years 03/06/2028 01/09/2028 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00002050/202806 NAP 2051 micafungin 25/04/2008 5 years 08/10/2029 06/01/2030 No 25/06/2025 PSUR frequency amended and DLP updated on 25/06/2025 PSUSA/00002051/202910 Dennis Lex Germany CAP 2052 miconazole, hydrocortisone / miconazole nitrate, miconazole nitrate / zinc oxide, benzoyl peroxide / miconazole 31/07/1971 10 years 09/10/2034 07/01/2035 No 02/06/2026 PSUSA/00002052/203410 Jenny Jönsson Sweden NAP 2057 midazolam (all pharmaceutical forms and indications apart from oromucosal and nasal routes of administration) 10/09/1982 5 years 09/09/2027 08/12/2027 No 01/04/2026 Active substance name was amended on 01/04/2026 DLP was amended on 03/05/2023 DLP correction on 19/12/2018 DLP was updated on 06/06/2018 Name of entry was amended, and Lead MS added on 12/05/2015. Name of entry was amended on 06/10/2014 Name of active substance was amended on 30/04/2013 PSUSA/00002057/202709 Dennis Lex Germany NAP 2058 midecamycin 24/05/1984 9 years 01/12/2028 01/03/2029 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00002058/202812 NAP 2059 mifamurtide 06/03/2009 5 years 05/03/2027 03/06/2027 No 16/11/2022 PSUR frequency and DLP were updated on 16/11/2022 DLP was updated on 23/10/2019 PRAC Representative updated on 26/09/2018 PSUR Frequency amended and DLP updated on 19/10/2016 Next DLP was updated on 30/09/2015 PSUSA/00002059/202703 Bianca Mulder Netherlands CAP 2060 mifepristone 31/05/1988 3 years 31/05/2026 29/08/2026 No 02/06/2026 PSUSA/00002060/202605 Jenny Jönsson Sweden NAP 2062 miglustat (all other indications) 20/11/2002 5 years 19/10/2029 17/01/2030 No 02/06/2026 PSUSA/00002062/202910 Karin Bolin Sweden CAP 2063 milnacipran 06/12/1966 3 years 30/04/2028 29/07/2028 Yes 25/09/2024 DLP was amended on 25/09/2024 Information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" was amended on 25/09/2024 DLP was updated on 02/02/2022 PRAC representative was updated on 29/07/2020 PRAC representative was updated on 03/06/2020 DLP was updated on 06/02/2019 PRAC representative was updated on 03/06/2020 PRAC Rapporteur name updated on 21/07/2017 PRAC Rapporteur name was amended on 28/07/2016 Next DLP was amended on 04/02/2016 Lead MS was added on 06/03/2015 PSUSA/00002063/202804 Tiphaine Vaillant France NAP 2064 milrinone 16/10/1987 3 years 16/10/2027 14/01/2028 No 25/06/2025 DLP was amended on 25/06/2025 PSUSA/00002064/202710 Jan Neuhauser Austria NAP 2065 minocycline 07/08/1961 5 years 31/08/2027 29/11/2027 No 03/05/2023 DLP was amended on 03/05/2023 PRAC Representative name was corrected on 29/07/2020 PRAC Representative updated on 26/09/2018 DLP was updated on 06/06/2018 Information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" was amended on 28/03/2017 Lead MS and PRAC Rapporteur name was added on 28/02/2017 PSUSA/00002065/202708 Maria del Pilar Rayon Spain NAP 2066 minoxidil (non topical formulations) 18/10/1979 3 years 31/10/2028 29/01/2029 No 01/07/2026 PSUR frequency amended and DLP updated on 01/07/2026 DLP was updated on 30/06/2021 PRAC Rapporteur name updated on 23/10/2018 Next DLP was amended on 28/07/2016 "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended? Yes/No" was amended on 16/07/2015 Lead MS added on 16/06/2015 PSUSA/00002066/202810 Eamon O'Murchu Ireland NAP 2067 minoxidil (topical formulation) 18/10/1979 3 years 31/10/2026 29/01/2027 No 03/07/2024 DLP was amended on 03/07/2024 PSUSA/00002067/202610 Eamon O'Murchu Ireland NAP 2068 mirtazapine 01/09/1994 5 years 31/08/2028 29/11/2028 No 30/04/2024 DLP was amended on 30/04/2024 PSUSA/00002068/202808 Liana Martirosyan Netherlands NAP 2074 mitomycin 05/10/1962 9 years 03/03/2028 01/06/2028 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00002074/202803 NAP 2075 mitotane 28/04/2004 5 years 28/04/2028 27/07/2028 No 25/06/2025 Information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" was amended on 25/06/2025 PSUR frequency amended and DLP updated on 20/12/2023 PSUSA/00002075/202804 Maria del Pilar Rayon Spain CAP 2076 mitoxantrone 15/06/1981 3 years 30/06/2028 28/09/2028 No 04/03/2026 DLP was amended on 04/03/2026 PSUSA/00002076/202806 Karin Erneholm Denmark NAP 2077 mivacurium 22/01/1992 10 years 31/01/2028 30/04/2028 No 23/10/2018 PRAC Rapporteur name updated on 23/10/2018 PSUR frequency amended and DLP updated on 23/10/2018 Information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" was amended on 21/07/2017 Lead MS and PRAC Rapporteur name was added on 27/06/2017 PSUSA/00002077/202801 Eamon O'Murchu Ireland NAP 2078 mizolastine 21/11/1995 5 years 21/11/2027 19/02/2028 No 12/09/2025 Next DLP was updated on 26/07/2023 PSUSA/00002078/202711 Veronika Macurová Czech Republic NAP 2079 moclobemide 26/10/1989 5 years 01/04/2027 30/06/2027 No 21/12/2022 DLP was updated on 21/12/2022 PRAC Rapporteur name updated on 23/10/2018 PRAC Representative updated on 26/09/2018 DLP was updated on 19/12/2017 Lead MS and PRAC Rapporteur name was added on 19/10/2016 PSUSA/00002079/202704 Liana Martirosyan Netherlands NAP 2084 molsidomine Not available* 9 years 02/12/2031 01/03/2032 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00002084/203112 NAP 2085 mometasone 22/01/1997 5 years 22/05/2028 20/08/2028 No 31/01/2024 PSUR frequency amended and DLP updated on 31/01/2024 PSUSA/00002085/202805 Karin Bolin Sweden NAP 2087 montelukast 25/08/1997 3 years 30/07/2027 28/10/2027 No 02/04/2025 DLP was amended on 02/04/2025 PSUSA/00002087/202707 Kimmo Jaakkola Finland NAP 2088 morniflumate Not available* 8 years 03/11/2026 01/02/2027 No 05/01/2025 Correction of DLP on 20/11/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00002088/202611 Amelia Cupelli Italy NAP 2089 moroctocog alfa 13/04/1999 5 years 26/08/2029 24/11/2029 No 30/04/2025 PSUR frequency amended and DLP updated on 30/04/2025 PSUSA/00002089/202908 Marie Louise Schougaard Christiansen Denmark CAP 2093 caffeine / moxastine teoclate Not available* 11 years 03/03/2040 01/06/2040 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00002093/204003 NAP 2094 moxifloxacin (topical ophthalmic use) 31/05/1999 5 years 31/05/2026 29/08/2026 No 02/02/2022 DLP was updated on 02/02/2022 Next DLP was amended on 30/01/2017 'Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended? Yes/No' was amended on 27/11/2015. PRAC Rapporteur and Lead Member state was added on 27/11/2015 Name of active substance was amended on 21/12/2012 PSUSA/00002094/202605 Dennis Lex Germany NAP 2095 moxonidine 23/01/1991 5 years 23/01/2027 23/04/2027 No 19/10/2022 DLP was updated on 19/10/2022 PRAC representative was updated on 06/05/2020 DLP was updated on 17/10/2017 Lead MS and PRAC Rapporteur name was added on 28/07/2016 PSUSA/00002095/202701 Melinda Palfi Hungary NAP 2096 mupirocin 26/03/1985 5 years 31/03/2027 29/06/2027 No 21/12/2022 DLP was updated on 21/12/2022 PRAC representative was updated on 28/07/2021 PRAC representative was updated on 28/04/2021 Lead MS and PRAC Rapporteur name amended on 19/12/2018 DLP was updated on 19/12/2017 Lead MS and PRAC Rapporteur name was added on 19/10/2016 PSUSA/00002096/202703 Polona Golmajer Slovenia NAP 2100 nabilone Not available* 6 years 02/12/2029 02/03/2030 Yes 31/07/2024 DLP was amended on 31/07/2024 PSUSA/00002100/202912 Jan Neuhauser Austria NAP 2101 nabumetone 15/03/1984 10 years 01/03/2027 30/05/2027 No 15/11/2017 PRAC Rapporteur name updated on 23/10/2018 PRAC Representative updated on 26/09/2018 PSUR frequency amended and DLP updated on 15/11/2017 Lead MS was added on 22/09/2016 PSUSA/00002101/202703 Liana Martirosyan Netherlands NAP 2102 nadifloxacin 06/07/2000 5 years 31/05/2026 29/08/2026 No 02/02/2022 DLP was updated on 02/02/2022 Next DLP updated on 30/01/2017 PRAC Rapporteur and Lead Member State added on 27/11/2015. PSUSA/00002102/202605 Dennis Lex Germany NAP 2103 nadolol 22/07/1976 9 years 03/08/2028 01/11/2028 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00002103/202808 NAP 2104 nadroparin 04/03/1985 5 years 31/03/2026 29/06/2026 No 19/09/2025 PRAC Representative updated on 16/11/2022 PSUR frequency and DLP were updated on 22/12/2021 DLP was updated on 19/12/2018 PRAC Rapporteur name was amended on 25/09/2017 Next DLP was updated on 21/12/2015. Lead MS was added on 06/03/2015 PSUSA/00002104/202603 Maria Martinez Gonzalez Spain NAP 2105 nafarelin 15/02/1990 5 years 14/02/2029 15/05/2029 No 20/10/2021 DLP was updated on 20/10/2021 DLP was updated on 23/10/2018 PRAC Rapporteur name was updated on 04/07/2018 PRAC Rapporteur name was amended on 27/06/2017 The DLP was amended on 29/10/2015 Lead MS was added on 04/02/2015 PSUSA/00002105/202902 Karen Pernille Harg Norway NAP 2107 naftazone 18/12/1987 9 years 01/01/2029 01/04/2029 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00002107/202901 NAP 2108 naftidrofuryl 30/10/1970 9 years 06/03/2028 04/06/2028 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00002108/202803 NAP 2109 naftifine Not available* 8 years 01/08/2028 30/10/2028 No 31/03/2021 DLP was updated on 31/03/2021 PRAC representative was added on 06/05/2020 LMS was added on 01/04/2020 DLP was updated on 05/06/2019 PSUSA/00002109/202808 Maia Uusküla Estonia NAP 2110 nalbuphine 15/05/1979 5 years 01/05/2028 30/07/2028 Yes 31/01/2024 DLP was amended on 31/01/2024 PSUSA/00002110/202805 Eva Jirsová Czech Republic NAP 2112 naloxone (for use in medical settings only) 14/04/1975 9 years 03/08/2028 01/11/2028 No 24/09/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00002112/202808 Adam Przybylkowski Poland NAP 2113 buprenorphine / naloxone 26/09/2006 4 years 26/09/2027 25/12/2027 No 05/06/2024 DLP was amended on 05/06/2024 PSUSA/00002113/202709 Dennis Lex Germany CAP NAP 2114 naloxone / oxycodone 31/05/2006 3 years 03/08/2026 01/11/2026 No 30/04/2024 PSUR frequency amended and DLP updated on 30/04/2024 PSUSA/00002114/202608 Dennis Lex Germany NAP 2117 naltrexone 20/11/1984 5 years 19/11/2030 17/02/2031 Yes 29/07/2026 PSUR frequency amended and DLP updated on 29/07/2026 PSUSA/00002117/203011 Eamon O'Murchu Ireland NAP 2118 nandrolone 01/01/1960 10 years 03/03/2034 01/06/2034 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00002118/203403 NAP 2120 methylthioninium / naphazoline Not available* 10 years 03/08/2036 01/11/2036 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00002120/203608 NAP 2125 naproxen 04/08/1961 3 years 03/08/2026 01/11/2026 No 30/04/2024 DLP was amended on 30/04/2024 PSUSA/00002125/202608 Amelia Cupelli Italy NAP 2126 naratriptan 10/03/1997 5 years 28/02/2027 29/05/2027 No 16/11/2022 DLP was updated on 16/11/2022 PRAC Rapporteur name was amended on 31/07/2018 DLP was amended on 15/11/2017 Lead MS was added on 22/09/2016 PSUSA/00002126/202702 Karin Bolin Sweden NAP 2127 natalizumab 27/06/2006 3 years 07/08/2027 05/11/2027 No 06/10/2025 DLP was amended on 02/04/2025 PSUSA/00002127/202708 Dirk Mentzer Germany CAP 2129 nebivolol 18/10/1995 6 years 31/03/2030 29/06/2030 No 18/12/2024 DLP was amended on 18/12/2024 PSUSA/00002129/203003 Bianca Mulder Netherlands NAP 2130 nedocromil 24/04/1986 9 years 01/12/2028 01/03/2029 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00002130/202812 NAP 2131 nefopam Not available* 5 years 30/03/2030 28/06/2030 No 17/12/2025 PSUR frequency amended and DLP updated on 17/12/2025 PSUSA/00002131/203003 Barbara Kovacic Bytyqi Croatia NAP 2132 nelarabine 22/08/2007 3 years 27/10/2026 25/01/2027 No 03/07/2024 DLP was amended on 03/07/2024 PSUSA/00002132/202610 Marie Louise Schougaard Christiansen Denmark CAP 2134 neomycin 24/06/1954 10 years 31/01/2034 01/05/2034 No 15/01/2025 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00002134/203401 Ana Sofia Diniz Martins Portugal NAP 2135 hydrocortisone / neomycin Not available* 11 years 02/04/2040 01/07/2040 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00002135/204004 NAP 2139 neomycin sulfate / nystatin / polymyxin b sulfate Not available* 8 years 03/11/2032 01/02/2033 No 30/07/2025 DLP was amended on 30/07/2025 PSUSA/00002139/203211 Zoubida Amimour France NAP 2140 neomycin sulfate / nystatin / triamcinolone acetonide Not available* 6 years 02/12/2029 02/03/2030 No 31/07/2024 DLP was amended on 31/07/2024 PSUSA/00002140/202912 Adam Przybylkowski Poland NAP 2143 nepafenac 11/12/2007 5 years 30/05/2027 28/08/2027 No 01/02/2023 PSUR frequency and DLP were updatde on 01/02/2023 PRAC Representative updated on 16/11/2022 Reference to NAP added on 29/06/2022 DLP was updated on 05/02/2020 Next DLP updated on 30/01/2017 PRAC Representative amended on 28/06/2016 PSUR Frequency amended and DLP updated on 04/02/2016 DLP was amended on 04/02/2015 Next DLP was amended on 31/01/2014 Next DLP was amended on 31/01/2014 PSUSA/00002143/202705 Maria del Pilar Rayon Spain CAP NAP 2146 netilmicin 01/01/1982 9 years 03/11/2028 01/02/2029 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00002146/202811 NAP 2147 nevirapine 05/02/1998 5 years 06/05/2026 04/08/2026 No 02/02/2022 DLP and PSUR frequency were updated on 02/02/2022 DLP was updated on 06/02/2019 Reference to NAP removed on 15/11/2017 Correction of PRAC Rapporteur name on 28/02/2017 PRAC Rapporteur name was amended on 20/12/2016 Next DLP was amended on 04/02/2016 "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?Yes/No" was amended on 06/03/2015 PSUSA/00002147/202605 Ana Sofia Diniz Martins Portugal CAP 2149 nicardipine 31/05/1981 3 years 31/05/2028 29/08/2028 No 04/02/2026 DLP was amended on 04/02/2026 PSUSA/00002149/202805 Amelia Cupelli Italy NAP 2150 nicergoline 26/05/1972 5 years 25/05/2030 23/08/2030 No 04/02/2026 DLP was amended on 04/02/2026 PSUSA/00002150/203005 Zane Neikena Latvia NAP 2151 niclosamide 23/03/1964 5 years 01/08/2028 30/10/2028 No 27/03/2024 PSUR frequency amended and DLP updated on 27/03/2024 PSUSA/00002151/202808 Amelia Cupelli Italy NAP 2152 nicorandil 09/02/1990 3 years 28/02/2026 29/05/2026 Yes 30/07/2025 Information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" was amended on 30/07/2025 DLP was amended on 25/06/2025 DLP was updated on 16/11/2022 DLP was updated on 20/11/2019 Next DLP was updated on 18/11/2016 Lead Member State was added on 30/09/2015 PSUSA/00002152/202602 Jan Neuhauser Austria NAP 2153 nicotine Not available* 10 years 01/12/2034 01/03/2035 No 30/07/2025 PSUR frequency amended and DLP updated on 30/07/2025 PSUSA/00002153/203412 Karin Erneholm Denmark NAP 2156 nifedipine 31/08/1993 8 years 31/08/2033 29/11/2033 No 27/05/2026 DLP was corrected on 27/05/2026 PSUR frequency amended and DLP updated on 29/04/2026 PSUSA/00002156/203308 Bianca Mulder Netherlands NAP 2157 niflumic acid Not available* 5 years 31/12/2029 31/03/2030 No 24/09/2025 PSUR frequency amended and DLP updated on 24/09/2025 PSUSA/00002157/202912 Melinda Palfi Hungary NAP 2158 nifuratel 04/05/1965 10 years 03/06/2034 01/09/2034 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00002158/203406 NAP 2159 nifuratel / nystatin 12/10/1976 9 years 02/09/2028 01/12/2028 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00002159/202809 NAP 2160 nifuroxazide 18/08/1992 5 years 18/08/2026 16/11/2026 No 13/08/2025 Information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" was amended on 25/09/2024 PSUR frequency and DLP were updated on 28/04/2022 PSUR frequency, DLP and Information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended" were updated on 06/05/2020 LMS and PRAC representatives were added on 31/07/2019 PSUR Frequency and Next DLP amended on 16/07/2015 PSUSA/00002160/202608 Veronika Macurová Czech Republic NAP 2162 nilotinib 19/11/2007 3 years 31/01/2027 01/05/2027 No 22/09/2021 PRAC Rapporteur name was amended on 28/04/2022 DLP and PSUR frequency were updated on 22/09/2021 PRAC representative was updated on 31/03/2021 DLP was updated on 23/09/2020 PRAC representative and DLP were updated on 25/09/2019 PRAC Rapporteur name was amended on 03/04/2019 DLP was updated on 26/09/2018 Next DLP was amended on 25/09/2017 Next DLP was updated on 22/09/2016 Next DLP was updated on 30/09/2015 PSUSA/00002162/202701 Marie Louise Schougaard Christiansen Denmark CAP 2163 nilutamide 02/07/1986 6 years 02/07/2030 30/09/2030 No 05/03/2025 DLP was amended on 05/03/2025 PSUSA/00002163/203007 Bianca Mulder Netherlands NAP 2165 nimesulide (topical formulations) 10/12/1999 5 years 30/06/2028 28/09/2028 No 28/02/2024 DLP was amended on 28/02/2024 PSUSA/00002165/202806 Amelia Cupelli Italy NAP 2166 nimodipine 01/11/1987 5 years 01/11/2028 30/01/2029 No 03/07/2024 DLP was amended on 03/07/2024 PSUSA/00002166/202811 Karen Pernille Harg Norway NAP 2169 nitisinone 21/02/2005 3 years 20/02/2028 20/05/2028 No 22/10/2025 DLP was amended on 22/10/2025 PSUSA/00002169/202802 Amelia Cupelli Italy CAP 2170 nitrazepam 02/03/1965 3 years 02/03/2027 31/05/2027 No 20/11/2024 DLP was amended on 20/11/2024 PSUSA/00002170/202703 Karin Erneholm Denmark NAP 2171 nitrendipine 31/03/1985 3 years 31/03/2027 29/06/2027 No 18/12/2024 DLP was amended on 18/12/2024 PSUSA/00002171/202703 Jan Neuhauser Austria NAP 2172 nitric oxide 23/12/1999 3 years 23/12/2027 22/03/2028 Yes 24/09/2025 DLP was amended on 24/09/2025 PSUSA/00002172/202712 Jo Robays Belgium CAP NAP 2173 nitrofural Not available* 11 years 03/05/2040 01/08/2040 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00002173/204005 none NAP 2174 nitrofurantoin, nitrofurantoin / pyridoxine hydrochloride 28/02/1953 5 years 28/02/2026 29/05/2026 No 05/08/2025 Active substance name was amended on 18/10/2023 PSUR frequency and DLP were updated on 17/11/2021 Active substance name was amended on 22/09/2021 PRAC Rapporteur name was amended on 06/03/2019 DLP was updated on 21/11/2018 Information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" was amended on 17/10/2017 The next DLP was amended on 29/10/2015. Lead MS was added on 04/02/2015 Name of active substance was amended on 03/07/2013 PSUSA/00002174/202602 Rugile Pilviniene Lithuania NAP 2181 nomegestrol Not available* 3 years 31/01/2027 01/05/2027 No 09/07/2026 DLP was updated on 20/10/2021 DLP was updated on 23/10/2018 The next DLP was amended on 29/10/2015 Lead MS was added on 04/02/2015 PSUSA/00002181/202701 Katarzyna Ziolkowska Poland NAP 2182 estradiol / nomegestrol acetate 27/07/2011 5 years 26/01/2029 26/04/2029 No 25/09/2024 PSUR frequency amended and DLP updated on 25/09/2024 PSUSA/00002182/202901 Zoubida Amimour France CAP NAP 2183 nonacog alfa 27/08/1997 5 years 10/08/2028 08/11/2028 No 06/10/2025 PSUR frequency amended and DLP updated on 30/04/2024 PSUSA/00002183/202808 Dirk Mentzer Germany CAP 2186 nordazepam Not available* 9 years 02/12/2031 01/03/2032 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00002186/203112 NAP 2187 norepinephrine 30/10/1962 9 years 03/03/2028 01/06/2028 No 26/07/2023 Information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" was amended on 26/07/2023 Update of PSUR frequency & DLP resulting from PRAC re-allocation exercise for entries with DLPs in 2025 on 26/07/2023 PSUSA/00002187/202803 none NAP 2188 norethisterone 29/04/1971 5 years 06/08/2027 04/11/2027 No 05/04/2023 DLP was updated on 05/04/2023 DLP was updated on 07/05/2018 PRAC representative and Lead Member State were added on 30/01/2017 PSUSA/00002188/202708 Kimmo Jaakkola Finland NAP 2190 norfloxacin 04/11/1982 13 years 04/06/2036 02/09/2036 No 31/01/2024 DLP was amended on 31/01/2024 PSUSA/00002190/203606 Maria del Pilar Rayon Spain NAP 2192 nortriptyline 31/03/1963 5 years 31/03/2028 29/06/2028 No 20/12/2023 DLP was amended on 20/12/2023 PSUSA/00002192/202803 Maia Uusküla Estonia NAP 2193 diazepam / nortriptyline hydrochloride 17/03/1969 10 years 03/08/2034 01/11/2034 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00002193/203408 NAP 2194 noscapine Not available* 10 years 03/08/2036 01/11/2036 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00002194/203608 NAP 2195 nystatin 13/08/1954 10 years 31/01/2034 01/05/2034 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00002195/203401 NAP 2197 obidoxime 29/01/1964 11 years 03/07/2039 01/10/2039 No 15/01/2025 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00002197/203907 Dennis Lex Germany NAP 2199 octenidine dihydrochloride / phenoxyethanol Not available* 10 years 01/01/2032 31/03/2032 Yes 21/09/2022 PSUR frequency and DLP were updated on 21/09/2022 PRAC Rapporteur name was amended on 06/03/2019 Next DLP was amended on 25/09/2017 Lead MS and PRAC Rapporteur name was added on 28/07/2016 PSUR Frequency and DLP was amended on 27/11/2015 PSUSA/00002199/203201 Rugile Pilviniene Lithuania NAP 2200 octocog alfa 04/08/2000 5 years 26/08/2030 24/11/2030 No 27/05/2026 DLP was corrected on 27/05/2026 PSUR frequency amended and DLP updated on 29/04/2026 PSUSA/00002200/203008 Dirk Mentzer Germany CAP NAP 2201 octreotide (for nationally authorised products) 23/06/1995 3 years 30/06/2026 28/09/2026 No 28/02/2024 DLP was amended on 28/02/2024 PSUSA/00002201/202606 Eamon O'Murchu Ireland NAP 2203 ofloxacin (systemic use) 16/04/1985 5 years 16/04/2030 15/07/2030 No 17/12/2025 Information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" was amended on 17/12/2025 PSUR frequency amended and DLP updated on 17/12/2025 PSUSA/00002203/203004 Petar Mas Croatia NAP 2204 ofloxacin (topical use) 02/05/1989 5 years 16/04/2029 15/07/2029 No 18/12/2024 PSUR frequency amended and DLP updated on 18/12/2024 PSUSA/00002204/202904 Petar Mas Croatia NAP 2207 olmesartan 25/04/2002 5 years 24/10/2026 22/01/2027 No 29/06/2022 DLP was updated on 29/06/2022 PRAC Rapporteur name was amended on 31/07/2018 Next DLP was amended on 27/06/2017 PRAC representative and Lead Member State were added on 03/05/2016 The DLP was amended on 08/01/2014 Information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" was amended on 30/11/2012 PSUSA/00002207/202610 Dennis Lex Germany NAP 2208 amlodipine / olmesartan 25/04/2012 5 years 24/04/2027 23/07/2027 No 31/01/2024 PRAC representative updated on 31/01/2024 PSUSA/00002208/202704 Bianca Mulder Netherlands NAP 2209 hydrochlorothiazide / olmesartan 25/04/2002 5 years 24/10/2026 22/01/2027 No 29/06/2022 DLP was updated on 29/06/2022 PRAC Rapporteur name was amended on 31/07/2018 Next DLP was amended on 27/06/2017 PRAC representative and Lead Member State were added on 03/05/2016 EURD and DLP were amended on 08/01/2014 PSUSA/00002209/202610 Dennis Lex Germany NAP 2210 amlodipine besilate / hydrochlorothiazide / olmesartan medoxomil 02/12/2010 5 years 24/04/2027 23/07/2027 No 12/09/2025 DLP was updated on 21/12/2022 Lead MS and PRAC Rapporteur name amended on 19/12/2018 DLP was amended on 31/01/2018 Lead MS and PRAC Rapporteur name was added on 19/10/2016 PSUSA/00002210/202704 Veronika Macurová Czech Republic NAP 2211 olopatadine 17/05/2002 5 years 30/04/2029 29/07/2029 No 05/02/2025 PSUR frequency amended and DLP updated on 05/02/2025 PSUSA/00002211/202904 Eamon O Murchu Ireland CAP NAP 2213 olsalazine 01/06/1986 5 years 31/05/2027 29/08/2027 No 01/02/2023 DLP was updated on 01/02/2023 DLP was amended on 31/01/2018 Lead MS and PRAC Rapporteur name was added on 19/10/2016 PSUSA/00002213/202705 Terhi Lehtinen Finland NAP 2214 omalizumab 25/10/2005 3 years 31/12/2025 31/03/2026 No 02/06/2026 PSUSA/00002214/202512 Karin Bolin Sweden CAP 2215 omeprazole 15/04/1987 5 years 15/04/2027 14/07/2027 No 21/12/2022 DLP was updated on 21/12/2022 PRAC representative was updated was updated on 04/03/2020 DLP was updated and PRAC Representative amended on 19/12/2017 Lead MS and PRAC Rapporteur name was added on 19/10/2016 PSUSA/00002215/202704 Liana Martirosyan Netherlands NAP 2216 omoconazole 23/09/1987 9 years 01/01/2029 01/04/2029 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00002216/202901 NAP 2217 ondansetron 23/02/1990 3 years 28/02/2027 29/05/2027 No 17/11/2021 DLP was updated on 17/11/2021 PRAC representative was updated on 28/07/2021 PRAC representative was updated on 28/04/2021 DLP was updated on 21/11/2018 Lead MS was amended on 22/09/2016 The next DLP was amended on 29/10/2015 Lead MS was added on 04/02/2015 Information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" was amended on 30/11/2012 PSUSA/00002217/202702 Polona Golmajer Slovenia NAP 2218 opipramol 12/10/1961 9 years 01/02/2028 01/05/2028 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00002218/202802 NAP 2220 orlistat 08/08/1997 3 years 07/02/2028 07/05/2028 No 22/10/2025 DLP was amended on 22/10/2025 PSUSA/00002220/202802 Zoubida Amimour France CAP NAP 2221 ornidazole 19/06/1979 9 years 03/11/2028 01/02/2029 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00002221/202811 NAP 2224 orphenadrine / paracetamol, orphenadrine Not available* 10 years 03/08/2036 01/11/2036 No 23/10/2024 Active substance name was amended on 23/10/2024 PSUR frequency amended and DLP updated on 25/09/2024 PSUSA/00002224/203608 none NAP 2225 oseltamivir 20/06/2002 5 years 20/09/2029 19/12/2029 No 23/10/2024 Reference to NAP removed on 23/10/2024 DLP was updated on 25/05/2022 DLP was updated on 05/06/2019 Reference to NAP added on 31/01/2018 Next DLP was amended on 03/06/2016 PSUSA/00002225/202909 Terhi Lehtinen Finland CAP 2226 otilonium bromide 08/09/1976 9 years 02/09/2028 01/12/2028 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00002226/202809 NAP 2227 oxaceprol 15/10/1977 9 years 03/11/2028 01/02/2029 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00002227/202811 NAP 2228 oxacillin 01/01/1962 10 years 03/05/2034 01/08/2034 No 03/10/2024 Updated & published on 23/10/2024 PSUSA/00002228/203405 NAP 2229 oxaliplatin 12/04/1996 5 years 12/04/2029 11/07/2029 Yes 18/12/2024 PSUR frequency amended and DLP updated on 18/12/2024 PSUSA/00002229/202904 Tiphaine Vaillant France NAP 2234 oxazepam 11/12/1963 9 years 03/03/2028 01/06/2028 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00002234/202803 NAP 2235 oxcarbazepine 10/08/1999 3 years 31/08/2027 29/11/2027 No 30/04/2025 DLP was amended on 30/04/2025 PSUSA/00002235/202708 Karin Erneholm Denmark NAP 2237 oxeladin 06/06/1967 10 years 03/07/2034 01/10/2034 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00002237/203407 NAP 2240 oxetorone 20/08/1973 9 years 03/06/2028 01/09/2028 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00002240/202806 NAP 2241 oxiconazole Not available* 10 years 03/08/2036 01/11/2036 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00002241/203608 NAP 2244 oxitriptan Not available* 9 years 03/03/2032 01/06/2032 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00002244/203203 NAP 2246 oxolamine 18/06/1960 11 years 03/06/2039 01/09/2039 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00002246/203906 NAP 2247 oxolamine / propyphenazone 05/03/1963 10 years 03/05/2034 01/08/2034 No 03/10/2024 Updated & published on 23/10/2024 PSUSA/00002247/203405 NAP 2249 oxomemazine 11/03/1964 10 years 03/06/2034 01/09/2034 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00002249/203406 NAP 2250 oxprenolol 26/02/1968 11 years 01/02/2040 01/05/2040 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00002250/204002 none NAP 2251 oxybuprocaine 20/03/1957 11 years 03/10/2037 01/01/2038 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00002251/203710 NAP 2253 oxybutynin 17/07/1984 5 years 17/07/2027 15/10/2027 No 05/04/2023 DLP was updated on 05/04/2023 PRAC representative was updated on 19/10/2022 PRAC Representative amended on 28/04/2022 DLP was updated on 27/03/2018 PRAC Representative amended on 18/11/2016 PSUSA/00002253/202707 Jo Robays Belgium CAP NAP 2254 oxycodone 12/12/1995 3 years 12/04/2027 11/07/2027 No 20/11/2024 PSUR frequency amended and DLP updated on 20/11/2024 PSUSA/00002254/202704 Liana Martirosyan Netherlands NAP 2255 acetylsalicylic acid / oxycodone hydrochloride Not available* 9 years 03/03/2029 01/06/2029 Yes 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00002255/202903 NAP 2256 oxycodone hydrochloride / paracetamol Not available* 3 years 03/07/2027 01/10/2027 Yes 05/02/2025 PSUR frequency amended and DLP updated on 05/02/2025 PSUSA/00002256/202707 Amelia Cupelli Italy NAP 2257 oxygen Not available* 7 years 01/12/2031 29/02/2032 No 30/07/2025 DLP was amended on 30/07/2025 PSUSA/00002257/203112 Amelia Cupelli Italy NAP 2258 oxymetazoline 31/05/1962 6 years 01/08/2026 30/10/2026 No 31/03/2021 DLP was updated on 31/03/2021 PSUR frequency, DLP and PRAC rapporteur were updated on 05/06/2019 PSUSA/00002258/202608 Maia Uusküla Estonia NAP 2261 oxymorphone Not available* 9 years 03/03/2032 01/06/2032 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00002261/203203 NAP 2262 oxytetracycline, hydrocortisone / oxytetracycline, hydrocortisone / oxytetracycline / polymyxin b, oxytetracycline / polymyxin b 31/05/1950 11 years 03/06/2040 01/09/2040 No 25/09/2024 PSUR frequency amended and DLP updated on 25/09/2024 Entry name updated on 25/09/2024 PSUSA/00002262/204006 none NAP 2264 paclitaxel 29/12/1992 5 years 28/12/2026 28/03/2027 No 20/05/2026 Reference to CAP removed on 28/02/2024 PSUR frequency and DLP were updated on 21/09/2022 DLP was updated on 31/07/2019 New CAP authorised on 20/11/2018 PRAC Representative updated on 26/09/2018 Next DLP was updated on 22/09/2016 Lead MS was added on 13/07/2015 PSUSA/00002264/202612 Ana Sofia Diniz Martins Portugal NAP 2266 paliperidone 25/06/2007 3 years 30/06/2027 28/09/2027 No 05/03/2025 DLP was amended on 05/03/2025 PSUSA/00002266/202706 Karin Bolin Sweden CAP 2267 palivizumab 13/08/1999 5 years 18/06/2029 16/09/2029 No 05/03/2025 PSUR frequency amended and DLP updated on 05/03/2025 PSUSA/00002267/202906 Marie Louise Schougaard Christiansen Denmark CAP 2268 palonosetron 22/03/2005 5 years 24/07/2030 22/10/2030 No 01/04/2026 PSUR frequency amended and DLP updated on 01/04/2026 PSUSA/00002268/203007 Rhea Fitzgerald Ireland CAP NAP 2269 pamidronate 02/05/1989 5 years 31/05/2026 29/08/2026 No 31/01/2024 PRAC representative updated on 31/01/2024 PSUSA/00002269/202605 Bianca Mulder Netherlands NAP 2273 amylase / bromelain / chymotrypsin / lipase / pancreatin / papain / rutoside / trypsin, trypsin/ bromelain/ rutoside trihydrate Not available* 9 years 03/03/2029 01/06/2029 No 12/09/2025 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00002273/202903 Veronika Macurová Czech Republic NAP 2275 pancuronium 01/01/1991 10 years 01/12/2035 29/02/2036 Yes 29/07/2026 PSUR frequency amended and DLP updated on 29/07/2026 PSUSA/00002275/203512 Dennis Lex Germany NAP 2281 pandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) 19/10/2009 3 years 19/05/2027 17/08/2027 No 05/02/2025 DLP was amended on 05/02/2025 PSUSA/00002281/202705 Liana Martirosyan Netherlands CAP 2283 panitumumab 03/12/2007 5 years 30/09/2030 29/12/2030 No 01/07/2026 PSUR frequency amended and DLP updated on 01/07/2026 PSUR frequency amended and DLP updated on 03/05/2023 DLP was updated on 25/05/2022 DLP was updated on 26/05/2021 DLP was updated on 06/05/2020 DLP was updated on 30/04/2019 Lead MS and PRAC Rapporteur name updated on 23/10/2018 DLP was updated on 07/05/2018 DLP was updated on 23/05/2017 PRAC Representative amended on 28/03/2017 Next DLP was amended on 03/05/2016 Conditional approval Next DLP was amended on 28/05/2014 PSUSA/00002283/203009 David Olsen Norway CAP 2285 pantoprazole 23/08/1994 5 years 23/08/2027 21/11/2027 No 03/05/2023 DLP was amended on 03/05/2023 LMS and PRAC representative updated 05/06/2019 DLP was updated on 07/05/2018 PRAC Representative amended on 28/03/2017 PSUSA/00002285/202708 Rugile Pilviniene Lithuania CAP NAP 2286 amoxicillin / clarithromycin / pantoprazole 23/08/1994 3 years 03/08/2028 01/11/2028 No 01/04/2026 PSUR frequency amended and DLP updated on 01/04/2026 PSUSA/00002286/202808 Dennis Lex Germany NAP 2287 papaverine 21/02/1950 10 years 01/12/2032 01/03/2033 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00002287/203212 NAP 2289 paracetamol (non IV formulations) 21/12/1959 11 years 03/05/2039 01/08/2039 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00002289/203905 NAP 2291 acetylsalicylic acid / caffeine / paracetamol 24/10/1972 15 years 01/12/2038 01/03/2039 No 30/07/2025 PSUR frequency amended and DLP updated on 30/07/2025 PSUSA/00002291/203812 Dennis Lex Germany NAP 2294 caffeine / paracetamol 24/06/1969 11 years 03/03/2040 01/06/2040 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00002294/204003 NAP 2297 caffeine / paracetamol / phenylephrine hydrochloride Not available* 9 years 03/06/2029 01/09/2029 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00002297/202906 NAP 2298 caffeine / paracetamol / propyphenazone, paracetamol / propyphenazone Not available* 8 years 01/12/2033 01/03/2034 No 29/07/2026 DLP was amended on 29/07/2026 PSUSA/00002298/203312 Roxana Stefania Udrescu Romania NAP 2300 dextromethorphan hydrobromide / paracetamol / promethazine hydrochloride Not available* 7 years 03/11/2031 01/02/2032 No 30/07/2025 DLP was amended on 30/07/2025 PSUSA/00002300/203111 John Joseph Borg Malta NAP 2302 caffeine / guaifenesin / paracetamol Not available* 9 years 03/06/2029 01/09/2029 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00002302/202906 NAP 2303 hyoscine butylbromide / paracetamol 10/08/1983 8 years 03/05/2033 01/08/2033 No 04/02/2026 DLP was amended on 04/02/2026 PSUSA/00002303/203305 Dennis Lex Germany NAP 2305 ascorbic acid / caffeine / paracetamol / phenylephrine hydrochloride / terpine Not available* 8 years 03/11/2033 01/02/2034 No 01/07/2026 DLP was amended on 01/07/2026 PSUSA/00002305/203311 Melinda Pálfi Hungary NAP 2306 guaifenesin / paracetamol / phenylephrine hydrochloride Not available* 8 years 03/08/2026 01/11/2026 No 18/11/2025 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00002306/202608 Maia Uusküla Estonia NAP 2307 paracetamol / pseudoephedrine, dextromethorphan / paracetamol / pseudoephedrine, ascorbic acid / dextromethorphan / paracetamol / pseudoephedrine Not available* 5 years 28/06/2028 26/09/2028 Yes 01/07/2026 Lead MS and PRAC Rapporteur name removed on 01/07/2026 Information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" was amended on 23/10/2024 Active substance name was amended on 23/10/2024 DLP was amended on 28/02/2024 PSUSA/00002307/202806 none NAP 2308 ascorbic acid / paracetamol / pseudoephedrine Not available* 9 years 03/05/2029 01/08/2029 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00002308/202905 NAP 2310 paracetamol / tramadol Not available* 5 years 01/08/2028 30/10/2028 No 27/03/2024 DLP was amended on 27/03/2024 PSUSA/00002310/202808 Tiphaine Vaillant France NAP 2311 paracetamol (IV formulation) Not available* 5 years 07/05/2026 05/08/2026 Yes 02/02/2022 DLP and PSUR frequency were updated on 02/02/2022 PRAC representative was updated on 29/07/2020 PRAC representative was updated on 03/06/2020 PSUR frequency amended and DLP updated on 19/12/2018 DLP was updated on 19/12/2017 PRAC Rapporteur name updated on 21/07/2017 Next DLP was amended on 20/12/2016 PRAC Rapporteur name was amended on 28/07/2016 Next DLP was updated on 21/12/2015. Lead MS was added on 06/03/2015 PSUSA/00002311/202605 Tiphaine Vaillant France NAP 2312 caffeine / codeine / paracetamol / propyphenazone, acetylsalicylic acid / caffeine / codeine / paracetamol, acetylsalicylic acid / codeine / paracetamol, buclizine / codeine / paracetamol 01/06/1957 5 years 01/06/2030 30/08/2030 Yes 29/07/2026 Active substance name was amended on 29/07/2026 PSUR frequency amended and DLP updated on 04/02/2026 PSUSA/00002312/203006 Petar Mas Croatia NAP 2314 parecoxib 22/03/2002 3 years 31/03/2026 29/06/2026 No 20/12/2023 DLP was amended on 20/12/2023 PSUSA/00002314/202603 Rhea Fitzgerald Ireland CAP 2316 paricalcitol 17/04/1998 5 years 17/08/2027 15/11/2027 No 19/09/2025 PSUR frequency amended and DLP updated on 03/05/2023 PRAC Representative updated on 16/11/2022 DLP was updated on 06/05/2020 PRAC Representative updated on 26/09/2018 Next DLP was amended on 26/04/2017 PRAC representative and Lead Member State were added on 04/03/2016 PSUSA/00002316/202708 Maria Martinez Gonzalez Spain NAP 2318 paromomycin 29/11/1960 10 years 02/04/2034 01/07/2034 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00002318/203404 NAP 2319 paroxetine 11/12/1990 5 years 10/12/2027 09/03/2028 No 20/09/2023 DLP amended on 20/09/2023 PSUSA/00002319/202712 Liana Martirosyan Netherlands NAP 2320 patent blue V sodium 31/03/1974 5 years 30/04/2028 29/07/2028 Yes 31/01/2024 DLP was amended on 31/01/2024 PSUSA/00002320/202804 Melinda Palfi Hungary NAP 2321 pazopanib 14/06/2010 5 years 18/10/2029 16/01/2030 No 25/06/2025 PSUR frequency amended and DLP updated on 25/06/2025 PSUSA/00002321/202910 Marie Louise Schougaard Christiansen Denmark CAP 2322 pefloxacin 07/08/1984 3 years 31/08/2026 29/11/2026 Yes 30/04/2024 DLP was amended on 30/04/2024 PSUSA/00002322/202608 Polona Golmajer Slovenia NAP 2326 pegfilgrastim 31/01/2002 5 years 31/01/2030 01/05/2030 No 22/10/2025 PSUR frequency amended and DLP updated on 22/10/2025 PSUSA/00002326/203001 Bianca Mulder Netherlands CAP 2328 pegvisomant 13/11/2002 3 years 30/11/2028 28/02/2029 No 29/07/2026 DLP was amended on 29/07/2026 PSUSA/00002328/202811 Zoubida Amimour France CAP 2329 pelargonium sidoides dc and/or pelargonium reniforme curt. / radix Not available* 5 years 01/06/2028 30/08/2028 Yes 31/01/2024 DLP was amended on 31/01/2024 PSUSA/00002329/202806 Melinda Palfi Hungary NAP 2330 pemetrexed 20/09/2004 5 years 04/02/2029 05/05/2029 No 05/06/2024 New CAP authorised on 09/12/2022 DLP was updated on 20/10/2021 PRAC representative was updated on 29/07/2020 PRAC representative was updated on 03/06/2020 DLP was updated on 23/10/2018 Reference to NAP added on 25/09/2017 PRAC Rapporteur name updated on 21/07/2017 PRAC Rapporteur name was amended on 28/07/2016 PRAC Rapporteur name updated on 03/06/2016 Next DLP was updated on 30/09/2015 PSUSA/00002330/202902 Tiphaine Vaillant France CAP NAP 2333 penciclovir 28/02/1996 5 years 28/08/2026 26/11/2026 No 28/04/2022 DLP was updated on 28/04/2022 Lead MS and PRAC Rapporteur name amended on 19/12/2018 DLP was updated on 23/05/2017 Lead MS and PRAC Rapporteur name was added on 07/04/2016 PSUSA/00002333/202608 Jan Neuhauser Austria NAP 2335 penicillamine 04/04/1963 9 years 03/03/2028 01/06/2028 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00002335/202803 NAP 2336 pentaerithrityl tetranitrate Not available* 9 years 03/03/2032 01/06/2032 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00002336/203203 NAP 2337 pentagastrin 09/11/1981 10 years 03/05/2035 01/08/2035 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00002337/203505 NAP 2338 pentamidine 15/06/1988 5 years 15/06/2027 13/09/2027 No 01/03/2023 DLP was updated on 01/03/2023 PRAC representative was updated on 19/10/2022 PRAC Representative amended on 28/04/2022 DLP was updated on 28/02/2018 PRAC representative and Lead Member State were added on 18/11/2016 PSUSA/00002338/202706 Jo Robays Belgium NAP 2339 pentazocine 15/09/1966 9 years 03/03/2028 01/06/2028 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00002339/202803 NAP 2341 pentosan polysulfate sodium (apart from centrally authorised product) 13/06/1961 10 years 02/04/2034 01/07/2034 No 05/01/2025 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00002341/203404 Melinda Palfi Hungary NAP 2343 pentostatin Not available* 8 years 03/11/2026 01/02/2027 No 05/01/2025 Correction of DLP on 20/11/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00002343/202611 Marie Louise Schougaard Christiansen Denmark NAP 2344 pentoxifylline 14/05/1967 9 years 02/04/2028 01/07/2028 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00002344/202804 NAP 2345 pentoxyverine 15/12/1954 5 years 31/12/2028 31/03/2029 No 25/09/2024 DLP was amended on 25/09/2024 PSUSA/00002345/202812 Dennis Lex Germany NAP 2347 peptidic preparation from porcine brain (cerebrolysin) Not available* 10 years 03/08/2036 01/11/2036 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00002347/203608 NAP 2350 perflutren 18/05/1998 5 years 27/12/2029 27/03/2030 No 02/06/2026 PSUSA/00002350/202912 Karin Bolin Sweden CAP 2352 periciazine 09/05/1963 10 years 03/05/2034 01/08/2034 No 03/10/2024 Updated & published on 23/10/2024 PSUSA/00002352/203405 NAP 2354 perindopril 22/06/1988 5 years 22/10/2030 20/01/2031 No 01/07/2026 DLP was amended on 01/07/2026 PSUSA/00002354/203010 Karin Erneholm Denmark NAP 2355 permethrin Not available* 3 years 31/08/2026 29/11/2026 No 30/04/2024 DLP was amended on 30/04/2024 PSUSA/00002355/202608 Dennis Lex Germany NAP 2356 perphenazine 15/10/1952 10 years 01/01/2034 01/04/2034 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00002356/203401 NAP 2357 pethidine 28/03/1941 5 years 01/08/2030 30/10/2030 No 01/04/2026 DLP was amended on 01/04/2026 PSUSA/00002357/203008 Melinda Palfi Hungary NAP 2358 phenazone Not available* 9 years 03/03/2032 01/06/2032 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00002358/203203 NAP 2359 lidocaine / phenazone Not available* 5 years 01/01/2030 01/04/2030 Yes 24/09/2025 DLP was amended on 24/09/2025 PSUSA/00002359/203001 Rugile Pilviniene Lithuania NAP 2363 phenelzine 01/03/1962 10 years 03/05/2034 01/08/2034 No 03/10/2024 Updated & published on 23/10/2024 PSUSA/00002363/203405 NAP 2368 paracetamol / pheniramine hydrogenomaleate / phenylephrine hydrochloride, ascorbic acid / paracetamol / pheniramine maleate, ascorbic acid / paracetamol / pheniramine hydrogenomaleate / phenylephrine hydrochloride 06/06/1980 8 years 07/03/2028 05/06/2028 No 22/10/2025 Active substance name was amended on 22/10/2025 DLP was updated on 18/11/2020 PRAC representative was added on 06/05/2020 LMS was added on 31/07/2019 PSUSA/00002368/202803 Maia Uusküla Estonia NAP 2370 phenobarbital 27/01/1943 8 years 27/01/2028 26/04/2028 No 21/10/2020 DLP was updated on 21/10/2020 PRAC representative was added on 06/05/2020 LMS was added on 01/04/2020 PSUR frequency, "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?Yes/No" and DLP were updated on 25/09/2019 PSUSA/00002370/202801 Maia Uusküla Estonia NAP 2373 phenoxymethylpenicillin 01/06/1956 9 years 02/12/2027 01/03/2028 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00002373/202712 NAP 2374 phenprocoumon 16/02/1955 9 years 02/12/2027 01/03/2028 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00002374/202712 NAP 2376 phentolamine 02/04/1951 10 years 01/12/2032 01/03/2033 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00002376/203212 NAP 2377 phenylbutazone 19/02/1952 10 years 01/12/2032 01/03/2033 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00002377/203212 NAP 2382 ascorbic acid / guaifenesin / paracetamol / phenylephrine hydrochloride Not available* 9 years 03/05/2029 01/08/2029 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00002382/202905 NAP 2386 mepyramine / phenylephrine Not available* 9 years 02/09/2031 01/12/2031 No 18/12/2024 Active substance name was amended on 18/12/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00002386/203109 none NAP 2387 paracetamol / phenylephrine hydrochloride Not available* 9 years 03/03/2032 01/06/2032 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00002387/203203 NAP 2392 phenytoin 12/08/1960 3 years 12/08/2026 10/11/2026 No 30/04/2024 DLP was amended on 30/04/2024 PSUSA/00002392/202608 Eamon O'Murchu Ireland NAP 2393 metylphenobarbital / phenytoin sodium 20/04/1950 10 years 01/12/2032 01/03/2033 No 18/10/2023 Information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?", PSUR frequency and DLP were amended on 18/10/2023 PSUSA/00002393/203212 none NAP 2398 phosphocreatine Not available* 8 years 03/11/2032 01/02/2033 No 30/07/2025 DLP was amended on 30/07/2025 PSUSA/00002398/203211 Amelia Cupelli Italy NAP 2400 phytomenadione, menadiol 01/01/1954 10 years 01/01/2034 01/04/2034 No 23/10/2024 Active substance name was amended on 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00002400/203401 none NAP 2402 phytosterol Not available* 10 years 03/08/2036 01/11/2036 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00002402/203608 NAP 2403 picloxydine 13/04/1962 11 years 03/07/2039 01/10/2039 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00002403/203907 NAP 2408 pilocarpine / timolol 13/02/1989 5 years 15/07/2026 13/10/2026 No 16/10/2023 PRAC Rapporteur name was amended on 18/10/2023 PSUSA/00002408/202607 Karin Erneholm Denmark NAP 2409 pilocarpine (non ophthalmic formulations) 01/04/1994 5 years 31/07/2027 29/10/2027 No 15/11/2023 PRAC Rapporteur updated on 15/11/2023 PSUSA/00002409/202707 Petar Mas Croatia NAP 2410 pilocarpine (ophthalmic formulation) 01/04/1994 7 years 31/08/2028 29/11/2028 No 15/11/2023 PRAC Rapporteur updated on 15/11/2023 PSUSA/00002410/202808 Petar Mas Croatia NAP 2411 pimecrolimus 14/12/2001 3 years 31/03/2026 29/06/2026 No 20/12/2023 DLP was amended on 20/12/2023 PSUSA/00002411/202603 Marie Louise Schougaard Christiansen Denmark NAP 2413 pimozide 15/02/1971 12 years 15/02/2037 16/05/2037 No 22/10/2025 DLP was amended on 22/10/2025 PSUSA/00002413/203702 Jo Robays Belgium NAP 2414 pinaverium 01/12/1975 9 years 03/08/2028 01/11/2028 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00002414/202808 NAP 2415 pindolol 10/11/1969 9 years 03/05/2028 01/08/2028 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00002415/202805 NAP 2417 glimepiride / pioglitazone hydrochloride, metformin / pioglitazone, pioglitazone 13/10/2000 3 years 31/07/2027 29/10/2027 No 02/04/2025 DLP was amended on 02/04/2025 PSUSA/00002417/202707 Rhea Fitzgerald Ireland CAP 2420 pipamperone 14/10/1965 15 years 14/10/2040 12/01/2041 No 01/07/2026 DLP was amended on 01/07/2026 PSUSA/00002420/204010 Dennis Lex Germany NAP 2422 pipecuronium Not available* 9 years 03/05/2032 01/08/2032 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00002422/203205 NAP 2424 piperacillin 07/05/1980 8 years 03/03/2026 01/06/2026 Yes 30/07/2025 Information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" was amended on 30/07/2025 PSUR frequency amended and DLP updated on 03/07/2024 PSUSA/00002424/202603 Amelia Cupelli Italy NAP 2425 piperacillin / tazobactam 02/07/1992 5 years 01/09/2027 30/11/2027 No 17/02/2026 DLP was amended on 03/05/2023 PRAC representative was updated on 27/07/2022 PRAC representative was updated on 06/05/2020 Lead MS and PRAC Rapporteur name amended on 19/12/2018 DLP was updated on 06/06/2018 Lead MS and PRAC Rapporteur name was added on 28/02/2017 PSUSA/00002425/202709 Jana Pecherova Slovakia NAP 2426 piperazine Not available* 10 years 03/11/2036 01/02/2037 No 15/01/2025 PSUR frequency amended and DLP updated on 31/01/2024 PSUSA/00002426/203611 Ana Sofia Diniz Martins Portugal NAP 2429 piracetam 19/04/1971 5 years 30/04/2027 29/07/2027 No 01/02/2023 DLP was updated on 01/02/2023 DLP was amended on 31/01/2018 Lead MS and PRAC Rapporteur name was added on 19/10/2016 PSUSA/00002429/202704 Terhi Lehtinen Finland NAP 2430 dihydroergocristine / piracetam Not available* 9 years 03/11/2030 01/02/2031 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00002430/203011 NAP 2431 pirenoxine Not available* 7 years 01/01/2032 31/03/2032 No 24/09/2025 DLP was amended on 24/09/2025 PSUSA/00002431/203201 Amelia Cupelli Italy NAP 2434 piretanide / ramipril, piretanide 17/10/1980 8 years 03/08/2033 01/11/2033 No 01/04/2026 DLP was amended on 01/04/2026 PSUSA/00002434/203308 Zoubida Amimour France NAP 2435 pirfenidone 28/02/2011 3 years 27/02/2027 28/05/2027 No 20/10/2021 New CAP authorised on 10/01/2023 New CAP authorised on 20/06/2022 DLP and PSUR frequency were updated on 20/10/2021 DLP was updated on 21/10/2020 DLP was updated on 25/09/2019 Lead MS and PRAC Rapporteur name updated on 30/04/2019 DLP was updated on 26/09/2018 DLP was updated on 17/10/2017 Next DLP was amended on 19/10/2016 Next DLP was updated on 30/09/2015 Next DLP was amended on 02/05/2014 PSUSA/00002435/202702 Rhea Fitzgerald Ireland CAP 2436 piribedil 10/10/1990 3 years 31/03/2026 29/06/2026 No 20/12/2023 DLP was amended on 20/12/2023 PSUSA/00002436/202603 Zane Neikena Latvia NAP 2437 piritramide 01/04/1969 5 years 31/03/2030 29/06/2030 No 17/12/2025 PSUR frequency amended and DLP updated on 17/12/2025 PSUSA/00002437/203003 Jo Robays Belgium NAP 2438 piroxicam 03/04/1979 3 years 01/04/2026 30/06/2026 No 20/12/2023 DLP was amended on 20/12/2023 PSUSA/00002438/202604 Melinda Palfi Hungary NAP 2441 fenpiverinium bromide / metamizole sodium / pitofenone hydrochloride Not available* 9 years 03/11/2030 01/02/2031 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00002441/203011 NAP 2443 metamizole sodium / pitofenone hydrochloride Not available* 7 years 01/12/2031 29/02/2032 No 30/07/2025 DLP was amended on 30/07/2025 PSUSA/00002443/203112 Miroslava Gocova Slovakia NAP 2444 pivampicillin 31/10/1974 9 years 03/08/2028 01/11/2028 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00002444/202808 NAP 2445 pivmecillinam 31/05/1977 9 years 03/11/2028 01/02/2029 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00002445/202811 NAP 2446 pizotifen 14/07/1969 9 years 03/05/2028 01/08/2028 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00002446/202805 NAP 2451 plerixafor 31/07/2009 3 years 15/12/2025 15/03/2026 No 20/09/2023 DLP amended on 20/09/2023 PSUSA/00002451/202512 Bianca Mulder Netherlands CAP 2453 pneumococcal polysaccharide vaccine 06/02/1981 3 years 03/05/2028 01/08/2028 No 04/02/2026 PSUR frequency amended and DLP updated on 04/02/2026 PSUSA/00002453/202805 Pernille Harg Norway NAP 2454 podophyllotoxin Not available* 6 years 15/09/2026 14/12/2026 No 02/02/2026 DLP was updated on 26/05/2021 PRAC representative and LMS were added on 04/03/2020 PSUR frequency and DLP were updated on 05/06/2019 PSUSA/00002454/202609 Rhea Fitzgerald Ireland NAP 2455 policresulen Not available* 8 years 01/12/2026 01/03/2027 No 23/10/2024 DLP amended on 23/10/2024 PSUSA/00002455/202612 NAP 2456 lauromacrogol 400 / urea Not available* 8 years 01/12/2026 01/03/2027 No 01/07/2026 Active substance name was amended on 01/07/2026 DLP amended on 23/10/2024 PSUSA/00002456/202612 Dennis Lex Germany NAP 2459 poliovirus type 1 / poliovirus type 2 / poliovirus type 3 vaccine (inactivated) 02/07/1982 5 years 01/07/2030 29/09/2030 No 31/01/2024 PSUR frequency amended and DLP updated on 31/01/2024 Entry re-introduced and entry name changed on 04/03/2020 PSUSA/00002459/203007 none NAP 2468 polygeline Not available* 10 years 03/11/2036 01/02/2037 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00002468/203611 NAP 2469 polymyxin b 01/01/1956 11 years 01/12/2036 01/03/2037 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00002469/203612 NAP 2470 polymyxin b / trimethoprim Not available* 9 years 03/05/2032 01/08/2032 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00002470/203205 NAP 2472 polystyrene sulfonate 26/10/1955 8 years 26/10/2030 24/01/2031 No 12/09/2025 PSUR frequency amended and DLP updated on 31/05/2023 DLP and Information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" was updated on 29/06/2022 PSUR frequency, DLP and PRAC representative and PSURs required for products referred to in Articles 10(1), 10a, 16a of Directive 2001/83/EC as amended? were updated on 30/06/2021 LMS were added on 01/04/2020 The DLP was amended on 30/09/2015 PSUSA/00002472/203010 Veronika Macurová Czech Republic NAP 2475 povidone, polyvinyl alcohol / povidone 01/01/1981 8 years 02/09/2033 01/12/2033 No 29/04/2026 DLP was amended on 29/04/2026 PSUSA/00002475/203309 Adam Przybylkowski Poland NAP 2476 polyvinyl alcohol 27/08/1965 10 years 03/06/2034 01/09/2034 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00002476/203406 NAP 2478 poractant alfa 06/08/1992 5 years 31/08/2030 29/11/2030 No 29/04/2026 DLP was amended on 29/04/2026 PSUSA/00002478/203008 Terhi Lehtinen Finland NAP 2480 posaconazole 25/10/2005 3 years 25/10/2026 23/01/2027 No 19/09/2024 PSUSA/00002480/202610 Zoubida Amimour France CAP NAP 2481 potassium / sodium Not available* 8 years 01/12/2026 01/03/2027 No 08/04/2026 DLP amended on 23/10/2024 PSUSA/00002481/202612 Amelia Cupelli Italy NAP 2483 potassium chloride Not available* 9 years 03/05/2032 01/08/2032 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00002483/203205 NAP 2485 potassium iodate 06/03/1978 10 years 03/03/2035 01/06/2035 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00002485/203503 NAP 2486 perchlorates Not available* 7 years 20/03/2026 18/06/2026 Yes 05/08/2025 DLP was amended on 28/05/2025 Information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" was amended on 28/05/2025 PSUR frequency and DLP amended on 27/03/2024 PSUSA/00002486/202603 Jan Neuhauser Austria NAP 2487 povidone iodinated 24/04/1996 5 years 02/01/2029 02/04/2029 No 25/09/2024 PSUR frequency amended and DLP updated on 25/09/2024 PSUSA/00002487/202901 Zoubida Amimour France NAP 2488 allantoine / povidone iodinated Not available* 9 years 03/03/2029 01/06/2029 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00002488/202903 NAP 2489 prajmalium 22/12/1972 10 years 31/01/2035 01/05/2035 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00002489/203501 NAP 2490 pralidoxime 02/07/1968 10 years 03/08/2034 01/11/2034 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00002490/203408 NAP 2491 pramipexole 14/10/1997 3 years 06/04/2026 05/07/2026 No 15/11/2023 PSUR frequency amended and DLP updated on 15/11/2023 PSUSA/00002491/202604 Karin Erneholm Denmark CAP NAP 2492 pramiracetam Not available* 5 years 30/09/2029 29/12/2029 No 03/06/2020 DLP was updated on 03/06/2020 Next DLP amended on 13/07/2015 'PRAC Rapporteur name amended on 16/06/2015 PRAC Rapporteur name and country updated on 01/12/2014 PSUSA/00002492/202909 Zane Neikena Latvia NAP 2498 estradiol / prasterone enantate Not available* 10 years 03/06/2035 01/09/2035 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00002498/203506 NAP 2499 prasugrel 23/02/2009 5 years 25/02/2029 26/05/2029 No 20/10/2021 DLP was updated on 20/10/2021 PRAC Rapporteur name was corrected on 03/04/2019 PSUR Frequency and DLP updated on 26/09/2018 PRAC Rapporteur name was amended on 06/06/2018 DLP was updated and PRAC representative amended on 17/10/2017 Next DLP was updated on 22/09/2016 Next DLP was updated on 30/09/2015 The next DLP was amended on 01/04/2014 PSUSA/00002499/202902 Marie Louise Schougaard Christiansen Denmark CAP 2500 pravastatin 31/03/1989 5 years 30/03/2028 28/06/2028 No 19/09/2024 PSUSA/00002500/202803 Zoubida Amimour France NAP 2502 prazepam 18/12/1974 8 years 03/03/2033 01/06/2033 No 19/11/2025 DLP was amended on 19/11/2025 PSUSA/00002502/203303 Jo Robays Belgium NAP 2503 praziquantel 30/04/1980 3 years 30/04/2027 29/07/2027 No 05/02/2025 DLP was amended on 05/02/2025 PSUSA/00002503/202704 Zoubida Amimour France NAP 2504 prazosin 24/05/1974 9 years 03/08/2028 01/11/2028 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00002504/202808 NAP 2505 prednicarbate 02/10/1985 9 years 01/12/2028 01/03/2029 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00002505/202812 NAP 2506 prednisolone 13/07/1956 6 years 03/08/2029 01/11/2029 No 30/04/2024 DLP was amended on 30/04/2024 PSUSA/00002506/202908 Polona Golmajer Slovenia NAP 2507 prednisolone / salicylic acid Not available* 8 years 01/12/2026 01/03/2027 No 08/04/2026 DLP amended on 23/10/2024 PSUSA/00002507/202612 Petar Mas Croatia NAP 2508 estradiol benzoate / prednisolone / salicylic acid Not available* 8 years 03/05/2026 01/08/2026 No 23/09/2025 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00002508/202605 Dennis Lex Germany NAP 2510 prednisone 18/05/1955 8 years 31/01/2033 01/05/2033 No 22/10/2025 DLP was amended on 22/10/2025 PSUSA/00002510/203301 Karin Erneholm Denmark NAP 2511 pregabalin 06/07/2004 3 years 31/01/2026 01/05/2026 No 18/10/2023 PSUR frequency amended and DLP updated on 18/10/2023 PSUSA/00002511/202601 Liana Martirosyan Netherlands CAP NAP 2512 prenoxdiazin hydrochloride 26/05/1965 13 years 26/05/2026 24/08/2026 No 18/11/2025 Entry reintroduced and renamed 24/09/2025 PSUSA/00002512/202605 Melinda Palfi Hungary NAP 2522 prilocaine 01/01/1963 9 years 03/03/2028 01/06/2028 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00002522/202803 NAP 2524 felypressin / prilocaine hydrochloride Not available* 10 years 12/02/2035 13/05/2035 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00002524/203502 NAP 2525 primidone 30/06/1953 8 years 30/06/2028 28/09/2028 No 03/03/2021 DLP was updated on 03/03/2021 LMS and PRAC representative were added on 04/03/2020 PSUR frequency, "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?Yes/No" and DLP were updated on 25/09/2019 PSUSA/00002525/202806 Dennis Lex Germany NAP 2527 probenecid 01/05/1960 10 years 02/04/2034 01/07/2034 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00002527/203404 NAP 2528 procainamide Not available* 11 years 03/05/2040 01/08/2040 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00002528/204005 NAP 2529 procaine Not available* 10 years 03/11/2036 01/02/2037 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00002529/203611 NAP 2533 phenazone / procaine hydrochloride Not available* 11 years 03/05/2040 01/08/2040 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00002533/204005 none NAP 2534 procarbazine 07/10/1966 9 years 03/03/2028 01/06/2028 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00002534/202803 NAP 2536 perazine 06/12/1957 9 years 02/12/2027 01/03/2028 No 31/01/2024 Active substance name, PSUR frequency amended and DLP updated on 31/01/2024 PSUSA/00002536/202712 none NAP 2537 procyanidolic oligomers 11/05/1977 10 years 11/05/2032 09/08/2032 No 01/02/2023 DLP was updated on 01/02/2023 LMS and PRAC representative were added on 20/10/2021 PSUSA/00002537/203205 Melinda Palfi Hungary NAP 2538 procyclidine 07/03/1953 10 years 01/01/2034 01/04/2034 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00002538/203401 NAP 2540 progesterone 09/09/1971 10 years 09/09/2035 08/12/2035 No 02/06/2026 PSUSA/00002540/203509 Jenny Jönsson Sweden NAP 2541 proglumetacin 01/02/1980 9 years 03/11/2028 01/02/2029 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00002541/202811 Carla Torre Portugal NAP 2543 promazine 13/04/1956 10 years 31/01/2034 01/05/2034 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00002543/203401 NAP 2544 promegestone 31/07/1981 9 years 03/11/2028 01/02/2029 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00002544/202811 NAP 2545 promethazine 26/10/1948 9 years 26/04/2033 25/07/2033 No 18/12/2024 DLP was amended on 18/12/2024 PSUSA/00002545/203304 Eva Jirsová Czech Republic NAP 2547 carbocisteine / promethazine hydrochloride Not available* 13 years 03/11/2026 01/02/2027 Yes 28/05/2025 DLP was amended on 28/05/2025 Information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" was amended on 28/05/2025 DLP was amended on 19/10/2023 PSUSA/00002547/202611 Amelia Cupelli Italy NAP 2550 propafenone 10/12/1978 5 years 31/01/2026 01/05/2026 No 20/10/2021 DLP was updated on 20/10/2021 PRAC representative was updated on 28/07/2021 PRAC representative was updated on 28/04/2021 Lead MS and PRAC Rapporteur name amended on 19/12/2018 Next DLP was amended on 19/10/2016 The DLP was amended on 30/09/2015 Lead MS was added on 13/07/2015 PSUSA/00002550/202601 Polona Golmajer Slovenia NAP 2554 propiverine 22/10/1981 9 years 03/11/2028 01/02/2029 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00002554/202811 NAP 2555 propofol 08/11/1995 5 years 07/11/2027 05/02/2028 No 26/07/2023 Next DLP was updated on 26/07/2023 PSUSA/00002555/202711 Karen Pernille Harg Norway NAP 2558 propylthiouracil Not available* 7 years 31/01/2032 30/04/2032 No 22/10/2025 DLP was amended on 22/10/2025 PSUSA/00002558/203201 Maia Uusküla Estonia NAP 2562 protamine 31/12/1951 11 years 31/12/2034 31/03/2035 No 18/12/2024 PSUR frequency amended and DLP updated on 18/12/2024 PSUSA/00002562/203412 none NAP 2563 human protein C 16/07/2001 5 years 31/07/2030 29/10/2030 No 01/04/2026 PSUR frequency amended and DLP updated on 01/04/2026 PSUSA/00002563/203007 Dirk Mentzer Germany CAP NAP 2564 prothipendyl 07/10/2005 3 years 07/10/2028 05/01/2029 No 01/07/2026 DLP was amended on 01/07/2026 PSUSA/00002564/202810 Jan Neuhauser Austria NAP 2565 protionamide Not available* 7 years 31/01/2027 01/05/2027 Yes 30/07/2025 Information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" was amended on 30/07/2025 DLP was amended on 30/07/2025 PSUR frequency amended and DLP updated on 30/04/2024 PSUSA/00002565/202701 Dennis Lex Germany NAP 2567 proxymetacaine 01/03/1971 10 years 02/09/2034 01/12/2034 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00002567/203409 NAP 2568 prucalopride 15/10/2009 3 years 14/10/2028 12/01/2029 No 01/07/2026 PSUR frequency amended and DLP updated on 01/07/2026 PSUSA/00002568/202810 Karin Bolin Sweden CAP 2569 prulifloxacin 21/06/2004 3 years 30/09/2026 29/12/2026 No 05/06/2024 DLP was amended on 05/06/2024 PSUSA/00002569/202609 Amelia Cupelli Italy NAP 2578 pyrantel 30/12/1970 10 years 02/09/2034 01/12/2034 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00002578/203409 NAP 2579 pyrazinamide 25/01/1956 9 years 02/12/2027 01/03/2028 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00002579/202712 NAP 2580 pyridostigmine 01/12/1953 10 years 01/01/2034 01/04/2034 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00002580/203401 NAP 2582 pyrimethamine 01/01/1952 10 years 01/12/2032 01/03/2033 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00002582/203212 NAP 2583 pyrimethamine / sulfadoxine 14/07/1970 9 years 03/05/2028 01/08/2028 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00002583/202805 NAP 2584 pyrithione zinc Not available* 9 years 03/06/2032 01/09/2032 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00002584/203206 NAP 2585 pyritinol 17/01/1960 10 years 02/04/2034 01/07/2034 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00002585/203404 NAP 2587 pyrvinium Not available* 10 years 03/11/2036 01/02/2037 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00002587/203611 NAP 2589 quetiapine 31/07/1997 3 years 31/07/2026 29/10/2026 No 27/03/2024 DLP was amended on 27/03/2024 PSUSA/00002589/202607 Liana Martirosyan Netherlands NAP 2590 quinagolide 29/06/1993 10 years 31/07/2027 29/10/2027 No 02/06/2026 PSUSA/00002590/202707 Jenny Jönsson Sweden NAP 2591 quinapril 14/04/1989 5 years 13/04/2026 12/07/2026 No 16/10/2023 PRAC Rapporteur name was amended on 18/10/2023 PSUSA/00002591/202604 Karin Erneholm Denmark NAP 2592 hydrochlorothiazide / quinapril 14/04/1989 5 years 13/04/2026 12/07/2026 No 27/01/2026 DLP was updated on 22/12/2021 Next DLP was amended on 20/12/2016 Lead Member State and PRAC Rapporteur added on 27/11/2015. PSUSA/00002592/202604 Roxana Stefania Udrescu Romania NAP 2598 quinine 15/01/1951 5 years 30/11/2026 28/02/2027 No 27/07/2022 DLP was updated on 27/07/2022 PRAC Rapporteur name updated on 23/10/2018 Next DLP was amended on 25/09/2017 PRAC representative and Lead Member State were added on 30/01/2017 Next DLP was amended on 03/06/2016 The 8 digit unique identification number was corrected. PSUSA/00002598/202611 Eamon O'Murchu Ireland NAP 2600 quinisocaine Not available* 8 years 01/12/2026 01/03/2027 No 08/04/2026 DLP amended on 23/10/2024 PSUSA/00002600/202612 Dennis Lex Germany NAP 2601 rabeprazole 14/10/1997 5 years 13/10/2026 11/01/2027 No 29/06/2022 DLP was updated on 29/06/2022 EURD corrected on 05/06/2019 Next DLP was amended on 27/06/2017 PSUR Frequency amended and DLP updated on 28/06/2016 Lead MS added on 16/06/2015 The DLP was amended on 01/04/2014 PSUSA/00002601/202610 Jan Neuhauser Austria NAP 2602 racecadotril Not available* 5 years 31/03/2028 29/06/2028 No 19/09/2025 PSUR frequency amended and DLP updated on 20/12/2023 PSUSA/00002602/202803 Maria Martinez Gonzalez Spain NAP 2603 raloxifene 05/08/1998 5 years 09/12/2028 09/03/2029 No 31/07/2024 DLP was amended on 31/07/2024 PSUSA/00002603/202812 Terhi Lehtinen Finland CAP 2605 raltitrexed 11/08/1995 8 years 02/09/2033 01/12/2033 No 29/04/2026 DLP was amended on 29/04/2026 PSUSA/00002605/203309 Veronika Macurová Czech Republic NAP 2607 ramipril 10/01/1989 6 years 03/08/2029 01/11/2029 No 30/04/2024 DLP was amended on 30/04/2024 PSUSA/00002607/202908 Dennis Lex Germany NAP 2609 ranibizumab 22/01/2007 3 years 05/10/2028 03/01/2029 No 01/07/2026 DLP was amended on 01/07/2026 PSUSA/00002609/202810 Karin Bolin Sweden CAP 2610 ranitidine 15/06/1981 5 years 31/05/2029 29/08/2029 No 05/02/2025 PSUR frequency amended and DLP updated on 05/02/2025 PSUSA/00002610/202905 Amelia Cupelli Italy NAP 2611 ranolazine 09/07/2008 3 years 26/01/2027 26/04/2027 No 02/06/2026 PSUSA/00002611/202701 Karin Bolin Sweden CAP 2612 rasagiline 21/02/2005 5 years 02/01/2029 02/04/2029 No 25/09/2024 DLP was amended on 25/09/2024 PSUSA/00002612/202901 Ana Sofia Diniz Martins Portugal CAP NAP 2613 rasburicase 23/02/2001 5 years 23/02/2028 23/05/2028 No 18/10/2023 PSUR frequency amended and DLP updated on 18/10/2023 PSUSA/00002613/202802 Bianca Mulder Netherlands CAP 2615 reboxetine 10/04/1997 5 years 09/04/2030 08/07/2030 No 24/09/2024 DLP was updated on 16/12/2020 Lead MS and PRAC Rapporteur name amended on 19/12/2018 Next DLP amended on 21/12/2015 Lead MS was added on 06/03/2015 PSUSA/00002615/203004 Karin Bolin Sweden NAP 2616 regadenoson 10/04/2008 3 years 09/04/2027 08/07/2027 No 18/12/2024 DLP was amended on 18/12/2024 PSUSA/00002616/202704 Maria del Pilar Rayon Spain CAP 2617 remifentanil 17/05/1996 5 years 16/05/2026 14/08/2026 No 02/02/2022 DLP and PSUR frequency were updated on 02/02/2022 PRAC representative and LMS were added on 23/09/2020 "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?Yes/No" was amended on 12/05/2015 PSUSA/00002617/202605 Dennis Lex Germany NAP 2618 repaglinide 17/08/1998 5 years 31/12/2025 31/03/2026 No 31/01/2024 PRAC representative updated on 31/01/2024 PSUSA/00002618/202512 Bianca Mulder Netherlands CAP NAP 2620 resorcinol Not available* 10 years 03/11/2036 01/02/2037 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00002620/203611 NAP 2625 retinol 13/10/1966 9 years 03/03/2028 01/06/2028 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00002625/202803 NAP 2633 a-tocopherol / ergocalciferol / phytomenadion / retinol palmitate Not available* 10 years 03/11/2035 01/02/2036 No 01/07/2026 PSUR frequency amended and DLP updated on 01/07/2026 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00002633/203511 Miroslava Gocova Slovakia NAP 2638 haemophilus influenzae / membrane fraction of klebsiella pneumoniae / ribosomal fractions of klebsiella pneumoniae / streptococcus pneumoniae / streptococcus pyogenes vaccine 30/03/1989 9 years 31/01/2029 01/05/2029 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00002638/202901 NAP 2639 rifabutin 19/10/1992 11 years 03/07/2036 01/10/2036 No 04/03/2026 PSUR frequency amended and DLP updated on 04/03/2026 PSUSA/00002639/203607 Marie Louise Schougaard Christiansen Denmark NAP 2640 rifampicin 01/05/1968 5 years 03/03/2030 01/06/2030 No 19/11/2025 PSUR frequency amended and DLP updated on 19/11/2025 PSUSA/00002640/203003 Maria Popova-Kiradjieva Bulgaria NAP 2641 rifamycin 01/04/1962 11 years 01/04/2034 30/06/2034 No 20/12/2023 DLP was amended on 20/12/2023 PSUSA/00002641/203404 Marie Louise Schougaard Christiansen Denmark NAP 2642 rifaximin 14/09/1985 8 years 03/05/2033 01/08/2033 No 04/02/2026 DLP was amended on 04/02/2026 PSUSA/00002642/203305 Melinda Pálfi Hungary NAP 2643 rilmenidine 23/04/1987 5 years 23/08/2029 21/11/2029 No 30/04/2025 PSUR frequency amended and DLP updated on 30/04/2025 PSUSA/00002643/202908 Melinda Palfi Hungary NAP 2645 riluzole 10/12/1995 5 years 12/12/2028 12/03/2029 No 31/07/2024 PSUR frequency amended and DLP updated on 31/07/2024 PSUSA/00002645/202812 Karin Erneholm Denmark CAP NAP 2648 risedronate, risedronate / calcium / colecalciferol 31/03/1998 5 years 31/03/2026 29/06/2026 No 02/06/2026 PSUSA/00002648/202603 Karin Bolin Sweden NAP 2649 risperidone 01/06/1993 5 years 31/05/2027 29/08/2027 No 26/07/2023 Reference to CAP added and active substance name was amended on 26/07/2023 DLP was updated on 01/02/2023 Active substance name updated on 02/03/2022 DLP was amended on 31/01/2018 Lead MS and PRAC Rapporteur name was added on 19/10/2016 Information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" was amended on 19/10/2016 PSUSA/00002649/202705 Dennis Lex Germany CAP NAP 2650 ritodrine hydrochloride Not available* 8 years 01/12/2026 01/03/2027 No 08/04/2026 DLP amended on 23/10/2024 PSUSA/00002650/202612 Pilar Rayón Iglesias Spain NAP 2651 ritonavir 26/08/1996 5 years 31/08/2028 29/11/2028 No 29/04/2026 PSUR frequency amended and DLP updated on 29/04/2026 PSUSA/00002651/202808 Liana Martirosyan Netherlands CAP 2652 rituximab 02/06/1998 3 years 17/11/2026 15/02/2027 No 28/08/2024 New CAP authorised on 19/09/2024 PSUR frequency amended and DLP updated on 28/08/2024 DLP was amended on 03/07/2024 PSUSA/00002652/202611 Karin Erneholm Denmark CAP 2653 rivaroxaban, acetylsalicylic acid / rivaroxaban 30/09/2008 3 years 15/09/2027 14/12/2027 No 02/06/2026 PSUSA/00002653/202709 Karin Bolin Sweden CAP NAP 2654 rivastigmine 12/05/1998 5 years 31/01/2029 01/05/2029 No 25/09/2019 Reference to NAP added on 23/10/2024 PRAC representative was updated on 29/07/2020 PRAC representative was updated on 03/06/2020 PSUR frequency and DLP were updated on 25/09/2019 Reference to NAP products removed on 04/07/2018 PRAC Rapporteur name updated on 21/07/2017 PSUR Frequency amended and DLP updated on 22/09/2016 PRAC Rapporteur name was amended on 28/07/2016 Next DLP was updated on 30/09/2015 Rapporteur amended on 04/11/2014 PSUSA/00002654/202901 Tiphaine Vaillant France CAP NAP 2655 rizatriptan 11/02/1998 5 years 11/06/2028 09/09/2028 No 28/02/2024 DLP was amended on 28/02/2024 PSUSA/00002655/202806 Liana Martirosyan Netherlands NAP 2656 rocuronium 17/03/1994 5 years 28/02/2030 29/05/2030 No 19/11/2025 PSUR frequency amended and DLP updated on 19/11/2025 PSUSA/00002656/203002 Eva Jirsová Czech Republic NAP 2658 roflumilast 05/07/2010 5 years 05/01/2029 05/04/2029 No 19/09/2025 PSUR frequency amended and DLP updated on 25/09/2024 PSUSA/00002658/202901 Maria Martinez Gonzalez Spain CAP 2660 romiplostim 04/02/2009 5 years 31/07/2027 29/10/2027 No 19/09/2025 PSUR frequency amended and DLP updated on 05/04/2023 DLP was updated on 01/04/2020 PSUR Frequency amended and DLP updated on 28/02/2017 PRAC Representative amended on 28/06/2016 Next DLP was updated on 04/03/2016 The DLP was amended on 06/03/2015 The DLP was amended on 01/04/2014 PSUSA/00002660/202707 Maria Martinez Gonzalez Spain CAP 2661 ropinirole 08/07/1996 3 years 08/07/2028 06/10/2028 No 04/03/2026 DLP was amended on 04/03/2026 PSUSA/00002661/202807 Tiphaine Vaillant France NAP 2662 ropivacaine 15/09/1995 5 years 14/09/2027 13/12/2027 No 06/06/2018 Next DLP was updated on 31/05/2023 PSUSA/00002662/202709 Liana Martirosyan Netherlands NAP 2664 rosuvastatin 06/11/2002 5 years 06/11/2027 04/02/2028 No 31/01/2024 PRAC representative updated on 31/01/2024 PSUSA/00002664/202711 Bianca Mulder Netherlands NAP 2665 rotavirus vaccine monovalent (live, oral) 21/02/2006 3 years 11/07/2028 09/10/2028 No 04/03/2026 DLP was amended on 04/03/2026 PSUSA/00002665/202807 Jean-Michel Dogné Belgium CAP 2666 rotavirus vaccine pentavalent (live, oral) 27/06/2006 3 years 27/11/2026 25/02/2027 No 02/06/2026 PSUSA/00002666/202611 Karin Bolin Sweden CAP 2667 rotigotine 15/02/2006 3 years 15/02/2026 16/05/2026 No 18/10/2023 Next DLP was updated on 18/10/2023 PSUSA/00002667/202602 Ana Sofia Diniz Martins Portugal CAP 2669 roxithromycin 04/08/1986 3 years 31/12/2027 30/03/2028 No 24/09/2025 DLP was amended on 24/09/2025 PSUSA/00002669/202712 Amelia Cupelli Italy NAP 2671 rufinamide 16/01/2007 5 years 15/01/2028 14/04/2028 No 25/06/2025 Information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" was amended on 25/06/2025 DLP and PSUR frequency amended on 20/09/2023 PSUSA/00002671/202801 Tiphaine Vaillant France CAP 2673 rupatadine 12/12/2005 5 years 30/12/2028 30/03/2029 No 19/09/2025 PSUR frequency amended and DLP updated on 25/09/2024 PSUSA/00002673/202812 Maria Martinez Gonzalez Spain NAP 2674 rutoside 31/10/1962 10 years 03/05/2034 01/08/2034 No 03/10/2024 Updated & published on 23/10/2024 PSUSA/00002674/203405 NAP 2679 salicylamide Not available* 8 years 01/12/2026 01/03/2027 No 23/10/2024 DLP amended on 23/10/2024 PSUSA/00002679/202612 NAP 2680 salicylic acid (topical use) Not available* 6 years 02/12/2029 02/03/2030 No 31/07/2024 DLP was amended on 31/07/2024 PSUSA/00002680/202912 Dennis Lex Germany NAP 2681 salmeterol 25/10/1990 5 years 31/10/2030 29/01/2031 No 01/07/2026 DLP was amended on 01/07/2026 PSUSA/00002681/203010 Karin Bolin Sweden NAP 2682 samarium (153sm) lexidronam 05/02/1998 5 years 04/02/2029 05/05/2029 No 25/09/2019 PSUR frequency, DLP and PRAC representative were updated on 25/09/2019 Lead MS and PRAC Rapporteur name updated on 30/04/2019 PRAC Representative amended on 28/03/2017 Next DLP was updated on 22/09/2016 PSUSA/00002682/202902 Karin Erneholm Denmark CAP 2683 sapropterin 02/12/2008 3 years 01/12/2027 29/02/2028 No 30/07/2025 DLP was amended on 30/07/2025 PSUSA/00002683/202712 Eamon O Murchu Ireland CAP 2685 saxagliptin, metformin / saxagliptin 01/10/2009 3 years 30/07/2026 28/10/2026 No 27/03/2024 DLP was amended on 27/03/2024 PSUSA/00002685/202607 Bianca Mulder Netherlands CAP 2687 secnidazole Not available* 9 years 03/06/2032 01/09/2032 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00002687/203206 NAP 2688 selegiline 14/03/1980 8 years 03/03/2033 01/06/2033 No 19/11/2025 DLP was amended on 19/11/2025 PSUSA/00002688/203303 Veronika Macurová Czech Republic NAP 2690 selenium Not available* 8 years 01/12/2026 01/03/2027 No 08/04/2026 DLP amended on 23/10/2024 PSUSA/00002690/202612 Dennis Lex Germany NAP 2693 serrapeptase 30/09/1968 10 years 03/08/2034 01/11/2034 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00002693/203408 NAP 2694 sertaconazole 10/03/1992 10 years 03/06/2035 01/09/2035 No 04/02/2026 PSUR frequency amended and DLP updated on 04/02/2026 PSUSA/00002694/203506 Ana Sofia Martins Portugal NAP 2695 sertindole 11/07/2002 3 years 11/01/2026 11/04/2026 Yes 20/09/2023 DLP amended on 20/09/2023 PSUSA/00002695/202601 Melinda Palfi Hungary NAP 2696 sertraline 01/03/1990 5 years 31/03/2027 29/06/2027 No 21/12/2022 DLP was updated on 21/12/2022 PRAC Rapporteur name updated on 23/10/2018 PRAC Representative updated on 26/09/2018 DLP was updated on 19/12/2017 Lead MS and PRAC Rapporteur name was added on 19/10/2016 Transferred from the List of substances under PSUR Work Sharing scheme and other substances contained in Nationally Authorised Products with DLP synchronised on 06/03/2015 PSUSA/00002696/202703 Liana Martirosyan Netherlands NAP 2697 sevelamer 30/10/1998 3 years 30/10/2027 28/01/2028 No 25/06/2025 DLP was amended on 25/06/2025 PSUSA/00002697/202710 Jo Robays Belgium CAP NAP 2698 sevoflurane 23/01/1990 5 years 31/01/2030 01/05/2030 No 22/10/2025 DLP was amended on 22/10/2025 PSUSA/00002698/203001 Eamon O'Murchu Ireland NAP 2699 sildenafil (indicated for erectile dysfunction) 14/09/1998 5 years 31/12/2026 31/03/2027 No 21/09/2022 DLP was updated on 21/09/2022 Reference to NAP added on 25/05/2022 PSUR Frequency amended and next DLP updated on 25/09/2017 PSUSA procedure published on 01/04/2014. Information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" was amended on 30/11/2012 PSUSA/00002699/202612 Liana Martirosyan Netherlands CAP NAP 2700 sildenafil (indicated for pulmonary hypertension) 28/10/2005 3 years 31/05/2027 29/08/2027 No 05/02/2025 DLP was amended on 05/02/2025 PSUSA/00002700/202705 Bianca Mulder Netherlands CAP NAP 2701 silodosin 29/01/2010 3 years 30/01/2026 30/04/2026 No 18/10/2023 Next DLP was updated on 18/10/2023 PSUSA/00002701/202601 Amelia Cupelli Italy CAP 2702 silver sulfadiazine 25/01/1973 8 years 15/09/2033 14/12/2033 No 27/05/2026 PSUR frequency amended and DLP updated on 27/05/2026 DLP was updated on 26/05/2021 PRAC representative was added on 06/05/2020 LMS was added on 01/04/2020 PSUR frequency and DLP were updated on 05/06/2019 PSUSA/00002702/203309 Maia Uusküla Estonia NAP 2703 cerium nitrate / silver sulfadiazine 25/01/1973 10 years 31/01/2035 01/05/2035 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00002703/203501 NAP 2705 simeticone, pancreatin / simeticone, dimethicone / pancreatin, pancreatic enzymes, pancreatic extracts, pancreatin 28/04/1967 9 years 02/04/2028 01/07/2028 No 18/10/2023 Active substance name, PSUR frequency and DLP were amended on 18/10/2023 Information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" was amended on 30/11/2012 PSUSA/00002705/202804 none NAP 2706 aluminium oxide / magnesium hydroxide / simeticone Not available* 9 years 03/03/2029 01/06/2029 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00002706/202903 NAP 2709 simvastatin 06/04/1988 5 years 05/04/2030 04/07/2030 No 16/12/2020 PSUR frequency and DLP were updated on 16/12/2020 Lead MS and PRAC Rapporteur name amended on 19/12/2018 DLP was updated on 19/12/2017 Lead MS and PRAC Rapporteur name was added on 19/10/2016 Transferred from the List of substances under PSUR Work Sharing scheme and other substances contained in Nationally Authorised Products with DLP synchronised on 06/03/2015 PSUSA/00002709/203004 Terhi Lehtinen Finland NAP 2710 sirolimus (for prophylaxis of organ rejection indication) 13/03/2001 3 years 14/09/2026 13/12/2026 No 02/06/2026 PSUSA/00002710/202609 Karin Bolin Sweden CAP 2713 sobrerol Not available* 9 years 03/06/2032 01/09/2032 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00002713/203206 NAP 2719 sodium benzoate / sodium phenylacetate Not available* 9 years 03/06/2032 01/09/2032 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00002719/203206 NAP 2723 sodium bicarbonate / sodium hydrogen phoshate / sodium sulphate 11/01/1966 11 years 02/12/2039 01/03/2040 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00002723/203912 NAP 2724 solutions for haemofiltration and haemodiafiltration, solutions for haemodialysis Not available* 9 years 03/08/2032 01/11/2032 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00002724/203208 none NAP 2731 succinylated gelatin, sodium chloride / sodium hydroxide / succinylated gelatin, calcium chloride / magnesium chloride / potassium chloride / sodium acetate /sodium chloride / succinylated gelatin, gelatin / sodium chloride / potassium chloride / magnesium chloride hexahydrate / sodium lactate 27/09/2006 15 years 26/09/2033 25/12/2033 No 23/10/2024 PSUR frequency amended and DLP updated on 23/10/2024 EURD added on 23/10/2024 Active substance name was amended on 01/04/2020 Active substance name was amended on 05/02/2020 PSUSA/00002731/203309 Liana Martirosyan Netherlands NAP 2732 sodium chloride / urea Not available* 8 years 01/12/2026 01/03/2027 No 23/10/2024 DLP amended on 23/10/2024 PSUSA/00002732/202612 NAP 2735 sodium citrate / sodium lauryl sulfoacetate, sodium citrate / sodium lauryl sulfoacetate / sorbitol Not available* 7 years 31/01/2032 30/04/2032 No 22/10/2025 DLP was amended on 22/10/2025 PSUSA/00002735/203201 Zoubida Amimour France NAP 2737 disodium hydrogen phosphate / sodium dihydrogen phosphate, phosphate sodium 06/01/2005 13 years 06/01/2038 06/04/2038 No 24/09/2025 DLP was amended on 24/09/2025 PSUSA/00002737/203801 Guðrún Stefánsdóttir Iceland NAP 2738 disodium edetate dihydrate / sodium dihydrogen phosphate dihydrate / sodium hydrogen phosphate dodecahydrate / water for injection Not available* 9 years 03/11/2030 01/02/2031 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00002738/203011 none NAP 2739 glucose monohydrate / sodium dihydrogen phosphate dihydrate / zinc acetate dihydrate Not available* 9 years 03/03/2031 01/06/2031 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00002739/203103 NAP 2745 sodium glycerophosphate pentahydrate Not available* 8 years 01/12/2026 01/03/2027 No 08/04/2026 DLP amended on 23/10/2024 PSUSA/00002745/202612 Jo Robays Belgium NAP 2748 sodium hydrogen carbonate Not available* 9 years 03/08/2032 01/11/2032 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00002748/203208 NAP 2752 sodium iodide (123i) 31/01/1995 7 years 31/03/2027 29/06/2027 No 16/10/2023 PRAC Rapporteur name was amended on 18/10/2023 PSUSA/00002752/202703 Karin Erneholm Denmark NAP 2753 sodium iodide (131i) 01/10/1973 5 years 01/03/2027 30/05/2027 No 31/01/2024 PRAC representative updated on 31/01/2024 PSUSA/00002753/202703 Carla Torre Portugal NAP 2756 sodium nitroprusside 30/11/1976 9 years 02/09/2028 01/12/2028 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00002756/202809 NAP 2758 sodium phenylbutyrate 08/12/1999 3 years 31/12/2027 30/03/2028 No 24/09/2025 DLP was amended on 24/09/2025 PSUSA/00002758/202712 Rhea Fitzgerald Ireland CAP 2759 sodium picosulfate 01/10/1967 9 years 02/04/2028 01/07/2028 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00002759/202804 NAP 2760 liquid paraffin / sodium picosulfate Not available* 13 years 03/06/2040 01/09/2040 No 23/10/2024 DLP amended on 23/10/2024 PSUSA/00002760/204006 NAP 2767 sodium tetradecyl sulphate Not available* 3 years 30/04/2026 29/07/2026 Yes 12/09/2025 PSUR frequency amended and DLP updated on 20/12/2023 PSUSA/00002767/202604 Veronika Macurová Czech Republic NAP 2769 solifenacin 08/06/2004 5 years 08/06/2030 06/09/2030 No 04/02/2026 DLP was amended on 04/02/2026 PSUSA/00002769/203006 Liana Martirosyan Netherlands NAP 2770 somatorelin 01/01/1986 9 years 01/12/2028 01/03/2029 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00002770/202812 NAP 2771 somatostatin 03/12/1989 8 years 03/06/2033 01/09/2033 No 04/02/2026 DLP was amended on 04/02/2026 PSUSA/00002771/203306 Maria Martinez Gonzalez Spain NAP 2772 somatropin 28/04/1988 3 years 31/03/2026 29/06/2026 No 20/12/2023 DLP was amended on 20/12/2023 PSUSA/00002772/202603 Karin Erneholm Denmark CAP NAP 2773 sorafenib 19/07/2006 5 years 31/12/2029 31/03/2030 No 02/06/2026 PSUSA/00002773/202912 Jenny-Maria Jönsson Sweden CAP NAP 2774 sotalol 22/08/1973 7 years 21/08/2031 19/11/2031 No 30/04/2025 PSUR frequency amended and DLP updated on 30/04/2025 PSUSA/00002774/203108 Karin Erneholm Denmark NAP 2775 spaglumic acid Not available* 9 years 03/11/2032 01/02/2033 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00002775/203211 NAP 2777 spectinomycin 21/08/1970 10 years 02/09/2034 01/12/2034 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00002777/203409 NAP 2778 spiramycin 08/02/1955 9 years 02/12/2027 01/03/2028 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00002778/202712 NAP 2780 spironolactone 01/03/1962 3 years 08/03/2027 06/06/2027 No 20/11/2024 DLP was amended on 20/11/2024 PSUSA/00002780/202703 Terhi Lehtinen Finland CAP NAP 2781 altizide / spironolactone 21/01/1964 3 years 21/01/2027 21/04/2027 No 25/09/2024 DLP was amended on 25/09/2024 PSUSA/00002781/202701 Barbara Kovacic Bytyqi Croatia NAP 2786 bacterial lysate of haemophilus influenzae / klebsiella pneumoniae / moraxella catarrhalis / staphylococcus aureus / streptococcus mitis / streptococcus pneumoniae / streptococcus pyogenes, bacterial lysate of haemophilus influenzae / klebsiella pneumoniae / moraxella catarrhalis / staphylococcus aureus / streptococcus pneumoniae / streptococcus pyogenes, streptococcus pneumoniae / streptococcus agalactiae / staphylococcus aureus / haemophilus influenzae 11/01/1974 5 years 31/03/2026 29/06/2026 No 06/10/2025 PRAC representative was updated on 01/03/2023 DLP was updated on 22/12/2021 Entry name and EURD were amended on 31/01/2018 Next DLP was amended on 20/12/2016 DLP was corrected on 04/02/2016. Active Substance and DLP was amended on 21/12/2015. PRAC representative name was amended on 31/07/2015 Active Substance name amended on 16/07/2015 Lead MS was added on 04/02/2015 PSUSA/00002786/202603 Dirk Mentzer Germany NAP 2788 stibogluconate 30/03/1966 10 years 03/07/2034 01/10/2034 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00002788/203407 NAP 2789 stiripentol 04/01/2007 1 year 04/11/2026 13/01/2027 04/11/2027 13/01/2028 Yes 01/07/2026 DLP was amended on 01/07/2026 PSUSA/00002789/202611 PSUSA/00002789/202711 Maia Uusküla Estonia CAP NAP 2791 streptodornase / streptokinase 01/03/1933 11 years 03/11/2036 01/02/2037 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00002791/203611 NAP 2792 streptokinase Not available* 10 years 03/11/2036 01/02/2037 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00002792/203611 NAP 2793 streptomycin 15/04/1956 10 years 31/01/2034 01/05/2034 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00002793/203401 NAP 2794 streptozocin 07/05/1982 9 years 01/12/2028 01/03/2029 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00002794/202812 NAP 2796 sucralfate 23/02/1968 9 years 02/04/2028 01/07/2028 No 15/01/2025 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00002796/202804 Amelia Cupelli Italy NAP 2798 sufentanil 30/11/1978 3 years 30/11/2027 28/02/2028 No 30/07/2025 DLP was amended on 30/07/2025 PSUSA/00002798/202711 Adam Przybylkowski Poland CAP NAP 2799 sugammadex 25/07/2008 5 years 31/01/2029 01/05/2029 No 23/10/2019 Reference to NAP added on 03/07/2024 New CAP authorised on 23/06/2023 New CAP authorised on 26/05/2023 New CAP authorised on 10/01/2023 New CAP authorised on 15/07/2022 New CAP authorised on 15/11/2021 DLP and frequency were updated on 23/10/2019 DLP was updated on 25/09/2019 Next DLP was updated on 22/09/2016 The DLP was amended on 08/01/2014 PSUSA/00002799/202901 Terhi Lehtinen Finland CAP NAP 2801 sulbutiamine 28/05/1973 10 years 03/11/2035 01/02/2036 No 01/07/2026 PSUR frequency amended and DLP updated on 01/07/2026 EURD updated on 01/07/2026 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00002801/203511 Tiphaine Vaillant France NAP 2802 sulconazole 30/09/1987 9 years 01/01/2029 01/04/2029 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00002802/202901 NAP 2805 sulfacetamide Not available* 10 years 03/11/2036 01/02/2037 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00002805/203611 NAP 2806 sulfadiazine Not available* 8 years 03/08/2027 01/11/2027 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00002806/202708 NAP 2807 sodium hyaluronate / sulfadiazine silver Not available* 8 years 01/12/2026 01/03/2027 No 08/04/2026 DLP amended on 23/10/2024 PSUSA/00002807/202612 Amelia Cupelli Italy NAP 2809 sulfaguanidine 07/01/1974 10 years 03/03/2035 01/06/2035 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00002809/203503 NAP 2816 sulfasalazine 25/04/1942 10 years 02/12/2033 02/03/2034 No 31/07/2024 PSUR frequency amended and DLP updated on 31/07/2024 PSUSA/00002816/203312 Marie Louise Schougaard Christiansen Denmark NAP 2818 sulfinpyrazone 25/09/1958 10 years 31/01/2034 01/05/2034 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00002818/203401 NAP 2822 sulfur hexafluoride 26/03/2001 3 years 30/09/2026 29/12/2026 No 05/06/2024 DLP was amended on 05/06/2024 PSUSA/00002822/202609 Tiphaine Vaillant France CAP 2823 sulindac 30/06/1975 9 years 03/08/2028 01/11/2028 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00002823/202808 NAP 2824 sulodexide 09/10/1972 10 years 01/12/2034 01/03/2035 No 05/01/2025 Correction of DLP on 20/11/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00002824/203412 Amelia Cupelli Italy NAP 2828 sulprostone 17/12/1980 3 years 21/04/2028 20/07/2028 No 19/09/2024 PSUSA/00002828/202804 Zoubida Amimour France NAP 2829 sultamicillin 01/11/1983 5 years 20/11/2030 18/02/2031 No 29/07/2026 DLP was amended on 29/07/2026 PSUSA/00002829/203011 Maia Uusküla Estonia NAP 2830 sultiame Not available* 10 years 03/11/2036 01/02/2037 No 18/10/2023 Information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" , PSUR frequency and DLP were amended on 18/10/2023 PSUSA/00002830/203611 none NAP 2831 sultopride 01/10/1986 9 years 01/12/2028 01/03/2029 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00002831/202812 NAP 2832 sumatriptan, naproxen / sumatriptan 11/04/1991 5 years 30/09/2029 29/12/2029 No 21/12/2022 Active substance name changed on 21/12/2022 DLP was updated on 03/06/2020 PRAC Rapporteur name updated on 23/10/2018 PRAC Representative updated on 26/09/2018 Next DLP amended on 13/07/2015 PRAC Rapporteur name and country updated on 01/12/2014 Information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" was amended on 30/11/2012 PSUSA/00002832/202909 Liana Martirosyan Netherlands NAP 2833 sunitinib 19/07/2006 3 years 30/04/2026 29/07/2026 No 31/01/2024 DLP was amended on 31/01/2024 PSUSA/00002833/202604 Amelia Cupelli Italy CAP 2834 suxamethonium 14/08/1952 3 years 13/08/2026 11/11/2026 No 30/04/2024 DLP was amended on 30/04/2024 PSUSA/00002834/202608 Barbara Kovacic Bytyqi Croatia NAP 2835 suxibuzone Not available* 10 years 03/11/2036 01/02/2037 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00002835/203611 NAP 2838 tacalcitol Not available* 8 years 03/08/2027 01/11/2027 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00002838/202708 NAP 2839 tacrolimus (systemic formulations) 02/04/1993 3 years 31/03/2027 29/06/2027 No 18/12/2024 DLP was amended on 18/12/2024 PSUSA/00002839/202703 Eamon O'Murchu Ireland CAP NAP 2840 tacrolimus (topical formulations) 28/02/2002 3 years 31/03/2028 29/06/2028 No 17/12/2025 PSUR frequency amended and DLP updated on 17/12/2025 PSUSA/00002840/202803 Rhea Fitzgerald Ireland CAP NAP 2841 tadalafil 12/11/2002 3 years 15/10/2028 13/01/2029 No 01/07/2026 DLP was amended on 01/07/2026 PSUSA/00002841/202810 Maria del Pilar Rayon Spain CAP NAP 2842 tafamidis 16/11/2011 2 years 15/05/2026 13/08/2026 No 18/12/2024 PSUR frequency amended and DLP updated on 18/12/2024 PSUSA/00002842/202605 Zoubida Amimour France CAP 2843 tafluprost 30/04/2008 3 years 29/04/2027 28/07/2027 No 05/02/2025 DLP was amended on 05/02/2025 PSUSA/00002843/202704 Dennis Lex Germany NAP 2846 tamoxifen 29/04/1974 5 years 29/04/2030 28/07/2030 No 04/02/2026 DLP was amended on 04/02/2026 PSUSA/00002846/203004 Eamon O'Murchu Ireland NAP 2847 tamsulosin 02/07/1993 5 years 01/07/2026 29/09/2026 No 31/01/2024 PRAC representative updated on 31/01/2024 PSUSA/00002847/202607 Liana Martirosyan Netherlands NAP 2849 tapentadol 20/11/2008 5 years 20/11/2029 18/02/2030 No 30/07/2025 PSUR frequency amended and DLP updated on 30/07/2025 PSUSA/00002849/202911 Dennis Lex Germany NAP 2850 tasonermin 13/04/1999 7 years 14/08/2032 12/11/2032 No 29/07/2026 DLP was coirrected on 29/07/2026 PSUR frequency amended and DLP updated on 29/04/2026 PSUSA/00002850/203208 Karin Erneholm Denmark CAP 2855 technetium (99mtc) albumin nanocolloid 29/11/1993 15 years 29/11/2027 27/02/2028 No 25/09/2019 PSUR frequency and DLP were updated on 25/09/2019 PSUSA/00002855/202711 NAP 2856 technetium (99mTc) bicisate 08/10/1993 15 years 07/10/2034 05/01/2035 No 16/10/2023 PRAC Rapporteur name was amended on 18/10/2023 PSUSA/00002856/203410 Karin Erneholm Denmark NAP 2857 technetium (99mtc) depreotide 29/11/2000 15 years 15/09/2027 14/12/2027 No 25/09/2019 PSUR frequency and DLP were updated on 25/09/2019 DLP was updated on 05/06/2019 PSUSA/00002857/202709 NAP 2859 technetium (99mtc) human albumin Not available* 15 years 01/01/2027 01/04/2027 No 25/09/2019 PSUR frequency and DLP were updated on 25/09/2019 PSUSA/00002859/202701 NAP 2860 technetium (99mtc) macrosalb 02/03/1990 15 years 28/02/2028 28/05/2028 No 16/10/2023 PRAC Rapporteur name was amended on 18/10/2023 PSUSA/00002860/202802 Karin Erneholm Denmark NAP 2861 technetium (99mtc) mebrofenin 29/11/1993 15 years 01/11/2030 30/01/2031 No 16/10/2023 PRAC Rapporteur name was amended on 18/10/2023 PSUSA/00002861/203011 Karin Erneholm Denmark NAP 2862 technetium (99mtc) medronic acid Not available* 15 years 01/01/2027 01/04/2027 No 20/05/2026 PSUR frequency and DLP were updated on 25/09/2019 PSUSA/00002862/202701 Katarzyna Ziolkowska Poland NAP 2863 technetium (99mTc) mertiatide, technetium (99mTc) betiatide Not available* 15 years 01/01/2027 01/04/2027 Yes 20/05/2026 Active substance name was amended and 'Are PSURs required for products referred to in Articles 10(1), 10a, 16a of Directive 2001/83/EC as amended?' was updated on 29/07/2020 PSUR frequency and DLP were updated on 25/09/2019 PSUSA/00002863/202701 Katarzyna Ziolkowska Poland NAP 2864 technetium (99mtc) oxidronate 21/03/1983 15 years 21/03/2027 19/06/2027 No 25/09/2019 PSUR frequency and DLP were updated on 25/09/2019 PSUSA/00002864/202703 NAP 2865 technetium (99mtc) pentetate 21/06/1990 15 years 21/06/2027 19/09/2027 No 25/09/2019 PSUR frequency and DLP were updated on 25/09/2019 PSUSA/00002865/202706 NAP 2866 technetium (99mTc) pertechnetate 01/06/1983 15 years 01/06/2032 30/08/2032 No 16/10/2023 PRAC Rapporteur name was amended on 18/10/2023 PSUSA/00002866/203206 Karin Erneholm Denmark NAP 2867 sodium pyrophosphate, technetium (99mtc) pyrophosphate (for diagnosistic purpose) 04/02/1991 15 years 04/02/2027 05/05/2027 Yes 09/07/2026 PSUR frequency and DLP were updated on 25/09/2019 Entry name amended and information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" was amended on 21/07/2017 PSUSA/00002867/202702 Jo Robays Belgium NAP 2868 technetium (99mtc) sestamibi 09/12/1987 15 years 08/06/2032 06/09/2032 Yes 16/10/2023 PRAC Rapporteur name was amended on 18/10/2023 PSUSA/00002868/203206 Karin Erneholm Denmark NAP 2869 technetium (99mTc) succimer Not available* 15 years 01/01/2027 01/04/2027 No 25/09/2019 PSUR frequency and DLP were updated on 25/09/2019 PSUSA/00002869/202701 NAP 2870 technetium (99mTc) tetrofosmin, tetrofosmin 31/05/1993 15 years 31/05/2032 29/08/2032 No 16/10/2023 PRAC Rapporteur name was amended on 18/10/2023 PSUSA/00002870/203205 Karin Erneholm Denmark NAP 2872 technetium (99mTc) tin colloid Not available* 15 years 01/01/2027 01/04/2027 No 25/09/2019 PSUR frequency and DLP were updated on 25/09/2019 PSUSA/00002872/202701 NAP 2873 technetium (99mTc) trimethylphenylcarbamoylmethyliminodiacetic acid Not available* 15 years 01/01/2027 01/04/2027 No 25/09/2019 PSUR frequency and DLP were updated on 25/09/2019 PSUSA/00002873/202701 NAP 2874 tegafur Not available* 8 years 03/08/2027 01/11/2027 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00002874/202708 NAP 2875 gimeracil / oteracil monopotassium / tegafur 14/03/2011 5 years 24/01/2026 24/04/2026 No 04/03/2026 Reference to NAP added on 04/03/2026 PSUR frequency and DLP were updated on 20/10/2021 PSUR Frequency, DLP and PRAC Representative were updated on 26/09/2018 Next DLP was amended on 25/09/2017 Next DLP was updated on 22/09/2016 Next DLP was updated on 30/09/2015 Next DLP was amended on 28/05/2014 PSUSA/00002875/202601 Bianca Mulder Netherlands CAP NAP 2878 teicoplanin 01/11/1986 5 years 01/11/2026 30/01/2027 No 29/06/2022 DLP was updated on 29/06/2022 Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended? Yes/No was corrected on 07/05/2018 DLP was updated and information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" was amended on 21/07/2017 Lead MS and PRAC Rapporteur name was added on 03/06/2016 PSUSA/00002878/202611 Eva Jirsová Czech Republic NAP 2882 hydrochlorothiazide / telmisartan, telmisartan 11/12/1998 5 years 31/03/2030 29/06/2030 No 17/12/2025 PSUR frequency amended and DLP updated on 17/12/2025 PSUSA/00002882/203003 Amelia Cupelli Italy CAP NAP 2883 temazepam 26/11/1969 9 years 03/05/2028 01/08/2028 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00002883/202805 NAP 2884 temocillin 25/10/1984 9 years 01/12/2028 01/03/2029 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00002884/202812 NAP 2885 temoporfin 24/10/2001 13 years 30/04/2037 29/07/2037 No 05/02/2025 PSUR frequency amended and DLP updated on 05/02/2025 PSUSA/00002885/203704 Bianca Mulder Netherlands CAP 2886 temozolomide 26/01/1999 3 years 12/07/2026 10/10/2026 No 27/03/2024 DLP was amended on 27/03/2024 PSUSA/00002886/202607 Dennis Lex Germany CAP 2887 temsirolimus 19/11/2007 5 years 31/03/2029 29/06/2029 No 25/06/2025 Information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" was amended on 25/06/2025 Information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" was amended on 18/12/2024 PSUR frequency amended and DLP updated on 18/12/2024 DLP was updated on 22/12/2021 DLP was updated on 21/11/2018 Next DLP and PRAC Rapporteur amended on 27/11/2015. PRAC Representative amended on 31/07/2015 PSUSA/00002887/202903 Dennis Lex Germany CAP 2888 tenecteplase 23/02/2001 3 years 31/08/2028 29/11/2028 No 29/04/2026 DLP was amended on 29/04/2026 PSUSA/00002888/202808 Dennis Lex Germany CAP 2889 teniposide 05/04/1976 9 years 03/08/2028 01/11/2028 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00002889/202808 NAP 2891 eucalyptus / paracetamol / tenoate sodium 15/05/1964 11 years 02/12/2039 01/03/2040 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00002891/203912 NAP 2892 tenofovir disoproxil 05/02/2002 3 years 31/03/2026 29/06/2026 No 19/09/2024 PSUSA/00002892/202603 Zoubida Amimour France CAP 2893 tenoxicam 20/02/1986 5 years 28/02/2026 29/05/2026 No 19/10/2022 PRAC representative was updated on 19/10/2022 PRAC representative was updated on 27/07/2022 DLP and PSUR frequency were updated on 17/11/2021 PRAC representative was updated on 30/06/2021 DLP was updated on 21/11/2018 PRAC Rapporteur name was updated on 04/07/2018 Information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" was amended on 17/10/2017 PRAC Rapporteur name updated on 04/02/2016 PRAC Representative amended on 27/11/2015. The Next DLP was amended on 29/10/2015 Lead MS was added on 04/02/2015 PSUSA/00002893/202602 Amelia Cupelli Italy NAP 2895 terazosin 30/11/1984 8 years 20/11/2031 18/02/2032 No 31/07/2024 PSUR frequency amended and DLP updated on 31/07/2024 PSUSA/00002895/203111 Liana Martirosyan Netherlands NAP 2896 terbinafine 03/10/1990 3 years 30/09/2028 29/12/2028 No 01/07/2026 DLP was amended on 01/07/2026 PSUSA/00002896/202809 Jana Pecherova Slovakia NAP 2897 terbutaline 31/12/1970 5 years 31/12/2026 31/03/2027 No 21/09/2022 PLP was updated on 21/09/2022 PRAC representative was updated on 23/09/2020 Next DLP was amended on 25/09/2017 Lead MS and PRAC Rapporteur name was added on 28/07/2016 PSUSA/00002897/202612 Melinda Palfi Hungary NAP 2898 guaifenesin / terbutaline sulfate Not available* 9 years 03/03/2031 01/06/2031 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00002898/203103 NAP 2903 teriparatide 10/06/2003 3 years 12/09/2027 11/12/2027 No 28/05/2025 New CAP authorised on 27/04/2026 Information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" was amended on 28/05/2025 DLP was amended on 28/05/2025 New CAP authorised on 12/01/2023 New CAPs authorised on 18/11/2022 DLP and Information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" were amended on 25/05/2022 New CAP authorised on 24/03/2022 PRAC representative was updated on 26/05/2021 New CAPs authorised on 27/08/2020 DLP updated on 05/06/2019 Lead MS and PRAC Rapporteur name amended on 06/02/2019 Lead MS and PRAC Rapporteur name amended on 21/11/2018 Reference to NAP added on 31/01/2018 PSUR Frequency amended and DLP updated on 03/05/2016 PSUSA/00002903/202709 Tiphaine Vaillant France CAP NAP 2904 terizidone 25/01/1973 5 years 15/09/2030 14/12/2030 No 27/05/2026 DLP was amended on 27/05/2026 PSUSA/00002904/203009 Rugile Pilviniene Lithuania NAP 2905 terlipressin 01/05/1980 3 years 30/04/2027 29/07/2027 No 05/02/2025 DLP was amended on 05/02/2025 PSUSA/00002905/202704 Karin Erneholm Denmark NAP 2906 tertatolol 25/04/1986 9 years 01/12/2028 01/03/2029 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00002906/202812 NAP 2908 testosterone (topical use) 28/07/2006 3 years 31/12/2027 30/03/2028 No 24/09/2025 DLP was amended on 24/09/2025 PSUSA/00002908/202712 Maia Uusküla Estonia NAP 2909 human tetanus immunoglobulin 30/08/1999 5 years 29/08/2027 27/11/2027 No 06/10/2025 DLP was amended on 03/05/2023 PRAC representative was updated on 01/03/2023 DLP was updated on 07/05/2018 PRAC representative and Lead Member State were added on 30/01/2017 PSUSA/00002909/202708 Dirk Mentzer Germany NAP 2910 tetanus vaccines 01/01/1978 5 years 01/01/2028 31/03/2028 No 06/10/2025 DLP amended on 20/09/2023 PSUSA/00002910/202801 Dirk Mentzer Germany NAP 2911 tetrabenazine 23/10/1995 5 years 31/10/2028 29/01/2029 No 03/07/2024 PSUR frequency amended and DLP updated on 03/07/2024 PSUSA/00002911/202810 Eamon O'Murchu Ireland NAP 2912 tetracaine 01/06/1973 9 years 03/06/2028 01/09/2028 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00002912/202806 NAP 2914 tetracosactide 07/05/1965 9 years 03/03/2028 01/06/2028 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00002914/202803 NAP 2915 tetracycline 19/11/1953 10 years 01/01/2034 01/04/2034 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00002915/203401 NAP 2918 tetryzoline Not available* 10 years 03/11/2036 01/02/2037 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00002918/203611 NAP 2919 thalidomide 16/04/2008 3 years 09/10/2027 07/01/2028 Yes 25/06/2025 PSUR frequency amended and DLP updated on 25/06/2025 PSUSA/00002919/202710 Tiphaine Vaillant France CAP NAP 2920 thallium [201TL] 31/08/1980 10 years 31/08/2034 29/11/2034 Yes 30/04/2025 DLP was amended on 30/04/2025 PSUSA/00002920/203408 Jean-Michel Dogné Belgium NAP 2921 theophylline 14/06/1947 5 years 14/06/2027 12/09/2027 No 01/03/2023 DLP was updated on 01/03/2023 European Union reference date and DLP amended on 0405/2018 DLP was updated on 27/03/2018 Lead MS and PRAC Rapporteur name was added on 20/12/2016 PSUSA/00002921/202706 Maria Popova-Kiradjieva Bulgaria NAP 2922 thiamazole 30/06/1978 8 years 03/03/2033 01/06/2033 No 19/11/2025 DLP was amended on 19/11/2025 PSUSA/00002922/203303 Dennis Lex Germany NAP 2924 cyanocobalamin / pyridoxine / thiamine Not available* 10 years 03/06/2035 01/09/2035 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00002924/203506 NAP 2925 thiamphenicol 14/07/1960 5 years 31/05/2028 29/08/2028 No 31/01/2024 DLP was amended on 31/01/2024 PSUSA/00002925/202805 Amelia Cupelli Italy NAP 2928 thioctic acid Not available* 8 years 03/08/2027 01/11/2027 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00002928/202708 NAP 2929 thiopental 15/10/1945 15 years 31/03/2031 29/06/2031 No 20/12/2016 PRAC Rapporteur name updated on 23/10/2018 PSUR Frequency amended and DLP updated on 20/12/2016 Lead Member State and PRAC Representative added on 27/11/2015. PSUSA/00002929/203103 Eamon O'Murchu Ireland NAP 2931 thioridazine 01/02/1959 9 years 02/12/2027 01/03/2028 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00002931/202712 NAP 2932 thiotepa 09/03/1959 3 years 31/03/2027 29/06/2027 Yes 18/12/2024 DLP was amended on 18/12/2024 PSUSA/00002932/202703 Tiphaine Vaillant France CAP NAP 2936 thiamphenicol glycinate acetylcysteinate Not available* 10 years 03/11/2036 01/02/2037 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00002936/203611 Amelia Cupelli Italy NAP 2940 thyrotropin alfa 30/11/1998 5 years 30/11/2029 28/02/2030 No 30/07/2025 PSUR frequency amended and DLP updated on 30/07/2025 PSUSA/00002940/202911 Rhea Fitzgerald Ireland CAP 2942 tiagabine 14/06/1996 5 years 30/06/2029 28/09/2029 Yes 05/03/2025 PSUR frequency amended and DLP updated on 05/03/2025 PSUSA/00002942/202906 Tiphaine Vaillant France NAP 2943 tianeptine 06/02/1987 5 years 30/06/2029 28/09/2029 No 05/03/2025 PSUR frequency amended and DLP updated on 05/03/2025 PSUSA/00002943/202906 Tiphaine Vaillant France NAP 2944 tiapride 27/07/1988 3 years 27/07/2027 25/10/2027 No 02/04/2025 DLP was amended on 02/04/2025 PSUSA/00002944/202707 Tiphaine Vaillant France NAP 2945 tiaprofenic acid 26/08/1974 9 years 03/08/2028 01/11/2028 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00002945/202808 NAP 2946 tibezonium iodide 23/11/1976 10 years 03/03/2035 01/06/2035 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00002946/203503 NAP 2947 tibolone 01/12/1987 5 years 01/12/2029 01/03/2030 No 02/06/2026 PSUSA/00002947/202912 Jenny Jönsson Sweden NAP 2948 ticagrelor, acetylsalicylic acid / ticagrelor 03/12/2010 3 years 31/12/2026 31/03/2027 No 01/04/2026 Reference to NAP added on 01/04/2026 Active substance name was amended on 01/04/2026 DLP was amended on 25/09/2024 PSUSA/00002948/202612 Bianca Mulder Netherlands CAP NAP 2950 clavulanate / ticarcillin 12/09/1973 10 years 03/03/2035 01/06/2035 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00002950/203503 NAP 2951 tick-borne encephalitis vaccine (inactivated) 29/01/2001 3 years 31/01/2026 01/05/2026 No 06/10/2025 Next DLP was updated on 18/10/2023 PSUSA/00002951/202601 Dirk Mentzer Germany NAP 2952 ticlopidine 08/05/1978 8 years 08/05/2033 06/08/2033 No 04/02/2026 PSUR frequency amended and DLP updated on 04/02/2026 PSUSA/00002952/203305 Amelia Cupelli Italy NAP 2954 tigecycline 24/04/2006 5 years 14/06/2028 12/09/2028 No 28/02/2024 PSUR frequency amended and DLP updated on 28/02/2024 PSUSA/00002954/202806 Maria del Pilar Rayon Spain CAP 2955 tilactase Not available* 9 years 03/11/2032 01/02/2033 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00002955/203211 NAP 2957 tilidine 08/07/1970 9 years 03/05/2028 01/08/2028 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00002957/202805 NAP 2958 tilbroquinol / tiliquinol 15/11/1965 10 years 03/06/2034 01/09/2034 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00002958/203406 NAP 2961 bimatoprost / timolol 19/06/2006 5 years 19/11/2026 17/02/2027 No 27/07/2022 PSUR frequency and DLP were updated on 27/07/2022 DLP was updated on 31/07/2019 PRAC Rapporteur name was corrected on 03/04/2019 Reference to NAP added on 19/12/2018 PRAC Rapporteur name was amended on 06/06/2018 PRAC Representative amended on 17/10/2017 Next DLP was amended on 28/07/2016 PSUSA/00002961/202611 Karin Erneholm Denmark CAP NAP 2962 timolol / travoprost 24/04/2006 5 years 28/02/2028 28/05/2028 No 15/11/2023 PSUR frequency amended and DLP updated on 15/11/2023 PSUSA/00002962/202802 Maria del Pilar Rayon Spain CAP NAP 2967 tinzaparin 28/02/1991 7 years 02/12/2030 02/03/2031 No 31/07/2024 DLP was amended on 31/07/2024 PSUSA/00002967/203012 Jo Robays Belgium NAP 2969 tioguanine 18/01/1966 9 years 03/03/2028 01/06/2028 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00002969/202803 NAP 2972 tiotropium 09/10/2001 5 years 09/10/2026 07/01/2027 No 31/01/2024 PRAC representative updated on 31/01/2024 PSUSA/00002972/202610 Bianca Mulder Netherlands NAP 2973 tipranavir 25/10/2005 5 years 31/12/2027 30/03/2028 No 19/09/2024 PSUSA/00002973/202712 Zoubida Amimour France CAP 2974 tirofiban 14/05/2003 5 years 31/05/2027 29/08/2027 No 01/02/2023 PSUR frequency and DLP were updated on 01/02/2023 DLP was updated on 05/02/2020 Next DLP updated on 30/01/2017 PRAC Rapporteur and Lead Member State was added on 27/11/2015. PSUSA number was amended on 06/10/2014 PSUSA/00002974/202705 Dennis Lex Germany NAP 2975 tiropramide 30/03/1982 9 years 03/11/2028 01/02/2029 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00002975/202811 NAP 2977 tizanidine 15/12/1983 5 years 31/12/2029 31/03/2030 No 24/09/2025 DLP was amended on 24/09/2025 PSUSA/00002977/202912 Terhi Lehtinen Finland NAP 2980 tocilizumab 11/04/2005 3 years 10/04/2028 09/07/2028 No 06/10/2025 New CAP authorised on 27/04/2026 New CAP authorised on 14/02/2025 New CAP authorised on 20/06/2024 New CAP authorised on 15/09/2023 PRAC representative was updated on 01/03/2023 DLP was updated on 21/12/2022 PSUR frequency and DLP were updated on 20/11/2019 DLP was updated on 21/11/2018 DLP was amended on 15/11/2017 PSUR Frequency amended and DLP updated on 23/05/2017 Next DLP was updated on 18/11/2016 Next DLP was amended on 03/06/2016 Next DLp was updated on 27/11/2015. Next DLP was amended on 01/12/2014 Next DLP was amended on 28/05/2014 Next DLP was amended 30/11/2013 PSUSA/00002980/202804 Dirk Mentzer Germany CAP 2981 tocofersolan 24/07/2009 1 year 31/07/2026 09/10/2026 31/07/2027 09/10/2027 No 04/03/2026 DLP was amended on 04/03/2026 PSUSA/00002981/202607 PSUSA/00002981/202707 Melinda Palfi Hungary CAP 2982 tofisopam Not available* 7 years 31/01/2032 30/04/2032 No 22/10/2025 DLP was amended on 22/10/2025 PSUSA/00002982/203201 Melinda Palfi Hungary NAP 2984 tolbutamide Not available* 10 years 03/11/2036 01/02/2037 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00002984/203611 NAP 2985 tolcapone 27/08/1997 3 years 01/03/2027 30/05/2027 No 17/11/2021 DLP was updated on 17/11/2021 PRAC Rapporteur name updated on 19/12/2018 DLP and PRAC Rapporteur name updated on 23/10/2018 The Next DLP was amended on 29/10/2015 PSUSA/00002985/202703 Eamon O Murchu Ireland CAP 2986 tolfenamic acid Not available* 8 years 03/08/2027 01/11/2027 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00002986/202708 NAP 2988 tolnaftate 16/10/1977 9 years 03/11/2028 01/02/2029 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00002988/202811 NAP 2989 nystatine / tolnaftate Not available* 9 years 03/03/2032 01/06/2032 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00002989/203203 NAP 2990 tolnaftate / triclosan Not available* 9 years 03/11/2032 01/02/2033 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00002990/203211 NAP 2991 tolperisone Not available* 3 years 01/06/2027 30/08/2027 Yes 05/02/2025 PSUR frequency amended and DLP updated on 05/02/2025 PSUSA/00002991/202706 Melinda Palfi Hungary NAP 2993 tolterodine 05/09/1997 5 years 05/09/2026 04/12/2026 No 02/06/2026 PSUSA/00002993/202609 Jenny Jönsson Sweden NAP 2994 tolvaptan (indicated for adults with hyponatraemia secondary to syndrome of inappropriate antidiuretic hormone secretion (SIADH)) 03/08/2009 3 years 18/05/2027 16/08/2027 No 05/02/2025 DLP was amended on 05/02/2025 PSUSA/00002994/202705 Amelia Cupelli Italy CAP 2996 topiramate 18/07/1995 5 years 18/01/2027 18/04/2027 No 21/09/2022 DLP was updated on 21/09/2022 PRAC Rapporteur name was amended on 31/07/2018 Next DLP was amended on 25/09/2017 Information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" was amended on 25/09/2017 Lead MS and PRAC Rapporteur name was added on 28/07/2016 PSUSA/00002996/202701 Karin Bolin Sweden NAP 2997 topotecan 12/11/1996 5 years 28/05/2030 26/08/2030 No 02/06/2026 PSUSA/00002997/203005 Jenny Jönsson Sweden CAP NAP 2998 torasemide 14/04/1987 8 years 03/06/2033 01/09/2033 No 04/02/2026 DLP was amended on 04/02/2026 PSUSA/00002998/203306 Dennis Lex Germany NAP 2999 toremifene 14/02/1996 5 years 30/09/2028 29/12/2028 No 05/06/2024 PSUR frequency amended and DLP updated on 05/06/2024 PSUSA/00002999/202809 Tiphaine Vaillant France CAP 3000 tosylchloramide Not available* 8 years 03/11/2026 01/02/2027 Yes 28/05/2025 DLP was amended on 28/05/2025 Information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" was amended on 28/05/2025 PSUR frequency and DLP amended on 28/08/2024 PSUSA/00003000/202611 Amelia Cupelli Italy NAP 3001 trabectedin 17/09/2007 3 years 17/09/2028 16/12/2028 No 27/05/2026 DLP was amended on 27/05/2026 PSUSA/00003001/202809 Marie Louise Schougaard Christiansen Denmark CAP NAP 3002 tramadol 18/04/1973 3 years 22/06/2026 20/09/2026 No 28/02/2024 DLP was amended on 28/02/2024 PSUSA/00003002/202606 Tiphaine Vaillant France NAP 3003 tramazoline 01/02/1964 11 years 02/12/2039 01/03/2040 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00003003/203912 NAP 3004 trandolapril, verapamil / trandolapril 19/02/1992 8 years 18/02/2027 19/05/2027 No 10/07/2026 Active substance name was amended on 19/11/2025 DLP was amended on 19/11/2025 PRAC representative updated on 31/01/2024 PSUSA/00003004/202702 Bianca Mulder Netherlands NAP 3006 tranexamic acid 21/01/1966 8 years 03/03/2033 01/06/2033 No 19/11/2025 DLP was amended on 19/11/2025 PSUSA/00003006/203303 Rhea Fitzgerald Ireland NAP 3007 transfer factor porcine Not available* 9 years 03/11/2032 01/02/2033 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00003007/203211 NAP 3008 tranylcypromine Not available* 8 years 03/11/2027 01/02/2028 No 05/01/2025 Correction of DLP on 20/11/2024 PSUR frequency and DLP amended on 28/08/2024 PSUSA/00003008/202711 Dennis Lex Germany NAP 3010 trastuzumab 25/09/1998 3 years 24/09/2027 23/12/2027 No 06/10/2025 New CAP authorised on 30/06/2025 New CAP authorised on 19/09/2024 New CAP authorised on 15/11/2023 PRAC representative was updated on 01/03/2023 DLP was updated on 29/06/2022 PSUR frequency and DLP were updated on 05/06/2019 New CAP authorised on 12/12/2018 PSUR Frequency amended and DLP updated on 26/04/2017 Next DLP was amended on 03/05/2016 The Next DLP was amended on 29/10/2015 Next DLP was amended on 16/07/2015, and the 1-yearly cycle PSUR should be submitted after the current Next DLP (24/09/2015). Next DLP was amended on 04/11/2014 Next DLP was amended on 02/05/2014 PSUSA/00003010/202709 Dirk Mentzer Germany CAP 3011 travoprost 27/11/2001 5 years 28/02/2027 29/05/2027 No 16/11/2022 PSUR frequency and DLP were updated on 16/11/2022 DLP was updated on 20/11/2019 PSUR Frequency amended and DLP updated on 19/10/2016 PRAC Representative amended on 28/06/2016 The Next DLP was amended on 29/10/2015 PSUSA/00003011/202702 Maria del Pilar Rayon Spain CAP NAP 3012 trazodone 15/10/1971 6 years 03/08/2029 01/11/2029 No 30/04/2024 DLP was amended on 30/04/2024 PSUSA/00003012/202908 Rugile Pilviniene Lithuania NAP 3013 treprostinil 21/05/2002 3 years 21/05/2028 19/08/2028 No 04/02/2026 PSUR frequency amended and DLP updated on 04/02/2026 PSUSA/00003013/202805 Zane Neikena Latvia CAP NAP 3015 tretinoin (oral formulations) 31/03/1994 5 years 30/03/2027 28/06/2027 No 11/06/2025 DLP was updated on 21/12/2022 PRAC representative was updated on 19/10/2022 PRAC representative was updated on 17/11/2021 PRAC representative was updated on 28/07/2021 Lead MS and PRAC Rapporteur name amended on 19/12/2018 DLP was updated on 19/12/2017 Lead MS and PRAC Rapporteur name was added on 19/10/2016 PSUSA/00003015/202703 Zoubida Amimour France NAP 3016 tretinoin (topical formulations) 25/01/1973 5 years 31/08/2027 29/11/2027 Yes 03/05/2023 DLP was amended on 03/05/2023 Lead MS and PRAC Rapporteur name amended on 19/12/2018 DLP was updated on 06/06/2018 Lead MS and PRAC Rapporteur name was added on 28/02/2017 PSUSA/00003016/202708 Adam Przybylkowski Poland NAP 3017 triamcinolone (topical and nasal formulations) 14/12/1953 5 years 13/07/2027 11/10/2027 No 31/01/2024 PRAC representative updated on 31/01/2024 PSUSA/00003017/202707 Carla Torre Portugal NAP 3019 carbethopendecinium bromide / salicylic acid / triamcinolone Not available* 9 years 03/07/2029 01/10/2029 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00003019/202907 NAP 3020 chloroxine / triamcinolone Not available* 9 years 03/11/2029 01/02/2030 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00003020/202911 NAP 3021 salicylic acid / triamcinolone acetonide Not available* 8 years 01/12/2026 01/03/2027 No 08/04/2026 DLP amended on 23/10/2024 PSUSA/00003021/202612 Polona Golmajer Slovenia NAP 3022 triamterene 19/06/1963 10 years 03/05/2034 01/08/2034 No 03/10/2024 Updated & published on 23/10/2024 PSUSA/00003022/203405 NAP 3023 triazolam 08/03/1997 5 years 31/07/2027 29/10/2027 No 05/04/2023 DLP was updated on 05/04/2023 DLP was updated on 07/05/2018 PRAC representative and Lead Member State were added on 30/01/2017 PSUSA/00003023/202707 Kimmo Jaakkola Finland NAP 3024 tribenoside 06/04/1967 10 years 03/07/2034 01/10/2034 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00003024/203407 NAP 3025 lidocaine / tribenoside 01/06/1971 10 years 02/09/2034 01/12/2034 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00003025/203409 NAP 3027 triclocarban Not available* 9 years 03/11/2032 01/02/2033 No 11/06/2025 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00003027/203211 Zoubida Amimour France NAP 3028 triclosan 01/01/1985 9 years 01/12/2028 01/03/2029 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00003028/202812 NAP 3029 benzalkonium / chloride solution / light liquid paraffin / triclosan Not available* 9 years 03/06/2029 01/09/2029 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00003029/202906 NAP 3033 trifluperidol 31/01/1964 11 years 03/07/2039 01/10/2039 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00003033/203907 NAP 3035 triflusal 19/01/1981 9 years 03/11/2028 01/02/2029 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00003035/202811 NAP 3036 trihexyphenidyl 05/06/1956 11 years 03/10/2037 01/01/2038 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00003036/203710 NAP 3038 trimebutine 15/03/1988 9 years 01/01/2029 01/04/2029 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00003038/202901 NAP 3039 ruscogenin / trimebutine 10/12/1973 10 years 03/03/2035 01/06/2035 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00003039/203503 NAP 3040 trimecaine Not available* 9 years 03/11/2032 01/02/2033 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00003040/203211 NAP 3041 carbaethopendecinium bromide / trimecaine hydrochloride Not available* 8 years 01/12/2033 01/03/2034 No 29/07/2026 DLP was amended on 29/07/2026 PSUSA/00003041/203312 Eva Jirsová Czech Republic NAP 3043 trimetazidine 06/08/2001 3 years 06/08/2026 04/11/2026 No 30/04/2024 DLP was amended on 30/04/2024 PSUSA/00003043/202608 Amelia Cupelli Italy NAP 3045 trimethoprim Not available* 7 years 31/01/2032 30/04/2032 No 22/10/2025 DLP was amended on 22/10/2025 PSUSA/00003045/203201 Maia Uusküla Estonia NAP 3046 trimipramine 05/10/1960 11 years 03/06/2039 01/09/2039 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00003046/203906 NAP 3047 pseudoephedrine / triprolidine Not available* 3 years 31/12/2026 31/03/2027 No 25/09/2024 DLP was amended on 25/09/2024 PSUSA/00003047/202612 Dennis Lex Germany NAP 3048 triptorelin 05/03/1986 5 years 31/03/2027 29/06/2027 No 21/12/2022 DLP was updated on 21/12/2022 DLP was updated on 19/12/2017 Lead MS and PRAC Rapporteur name was added on 19/10/2016 PSUSA/00003048/202703 Dennis Lex Germany NAP 3049 trolamine Not available* 9 years 03/11/2032 01/02/2033 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00003049/203211 NAP 3050 tromantadine Not available* 9 years 03/11/2032 01/02/2033 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00003050/203211 NAP 3051 disodium phosphate anhydrous / sodium hydrogen carbonate / trometamol Not available* 9 years 03/11/2030 01/02/2031 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00003051/203011 NAP 3053 tropicamide 01/03/1951 10 years 01/12/2032 01/03/2033 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00003053/203212 NAP 3055 trospium 17/10/1984 9 years 01/12/2028 01/03/2029 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00003055/202812 none NAP 3056 troxerutin, troxerutin / heptaminol / ginkgo leaf 09/10/1970 8 years 03/11/2027 01/02/2028 No 05/01/2025 DLP correction on 20/11/2024 Active substance name, PSUR frequency and DLP were amended on 20/12/2023 PSUSA/00003056/202711 Dennis Lex Germany NAP 3059 amylase / cortex granati / gentiana lutea / lipase / quercus cortex / radix ratanhiae / rhizoma tormentillae / salicylic acid / tannic acid / trypsin Not available* 9 years 03/03/2029 01/06/2029 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00003059/202903 NAP 3062 tryptophan Not available* 8 years 03/11/2027 01/02/2028 Yes 28/05/2025 DLP was amended on 28/05/2025 Information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" was amended on 28/05/2025 PSUR frequency and DLP amended on 28/08/2024 PSUSA/00003062/202711 Dennis Lex Germany NAP 3063 tuberculin purified protein derivative 16/11/1979 7 years 01/09/2028 30/11/2028 No 16/10/2023 PRAC Rapporteur name was amended on 18/10/2023 PSUSA/00003063/202809 Karin Erneholm Denmark NAP 3065 typhoid polysaccharide vaccine 05/08/1998 3 years 05/08/2026 03/11/2026 No 06/10/2025 DLP was amended on 30/04/2024 PSUSA/00003065/202608 Dirk Mentzer Germany NAP 3067 typhoid vaccine (live, attenuated) 12/12/1984 3 years 31/12/2027 30/03/2028 Yes 06/10/2025 DLP was amended on 24/09/2025 PSUSA/00003067/202712 Dirk Mentzer Germany NAP 3068 tyrothricin 20/10/1950 11 years 03/11/2036 01/02/2037 Yes 29/07/2026 Information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" was amended on 29/07/2026 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00003068/203611 none NAP 3070 benzalkonium / benzocaine / tyrothricin Not available* 8 years 01/12/2033 01/03/2034 No 29/07/2026 DLP was amended on 29/07/2026 PSUSA/00003070/203312 Dennis Lex Germany NAP 3071 benzocaine / dequalinium chloride / dexamethasone / tyrothricin Not available* 9 years 03/06/2029 01/09/2029 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00003071/202906 NAP 3072 chlorhexidine digluconate / lidocaine hydrochloride / tyrothricin Not available* 13 years 01/01/2028 31/03/2028 Yes 21/07/2017 PSUR Frequency, DLP and information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" was amended updated on 21/07/2017 PSUSA/00003072/202801 NAP 3073 ubidecarenone Not available* 8 years 03/11/2026 01/02/2027 Yes 28/05/2025 DLP was amended on 28/05/2025 Information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" was amended on 28/05/2025 PSUR frequency and DLP amended on 28/08/2024 PSUSA/00003073/202611 Amelia Cupelli Italy NAP 3074 ulipristal (female emergency contraceptive) 15/05/2009 3 years 14/05/2027 12/08/2027 Yes 05/02/2025 DLP was amended on 05/02/2025 PSUSA/00003074/202705 Bianca Mulder Netherlands CAP NAP 3075 ulobetasol Not available* 9 years 03/11/2032 01/02/2033 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00003075/203211 NAP 3076 undecylenic acid Not available* 8 years 03/11/2032 01/02/2033 Yes 30/07/2025 DLP was amended on 30/07/2025 PSUSA/00003076/203211 Polona Golmajer Slovenia NAP 3078 urapidil 31/07/1980 5 years 01/07/2026 29/09/2026 No 02/03/2022 DLP and PSUR frequency were updated on 02/03/2022 Next DLP was updated on 06/03/2019 Correction of Lead MS and PRAC Rapporteur on 28/02/2017 PRAC Representative amended on 18/11/2016 Lead MS and PRAC Rapporteur name were amended on 28/07/2016 Next DLP was updated on 04/03/2016 Lead MS added on 01/04/2015. PSUSA/00003078/202607 Eva Jirsová Czech Republic NAP 3080 uridine Not available* 9 years 03/11/2032 01/02/2033 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00003080/203211 NAP 3082 urofollitropin 24/03/2004 5 years 23/03/2027 21/06/2027 No 19/12/2018 Lead MS and PRAC Rapporteur name amended on 19/12/2018 DLP was updated on 19/12/2017 Lead MS and PRAC Rapporteur name was added on 19/10/2016 PSUSA/00003082/202703 Eamon O'Murchu Ireland NAP 3083 urokinase 24/05/1972 8 years 03/03/2033 01/06/2033 No 19/11/2025 DLP was amended on 19/11/2025 PSUSA/00003083/203303 Dennis Lex Germany NAP 3085 ustekinumab 16/01/2009 2 years 31/12/2025 31/03/2026 No 31/07/2024 New CAP authorised on 18/11/2025 New CAP authorised on 17/09/2025 New CAP authorised on 02/06/2025 New CAP authorised on 14/02/2025 New CAP authorised on 12/12/2024 New CAP authorised on 25/09/2024 New CAP authorised on 12/09/2024 New CAP authorised on 22/08/2024 PSUR frequency amended and DLP updated on 31/07/2024 PSUSA/00003085/202512 Rhea Fitzgerald Ireland CAP 3086 valaciclovir 20/12/1994 5 years 19/12/2029 19/03/2030 No 24/09/2025 PSUR frequency amended and DLP updated on 24/09/2025 PSUSA/00003086/202912 Veronika Macurová Czech Republic NAP 3089 valganciclovir 29/03/2001 5 years 28/03/2026 26/06/2026 No 22/12/2021 DLP was updated on 22/12/2021 PRAC representative was updated on 04/03/2020 PRAC Representative updated on 26/09/2018 Next DLP was amended on 20/12/2016 Lead Member State added on 27/11/2015. PSUSA/00003089/202603 Liana Martirosyan Netherlands NAP 3090 valproic acid, sodium valproate, valproate pivoxil, valproate semisodium, valpriomide, valproate bismuth, calcium valproate, valproate magnesium 23/01/1967 3 years 23/01/2027 23/04/2027 No 25/09/2024 DLP was amended on 25/09/2024 PSUSA/00003090/202701 Liana Martirosyan Netherlands NAP 3097 vancomycin 01/01/1955 5 years 31/01/2030 01/05/2030 No 22/10/2025 DLP was amended on 22/10/2025 PSUSA/00003097/203001 Marie Louise Schougaard Christiansen Denmark NAP 3098 vardenafil 04/03/2003 5 years 04/03/2029 02/06/2029 No 20/11/2024 DLP was amended on 20/11/2024 PSUSA/00003098/202903 Maria del Pilar Rayon Spain CAP 3099 varenicline 26/09/2006 3 years 09/05/2026 07/08/2026 No 31/01/2024 DLP was amended on 31/01/2024 PSUSA/00003099/202605 Karin Erneholm Denmark CAP 3102 vecuronium bromide 01/11/1990 8 years 30/11/2033 28/02/2034 Yes 29/07/2026 PSUR frequency amended and DLP updated on 29/07/2026 PSUSA/00003102/203311 Eva Jirsová Czech Republic NAP 3103 velaglucerase alfa 26/02/2010 2 years 25/02/2026 26/05/2026 No 16/11/2022 DLP was updated on 16/11/2022 DLP was updated on 21/10/2020 DLP was updated on 23/10/2018 PRAC Rapporteur name was amended on 31/07/2018 PSUR Frequency amended and DLP updated on 22/09/2016 Next DLP was updated on 06/10/2015 EURD was amended on 21/12/2012 PSUSA/00003103/202602 Dennis Lex Germany CAP 3104 venlafaxine, desvenlafaxine 23/09/1993 5 years 05/05/2028 03/08/2028 No 28/02/2024 Active substance name was amended on 28/02/2024 PSUR frequency amended and DLP updated on 20/12/2023 PSUSA/00003104/202805 Karin Bolin Sweden NAP 3105 verapamil 25/01/1963 7 years 25/01/2027 25/04/2027 No 21/10/2020 DLP was updated on 21/10/2020 PRAC representative was added on 06/05/2020 LMS was added on 31/07/2019 PSUSA/00003105/202701 Terhi Lehtinen Finland NAP 3107 hydrochlorothiazide / verapamil hydrochloride, hydrochlorothiazide / triamterene / verapamil hydrochloride Not available* 9 years 03/06/2031 01/09/2031 No 19/10/2023 Active substance name, PSUR frequency and DLP were amended on 19/10/2023 PSUSA/00003107/203106 none NAP 3109 vernakalant hydrochloride 01/09/2010 5 years 31/08/2028 29/11/2028 No 29/04/2026 PSUR frequency amended and DLP updated on 29/04/2026 PSUSA/00003109/202808 Bianca Mulder Netherlands CAP 3110 verteporfin 27/07/2000 3 years 31/12/2027 30/03/2028 No 24/09/2025 DLP was amended on 24/09/2025 PSUSA/00003110/202712 Zoubida Amimour France CAP 3112 vigabatrin 22/09/1989 3 years 22/09/2026 21/12/2026 No 05/06/2024 DLP was amended on 05/06/2024 PSUSA/00003112/202609 Terhi Lehtinen Finland CAP NAP 3113 vildagliptin, metformin / vildagliptin 26/09/2007 3 years 28/02/2027 29/05/2027 No 02/06/2026 PSUSA/00003113/202702 Karin Bolin Sweden CAP NAP 3117 vinblastine Not available* 9 years 03/11/2032 01/02/2033 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00003117/203211 NAP 3118 vinburnine Not available* 9 years 03/11/2032 01/02/2033 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00003118/203211 NAP 3119 vincamine 26/06/1982 9 years 01/12/2028 01/03/2029 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00003119/202812 NAP 3120 piracetam / vincamine Not available* 9 years 03/05/2032 01/08/2032 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00003120/203205 NAP 3121 vincristine 12/04/1995 6 years 03/08/2029 01/11/2029 No 30/04/2024 DLP was amended on 30/04/2024 PSUSA/00003121/202908 Dennis Lex Germany NAP 3122 vindesine 11/04/1979 9 years 03/11/2028 01/02/2029 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00003122/202811 NAP 3123 vinflunine 21/09/2009 5 years 21/09/2026 20/12/2026 No 25/05/2022 PSUR frequency and DLP were updated on 25/05/2022 PSUR frequency and DLP were updated on 05/06/2019 Lead MS and PRAC Rapporteur name amended on 21/11/2018 PSUR Frequency amended and DLP updated on 26/04/2017 PRAC Representative amended on 28/03/2017 Next DLP was amended on 03/05/2016 PSUSA/00003123/202609 Maria del Pilar Rayon Spain CAP 3124 vinorelbine 11/04/1989 5 years 01/04/2027 30/06/2027 No 21/12/2022 DLP was updated on 21/12/2022 DLP was updated on 19/12/2017 Lead MS and PRAC Rapporteur name was added on 19/10/2016 Information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" was amended on 30/11/2012 PSUSA/00003124/202704 Eva Jirsová Czech Republic NAP 3125 vinpocetine Not available* 9 years 03/11/2032 01/02/2033 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00003125/203211 NAP 3127 voriconazole 19/03/2002 3 years 28/02/2027 29/05/2027 No 17/11/2021 DLP corrected on 02/02/2022 DLP was updated on 17/11/2021 PSUR frequency, DLP and PRAC Rapporteur amended on 23/10/2018 DLP was updated on 17/10/2017 PRAC Rapporteur name was amended on 25/09/2017 Next DLP was amended on 19/10/2016 NAP products added on 22/09/2016 NAP products removed on 03/06/2016 The Next DLP was amended on 29/10/2015 Information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" was amended on 04/11/2014 PSUSA/00003127/202702 Liana Martirosyan Netherlands CAP NAP 3129 warfarin 31/05/1962 8 years 31/01/2033 01/05/2033 No 22/10/2025 DLP was amended on 22/10/2025 PSUSA/00003129/203301 Marie Louise Schougaard Christiansen Denmark NAP 3133 xipamide, triamterene / xipamide 30/07/1969 7 years 31/01/2032 30/04/2032 No 22/10/2025 DLP was amended on 22/10/2025 PSUSA/00003133/203201 Dennis Lex Germany NAP 3134 xylometazoline 29/08/1959 5 years 31/05/2028 29/08/2028 No 31/01/2024 PSUR frequency amended and DLP updated on 31/01/2024 PSUSA/00003134/202805 Zane Neikena Latvia NAP 3135 yellow fever vaccine (live) 27/01/1986 3 years 02/12/2028 02/03/2029 No 29/07/2026 DLP was amended on 29/07/2026 PSUSA/00003135/202812 Dirk Mentzer Germany NAP 3136 yohimbine 01/06/1944 5 years 31/05/2029 29/08/2029 Yes 05/02/2025 DLP was amended on 05/02/2025 PSUSA/00003136/202905 Jan Neuhauser Austria NAP 3137 yttrium (90y) chloride 24/03/2003 7 years 23/03/2032 21/06/2032 No 19/11/2025 PSUR frequency amended and DLP updated on 19/11/2025 PSUSA/00003137/203203 Karin Erneholm Denmark CAP 3141 zanamivir (except for centrally authorised products) 09/02/1999 5 years 31/01/2027 01/05/2027 No 02/06/2026 PSUSA/00003141/202701 Jenny Jönsson Sweden NAP 3142 ziconotide 21/02/2005 5 years 28/12/2029 28/03/2030 No 24/09/2025 PSUR frequency amended and DLP updated on 24/09/2025 PSUSA/00003142/202912 Jo Robays Belgium CAP 3143 zidovudine 03/03/1987 5 years 30/09/2029 29/12/2029 No 13/08/2025 DLP was updated on 29/06/2022 PSUR frequency and DLP updated on 05/06/2019 Lead MS and PRAC Rapporteur name amended on 21/11/2018 PSUR Frequency amended and DLP updated on 19/12/2017 Lead MS and PRAC Rapporteur name was added on 19/10/2016 PSUSA/00003143/202909 Veronika Macurová Czech Republic NAP 3144 abacavir / lamivudine / zidovudine 28/12/2000 3 years 31/12/2025 31/03/2026 Yes 19/09/2024 PSUSA/00003144/202512 Zoubida Amimour France CAP NAP 3145 zinc acetate dihydrate 13/10/2004 5 years 30/10/2026 28/01/2027 No 29/06/2022 DLP was updated on 29/06/2022 PRAC Rapporteur name updated on 19/12/2018 PRAC Rapporteur name was amended on 23/10/2018 Next DLP was amended on 27/06/2017 PSUSA/00003145/202610 Eamon O Murchu Ireland CAP 3146 ziprasidone 05/02/1998 5 years 31/07/2030 29/10/2030 No 01/04/2026 DLP was amended on 01/04/2026 PSUSA/00003146/203007 Karin Bolin Sweden NAP 3147 zofenopril 30/07/1998 7 years 02/01/2031 02/04/2031 No 25/09/2024 DLP was amended on 25/09/2024 PSUSA/00003147/203101 Amelia Cupelli Italy NAP 3148 hydrochlorothiazide / zofenopril 03/03/2004 7 years 03/05/2031 01/08/2031 No 05/02/2025 DLP was amended on 05/02/2025 PSUSA/00003148/203105 Amelia Cupelli Italy NAP 3149 zoledronic acid (indicated for cancer and fractures) 20/03/2001 3 years 31/08/2026 29/11/2026 No 30/04/2024 DLP was amended on 30/04/2024 PSUSA/00003149/202608 Karin Erneholm Denmark CAP NAP 3150 zolmitriptan 07/03/1997 5 years 06/03/2027 04/06/2027 No 16/11/2022 DLP was updated on 16/11/2022 PRAC Rapporteur name was amended on 31/07/2018 DLP was amended on 15/11/2017 Lead MS was added on 22/09/2016 PSUSA/00003150/202703 Karin Bolin Sweden NAP 3151 zolpidem 09/06/1987 3 years 03/08/2026 01/11/2026 No 30/04/2024 PSUR frequency amended and DLP updated on 30/04/2024 PSUSA/00003151/202608 Amelia Cupelli Italy NAP 3152 zonisamide 10/03/2005 3 years 31/03/2028 29/06/2028 No 21/12/2022 PSUR frequency and DLP were updated on 21/12/2022 DLP was corrected on 03/03/2021 PSUR frequency and DLP were updated on 18/11/2020 DLP was updated on 20/11/2019 DLP was updated on 21/11/2018 PRAC Rapporteur name was amended on 23/10/2018 Reference to NAP added on 31/07/2018 DLP was amended on 15/11/2017 DLP was updated on 18/11/2016 DLP was amended on 29/10/2015 Requirement to submit generics changed on 31/01/2014 PSUSA/00003152/202803 Rhea Fitzgerald Ireland CAP NAP 3153 zopiclone, eszopiclone 10/12/1984 9 years 01/12/2028 01/03/2029 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00003153/202812 NAP 3154 zotepine 07/12/1981 8 years 03/05/2033 01/08/2033 No 04/02/2026 DLP was amended on 04/02/2026 PSUSA/00003154/203305 Veronika Macurová Czech Republic NAP 3155 zuclopenthixol 31/05/1976 5 years 31/05/2028 29/08/2028 No 31/01/2024 PSUR frequency amended and DLP updated on 31/01/2024 PSUSA/00003155/202805 Jean-Michel Dogné Belgium NAP 3157 ascorbic acid 25/02/1960 11 years 03/06/2039 01/09/2039 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00003157/203906 Roxana Dondera Romania NAP 3158 N(2)-L-alanyl-L-glutamine 29/03/1995 5 years 29/03/2026 27/06/2026 No 27/01/2026 PRAC representative was updated on 31/05/2023 DLP was updated on 22/12/2021 PRAC representative was updated on 31/03/2021 Next DLP was amended on 20/12/2016 Lead Member State added on 27/11/2015. PSUSA/00003158/202603 Roxana Stefania Udrescu Romania NAP 3159 antithrombin III 01/01/1983 5 years 31/12/2025 31/03/2026 No 22/09/2021 PRAC representative was updated on 17/11/2021 PSUR frequency, DLP and active substance name were updated on 22/09/2021 PRAC representative was updated on 30/06/2021 PSUR frequency amended and DLP updated on 31/07/2018 Next DLP was amended on 25/09/2017 PSUR Frequency amended and DLP updated on 09/09/2016 PRAC Representative amended on 27/11/2015. Lead MS was added on 13/07/2015 PSUSA/00003159/202512 Amelia Cupelli Italy NAP 3160 arginine aspartate 07/10/1964 10 years 03/06/2034 01/09/2034 No 11/06/2025 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00003160/203406 Zoubida Amimour France NAP 3161 asparaginase, crisantaspase (L-asparaginase from Erwinia chrysanthemi) 03/04/1988 3 years 31/08/2027 29/11/2027 No 30/04/2025 DLP was amended on 30/04/2025 PSUSA/00003161/202708 Jan Neuhauser Austria CAP 3162 bendamustine hydrochloride 07/07/2010 5 years 06/01/2030 06/04/2030 No 24/09/2025 PSUR frequency amended and DLP updated on 24/09/2025 PSUSA/00003162/203001 Dennis Lex Germany NAP 3163 bilastine 08/09/2010 5 years 07/03/2029 05/06/2029 No 20/11/2024 PSUR frequency amended and DLP updated on 20/11/2024 PSUSA/00003163/202903 Roxana Dondera Romania NAP 3164 chlorquinaldol Not available* 8 years 01/12/2028 01/03/2029 Yes 27/05/2026 DLP was amended on 27/05/2026 Information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" was amended on 27/05/2026 PSUR frequency amended and DLP updated on 31/07/2024 PSUSA/00003164/202812 Roxana Stefania Udrescu Romania NAP 3165 ciclopirox and ciclopirox olamine 02/04/1975 10 years 03/03/2035 01/06/2035 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00003165/203503 Melinda Palfi Hungary NAP 3166 cycloserine Not available* 8 years 03/03/2034 01/06/2034 No 27/01/2026 PSUR frequency and DLP amended on 31/07/2024. PSUSA/00003166/203403 Roxana Stefania Udrescu Romania NAP 3167 dienogest 02/12/2009 5 years 02/12/2030 02/03/2031 No 29/07/2026 PSUR frequency amended and DLP updated on 29/07/2026 PSUSA/00003167/203012 Bianca Mulder Netherlands NAP 3168 dorzolamide 11/11/1994 5 years 18/02/2030 19/05/2030 No 22/10/2025 PSUR frequency amended and DLP updated on 22/10/2025 PSUSA/00003168/203002 Zoubida Amimour France NAP 3170 hexoprenaline sulfate 13/08/1970 5 years 13/08/2030 11/11/2030 No 29/04/2026 DLP was amended on 29/04/2026 PSUSA/00003170/203008 Roxana Dondera Romania NAP 3171 hypromellose 30/11/1955 10 years 31/01/2034 01/05/2034 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00003171/203401 NAP 3175 lanthanum Not available* 3 years 18/03/2027 16/06/2027 No 02/06/2026 PSUSA/00003175/202703 Karin Bolin Sweden NAP 3177 methandienone Not available* 8 years 03/11/2026 01/02/2027 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00003177/202611 NAP 3178 midodrine 06/02/1974 10 years 06/06/2026 04/09/2026 No 27/01/2026 PRAC representative was updated on 31/05/2023 PRAC representative was updated on 31/03/2021 PSUR Frequency amended and DLP updated on 28/02/2017 Lead MS and PRAC Rapporteur name updated on 04/02/2016 PSUSA number was amended on 06/10/2014 PSUSA/00003178/202606 Roxana Stefania Udrescu Romania NAP 3179 natamycin Not available* 8 years 03/11/2032 01/02/2033 No 30/07/2025 DLP was amended on 30/07/2025 PSUSA/00003179/203211 Adam Przybylkowski Poland NAP 3180 sodium chloride 24/11/1972 10 years 31/01/2035 01/05/2035 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00003180/203501 NAP 3181 riboflavin Not available* 10 years 03/11/2036 01/02/2037 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00003181/203611 NAP 3183 silibinin, dry extract from Milk Thistle fruit (silymarin)) Not available* 9 years 03/06/2032 01/09/2032 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00003183/203206 Roxana Dondera Romania NAP 3184 sorbitol Not available* 8 years 01/12/2026 01/03/2027 No 08/04/2026 DLP amended on 23/10/2024 PSUSA/00003184/202612 Roxana Dondera Romania NAP 3185 tenonitrozole 11/02/1997 13 years 11/02/2028 11/05/2028 No 27/01/2026 PRAC representative was updated on 31/05/2023 PRAC representative was updated on 31/03/2021 PRAC Rapporteur amended on 06/02/2019 PRAC Representative updated on 26/09/2018 PRAC Rapporteur amended on 28/02/2018 The PSUR Frequency and Next DLP was amended on 29/10/2015 Lead MS was added on 04/02/2015 PSUSA/00003185/202802 Roxana Stefania Udrescu Romania NAP 3186 a-tocopheril, a-tocopherol, vitamin E Not available* 8 years 03/11/2033 01/02/2034 No 01/07/2026 DLP was amended on 01/07/2026 PSUSA/00003186/203311 Roxana Stefania Udrescu Romania NAP 9004 aciclovir / hydrocortisone 31/07/2009 5 years 30/07/2028 28/10/2028 No 27/03/2024 PSUR frequency amended and DLP updated on 27/03/2024 PSUSA/00009004/202807 Jan Neuhauser Austria NAP 9005 aclidinium bromide 20/07/2012 1 year 20/07/2026 28/09/2026 20/07/2027 28/09/2027 No 04/03/2026 DLP was amended on 04/03/2026 PSUSA/00009005/202607 PSUSA/00009005/202707 Adam Przybylkowski Poland CAP 9050 aluminium chloride hexahydrate Not available* 10 years 03/11/2035 01/02/2036 No 01/07/2026 PSUR frequency amended and DLP updated on 01/07/2026 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00009050/203511 Dennis Lex Germany NAP 9052 amlodipine / bisoprolol, amlodipine / nebivolol Not available* 9 years 03/03/2027 01/06/2027 No 22/10/2025 DLP was amended on 22/10/2025 Active substance name was amended on 22/10/2025 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00009052/202703 none NAP 9054 amoxicillin / lansoprazole / metronidazole Not available* 9 years 03/03/2029 01/06/2029 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00009054/202903 NAP 9057 argatroban 31/01/1990 2 years 31/01/2026 01/05/2026 No 02/06/2026 PSUSA/00009057/202601 Karin Bolin Sweden NAP 9062 ascorbic acid / biotin / calcium pantotenate Not available* 9 years 03/05/2029 01/08/2029 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00009062/202905 NAP 9068 atropine sulfate / phenylephrine acetate / prednisolone acetate 13/12/1960 11 years 03/06/2039 01/09/2039 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00009068/203906 NAP 9071 bacampicillin Not available* 9 years 03/05/2029 01/08/2029 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00009071/202905 NAP 9074 balsalazide 18/12/1997 7 years 02/01/2031 02/04/2031 No 25/09/2024 DLP was amended on 25/09/2024 PSUSA/00009074/203101 Amelia Cupelli Italy NAP 9075 belimumab 13/07/2011 3 years 08/03/2027 06/06/2027 No 20/11/2024 DLP was amended on 20/11/2024 PSUSA/00009075/202703 Karin Bolin Sweden CAP 9080 bisulepin Not available* 7 years 03/08/2031 01/11/2031 Yes 23/10/2024 Information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" was amended on 23/10/2024 PSUR frequency and DLP amended on 27/03/2024 PSUSA/00009080/203108 Miroslava Gocova Slovakia NAP 9083 bornaprin 13/12/1974 10 years 03/03/2035 01/06/2035 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00009083/203503 NAP 9084 botulinum neurotoxin type a (150 kd) free from complexing proteins 31/05/2005 3 years 31/12/2027 30/03/2028 No 24/09/2025 DLP was amended on 24/09/2025 PSUSA/00009084/202712 Rhea Fitzgerald Ireland NAP 9088 caffeine / dextropropoxyphene / paracetamol Not available* 8 years 01/12/2033 01/03/2034 No 31/07/2024 PSUR frequency amended and DLP updated on 31/07/2024 PSUSA/00009088/203312 none NAP 9091 calcium lactate Not available* 8 years 01/12/2033 01/03/2034 No 30/10/2024 PSUR frequency amended and DLP updated on 31/07/2024 PSUSA/00009091/203312 John Joseph Borg Malta NAP 9092 calcium pantothenate Not available* 8 years 01/12/2033 01/03/2034 No 30/10/2024 PSUR frequency amended and DLP updated on 31/07/2024 PSUSA/00009092/203312 Polona Golmajer Slovenia NAP 9099 cefuroxime axetil 18/08/1987 5 years 07/04/2027 06/07/2027 No 21/12/2022 DLP was updated on 21/12/2022 DLP was updated on 19/12/2017 Lead MS and PRAC Rapporteur name was added on 19/10/2016 PSUSA/00009099/202704 Maia Uusküla Estonia NAP 9100 chloral hydrate 08/02/1967 9 years 03/03/2028 01/06/2028 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00009100/202803 NAP 9107 cloricromen hydrochloride 18/06/1986 9 years 01/12/2028 01/03/2029 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00009107/202812 NAP 9112 colistimethate sodium (dry inhalation powder) 13/02/2012 3 years 12/02/2026 13/05/2026 No 18/10/2023 Next DLP was updated on 18/10/2023 PSUSA/00009112/202602 Adam Przybylkowski Poland CAP 9113 conjugated estrogens 09/03/1950 10 years 01/12/2032 01/03/2033 No 11/06/2025 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00009113/203212 Guðrún Stefánsdóttir Iceland NAP 9114 conjugated estrogens / norgestrel Not available* 9 years 03/03/2030 01/06/2030 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00009114/203003 NAP 9118 decitabine 02/05/2006 5 years 01/05/2028 30/07/2028 No 31/01/2024 PSUR frequency amended and DLP updated on 31/01/2024 PSUSA/00009118/202805 Tiphaine Vaillant France CAP 9119 denosumab (indicated for skeletal related events associated with bone metastases and for giant cell tumour of bone) 13/07/2011 3 years 26/09/2026 25/12/2026 No 02/06/2026 PSUSA/00009119/202609 Karin Bolin Sweden CAP 9120 dexamethasone / heparin sodium 16/08/1961 11 years 03/06/2039 01/09/2039 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00009120/203906 NAP 9121 dexpanthenol / polyvinyl alcohol Not available* 9 years 03/08/2030 01/11/2030 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00009121/203008 NAP 9128 diclofenac / pyridoxine / thiamine Not available* 9 years 03/08/2030 01/11/2030 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00009128/203008 NAP 9129 didecyldimethylammonium chloride Not available* 9 years 03/08/2030 01/11/2030 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00009129/203008 NAP 9131 diethylamine salicylate / myrtecaine 20/11/1967 10 years 03/08/2034 01/11/2034 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00009131/203408 NAP 9142 emtricitabine / rilpivirine / tenofovir disoproxil 28/11/2011 3 years 10/08/2026 08/11/2026 No 30/04/2024 DLP was amended on 30/04/2024 PSUSA/00009142/202608 Liana Martirosyan Netherlands CAP 9143 escin 06/04/1983 9 years 01/12/2028 01/03/2029 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00009143/202812 NAP 9144 diethylamine-salicylate / escin Not available* 8 years 03/03/2026 01/06/2026 No 05/08/2025 PSUR frequency and DLP amended on 31/07/2024. PSUSA/00009144/202603 Eva Jirsová Czech Republic NAP 9145 estradiol (17-beta) / progesterone Not available* 7 years 01/12/2031 29/02/2032 No 30/07/2025 DLP was amended on 30/07/2025 PSUSA/00009145/203112 Amelia Cupelli Italy NAP 9146 estriol / lactobacillus acidophilus Not available* 8 years 03/06/2026 01/09/2026 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00009146/202606 NAP 9147 exenatide 20/11/2006 3 years 31/03/2027 29/06/2027 No 02/06/2026 PSUSA/00009147/202703 Karin Bolin Sweden CAP 9150 clonazoline hydrochloride / fluocinolone acetonide Not available* 9 years 01/12/2029 01/03/2030 No 28/08/2024 PSUR frequency and DLP amended on 28/08/2024. PSUSA/00009150/202912 NAP 9152 fluocinolone / neomycin, fluocinolone / neomycin / polymyxin b 01/05/1965 10 years 01/05/2033 30/07/2033 No 23/10/2024 PSUR frequency amended and DLP updated on 23/10/2024 Active substance name was amended on 23/10/2024 EURD added on 23/10/2024 Active substance name was amended on 22/12/2021 PSUSA/00009152/203305 Dennis Lex Germany NAP 9153 fluorescein (systemic use) 30/11/1971 3 years 30/04/2026 29/07/2026 No 31/01/2024 DLP was amended on 31/01/2024 PSUSA/00009153/202604 Dennis Lex Germany NAP 9154 fluticasone furoate 11/01/2008 3 years 26/04/2027 25/07/2027 No 18/12/2024 DLP was amended on 18/12/2024 PSUSA/00009154/202704 Adam Przybylkowski Poland CAP NAP 9159 gentamicin (systemic use) 28/02/1973 3 years 31/03/2026 29/06/2026 Yes 20/12/2023 DLP was amended on 20/12/2023 PSUSA/00009159/202603 Amelia Cupelli Italy NAP 9162 calcium chloride / glutamic acid / glutathione / histidine / lactobionic acid / magnesium chloride / mannitol / potassium chloride / sodium hydroxide 25/03/2004 5 years 25/03/2029 23/06/2029 No 20/11/2024 PSUR frequency amended and DLP updated on 20/11/2024 PSUSA/00009162/202903 Maria Popova-Kiradjieva Bulgaria NAP 9163 guaiazulene / matricaria oil Not available* 9 years 03/03/2031 01/06/2031 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00009163/203103 NAP 9164 guaifenesin / herbal extracts Not available* 9 years 03/03/2031 01/06/2031 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00009164/203103 NAP 9165 guaifenesin / levomenthol Not available* 8 years 03/08/2026 01/11/2026 No 18/11/2025 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00009165/202608 Rhea Fitzgerald Ireland NAP 9166 diphenhydramine / guaifenesin / levomenthol Not available* 9 years 03/11/2030 01/02/2031 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00009166/203011 NAP 9167 glucose / guaiphenesin / treacle Not available* 9 years 03/03/2031 01/06/2031 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00009167/203103 NAP 9168 halometasone Not available* 9 years 03/03/2031 01/06/2031 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00009168/203103 NAP 9169 halometasone / triclosan Not available* 9 years 03/06/2031 01/09/2031 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00009169/203106 NAP 9170 dexpanthenol / heparin Not available* 9 years 03/08/2030 01/11/2030 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00009170/203008 NAP 9171 hydroxyethyl salicylate / heparin / menthol Not available* 9 years 03/06/2031 01/09/2031 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00009171/203106 Jan Neuhauser Austria NAP 9172 benzyl nicotinate / heparin sodium Not available* 8 years 01/12/2033 01/03/2034 No 31/07/2024 PSUR frequency amended and DLP updated on 31/07/2024 PSUSA/00009172/203312 none NAP 9174 human coagulation factor VIII (inhibitor bypassing fraction) 04/02/1977 3 years 28/02/2027 29/05/2027 No 20/10/2021 PSUR frequency and DLP were updated on 20/10/2021 DLP was updated on 21/10/2020 DLP was updated on 23/10/2019 PRAC Rapporteur name was updated on 05/06/2019 DLP was updated on 23/10/2018 DLP was updated and PRAC Representative name amended on 17/10/2017 Next DLP was amended on 19/10/2016 DLP was amended on 30/09/2015. Lead MS was added on 13/07/2015 Transferred from the List of substances under PSUR Work Sharing scheme and other substances contained in Nationally Authorised Products with DLP synchronised on 06/03/2015 PSUSA/00009174/202702 Sonja Hrabcik Austria NAP 9175 human papillomavirus vaccine (rDNA) - 2-valent 20/09/2007 3 years 17/11/2028 15/02/2029 No 29/07/2026 DLP was amended on 29/07/2026 PSUSA/00009175/202811 Jean-Michel Dogné Belgium CAP 9176 hydrocortisone (for centrally authorised products for adrenal insufficiency, congenital adrenal hyperplasia, modified-release formulations) 03/11/2011 3 years 03/11/2028 01/02/2029 No 01/07/2026 DLP was amended on 01/07/2026 PSUSA/00009176/202811 Karin Bolin Sweden CAP 9177 dexpanthenol / hydrocortisone Not available* 9 years 03/08/2030 01/11/2030 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00009177/203008 NAP 9178 hydrogen peroxide Not available* 9 years 03/06/2031 01/09/2031 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00009178/203106 NAP 9179 hydrotalcite Not available* 8 years 03/11/2026 01/02/2027 No 27/02/2026 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00009179/202611 Dennis Lex Germany NAP 9180 hydrotalcite / simeticone Not available* 9 years 03/06/2031 01/09/2031 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00009180/203106 NAP 9182 hydroxycarbamide (except for centrally authorised product) 07/12/1967 3 years 06/12/2026 06/03/2027 No 31/07/2024 PSUR frequency amended and DLP updated on 31/07/2024 PSUSA/00009182/202612 Petar Mas Croatia NAP 9183 hyetellose / sodium chloride 11/01/1990 9 years 31/01/2029 01/05/2029 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00009183/202901 NAP 9187 ibuprofen / phenylephrine Not available* 8 years 03/11/2026 01/02/2027 No 27/02/2026 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00009187/202611 Adam Przybylkowski Poland NAP 9188 ichthammol / titanium dioxide / zinc oxide and other substances, zinc oxide/dimethicone 18/01/1934 13 years 03/06/2040 01/09/2040 No 23/10/2024 DLP amended on 23/10/2024 PSUSA/00009188/204006 NAP 9190 iloprost (intravenous (IV)use only) 27/04/1994 5 years 31/01/2029 01/05/2029 No 19/09/2024 PSUSA/00009190/202901 Zoubida Amimour France NAP 9191 indium (111In) pentetate 06/03/1992 8 years 15/07/2028 13/10/2028 Yes 28/04/2022 PRAC representative was updated on 19/10/2022 PRAC Representative was amended on 28/04/2022 DLP was updated on 31/03/2021 LMS and PRAC representative were added on 18/12/2019 DLP was updated on 05/06/2019 Active substance name was amended on 19/10/2016 PSUSA/00009191/202807 Jo Robays Belgium NAP 9192 indium (111In) pentetreotide 16/02/1994 8 years 15/07/2028 13/10/2028 No 31/03/2021 PRAC representative was updated on 19/10/2022 DLP was updated on 31/03/2021 PRAC representative was added on 06/05/2020 LMS was added on 01/04/2020 DLP was updated on 05/06/2019 PSUSA/00009192/202807 Jo Robays Belgium NAP 9200 ipilimumab 13/07/2011 3 years 24/03/2027 22/06/2027 No 20/11/2024 DLP was amended on 20/11/2024 PSUSA/00009200/202703 Bianca Mulder Netherlands CAP 9201 ipratropium / xylometazoline 07/04/2006 6 years 03/08/2029 01/11/2029 No 30/04/2024 DLP was amended on 30/04/2024 PSUSA/00009201/202908 Petar Mas Croatia NAP 9204 ivacaftor 23/07/2012 3 years 23/01/2026 23/04/2026 No 19/09/2025 Next DLP was updated on 18/10/2023 PSUSA/00009204/202601 Maria Martinez Gonzalez Spain CAP 9205 ketoprofen (topical use only) 23/01/1975 5 years 23/01/2027 23/04/2027 No 09/07/2026 PSUR frequency and DLP were updated on 19/10/2022 DLP was updated on 25/09/2019 DLP was corrected on 28/02/2018 PSUR Frequency amended and DLP updated and information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" amended on 23/05/201 Next DLP was amended on 03/06/2016 EURD and DLP amended on 16/07/2015 Lead MS added on 12/05/2015 For advice on submission for DLPs falling before 10/09/2015 please consult the List of substance under Work sharing scheme and other substance contained in Nationally Authorised Products with DLPs synchronised. PSUSA/00009205/202701 Amelia Cupelli Italy NAP 9206 propylene glycol Not available* 9 years 03/07/2031 01/10/2031 Yes 29/07/2026 Active substance name was amended on 29/07/2026 Information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" was amended on 01/04/2026 Active substance name was amended on 01/04/2026 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00009206/203107 none NAP 9207 lamivudine (HIV infections), lamivudine / zidovudine 18/03/1998 5 years 30/11/2029 28/02/2030 No 30/07/2025 PSUR frequency amended and DLP updated on 30/07/2025 PSUSA/00009207/202911 Zoubida Amimour France CAP 9208 white soft paraffin, white soft paraffin combinations (except ocular indications) 30/06/1982 13 years 30/06/2040 28/09/2040 No 01/04/2026 Active substance name was amended on 01/04/2026 DLP was amended on 18/12/2024 Name of active substance was amended on 21/12/2012 PSUSA/00009208/204006 Jo Robays Belgium NAP 9210 levomenthol Not available* 8 years 03/11/2026 01/02/2027 No 27/02/2026 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00009210/202611 Maria Popova-Kiradjieva Bulgaria NAP 9212 levothyroxine / potassium iodide Not available* 9 years 02/09/2031 01/12/2031 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00009212/203109 NAP 9213 fluorescein sodium / lidocain hydrochloride Not available* 9 years 01/12/2030 01/03/2031 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00009213/203012 NAP 9215 isopropyl myristate / liquid paraffin Not available* 9 years 03/07/2031 01/10/2031 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00009215/203107 NAP 9216 acetylated wool alcohols / liquid paraffin Not available* 9 years 31/01/2029 01/05/2029 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00009216/202901 NAP 9219 magaldrate Not available* 8 years 03/11/2026 01/02/2027 No 27/02/2026 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00009219/202611 Jo Robays Belgium NAP 9225 magnesium sulfate Not available* 5 years 30/06/2030 28/09/2030 No 04/03/2026 DLP was amended on 04/03/2026 PSUSA/00009225/203006 Marie Louise Schougaard Christiansen Denmark NAP 9226 mannitol (indicated in cystic fibrosis) 13/04/2012 3 years 12/04/2028 11/07/2028 No 19/09/2024 PSUSA/00009226/202804 Zoubida Amimour France CAP 9231 moxifloxacin (systemic use) 31/05/1999 4 years 31/05/2027 29/08/2027 No 31/01/2024 DLP was amended on 31/01/2024 PSUSA/00009231/202705 Dennis Lex Germany NAP 9234 nicotinamide Not available* 8 years 03/11/2026 01/02/2027 No 27/02/2026 Correction of DLP on 20/11/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00009234/202611 Tiphaine Vaillant France NAP 9236 nimesulide (systemic formulations) 06/08/1985 5 years 30/06/2029 28/09/2029 No 05/03/2025 PSUR frequency amended and DLP updated on 05/03/2025 PSUSA/00009236/202906 Amelia Cupelli Italy NAP 9237 nitroxoline Not available* 8 years 03/11/2026 01/02/2027 Yes 28/05/2025 DLP was amended on 28/05/2025 Information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" was amended on 28/05/2025 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00009237/202611 Dennis Lex Germany NAP 9239 amoxicillin / clarithromycin / omeprazole Not available* 9 years 03/03/2029 01/06/2029 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00009239/202903 NAP 9241 aspergillus orizae / pancreatin Not available* 9 years 03/05/2029 01/08/2029 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00009241/202905 NAP 9242 belladonna extract / hyosciamine / papaverine hydrochloride Not available* 9 years 03/05/2029 01/08/2029 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00009242/202905 NAP 9243 dextromethorphan / doxylamine / paracetamol Not available* 9 years 03/08/2030 01/11/2030 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00009243/203008 NAP 9244 dextromethorphan / doxylamine / ephedrine / paracetamol Not available* 9 years 03/08/2030 01/11/2030 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00009244/203008 NAP 9245 dextromethorphan / doxylamine / paracetamol / pseudoephedrine Not available* 9 years 03/08/2030 01/11/2030 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00009245/203008 NAP 9247 dextromethorphan / paracetamol / phenylephrine Not available* 10 years 03/11/2034 01/02/2035 Yes 30/07/2025 PSUR frequency amended and DLP updated on 30/07/2025 PSUSA/00009247/203411 Miroslava Gocova Slovakia NAP 9248 ascorbic acid / paracetamol / propyphenazone 21/12/1959 11 years 03/05/2039 01/08/2039 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00009248/203905 NAP 9251 paraffin liquid Not available* 12 years 03/06/2040 01/09/2040 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00009251/204006 Jo Robays Belgium NAP 9253 pasireotide 24/04/2012 3 years 24/10/2026 22/01/2027 No 02/06/2026 PSUSA/00009253/202610 Karin Bolin Sweden CAP 9254 peginterferon alfa-2a 05/07/2001 3 years 04/07/2026 02/10/2026 No 02/06/2026 PSUSA/00009254/202607 Karin Bolin Sweden CAP 9255 perampanel 23/07/2012 3 years 22/07/2028 20/10/2028 No 01/04/2026 DLP was amended on 01/04/2026 PSUSA/00009255/202807 Tiphaine Vaillant France CAP NAP 9256 phenol Not available* 10 years 16/04/2030 15/07/2030 Yes 16/12/2020 Correction of PSUR frequency and DLP on 29/06/2022 DLP was updated on 16/12/2020 PRAC Representative amended on 07/05/2018 DLP was updated and information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" was amended on 28/03/2017 Lead MS was added on 06/03/2015 PSUSA/00009256/203004 John Joseph Borg Malta NAP 9257 esculoside / phenylephrine Not available* 9 years 03/11/2030 01/02/2031 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00009257/203011 NAP 9258 piketoprofen 08/08/1983 9 years 01/12/2028 01/03/2029 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00009258/202812 NAP 9260 pinazepam 24/03/1975 10 years 03/03/2035 01/06/2035 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00009260/203503 NAP 9262 pneumococcal polysaccharide conjugate vaccine (adsorbed) - 10 valent 30/03/2009 5 years 10/12/2027 09/03/2028 No 02/06/2026 PSUSA/00009262/202712 Karin Bolin Sweden CAP 9263 pneumococcal polysaccharide conjugate vaccine (adsorbed) - 13 valent 09/12/2009 5 years 09/01/2028 08/04/2028 No 02/06/2026 PSUSA/00009263/202801 Karin Bolin Sweden CAP 9264 magnesium aspartate / potassium aspartate Not available* 8 years 03/11/2026 01/02/2027 No 27/02/2026 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00009264/202611 Melinda Palfi Hungary NAP 9266 potassium canrenoate Not available* 7 years 31/01/2026 01/05/2026 Yes 28/05/2025 DLP was amended on 28/05/2025 Information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" was amended on 28/05/2025 PSUR frequency amended and DLP updated on 30/04/2024 PSUSA/00009266/202601 Amelia Cupelli Italy NAP 9268 potassium iodide, potassium iodide / iodine Not available* 9 years 03/05/2032 01/08/2032 Yes 27/05/2026 Active substance name was amended on 27/05/2026 Information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" was amended on 28/05/2025 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00009268/203205 none NAP 9269 chloramphenicol hemisuccinate / prednisolone sodium succinate Not available* 9 years 03/08/2029 01/11/2029 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00009269/202908 none NAP 9271 promestriene (cream and vaginal capsules) 31/01/1974 5 years 31/03/2029 29/06/2029 No 27/01/2026 PSUR frequency amended and DLP updated on 18/12/2024 PSUSA/00009271/202903 Roxana Dondera Romania NAP 9272 chlorquinaldol (vaginal tablet) / promestriene 13/06/1977 13 years 30/09/2032 29/12/2032 No 03/06/2020 PRAC representative was updated on 31/03/2021 PSUR frequency and CLP were updated on 03/06/2020 PSUR Frequency amended and DLP updated on 23/05/2017 EURD date amended on 22/09/2016 PSUR Frequency amended and DLP updated on 03/06/2016 Lead MS added on 12/05/2015 PSUSA/00009272/203209 Roxana Dondera Romania NAP 9273 protirelin 01/01/1974 8 years 01/01/2032 31/03/2032 No 12/09/2025 PSUR frequency amended and DLP updated on 25/09/2024 PSUSA/00009273/203201 Veronika Macurová Czech Republic NAP 9275 pyridoxine Not available* 9 years 03/05/2032 01/08/2032 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00009275/203205 NAP 9276 l(+)biaspartate / glutamic acid / glycin / magnesium / potassium / pyridoxine 01/12/1975 10 years 03/03/2035 01/06/2035 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00009276/203503 NAP 9277 rabies vaccine 16/05/1975 5 years 11/03/2026 09/06/2026 No 17/11/2021 DLP was updated on 17/11/2021 PRAC representative was updated on 17/11/2021 PRAC representative was updated on 25/09/2019 Next DLP was updated on 18/11/2016 PRAC Representative was amended on 27/11/2015. Lead Member State was added on 30/09/2015 PSUSA/00009277/202603 Amelia Cupelli Italy NAP 9279 ascorbic acid / colecalciferol / retinol Not available* 9 years 03/05/2029 01/08/2029 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00009279/202905 NAP 9280 a-tocopherol nicotinate / retinol palmitate 31/12/1968 11 years 03/03/2040 01/06/2040 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00009280/204003 NAP 9282 rilpivirine (for oral use) 28/11/2011 3 years 19/05/2027 17/08/2027 No 05/02/2025 DLP was amended on 05/02/2025 PSUSA/00009282/202705 Liana Martirosyan Netherlands CAP 9284 saccharomyces boulardii Not available* 5 years 07/02/2028 07/05/2028 No 18/10/2023 PSUR frequency amended and DLP updated on 18/10/2023 PSUSA/00009284/202802 Eva Jirsová Czech Republic NAP 9286 flumetasone / salicylic acid Not available* 9 years 01/12/2030 01/03/2031 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00009286/203012 NAP 9288 scopolamine aminoxide hydrobromide Not available* 9 years 03/06/2032 01/09/2032 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00009288/203206 NAP 9292 silver nitrate Not available* 8 years 01/12/2026 01/03/2027 No 08/04/2026 DLP amended on 23/10/2024 PSUSA/00009292/202612 Benjamin Micallef Malta NAP 9295 sodium chloride (eye drops) Not available* 9 years 03/06/2032 01/09/2032 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00009295/203206 NAP 9296 sodium chloride (nasal drops) Not available* 9 years 03/08/2032 01/11/2032 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00009296/203208 NAP 9298 chamomile extract / glucose / potassium chloride / sodium chloride / sodium hydrogen carbonate Not available* 9 years 03/07/2029 01/10/2029 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00009298/202907 NAP 9300 strontium chloride hexahydrate Not available* 9 years 03/11/2032 01/02/2033 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00009300/203211 NAP 9302 sucrose Not available* 8 years 03/08/2027 01/11/2027 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00009302/202708 NAP 9303 hamamelis virginiana l. extract / phenazone / tannic acid Not available* 9 years 03/06/2031 01/09/2031 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00009303/203106 NAP 9305 teduglutide 30/08/2012 2 years 30/08/2026 28/11/2026 No 30/04/2025 PSUR frequency amended and DLP updated on 30/04/2025 PSUSA/00009305/202608 Marie Louise Schougaard Christiansen Denmark CAP 9310 tetracycline (topical use) 23/08/1984 9 years 01/12/2028 01/03/2029 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00009310/202812 NAP 9312 thiamine Not available* 9 years 03/11/2032 01/02/2033 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00009312/203211 NAP 9315 tobramycin (inhalation powder, capsules) 20/07/2011 6 years 30/06/2030 28/09/2030 No 05/03/2025 PSUR frequency amended and DLP updated on 05/03/2025 PSUSA/00009315/203006 Liana Martirosyan Netherlands CAP 9316 tobramycin (nebuliser solution) (apart from centrally authorised product) 10/12/1999 3 years 31/12/2026 31/03/2027 No 25/09/2024 DLP was amended on 25/09/2024 PSUSA/00009316/202612 Amelia Cupelli Italy NAP 9317 tobramycin (ophthalmic and otic use) 01/06/1977 5 years 31/03/2026 29/06/2026 No 31/01/2024 PRAC representative updated on 31/01/2024 PSUSA/00009317/202603 Carla Torre Portugal NAP 9318 tobramycin (systemic use) 29/10/1973 8 years 15/09/2028 14/12/2028 No 19/10/2022 PRAC representative was updated on 19/10/2022 PRAC representative was updated on 27/07/2022 DLP was updated on 26/05/2021 PRAC representative and LMS were added on 04/03/2020 DLP was updated on 05/06/2019 PSUSA/00009318/202809 Amelia Cupelli Italy NAP 9319 treosulfan (except for centrally authorised product) Not available* 5 years 31/08/2027 29/11/2027 No 03/05/2023 DLP was amended on 03/05/2023 PRAC Rapporteur name was amended on 28/04/2022 Active substance name amended on 31/07/2019 PRAC Rapporteur name was amended on 03/04/2019 DLP was updated on 06/06/2018 Lead MS and PRAC Rapporteur name was added on 28/02/2017 PSUSA/00009319/202708 Marie Louise Schougaard Christiansen Denmark NAP 9321 triamterene / trichlormethiazide Not available* 9 years 03/11/2032 01/02/2033 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00009321/203211 NAP 9323 cetrimonium bromide / lidocaine / tyrothricin 28/09/1966 10 years 03/07/2034 01/10/2034 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00009323/203407 NAP 9326 urea hydrogen peroxide Not available* 8 years 03/11/2032 01/02/2033 No 30/07/2025 DLP was amended on 30/07/2025 PSUSA/00009326/203211 Melinda Palfi Hungary NAP 9327 vandetanib 06/04/2011 3 years 06/04/2028 05/07/2028 No 01/07/2026 DLP was amended on 01/07/2026 PSUSA/00009327/202804 Tiphaine Vaillant France CAP 9329 vemurafenib 17/02/2012 3 years 16/08/2028 14/11/2028 No 02/06/2026 PSUSA/00009329/202808 Jenny-Maria Jönsson Sweden CAP 9330 xylene 14/05/1957 11 years 02/04/2038 01/07/2038 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00009330/203804 NAP 9331 zinc orotate Not available* 9 years 03/11/2032 01/02/2033 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00009331/203211 NAP 9333 zinc sulfate, zinc histidine 30/03/1973 10 years 31/01/2035 01/05/2035 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00009333/203501 Dennis Lex Germany NAP 9334 zoledronic acid (indicated for Osteoporosis) 15/04/2005 5 years 31/08/2028 29/11/2028 No 02/06/2026 PSUSA/00009334/202808 Karin Bolin Sweden CAP 9999 levomepromazine Not available* 9 years 03/07/2031 01/10/2031 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00009999/203107 NAP 10000 5 fluorouracil (topical application) Not available* 3 years 16/01/2026 16/04/2026 No 20/09/2023 DLP amended on 20/09/2023 PSUSA/00010000/202601 Dennis Lex Germany NAP 10002 fluorodopa (18F) Not available* 3 years 10/03/2027 08/06/2027 Yes 20/11/2024 DLP was amended on 20/11/2024 PSUSA/00010002/202703 John Joseph Borg Malta NAP 10005 mannitol (all indications apart from cystic fibrosis) Not available* 5 years 28/02/2030 29/05/2030 No 19/11/2025 DLP was amended on 19/11/2025 PSUSA/00010005/203002 Petar Mas Croatia NAP 10006 5-aminolevulinic acid (keratosis) 07/09/2007 5 years 14/06/2029 12/09/2029 No 05/02/2025 PSUR frequency amended and DLP updated on 05/02/2025 PSUSA/00010006/202906 Dennis Lex Germany CAP NAP 10007 ribavirin (oral formulations) 07/05/1999 3 years 24/07/2026 22/10/2026 Yes 18/11/2025 PSUSA/00010007/202607 Tiphaine Vaillant France NAP 10008 pandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted), prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted), prepandemic influenza vaccine (H5N8) (surface antigen, inactivated, adjuvanted) 19/10/2009 3 years 19/10/2027 17/01/2028 No 28/05/2025 Active substance name was amended on 28/05/2025 DLP was amended on 05/06/2024 PSUSA/00010008/202710 Amelia Cupelli Italy CAP 10012 ciprofloxacin / dexamethasone (ear drops, suspension) 31/05/2012 5 years 30/04/2030 29/07/2030 No 04/02/2026 DLP was amended on 04/02/2026 PSUSA/00010012/203004 Dennis Lex Germany NAP 10013 ceftaroline fosamil 29/10/2010 3 years 28/10/2027 26/01/2028 No 25/06/2025 DLP was amended on 25/06/2025 PSUSA/00010013/202710 Maia Uusküla Estonia CAP 10015 ruxolitinib 23/08/2012 1 year 22/02/2026 03/05/2026 22/02/2027 03/05/2027 No 02/06/2026 PSUSA/00010015/202602 PSUSA/00010015/202702 Jenny-Maria Jönsson Sweden CAP 10019 aflibercept (oncological indication(s)) 03/08/2012 5 years 03/08/2029 01/11/2029 No 02/06/2026 PSUSA/00010019/202908 Jenny-Maria Jönsson Sweden CAP 10020 aflibercept (ophthalmological indication(s)) 22/11/2012 3 years 30/11/2028 28/02/2029 No 29/07/2026 DLP was amended on 29/07/2026 PSUSA/00010020/202811 Zoubida Amimour France CAP 10021 alprostadil (patency of the ductus arteriosus) 23/07/1981 3 years 22/07/2027 20/10/2027 No 02/04/2025 DLP was amended on 02/04/2025 PSUSA/00010021/202707 Sonja Hrabcik Austria NAP 10022 axitinib 27/01/2012 3 years 26/01/2028 25/04/2028 No 22/10/2025 DLP was amended on 22/10/2025 PSUSA/00010022/202801 David Olsen Norway CAP 10025 linaclotide 30/08/2012 3 years 26/08/2028 24/11/2028 No 27/05/2026 DLP was corrected on 27/05/2026 PSUR frequency amended and DLP updated on 29/04/2026 PSUSA/00010025/202808 Dennis Lex Germany CAP 10028 concentrate of proteolytic enzymes enriched in bromelain 18/12/2012 2 years 17/12/2027 16/03/2028 No 29/07/2026 PSUR frequency amended and DLP updated on 29/07/2026 PSUSA/00010028/202712 Dennis Lex Germany CAP 10029 dapagliflozin, dapagliflozin / metformin, saxagliptin / dapagliflozin, dapagliflozin / sitagliptin 05/10/2012 3 years 04/10/2027 02/01/2028 No 02/06/2026 PSUSA/00010029/202710 Karin Bolin Sweden CAP 10030 dexpanthenol / xylometazoline Not available* 8 years 31/05/2028 29/08/2028 No 15/11/2023 PRAC Rapporteur updated on 15/11/2023 PSUSA/00010030/202805 Barbara Kovacic Bytyqi Croatia NAP 10031 mirabegron 01/07/2011 3 years 30/06/2028 28/09/2028 No 04/02/2026 PSUR frequency amended and DLP updated on 04/02/2026 PSUSA/00010031/202806 Maria del Pilar Rayon Spain CAP 10032 florbetapir (18f) 06/04/2012 5 years 06/04/2030 05/07/2030 No 17/12/2025 PSUR frequency amended and DLP updated on 17/12/2025 PSUSA/00010032/203004 Dennis Lex Germany CAP 10034 catridecacog 19/07/2012 3 years 31/07/2026 29/10/2026 No 27/03/2024 DLP was amended on 27/03/2024 PSUSA/00010034/202607 Tiphaine Vaillant France CAP 10036 insulin degludec, insulin degludec / insulin aspart 28/09/2012 3 years 30/09/2026 29/12/2026 No 02/06/2026 PSUSA/00010036/202609 Karin Bolin Sweden CAP 10039 brentuximab vedotin 19/08/2011 3 years 18/08/2028 16/11/2028 No 29/04/2026 DLP was amended on 29/04/2026 PSUSA/00010039/202808 Bianca Mulder Netherlands CAP 10041 magnesium pidolate 01/04/1992 15 years 03/06/2040 01/09/2040 No 04/02/2026 PSUR frequency amended and DLP updated on 04/02/2026 PSUSA/00010041/204006 Veronika Macurová Czech Republic NAP 10042 crizotinib 26/08/2011 3 years 25/08/2028 23/11/2028 No 26/08/2026 DLP was corrected on 26/08/2026 PSUR frequency amended and DLP updated on 29/04/2026 PSUSA/00010042/202808 Tiphaine Vaillant France CAP 10043 meningococcal group-B vaccine (rDNA, component, adsorbed) 14/01/2013 3 years 13/01/2027 13/04/2027 No 02/06/2026 PSUSA/00010043/202701 Karin Bolin Sweden CAP 10044 meningococcal group a, c, w135, y conjugate vaccine (conjugated to tetanus toxoid carrier protein) 20/04/2012 3 years 19/04/2026 18/07/2026 No 20/12/2023 PSUR frequency amended and DLP updated on 20/12/2023 PSUSA/00010044/202604 David Olsen Norway CAP 10047 glycopyrronium bromide (for centrally authorised product indicated for chronic obstructive pulmonary disease) 28/09/2012 5 years 28/09/2027 27/12/2027 No 31/05/2023 PSUR frequency amended and DLP updated on 31/05/2023 PRAC Rapporteur name was amended on 28/04/2022 PRAC representative was updated on 31/03/2021 DLP was updated on 03/06/2020 PRAC representative was updated on 25/09/2019 PRAC Rapporteur name was corrected on 03/04/2019 PRAC Rapporteur name was amended on 06/06/2018 PRAC Representative amended on 17/10/2017 PSUR Frequency amended and DLP updated on 26/04/2017 The name of the active substance was amended on 22/09/2016 Next DLP was amended on 03/05/2016 Next DLP amended on 04/11/2014 Next DLP amended on 02/05/2014 PSUSA/00010047/202709 Marie Louise Schougaard Christiansen Denmark CAP 10049 zinc gluconate Not available* 8 years 03/11/2026 01/02/2027 Yes 11/06/2025 DLP was amended on 28/05/2025 Information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" was amended on 28/05/2025 PSUR frequency and DLP amended on 28/08/2024 PSUSA/00010049/202611 Guðrún Stefánsdóttir Iceland NAP 10050 caffeine / dexpanthenol / nicotinamide / pyridoxine / riboflavine / thiamin 23/06/1966 11 years 02/12/2039 01/03/2040 No 02/06/2026 PSUSA/00010050/203912 Karin Bolin Sweden NAP 10051 lovastatin 21/07/1987 5 years 20/07/2026 18/10/2026 No 30/03/2022 PRAC Representative updated on 16/11/2022 DLP was updated on 30/03/2022 PRAC Representative updated on 26/09/2018 PSUR Frequency amended and DLP updated on 28/03/2017 Lead MS and PRAC Rapporteur name updated on 04/02/2016 PSUSA/00010051/202607 Maria del Pilar Rayon Spain NAP 10052 vortioxetine 18/12/2013 2 years 29/09/2026 28/12/2026 No 28/04/2022 Next DLP was updated on 31/05/2023 PSUSA/00010052/202609 Jo Robays Belgium CAP 10054 afatinib 25/09/2013 5 years 25/09/2028 24/12/2028 No 02/06/2026 PSUSA/00010054/202809 Jenny-Maria Jönsson Sweden CAP 10055 alemtuzumab 12/09/2013 3 years 12/09/2028 11/12/2028 No 27/05/2026 DLP was amended on 27/05/2026 PSUSA/00010055/202809 Karin Erneholm Denmark CAP 10061 alogliptin, alogliptin / metformin, alogliptin / pioglitazone 16/04/2013 3 years 15/04/2028 14/07/2028 No 17/12/2025 PSUR frequency amended and DLP updated on 17/12/2025 PSUSA/00010061/202804 Bianca Mulder Netherlands CAP 10066 avanafil 21/06/2013 5 years 21/06/2028 19/09/2028 No 28/02/2024 PSUR frequency amended and DLP updated on 28/02/2024 PSUSA/00010066/202806 Maria del Pilar Rayon Spain CAP 10067 azelastine / fluticasone 24/01/2013 5 years 26/10/2029 24/01/2030 No 25/06/2025 PSUR frequency amended and DLP updated on 25/06/2025 PSUSA/00010067/202910 Jan Neuhauser Austria NAP 10068 beclometasone / formoterol (inhalative application) 14/07/2006 5 years 14/07/2030 12/10/2030 No 01/04/2026 PSUR frequency amended and DLP updated on 01/04/2026 PSUSA/00010068/203007 Dennis Lex Germany NAP 10070 benzalkonium chloride / chlorhexidine digluconate 19/11/1998 7 years 01/11/2028 30/01/2029 No 29/06/2022 PSUR frequency and DLP were updated on 29/06/2022 PRAC Rapporteur name was amended on 06/03/2019 DLP was updated on 21/07/2017 Lead MS and PRAC Rapporteur name was added on 03/06/2016 PSUSA/00010070/202811 Rugile Pilviniene Lithuania NAP 10071 betamethasone / chloramphenicol 24/03/1964 18 years 31/08/2030 29/11/2030 No 29/11/2013 PSUSA/00010071/203008 NAP 10072 betamethasone / tetryzoline 17/05/1966 9 years 30/09/2033 29/12/2033 No 15/11/2023 PRAC Rapporteur updated on 15/11/2023 PSUSA/00010072/203309 Petar Mas Croatia NAP 10073 bosutinib 04/09/2012 3 years 03/03/2027 01/06/2027 No 20/11/2024 DLP was amended on 20/11/2024 PSUSA/00010073/202703 Dennis Lex Germany CAP 10074 bedaquiline 05/03/2014 3 years 05/09/2028 04/12/2028 No 02/06/2026 PSUSA/00010074/202809 Karin Bolin Sweden CAP 10075 dolutegravir, dolutegravir / abacavir / lamivudine, dolutegravir / lamivudine 16/01/2014 3 years 16/01/2028 15/04/2028 No 24/09/2025 PSUR frequency amended and DLP updated on 24/09/2025 PSUSA/00010075/202801 Dennis Lex Germany CAP 10077 canagliflozin, canagliflozin / metformin 29/03/2013 3 years 28/03/2026 26/06/2026 No 31/01/2024 PRAC representative updated on 31/01/2024 PSUSA/00010077/202603 Dennis Lex Germany CAP 10078 chloroprocaine hydrochloride 19/03/2012 5 years 19/03/2027 17/06/2027 No 15/11/2023 PRAC Rapporteur updated on 15/11/2023 PSUSA/00010078/202703 Petar Mas Croatia NAP 10080 clindamycin phosphate / tretinoin 22/03/2013 5 years 31/07/2027 29/10/2027 No 17/02/2026 DLP was updated on 05/04/2023 PRAC representative was updated on 22/12/2021 PRAC representative was updated on 06/05/2020 DLP was updated on 07/05/2018 PRAC representative and Lead Member State were added on 30/01/2017 PSUSA/00010080/202707 Jana Pecherova Slovakia NAP 10081 cobicistat 27/08/2013 3 years 26/08/2026 24/11/2026 No 30/04/2024 DLP was amended on 30/04/2024 PSUSA/00010081/202608 Ana Sofia Diniz Martins Portugal CAP 10082 cobicistat / elvitegravir / emtricitabine / tenofovir disoproxil 27/08/2012 3 years 26/08/2026 24/11/2026 No 30/04/2024 DLP was amended on 30/04/2024 PSUSA/00010082/202608 Ana Sofia Diniz Martins Portugal CAP 10084 dabrafenib 26/08/2013 3 years 29/05/2028 27/08/2028 No 02/06/2026 PSUSA/00010084/202805 Jenny Jönsson Sweden CAP 10086 defibrotide 18/10/2013 3 years 18/10/2026 16/01/2027 No 02/06/2026 PSUSA/00010086/202610 Karin Bolin Sweden CAP 10087 dexpanthenol / retinol palmitate 16/07/1975 20 years 31/08/2032 29/11/2032 No 29/11/2013 PSUSA/00010087/203208 NAP 10088 dextran 40 / sodium chloride / potassium chloride / magnesium sulphate heptahydrate / disodium phosphate dodecahydrate / monopotassium phosphate / dextrose monohydrate 22/05/1970 10 years 02/09/2034 01/12/2034 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00010088/203409 NAP 10091 diphtheria / tetanus / pertussis antigens (pertussis toxoid, filamentous haemagglutinin) (acellular, component) / hepatitis b (rdna) / poliomyelitis (inactivated) / haemophilus type b conjugate vaccines (adsorbed) 17/04/2013 3 years 17/04/2028 16/07/2028 No 06/10/2025 PRAC representative was updated on 01/03/2023 DLP was updated on 21/12/2022 PSUR frequency and DLP were updated on 20/11/2019 DLP was updated on 21/11/2018 DLP was amended on 15/11/2017 DLP was updated on 18/11/2016 DLP was updated on 27/11/2015 DLP was amended on 01/12/2014 DLP was amended on 28/05/2014 PSUSA/00010091/202804 Dirk Mentzer Germany CAP 10092 docosanol 14/11/2003 5 years 30/04/2026 29/07/2026 No 22/12/2021 DLP was updated on 22/12/2021 Next DLP was updated on 30/01/2017 PRAC Representative amended on 18/11/2016 Lead Member State and PRAC Representative was added on 27/11/2015. PSUSA/00010092/202604 Petar Mas Croatia NAP 10093 brimonidine (centrally authorised product only) 21/02/2014 3 years 21/02/2027 22/05/2027 No 20/10/2021 DLP and PSUR frequency were updated on 20/10/2021 DLP was updated on 21/10/2020 DLP was updated on 25/09/2019 Lead MS and PRAC Rapporteur name updated on 30/04/2019 DLP was updated on 26/09/2018 PSUR frequency amended and DLP updated on 27/03/2018 Next DLP was amended on 25/09/2017 DLP was updated and PRAC Representative amended on 28/03/2017 Next DLP was updated on 22/09/2016 Next DLP was amended on 07/04/2016 DLP and Next DLP was updated on 06/10/2015 Next DLP was amended on 01/04/2015 PSUSA/00010093/202702 Rhea Fitzgerald Ireland CAP 10094 florbetaben (18f) 20/02/2014 3 years 20/02/2026 21/05/2026 No 18/10/2023 Next DLP was updated on 18/10/2023 PSUSA/00010094/202602 Dennis Lex Germany CAP 10095 enzalutamide 31/08/2012 3 years 30/08/2026 28/11/2026 No 30/04/2024 New CAP authorised on 09/01/2026 DLP was amended on 30/04/2024 PSUSA/00010095/202608 Maria del Pilar Rayon Spain CAP 10096 fenofibrate / simvastatin 26/08/2013 3 years 25/02/2028 25/05/2028 No 22/10/2025 DLP was amended on 22/10/2025 PSUSA/00010096/202802 Maia Uusküla Estonia CAP 10097 fluprednidene Not available* 10 years 11/03/2034 09/06/2034 No 12/09/2025 DLP was amended on 20/11/2024 PSUSA/00010097/203403 Veronika Macurová Czech Republic NAP 10098 fluprednidene / gentamicin Not available* 10 years 11/03/2034 09/06/2034 No 12/09/2025 DLP was amended on 20/11/2024 PSUSA/00010098/203403 Veronika Macurová Czech Republic NAP 10099 fluticasone furoate / vilanterol 10/05/2013 5 years 09/05/2029 07/08/2029 No 19/09/2025 PSUR frequency amended and DLP updated on 30/04/2025 DLP was amended on 05/02/2025 PSUSA/00010099/202905 Maria Martinez Gonzalez Spain CAP 10100 framycetin sulphate / hydrocortisone acetate Not available* 9 years 31/01/2031 01/05/2031 No 12/09/2025 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00010100/203101 Veronika Macurová Czech Republic NAP 10101 granisetron (transdermal patch) 20/04/2012 3 years 19/10/2026 17/01/2027 No 03/07/2024 DLP was amended on 03/07/2024 PSUSA/00010101/202610 Rugile Pilviniene Lithuania CAP 10102 human coagulation factor viii / human von willebrand factor (centrally authorised product only) 12/08/2013 5 years 12/08/2026 10/11/2026 No 28/04/2022 PSUR frequency amended and DLP updated on 28/04/2022 PSUR frequency amended and DLP updated on 03/04/2019 PRAC Representative updated on 26/09/2018 DLP was updated on 27/03/2018 DLP was updated on 28/03/2017 Next DLP was updated on 22/09/2016 PSUR Frequency amended and DLP updated on 07/04/2016 Next DLP was updated on 30/09/2015 Next DLP was amended on 01/04/2015 Correction of PSUSA number (Next DLP) on 06/10/2014 Correction of submission date on 31/01/2014 Name of active substance was amended on 30/11/2013 PSUSA/00010102/202608 Bianca Mulder Netherlands CAP 10104 C1-inhibitor, human plasma derived (centrally authorised products) 16/07/2001 2 years 15/06/2027 13/09/2027 No 01/04/2026 Reference to CAP removed on 01/04/2026 Active substance name was amended on 01/04/2026 DLP was amended on 04/03/2026 PSUSA/00010104/202706 Dirk Mentzer Germany CAP 10105 indacaterol / glycopyrronium bromide 19/09/2013 5 years 28/09/2028 27/12/2028 No 05/06/2024 PSUR frequency amended and DLP updated on 05/06/2024 PSUSA/00010105/202809 Marie Louise Schougaard Christiansen Denmark CAP 10107 insulin human (Intraperitoneal use only) 19/09/2013 3 years 19/09/2026 18/12/2026 No 05/06/2024 DLP was amended on 05/06/2024 PSUSA/00010107/202609 Jean-Michel Dogné Belgium CAP 10108 isopropyl alcohol (covers other synonymous terms such as 2-propanol) / propyl alcohol / mecetronium ethyl sulfate 20/01/1984 5 years 30/09/2026 29/12/2026 No 04/02/2026 Active substance name was amended on 04/02/2026 PSUR frequency and DLP were updated on 29/06/2022 PRAC representative added on 25/05/2022 LMS was added on 03/03/2021 PSUSA/00010108/202609 Dennis Lex Germany NAP 10109 levobunolol (ophthalmic indication) 02/01/1985 5 years 02/01/2027 02/04/2027 No 21/09/2022 DLP was updated on 21/09/2022 Next DLP was amended on 25/09/2017 Lead MS and PRAC Rapporteur name was added on 28/07/2016 PSUSA/00010109/202701 Eva Jirsová Czech Republic NAP 10110 lidocaine / prilocaine (centrally authorised product only) 15/11/2013 5 years 15/05/2030 13/08/2030 No 04/02/2026 PSUR frequency amended and DLP updated on 04/02/2026 PSUSA/00010110/203005 Maria del Pilar Rayon Spain CAP 10111 lipegfilgrastim 25/07/2013 3 years 25/07/2027 23/10/2027 No 02/04/2025 DLP was amended on 02/04/2025 PSUSA/00010111/202707 Terhi Lehtinen Finland CAP 10112 lomitapide 31/07/2013 1 year 31/07/2026 09/10/2026 31/07/2027 09/10/2027 No 04/03/2026 DLP was amended on 04/03/2026 PSUSA/00010112/202607 PSUSA/00010112/202707 Bianca Mulder Netherlands CAP 10113 loxapine (pre-dispensed inhalation powder) 20/02/2013 3 years 20/08/2027 18/11/2027 No 30/04/2025 DLP was amended on 30/04/2025 PSUSA/00010113/202708 Liana Martirosyan Netherlands CAP 10114 lurasidone 28/10/2010 3 years 27/10/2026 25/01/2027 No 03/07/2024 DLP was amended on 03/07/2024 PSUSA/00010114/202610 Karin Bolin Sweden CAP 10115 macitentan 20/12/2013 3 years 17/10/2026 15/01/2027 No 03/07/2024 DLP was amended on 03/07/2024 PSUSA/00010115/202610 Maria del Pilar Rayon Spain CAP 10118 midazolam (oromucosal solution or nasal routes of administration) 05/09/2011 3 years 09/09/2028 08/12/2028 No 27/05/2026 DLP was amended on 27/05/2026 PSUSA/00010118/202809 Liana Martirosyan Netherlands CAP NAP 10119 smallpox and monkeypox vaccine (Live Modified Vaccinia Virus Ankara) 31/07/2013 1 year 31/07/2026 09/10/2026 31/07/2027 09/10/2027 No 04/03/2026 PSUR frequency amended and DLP updated on 04/03/2026 DLP was amended on 24/09/2025 PSUSA/00010119/202607 PSUSA/00010119/202707 Dirk Mentzer Germany CAP 10120 nalmefene 25/02/2013 3 years 24/02/2027 25/05/2027 No 20/10/2021 DLP was updated on 20/10/2021 PSUR Frequency and DLP updated on 26/09/2018 DLP was updated on 17/10/2017 Next DLP was updated on 22/09/2016 Next DLP was updated on 30/09/2015 Next DLP was amended on 06/10/2014 Next DLP was amended on 01/04/2014 PSUSA/00010120/202702 Dennis Lex Germany CAP 10123 paclitaxel albumin 11/01/2008 5 years 06/01/2027 06/04/2027 No 21/09/2022 PSUR frequency and DLP were updated on 21/09/2022 DLP was updated on 25/09/2019 New CAP authorised on 06/05/2019 PRAC Representative updated on 26/09/2018 PSUR Frequency amended and DLP updated on 22/09/2016 PSUSA/00010123/202701 Bianca Mulder Netherlands CAP 10124 papaverine / phentolamine Not available* 8 years 03/11/2026 01/02/2027 No 20/11/2024 DLP corrected on 20/11/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00010124/202611 Liana Martirosyan Netherlands NAP 10125 pertuzumab 08/06/2012 3 years 07/06/2027 05/09/2027 No 05/02/2025 New CAP authorised on 23/04/2026 DLP was amended on 05/02/2025 PSUSA/00010125/202706 Marie Louise Schougaard Christiansen Denmark CAP 10126 phenol-methanal-urea polycondensate / sulphonated / sodium salt Not available* 20 years 22/12/2034 22/03/2035 No 31/01/2014 PSUSA/00010126/203412 NAP 10127 pomalidomide 08/02/2013 5 years 07/02/2029 08/05/2029 Yes 19/09/2025 Information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" was amended on 20/11/2024 PSUR frequency and DLP were updated on 20/10/2021 Correction to PSUR frequency, DLP and submission date on 05/02/2020 DLP was updated on 25/09/2019 Lead MS and PRAC Rapporteur name updated on 30/04/2019 DLP was updated on 26/09/2018 Next DLP was amended on 25/09/2017 Correction of the next DLP and PSUR frequency on 11/04/2017 DLP was updated and PRAC representative amended on 28/03/2017 Next DLP was updated on 22/09/2016 Next DLP was amended on 07/04/2016 Next DLP was updated on 30/09/2015 Next DLP was amended on 01/04/2015 Next DLP was amended on 06/10/2014 PSUSA/00010127/202902 Maria Martinez Gonzalez Spain CAP 10128 ponatinib 14/12/2012 3 years 13/12/2026 13/03/2027 No 02/06/2026 PSUSA/00010128/202612 Jenny-Maria Jönsson Sweden CAP 10130 potassium para-aminobenzoate Not available* 5 years 04/02/2030 05/05/2030 No 22/10/2025 DLP was amended on 22/10/2025 PSUSA/00010130/203002 Dennis Lex Germany NAP 10132 radium-223 dichloride 13/11/2013 3 years 14/05/2027 12/08/2027 No 05/02/2025 DLP was amended on 05/02/2025 PSUSA/00010132/202705 Rugile Pilviniene Lithuania CAP 10133 regorafenib 26/09/2012 3 years 26/09/2026 25/12/2026 No 05/06/2024 DLP was amended on 05/06/2024 PSUSA/00010133/202609 Bianca Mulder Netherlands CAP 10134 sofosbuvir 06/12/2013 5 years 05/12/2029 05/03/2030 No 30/07/2025 PSUR frequency amended and DLP updated on 30/07/2025 PSUSA/00010134/202912 Ana Sofia Diniz Martins Portugal CAP 10135 teriflunomide 12/09/2013 3 years 12/09/2026 11/12/2026 Yes 05/06/2024 DLP was amended on 05/06/2024 PSUSA/00010135/202609 Dennis Lex Germany CAP NAP 10136 trastuzumab emtansine 15/11/2013 2 years 21/02/2026 22/05/2026 No 19/10/2022 PSUR frequency and DLP were updated on 19/10/2022 DLP was updated on 20/10/2021 PRAC representative was updated on 31/03/2021 DLP was updated on 21/10/2020 PRAC representative and DLP were updated on 25/09/2019 PRAC Rapporteur name was amended on 03/04/2019 DLP was updated on 26/09/2018 DLP was updated on 17/10/2017 Next DLP was updated on 22/09/2016 Next DLP was updated on 30/09/2015 The DLP was amended on 01/04/2014 PSUSA/00010136/202602 Karin Erneholm Denmark CAP 10137 triamcinolone (tablets and injectables) 28/09/1966 8 years 28/09/2028 27/12/2028 No 31/01/2024 PRAC representative updated on 31/01/2024 PSUSA/00010137/202809 Carla Torre Portugal NAP 10138 turoctocog alfa 15/10/2013 3 years 31/10/2026 29/01/2027 No 06/10/2025 DLP was amended on 03/07/2024 PSUSA/00010138/202610 Dirk Mentzer Germany CAP 10139 unsaturated fatty acids (C18:2)(topical use) 28/06/1968 28 years 28/06/2040 26/09/2040 No 29/11/2013 PSUSA/00010139/204006 NAP 10140 vismodegib 30/01/2012 3 years 29/01/2027 29/04/2027 No 02/06/2026 PSUSA/00010140/202701 Jenny-Maria Jönsson Sweden CAP 10143 dimethyl fumarate, diroximel fumarate (multiple sclerosis) 30/01/2014 3 years 26/03/2028 24/06/2028 No 19/11/2025 PSUR frequency amended and DLP updated on 19/11/2025 PSUSA/00010143/202803 Dennis Lex Germany CAP 10155 felbamate 15/05/1994 5 years 30/09/2030 29/12/2030 Yes 01/07/2026 PSUR frequency amended and DLP updated on 01/07/2026 Next DLP was updated on 31/05/2023 PSUSA/00010155/203009 Tiphaine Vaillant France NAP 10156 lidocaine / norepinephrine 01/10/1948 8 years 30/09/2021 29/12/2021 No 06/10/2014 PRAC representative and LMS were added on 03/03/2021 PSUSA/00010156/202109 Adam Przybylkowski Poland NAP 10163 C1-inhibitor, human plasma derived (nationally authorised products) 23/07/1979 2 years 04/08/2027 02/11/2027 No 01/04/2026 DLP was amended on 01/04/2026 Active substance name was amended on 01/04/2026 DLP was amended on 30/04/2024 PSUSA/00010163/202708 Dirk Mentzer Germany NAP 10171 para-aminosalicylic acid (centrally authorised product) 07/04/2014 5 years 07/10/2029 05/01/2030 Yes 25/06/2025 PSUR frequency amended and DLP updated on 25/06/2025 PSUSA/00010171/202910 Karin Bolin Sweden CAP 10174 riociguat 19/03/2013 3 years 19/09/2027 18/12/2027 No 25/05/2022 DLP was updated on 25/05/2022 PSUR frequency was amended on 01/10/2019 PRAC Rapporteur name was updated on 03/07/2019 DLP was updated on 30/04/2019 Lead MS and PRAC Rapporteur name updated on 23/10/2018 DLP was updated on 07/05/2018 Next DLP was amended on 26/04/2017 PSUR frequency and following DLP updated on 18/11/2016 Next DLP was amended on 19/10/2016 DLP and next DLP were amended on 03/05/2016 The Next DLP was amended on 29/10/2015. Next DLP was amended on 12/05/2015 EURD was amended on 04/11/2014 PSUSA/00010174/202709 Kimmo Jaakkola Finland CAP 10178 aztreonam (parenteral use) 04/08/1984 7 years 03/08/2030 01/11/2030 No 30/04/2024 PSUR frequency amended and DLP updated on 30/04/2024 PSUSA/00010178/203008 Marie Louise Schougaard Christiansen Denmark NAP 10180 cabozantinib 29/11/2012 3 years 28/11/2027 26/02/2028 No 30/07/2025 DLP was amended on 30/07/2025 PSUSA/00010180/202711 Bianca Mulder Netherlands CAP 10186 vedolizumab 20/05/2014 3 years 19/05/2027 17/08/2027 No 05/02/2025 DLP was amended on 05/02/2025 PSUSA/00010186/202705 Adam Przybylkowski Poland CAP 10187 amino acid combinations (only combinations of pure amino acids or combination of amino acids with mineral compounds/electrolytes, i.v. application) Not available* 7 years 01/01/2026 01/04/2026 No 25/09/2019 DLP was updated on 25/09/2019 PRAC Representative and Lead Member state assigned on 04/07/2018 PSUSA/00010187/202601 Dennis Lex Germany NAP 10190 amino acid combinations / glucose / triglyceride combinations (e.g. olive oil, soya bean oil, fish oil)/ with or without electrolytes/ mineral compounds (i.v. application) - only for the drug Numeta 20/01/2011 3 years 31/12/2027 30/03/2028 No 24/09/2025 DLP was amended on 24/09/2025 PSUSA/00010190/202712 Karin Bolin Sweden NAP 10191 amlodipine / candesartan, amlodipine / candesartan / hydrochlorothiazide, candesartan / amlodipine / atorvastatin 20/03/2014 5 years 28/04/2027 27/07/2027 No 23/10/2024 Active substance name was amended on 23/10/2024 Active substance name was amended on 20/12/2023 DLP was updated on 21/12/2022 DLP was updated on 21/11/2018 DLP was amended on 31/01/2018 Lead MS and PRAC Rapporteur name was added on 19/10/2016 PSUSA/00010191/202704 Eva Jirsová Czech Republic NAP 10192 amlodipine / lisinopril 30/04/2004 5 years 31/12/2026 31/03/2027 No 21/09/2022 DLP was updated on 21/09/2022 Next DLP was amended on 25/09/2017 Lead MS and PRAC Rapporteur name was added on 28/07/2016 PSUSA/00010192/202612 Zane Neikena Latvia NAP 10196 benfotiamine 21/08/2013 5 years 03/07/2028 01/10/2028 Yes 15/11/2023 DLP was amended on 15/11/2023 Lead MS and PRAC Rapporteur name added on 26/07/2023 Update of PSUR frequency & DLP resulting from PRAC re-allocation exercise for entries with DLPs in 2025 on 05/04/2023 PSUSA/00010196/202807 Maia Uusküla Estonia NAP 10198 bismuth salts and combinations (except for fixed dose combination bismuth subcitrate potassium / metronidazole / tetracycline) Not available* 23 years 01/01/2035 01/04/2035 No 01/10/2012 Name of entry was amended on 02/07/2014 PSUSA/00010198/203501 NAP 10199 bismuth subcitrate potassium / metronidazole / tetracycline 24/11/2011 3 years 24/05/2027 22/08/2027 No 05/02/2025 DLP was amended on 05/02/2025 PSUSA/00010199/202705 Barbara Kovacic Bytyqi Croatia NAP 10203 calcium gluconate / colecalciferol / nicotinic acid Not available* 13 years 20/01/2027 20/04/2027 No 17/10/2017 Entry name amended on 17/10/2017 Correction of DLP was done on 08/08/2014 PSUSA/00010203/202701 NAP 10204 calcium levofolinate, calcium folinate 03/04/1982 15 years 03/04/2029 02/07/2029 No 01/12/2014 PSUSA/00010204/202904 NAP 10206 cefuroxime sodium (for intracameral use) 18/08/1987 3 years 15/05/2027 13/08/2027 Yes 05/02/2025 DLP was amended on 05/02/2025 PSUSA/00010206/202705 Maia Uusküla Estonia NAP 10208 cholic acid (oxosteroid-reductase or hydroxy-steroid dehydrogenase deficiency indication) 12/09/2013 3 years 12/09/2027 11/12/2027 Yes 30/04/2025 PSUR frequency amended and DLP updated on 30/04/2025 PSUSA/00010208/202709 Maria Poulianiti Greece CAP 10209 cilostazol 20/01/1988 3 years 19/01/2026 19/04/2026 Yes 20/09/2023 DLP amended on 20/09/2023 PSUSA/00010209/202601 Adam Przybylkowski Poland NAP 10210 colistimethate sodium (all applications except for dry inhalation powder) 08/10/1962 13 years 31/12/2026 31/03/2027 No 06/10/2014 PSUSA/00010210/202612 NAP 10213 delamanid 28/04/2014 6 months 27/04/2026 06/07/2026 27/10/2026 05/01/2027 No 01/07/2026 DLP was amended on 01/07/2026 PSUSA/00010213/202604 PSUSA/00010213/202610 Jo Robays Belgium CAP 10217 drospirenone / ethinylestradiol 07/03/2000 5 years 06/09/2030 05/12/2030 No 27/05/2026 DLP was corrected on 27/05/2026 PSUR frequency amended and DLP updated on 29/04/2026 PSUSA/00010217/203009 Bianca Mulder Netherlands NAP 10218 elosulfase alfa 14/02/2014 3 years 13/02/2027 14/05/2027 No 20/10/2021 PSUR frequency updated on 17/11/2021 DLP was updated on 20/10/2021 DLP was updated on 23/09/2020 DLP was updated on 25/09/2019 Lead MS and PRAC Rapporteur name updated on 30/04/2019 DLP was updated on 26/09/2018 Next DLP was amended on 25/09/2017 PSUR Frequency and DLP updated and PRAC Representative amended on 28/03/2017 PSUR Frequency and following DLP updated and EURD date amended on 18/11/2016 PSUR Frequency amended and DLP updated on 22/09/2016 Next DLP was amended on 07/04/2016 Next DLP updated on 30/09/2015 The next DLP was amended on 01/04/2015 The DLP was corrected on 08/08/2014 PSUSA/00010218/202702 Rhea Fitzgerald Ireland CAP 10220 ethanol (cutaneous route of administration) Not available* 16 years 15/06/2030 13/09/2030 No 06/10/2015 PSUSA/00010220/203006 NAP 10221 ethyl esters of iodised fatty acids from poppyseed oil 31/03/1978 15 years 31/01/2028 30/04/2028 No 02/07/2014 PSUSA/00010221/202801 NAP 10224 fluocinolone acetonide (intravitreal implant in applicator) 04/05/2012 3 years 26/08/2028 24/11/2028 No 27/05/2026 DLP was corrected on 27/05/2026 PSUR frequency amended and DLP updated on 29/04/2026 PSUSA/00010224/202808 Carla Torre Portugal NAP 10226 fusidic acid (systemic use) 31/05/1962 3 years 30/05/2028 28/08/2028 No 04/02/2026 DLP was amended on 04/02/2026 PSUSA/00010226/202805 Zoubida Amimour France NAP 10227 fusidic acid (topical use) 31/05/1962 9 years 03/03/2028 01/06/2028 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00010227/202803 Zoubida Amimour France NAP 10228 hydroxocobalamin (only for products for chemical poisoning) 23/11/2007 3 years 23/11/2028 21/02/2029 No 29/07/2026 DLP was amended on 29/07/2026 PSUSA/00010228/202811 Zoubida Amimour France CAP 10230 indapamide / perindopril, indapamide / ramipril 30/08/2001 5 years 25/11/2026 23/02/2027 No 22/10/2025 Active substance name was amended on 22/10/2025 PRAC representative updated on 31/01/2024 PSUSA/00010230/202611 Carla Torre Portugal NAP 10233 iron in any combination with multivitamins and/or minerals and/or aminoacids (except for combinations with folic acid) 09/05/1969 13 years 03/11/2032 01/02/2033 No 11/06/2025 DLP was amended on 23/10/2024 Active substance name was amended on 23/10/2024 PSUSA/00010233/203211 Guðrún Stefánsdóttir Iceland NAP 10234 iron in combination with folic acid and/or multivitamins and/or minerals and/or aminoacids 10/07/1962 13 years 03/11/2032 01/02/2033 No 16/01/2025 DLP was amended on 23/10/2024 Active substance name was amended on 23/10/2024 PSUSA/00010234/203211 Georgia Gkegka Greece NAP 10235 iron / oral preparations 01/01/1949 10 years 03/11/2032 01/02/2033 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00010235/203211 Zane Neikena Latvia NAP 10239 magnesium sulfate / sodium sulfate / potassium sulfate 05/08/2010 3 years 05/08/2027 03/11/2027 No 12/09/2025 DLP was amended on 02/04/2025 PSUSA/00010239/202708 Veronika Macurová Czech Republic NAP 10242 modafinil 01/09/1994 3 years 31/08/2026 29/11/2026 No 30/04/2024 PSUR frequency amended and DLP updated on 30/04/2024 PSUSA/00010242/202608 Dennis Lex Germany NAP 10245 olodaterol 18/09/2013 5 years 03/03/2029 01/06/2029 No 20/11/2024 PSUR frequency amended and DLP updated on 20/11/2024 PSUSA/00010245/202903 Bianca Mulder Netherlands NAP 10250 propranolol (centrally authorised product) 23/04/2014 5 years 23/04/2029 22/07/2029 No 19/09/2025 PSUR frequency amended and DLP updated on 18/12/2024 DLP and PSUR frequency were updated on 02/02/2022 PSUR frequency and DLP were updated on 20/11/2019 DLP was updated on 21/11/2018 DLP was updated on 19/12/2017 Next DLP was amended on 20/12/2016 PRAC Representative amended on 28/06/2016 PSUR Frequency amended and DLP updated on 03/06/2016 Next DLP was updated on 27/11/2015. Next DLP was amended on 16/06/2015 PSUSA/00010250/202904 Maria Martinez Gonzalez Spain CAP 10251 propranolol (except for centrally authorised product) 30/06/1965 8 years 30/06/2032 28/09/2032 Yes 05/03/2025 PSUR frequency amended and DLP updated on 05/03/2025 PSUSA/00010251/203206 Guðrún Stefánsdóttir Iceland NAP 10252 anti-t lymphocyte immunoglobulin for human use, rabbit 16/04/1984 3 years 30/06/2027 28/09/2027 No 04/03/2026 Active substance name was amended on 04/03/2026 DLP was amended on 05/03/2025 PSUSA/00010252/202706 Maia Uusküla Estonia NAP 10254 siltuximab 23/04/2014 3 years 22/04/2028 21/07/2028 No 06/10/2025 PRAC representative was updated on 01/03/2023 DLP was updated on 21/12/2022 PSUR frequency and DLP were updated on 18/12/2019 DLP was updated on 20/11/2019 DLP was updated on 21/11/2018 DLP was updated on 06/06/2018 PSUR Frequency amended and DLP updated on 19/12/2017 DLP was updated on 23/05/2017 Next DLP was amended on 20/12/2016 Next DLP was amended on 03/06/2016 Next DLP was updated on 27/11/2015. Next DLP was amended on 16/06/2015 The DLP was corrected on 27/07/2014 PSUSA/00010254/202804 Dirk Mentzer Germany CAP 10256 sodium feredetate Not available* 8 years 01/12/2026 01/03/2027 No 08/04/2026 DLP amended on 23/10/2024 PSUSA/00010256/202612 Tiphaine Vaillant France NAP 10262 trametinib 29/05/2014 3 years 29/05/2028 27/08/2028 No 04/02/2026 PSUR frequency amended and DLP updated on 04/02/2026 PSUSA/00010262/202805 David Olsen Norway CAP 10263 umeclidinium 16/04/2014 3 years 17/12/2027 16/03/2028 No 24/09/2025 DLP was amended on 24/09/2025 PSUSA/00010263/202712 Amelia Cupelli Italy CAP 10264 umeclidinium bromide / vilanterol 18/12/2013 3 years 17/12/2027 16/03/2028 No 24/09/2025 DLP was amended on 24/09/2025 PSUSA/00010264/202712 Amelia Cupelli Italy CAP 10266 varicella-zoster immunoglobuline 29/12/1995 5 years 31/12/2029 31/03/2030 No 06/10/2025 DLP was amended on 24/09/2025 PSUSA/00010266/202912 Dirk Mentzer Germany NAP 10268 everolimus (indicated for advanced renal cell carcinoma, advanced breast cancer, advanced neuroendocrine tumors (gastrointestinal, lung, pancreatic cancers) (NET) 03/08/2009 5 years 31/03/2029 29/06/2029 No 25/06/2025 Information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" was amended on 25/06/2025 Information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" was amended on 18/12/2024 PSUR frequency amended and DLP updated on 18/12/2024 Reference to NAP added on 30/03/2022 PSUR frequency and DLP were updated on 22/12/2021 Active substance name was updated on 03/02/2021 PSUR frequency and DLP were amended on 15/11/2017 DLP was updated on 18/11/2016 The Next DLP was amended on 29/10/2015. PSUSA/00010268/202903 Dennis Lex Germany CAP NAP 10269 everolimus (indicated for rejection of transplanted organs) 08/07/2003 3 years 31/07/2027 29/10/2027 No 02/06/2026 PSUSA/00010269/202707 Karin Bolin Sweden NAP 10270 paracetamol / pseudoephedrine hydrochloride / triprolidine hydrochloride Not available* 8 years 03/11/2036 01/02/2037 No 30/07/2025 DLP was amended on 30/07/2025 PSUSA/00010270/203611 Amelia Cupelli Italy NAP 10271 ezetimibe / rosuvastatin 24/07/2014 3 years 24/07/2026 22/10/2026 No 27/03/2024 DLP was amended on 27/03/2024 PSUSA/00010271/202607 Barbara Kovacic Bytyqi Croatia NAP 10273 brinzolamide / brimonidine tartrate 18/07/2014 5 years 30/06/2027 28/09/2027 No 01/03/2023 PSUR frequency and DLP were updated on 01/03/2023 DLP was updated on 03/03/2021 PSUR frequency amended and DLP updated on 06/02/2019 PRAC Rapporteur name updated on 19/12/2018 DLP was amended on 31/01/2018 Next DLP updated on 30/01/2017 PSUR Frequency amended and DLP updated on 04/02/2016 PSUR Frequency and Next DLP amended on 31/07/2015 The Next DLP was amended on 01/12/2014 New CAP authorised on 18/07/2014 PSUSA/00010273/202706 Eamon O Murchu Ireland CAP 10275 peginterferon beta-1A 18/07/2014 3 years 18/07/2027 16/10/2027 No 05/02/2025 PSUR frequency and DLP corrected on 02/04/2025 PSUR frequency amended and DLP updated on 05/02/2025 PSUR Frequency and next DLP were updated on 02/03/2022 DLP was updated on 03/03/2021 DLP was updated on 04/03/2020 Next DLP, Lead MS and PRAC Rapporteur name were amended on 06/03/2019 DLP was updated on 28/02/2018 PSUR Frequency amended and next DLP updated on 25/09/2017 Next DLP was amended on 28/02/2017 Next DLP was updated on 22/09/2016 DLP and Next DLP were updated on 04/03/2016 Next DLP was updated on 30/09/2015 PSUSA/00010275/202707 Karin Bolin Sweden CAP 10276 simoctocog alfa 22/07/2014 2 years 22/01/2027 22/04/2027 No 02/06/2026 DLP was amended on 24/09/2025 PSUSA/00010276/202701 Karin Bolin Sweden CAP 10279 obinutuzumab 01/11/2013 3 years 31/10/2026 29/01/2027 No 02/06/2026 PSUSA/00010279/202610 Jenny-Maria Jönsson Sweden CAP 10280 acetylsalicylic acid / atorvastatin / ramipril 20/02/2014 3 years 20/02/2026 21/05/2026 No 18/10/2023 Next DLP was updated on 18/10/2023 PSUSA/00010280/202602 Jan Neuhauser Austria NAP 10283 gaxilose 10/11/2011 9 years 09/11/2032 07/02/2033 No 05/06/2024 Entry re-activated and DLP updated on 05/06/2024 PRAC Representative name was corrected on 29/07/2020 PRAC Representative updated on 26/09/2018 PSUR Frequency amended and next DLP updated on 25/09/2017 Next DLP was updated on 22/09/2016 PRAC Rapporteur name updated on 03/06/2016 PSUR Frequency amended and DLP updated on 07/04/2016 Active Substance corrected on 21/12/2015. Next DLP was updated on 30/09/2015 Lead MS was added on 22/12/2014 PSUSA/00010283/203211 Maria del Pilar Rayon Spain NAP 10285 solifenacin / tamsulosin 06/05/2013 5 years 01/07/2026 29/09/2026 No 31/01/2024 PRAC representative updated on 31/01/2024 PSUSA/00010285/202607 Bianca Mulder Netherlands NAP 10287 acetylsalicylic acid / bisoprolol 05/11/2010 7 years 05/11/2031 03/02/2032 No 17/02/2026 PSUR frequency amended and DLP updated on 30/07/2025 PSUSA/00010287/203111 Jana Pecherova Slovakia NAP 10288 clevidipine 23/11/2011 3 years 23/11/2026 21/02/2027 No 03/07/2024 PSUR frequency amended and DLP updated on 03/07/2024 PSUSA/00010288/202611 Jan Neuhauser Austria NAP 10289 lisdexamfetamine 23/02/2007 3 years 22/02/2028 22/05/2028 No 22/10/2025 PSUR frequency amended and DLP updated on 22/10/2025 PSUSA/00010289/202802 Karin Bolin Sweden NAP 10291 misoprostol (gastrointestinal indication) 28/06/1984 3 years 30/06/2028 28/09/2028 Yes 01/04/2026 Correction of DLP on 01/04/2026 PSUR frequency amended and DLP updated on 04/03/2026 PSUSA/00010291/202806 Marie Louise Schougaard Christiansen Denmark NAP 10292 triamcinolone (intraocular formulations) 31/03/2011 3 years 31/03/2028 29/06/2028 No 17/12/2025 PSUR frequency amended and DLP updated on 17/12/2025 PSUSA/00010292/202803 Carla Torre Portugal NAP 10293 flutemetamol (18f) 22/08/2014 3 years 31/10/2027 29/01/2028 No 25/06/2025 DLP was amended on 25/06/2025 PSUSA/00010293/202710 Dennis Lex Germany CAP 10296 sucroferric oxyhydroxide 27/11/2013 3 years 26/11/2027 24/02/2028 No 30/07/2025 DLP was amended on 30/07/2025 PSUSA/00010296/202711 Kimmo Jaakkola Finland CAP 10297 human fibrinogen / human thrombin 08/06/2004 3 years 08/06/2026 06/09/2026 No 06/10/2025 DLP was amended on 31/01/2024 PSUSA/00010297/202606 Dirk Mentzer Germany CAP 10298 influenza vaccine (split virion, inactivated) (non centrally authorised products) 08/08/1996 1 year 15/03/2026 24/05/2026 15/03/2027 24/05/2027 No 22/10/2025 DLP was amended on 22/10/2025 PSUSA/00010298/202603 PSUSA/00010298/202703 Dirk Mentzer Germany NAP 10300 influenza vaccine (surface antigen, inactivated, adjuvanted) 20/09/2010 1 year 15/03/2026 24/05/2026 15/03/2027 24/05/2027 No 22/10/2025 DLP was amended on 22/10/2025 PSUSA/00010300/202603 PSUSA/00010300/202703 Jean-Michel Dogné Belgium CAP 10301 ibrutinib 13/11/2013 3 years 12/11/2028 10/02/2029 No 29/07/2026 PSUR frequency amended and DLP updated on 29/07/2026 PSUSA/00010301/202811 Barbara Kovacic Bytyqi Croatia CAP 10302 ibuprofen / paracetamol Not available* 8 years 03/11/2026 01/02/2027 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00010302/202611 Lina Šeibokienė Lithuania NAP 10303 idelalisib 23/07/2014 5 years 22/07/2029 20/10/2029 No 02/04/2025 PSUR frequency amended and DLP updated on 02/04/2025 PSUSA/00010303/202907 Dennis Lex Germany CAP 10304 folinic acid, (di)sodium folinate, levomefolic acid 03/04/1982 15 years 03/04/2029 02/07/2029 No 28/02/2018 Entry name amended on 28/02/2018 PSUSA/00010304/202904 NAP 10305 Phenol / halogenated phenols / sodium salicylate / chloroxylenol / triclosan 07/07/1988 13 years 30/06/2027 28/09/2027 No 22/12/2014 PSUSA/00010305/202706 NAP 10306 sofosbuvir / ledipasvir 10/10/2014 5 years 09/10/2029 07/01/2030 No 25/06/2025 PSUR frequency amended and DLP updated on 25/06/2025 PSUSA/00010306/202910 Ana Sofia Diniz Martins Portugal CAP 10307 aclidinium bromide / formoterol fumarate dihydrate 19/11/2014 3 years 19/11/2028 17/02/2029 No 29/07/2026 DLP was amended on 29/07/2026 PSUSA/00010307/202811 Adam Przybylkowski Poland CAP 10311 dulaglutide 18/09/2014 3 years 18/09/2027 17/12/2027 No 27/07/2022 PRAC representative was updated on 27/07/2022 PSUR frequency and DLP were updated on 28/04/2022 PSUR frequency and DLP were corrected on 26/05/2021 PSUR frequency and DLP were updated on 28/04/2021 DLP was updated on 06/05/2020 PRAC representative was updated on 25/09/2019 DLP was updated on 30/04/2019 PRAC Rapporteur name amended on 04/07/2018 DLP was updated on 07/05/2018 PSUR Frequency amended and DLP updated on 17/10/2017 Next DLP was amended on 26/04/2017 Next DLP was amended on 19/10/2016 Next DLP was amended on 03/05/2016 The Next DLP was amended on 29/10/2015. New CAP authorised on 21/11/2014 PSUSA/00010311/202709 Amelia Cupelli Italy CAP 10312 omega-3-acid ethyl esters 12/07/2000 3 years 22/01/2028 21/04/2028 No 24/09/2025 PSUR frequency amended and DLP updated on 24/09/2025 PSUSA/00010312/202801 Amelia Cupelli Italy NAP 10314 afamelanotide 22/12/2014 2 years 22/06/2027 20/09/2027 No 04/03/2026 DLP was amended on 04/03/2026 PSUSA/00010314/202706 Dennis Lex Germany CAP 10315 darunavir / cobicistat 19/11/2014 3 years 18/05/2026 16/08/2026 No 31/01/2024 DLP was amended on 31/01/2024 PSUSA/00010315/202605 Amelia Cupelli Italy CAP 10316 ketoconazole (centrally authorised product only) 19/11/2014 3 years 19/11/2027 17/02/2028 Yes 30/07/2025 DLP was amended on 30/07/2025 PSUSA/00010316/202711 Petar Mas Croatia CAP 10317 naloxegol 16/09/2014 3 years 15/09/2027 14/12/2027 No 30/04/2025 PSUR frequency amended and DLP updated on 30/04/2025 PSUSA/00010317/202709 Eamon O Murchu Ireland CAP 10318 nintedanib (oncology indications) 15/10/2014 3 years 15/10/2028 13/01/2029 No 01/07/2026 DLP was amended on 01/07/2026 PSUSA/00010318/202810 Georgia Gkegka Greece CAP 10319 nintedanib (respiratory indication) 15/10/2014 6 months 15/04/2026 24/06/2026 15/10/2026 24/12/2026 No 01/07/2026 DLP was amended on 01/07/2026 PSUSA/00010319/202604 PSUSA/00010319/202610 Barbara Kovacic Bytyqi Croatia CAP 10320 nonacog gamma 19/12/2014 3 years 30/06/2026 28/09/2026 No 06/10/2025 DLP was amended on 28/02/2024 PSUSA/00010320/202606 Dirk Mentzer Germany CAP 10321 oestrogens conjugated / bazedoxifene 16/12/2014 5 years 02/04/2030 01/07/2030 No 17/12/2025 PSUR frequency amended and DLP updated on 17/12/2025 PSUSA/00010321/203004 Dennis Lex Germany CAP 10322 olaparib 16/12/2014 3 years 15/12/2027 14/03/2028 No 30/07/2025 PSUR frequency amended and DLP updated on 30/07/2025 PSUSA/00010322/202712 Amelia Cupelli Italy CAP 10323 ramucirumab 21/04/2014 3 years 21/04/2028 20/07/2028 No 06/10/2025 PRAC representative was updated on 01/03/2023 DLP was updated on 21/12/2022 PSUR frequency and DLP were updated on 20/11/2019 DLP was updated on 21/11/2018 DLP was updated on 19/12/2017 PSUR Frequency amended and DLP updated on 23/05/2017 Next DLP was amended on 20/12/2016 Next DLP was amended on 03/06/2016 Next DLP was updated on 27/11/2015. New CAP authorised on 19/12/2014. PSUSA/00010323/202804 Dirk Mentzer Germany CAP 10324 tafluprost / timolol 02/12/2014 3 years 02/12/2026 02/03/2027 No 31/07/2024 DLP was amended on 31/07/2024 PSUSA/00010324/202612 Dennis Lex Germany NAP 10325 yttrium (90Y) citrate 28/10/1985 10 years 27/10/2035 25/01/2036 Yes 23/10/2024 Information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" was amended on 23/10/2024 DLP was amended on 23/10/2024 DLP was amended on 03/07/2024 PSUSA/00010325/203510 Amelia Cupelli Italy NAP 10326 fosfomycin (oral formulation) 27/08/1986 5 years 31/07/2027 29/10/2027 No 19/09/2024 PSUSA/00010326/202707 Zoubida Amimour France NAP 10330 salbutamol 31/01/1969 3 years 31/01/2026 01/05/2026 No 18/10/2023 Next DLP was updated on 18/10/2023 PSUSA/00010330/202601 Melinda Palfi Hungary NAP 10332 porfimer 19/04/1993 3 years 19/04/2026 18/07/2026 No 20/12/2023 DLP was amended on 20/12/2023 PSUSA/00010332/202604 Petar Mas Croatia NAP 10333 tixocortol, chlorhexidine gluconate / tixocortol pivalate 18/11/1976 5 years 01/11/2027 30/01/2028 No 19/09/2024 PSUSA/00010333/202711 Zoubida Amimour France NAP 10335 bupivacaine, bupivacaine / epinephrine 27/04/1966 5 years 26/04/2029 25/07/2029 No 18/12/2024 DLP was amended on 18/12/2024 PSUSA/00010335/202904 Zane Neikena Latvia NAP 10336 fosfomycin (IV formulation) 13/07/1983 5 years 31/07/2027 29/10/2027 No 19/09/2024 PSUSA/00010336/202707 Zoubida Amimour France NAP 10338 apremilast 21/03/2014 3 years 20/03/2028 18/06/2028 No 19/11/2025 DLP was amended on 19/11/2025 PSUSA/00010338/202803 Maria Martinez Gonzalez Spain CAP 10339 fluticasone propionate / formoterol fumarate dihydrate 23/08/2012 5 years 31/07/2026 29/10/2026 No 02/06/2026 PSUSA/00010339/202607 Karin Bolin Sweden NAP 10340 ospemifene 26/02/2013 3 years 26/02/2027 27/05/2027 No 20/10/2021 PSUR frequency and DLP were updated on 20/10/2021 DLP was updated on 21/10/2020 DLP was updated on 25/09/2019 Lead MS and PRAC Rapporteur name updated on 30/04/2019 DLP was updated on 26/09/2018 PSUR frequency amended and DLP updated on 27/03/2018 DLP was updated on 17/10/2017 DLP was updated on 28/03/2017 Next DLP was amended on 19/10/2016 Next DLP was amended on 07/04/2016 New CAP authorised on 15/01/2015. PSUSA/00010340/202702 Terhi Lehtinen Finland CAP 10341 secukinumab 26/12/2014 3 years 25/12/2026 25/03/2027 No 19/09/2025 DLP was amended on 25/09/2024 PSUSA/00010341/202612 Maria Martinez Gonzalez Spain CAP 10342 diclofenac (topical formulations), diclofenac / heparin 11/05/1977 6 years 30/09/2029 29/12/2029 No 03/07/2024 Active substance name was amended on 03/07/2024 PSUR frequency amended and DLP updated on 05/06/2024 PSUSA/00010342/202909 Karin Erneholm Denmark NAP 10344 amlodipine / valsartan, amlodipine / hydrochlorothiazide / valsartan 16/01/2007 5 years 30/06/2026 28/09/2026 No 02/03/2022 DLP was updated on 02/03/2022 Correction of Reference to NAP added on 20/10/2021 PRAC Rapporteur name was corrected on 03/04/2019 PRAC Rapporteur name was amended on 06/06/2018 PRAC Representative amended on 17/10/2017 DLP was updated on 28/03/2017 PSUSA/00010344/202606 Karin Erneholm Denmark CAP NAP 10346 aprotinin / calcium chloride / human factor xiii / human fibrinogen / human thrombin, aprotinin / fibrinogen / fibronectin / human coagulation factor XIII / plasma protein fraction / plasminogen / thrombin, aprotinin / human fibrinogen / thrombin / calcium chloride, aprotinin / calcium chloride / factor xiii / human thrombin / human clottable protein containing mainly fibrinogen and fibronectin, calcium chloride / human fibrinogen / factor xiii / fibronectin / plasminogen / human thrombin / bovine aprotinin, calcium chloride / human fibrinogen / factor xiii / fibronectin / human thrombin / bovine aprotinin, human fibrinogen / calcium chloride dihydrate / plasma fibronectin / thrombin / bovine aprotinin / human coagulation factor xiii, human fibrinogen / calcium chloride dihydrate / plasma protein fraction / fibronectin / thrombin / bovine aprotinin / human coagulation factor xiii, human fibrinogen / plasminogen / human thrombin / bovine aprotinin / human coagulation factor xiii / human fibronectin Not available* 5 years 30/11/2026 28/02/2027 No 06/10/2025 PRAC representative was updated on 01/03/2023 DLP was updated on 27/07/2022 Next DLP was amended on 25/09/2017 Lead MS and PRAC Rapporteur name was added on 28/07/2016 The name of the active substance was amended on 06/10/2015 PSUSA/00010346/202611 Dirk Mentzer Germany NAP 10347 atorvastatin 07/11/1996 6 years 31/10/2029 29/01/2030 No 03/07/2024 DLP was amended on 03/07/2024 PSUSA/00010347/202910 Dennis Lex Germany NAP 10348 carmustine (implant) 23/09/1996 5 years 23/09/2029 22/12/2029 No 25/05/2022 DLP was updated on 25/05/2022 PRAC representative was updated on 29/07/2020 PRAC representative was updated on 03/06/2020 DLP was updated 05/06/2019 PRAC Rapporteur name updated on 21/07/2017 PRAC Rapporteur name was amended on 28/07/2016 Next DLP was amended on 03/06/2016 PRAC Rapporteur name updated on 07/04/2016 PRAC Rapporteur name updated on 04/02/2016 DLP was amended on 16/06/2015 PSUSA/00010348/202909 Tiphaine Vaillant France NAP 10349 carmustine (powder and solvent for solution for infusion) 23/04/1974 5 years 22/04/2029 21/07/2029 No 18/12/2024 PSUR frequency amended and DLP updated on 18/12/2024 PSUSA/00010349/202904 Tiphaine Vaillant France NAP 10350 dalbavancin 23/05/2014 3 years 22/11/2026 20/02/2027 No 31/07/2024 DLP was amended on 31/07/2024 PSUSA/00010350/202611 Rugile Pilviniene Lithuania CAP 10351 eliglustat 19/01/2015 3 years 19/08/2027 17/11/2027 No 30/04/2025 PSUR frequency amended and DLP updated on 30/04/2025 PSUSA/00010351/202708 Maria del Pilar Rayon Spain CAP 10352 ex vivo expanded autologous human corneal epithelial cells containing stem cells 17/02/2015 1 year 17/02/2026 28/04/2026 17/02/2027 28/04/2027 No 22/10/2025 DLP was amended on 22/10/2025 PSUSA/00010352/202602 PSUSA/00010352/202702 Eamon O Murchu Ireland CAP 10353 misoprostol (gynaecological indication - labour induction) Not available* 3 years 31/05/2028 29/08/2028 Yes 04/02/2026 PSUR frequency amended and DLP updated on 04/02/2026 PSUSA/00010353/202805 Marie Louise Schougaard Christiansen Denmark NAP 10354 misoprostol (gynaecological indication - termination of pregnancy) Not available* 3 years 31/05/2026 29/08/2026 Yes 31/01/2024 DLP was amended on 31/01/2024 PSUSA/00010354/202605 Marie Louise Schougaard Christiansen Denmark NAP 10355 phloroglucinol, phloroglucinol / trimethylphloroglucinol, phloroglucinol / simeticone 18/02/1992 3 years 30/09/2027 29/12/2027 No 02/04/2025 Active substance name was amended on 02/04/2025 PSUSA/00010355/202709 Zoubida Amimour France NAP 10356 safinamide 24/02/2015 5 years 24/02/2028 24/05/2028 No 18/10/2023 PSUR frequency amended and DLP updated on 18/10/2023 PSUSA/00010356/202802 Eamon O Murchu Ireland CAP 10358 amlodipine / indapamide, amlodipine / indapamide / perindopril 23/09/2013 5 years 25/11/2027 23/02/2028 No 31/01/2024 PRAC representative updated on 31/01/2024 PSUSA/00010358/202711 Bianca Mulder Netherlands NAP 10359 benzoyl peroxide hydrous / potassium hydroxyquinoline sulphate 03/02/1987 13 years 30/03/2033 28/06/2033 No 19/10/2022 Entry re-activated on 19/10/2022 LMS and PRAC representative were added on 06/05/2020 PSUSA/00010359/203303 Eamon O'Murchu Ireland NAP 10360 cangrelor 23/03/2015 3 years 23/03/2028 21/06/2028 No 19/11/2025 DLP was amended on 19/11/2025 PSUSA/00010360/202803 Amelia Cupelli Italy CAP 10361 chlorphenoxamine Not available* 9 years 17/05/2027 15/08/2027 Yes 26/07/2023 Information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" was amended on 26/07/2023 Active substance name, PSUR frequency and DLP were amended on 26/07/2023 DLP was updated on 06/02/2019 PRAC representative added on 17/10/2017 PSUSA/00010361/202705 Eva Jirsová Czech Republic NAP 10362 ciclosporin (topical use) 19/03/2015 1 year 19/03/2026 28/05/2026 19/03/2027 28/05/2027 No 22/10/2025 DLP was amended on 22/10/2025 PSUSA/00010362/202603 PSUSA/00010362/202703 Jan Neuhauser Austria CAP NAP 10364 germanium (68Ge) chloride / gallium (68Ga) chloride 15/09/2014 5 years 15/03/2030 13/06/2030 No 19/11/2025 PSUR frequency amended and DLP updated on 19/11/2025 PSUSA/00010364/203003 Eva Jirsová Czech Republic CAP NAP 10366 naltrexone / bupropion 26/03/2015 1 year 09/09/2026 18/11/2026 09/09/2027 18/11/2027 No 29/04/2026 DLP was amended on 29/04/2026 PSUSA/00010366/202609 PSUSA/00010366/202709 Dennis Lex Germany CAP 10368 oritavancin 19/03/2015 1 year 11/03/2026 20/05/2026 11/03/2027 20/05/2027 No 04/02/2026 DLP was amended on 04/02/2026 DLP was amended on 22/10/2025 PSUSA/00010368/202603 PSUSA/00010368/202703 Adam Przybylkowski Poland CAP 10369 tedizolid phosphate 20/06/2014 3 years 20/06/2026 18/09/2026 No 28/02/2024 DLP was amended on 28/02/2024 PSUSA/00010369/202606 Maria del Pilar Rayon Spain CAP 10370 tobramycin (nebuliser solution) (centrally authorised product only) 18/03/2015 3 years 18/09/2028 17/12/2028 No 27/05/2026 DLP was amended on 27/05/2026 PSUSA/00010370/202809 Karin Bolin Sweden CAP 10372 ceritinib 29/04/2014 3 years 28/10/2028 26/01/2029 No 01/07/2026 DLP was amended on 01/07/2026 PSUSA/00010372/202810 Jenny-Maria Jönsson Sweden CAP 10373 raltegravir 26/03/2015 3 years 26/09/2028 25/12/2028 No 01/07/2026 PSUR frequency amended and DLP updated on 01/07/2026 PSUSA/00010373/202809 Zoubida Amimour France CAP 10374 amitriptyline, amitriptyline / amitriptylinoxide, amitriptylinoxide 31/07/1961 3 years 10/01/2027 10/04/2027 No 25/09/2024 DLP was amended on 25/09/2024 PSUSA/00010374/202701 Georgia Gkegka Greece NAP 10376 ivermectin (topical use) 22/03/2015 3 years 22/04/2027 21/07/2027 No 18/12/2024 DLP was amended on 18/12/2024 PSUSA/00010376/202704 Zoubida Amimour France NAP 10377 ivermectin (systemic use) 15/10/1987 3 years 14/04/2028 13/07/2028 No 19/09/2024 PSUSA/00010377/202804 Zoubida Amimour France NAP 10378 mifepristone / misoprostol Not available* 3 years 31/05/2026 29/08/2026 No 31/01/2024 DLP was amended on 31/01/2024 PSUSA/00010378/202605 Bianca Mulder Netherlands NAP 10379 nivolumab 04/09/2014 3 years 03/07/2027 01/10/2027 No 05/03/2025 DLP was amended on 05/03/2025 PSUSA/00010379/202707 Dirk Mentzer Germany CAP 10380 lenvatinib 13/02/2015 3 years 12/02/2027 13/05/2027 No 02/06/2026 PSUSA/00010380/202702 Jenny Jönsson Sweden CAP 10382 tioconazole, tioconazole / hydrocortisone 13/04/1981 13 years 01/04/2030 30/06/2030 No 31/01/2024 PRAC representative updated on 31/01/2024 PSUSA/00010382/203004 Carla Torre Portugal NAP 10385 atorvastatin / ezetimibe 13/11/2014 7 years 15/07/2030 13/10/2030 No 27/03/2024 PSUR frequency amended and DLP updated on 27/03/2024 PSUSA/00010385/203007 Dennis Lex Germany NAP 10386 colecalciferol, colecalciferol / calcium, ergocalciferol, ergocalciferol / calcium Not available* 5 years 31/10/2029 29/01/2030 No 25/06/2025 DLP was amended on 25/06/2025 PSUSA/00010386/202910 Jan Neuhauser Austria NAP 10387 edoxaban 22/04/2011 3 years 21/10/2026 19/01/2027 No 19/09/2024 PSUSA/00010387/202610 Zoubida Amimour France CAP 10388 empagliflozin, empagliflozin / metformin 17/04/2014 2 years 17/04/2026 16/07/2026 No 18/12/2024 DLP was amended on 18/12/2024 PSUSA/00010388/202604 Maria del Pilar Rayon Spain CAP 10389 human papillomavirus 9-valent vaccine (recombinant, adsorbed) 10/12/2014 3 years 09/06/2028 07/09/2028 No 04/02/2026 DLP was amended on 04/02/2026 PSUSA/00010389/202806 Jean-Michel Dogné Belgium CAP 10390 lidocaine hydrochloride / phenylephrine hydrochloride / tropicamide 02/07/2015 5 years 21/07/2029 19/10/2029 No 02/04/2025 PSUR frequency amended and DLP updated on 02/04/2025 PSUSA/00010390/202907 Karin Erneholm Denmark NAP 10391 lutetium (177Lu) chloride 19/06/2015 3 years 19/12/2026 19/03/2027 Yes 25/09/2024 New CAP authorised on 26/03/2026 New CAP authorised on 22/11/2024 DLP was amended on 25/09/2024 PSUSA/00010391/202612 Rhea Fitzgerald Ireland CAP NAP 10392 macrogol 4000, macrogol 4000 combinations (oral use) 05/05/1995 5 years 31/05/2027 29/08/2027 No 19/09/2024 PSUSA/00010392/202705 Zoubida Amimour France NAP 10393 netupitant / palonosetron 10/10/2014 5 years 10/10/2029 08/01/2030 No 25/06/2025 PSUR frequency amended and DLP updated on 25/06/2025 PSUSA/00010393/202910 Amelia Cupelli Italy CAP 10394 tasimelteon 03/07/2015 3 years 03/07/2027 01/10/2027 No 05/02/2025 PSUR frequency amended and DLP updated on 05/02/2025 PSUSA/00010394/202707 Adam Przybylkowski Poland CAP 10395 tolvaptan (indicated for adults with autosomal dominant polycystic kidney disease (ADPKD)) 27/05/2015 3 years 18/05/2027 16/08/2027 No 05/02/2025 DLP was amended on 05/02/2025 PSUSA/00010395/202705 Amelia Cupelli Italy CAP 10396 valsartan, hydrochlorothiazide / valsartan 13/05/1996 5 years 30/04/2030 29/07/2030 No 02/06/2026 PSUSA/00010396/203004 Karin Bolin Sweden NAP 10398 chlorhexidine / phenol Not available* 13 years 16/03/2028 14/06/2028 No 06/10/2015 New active substance added on 06/10/2015 PSUSA/00010398/202803 NAP 10399 betamethasone dipropionate / clotrimazole / gentamicin 02/12/1986 9 years 01/12/2028 01/03/2029 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00010399/202812 Petar Mas Croatia NAP 10400 tinidazole, nystatin / tinidazole 15/06/1972 10 years 01/12/2034 01/03/2035 No 05/01/2025 Correction of DLP on 20/11/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00010400/203412 Adam Przybylkowski Poland NAP 10401 phenylephrine (IV, nasal or oral formulations ) 01/01/1940 13 years 01/01/2028 31/03/2028 No 29/10/2015 PSUSA/00010401/202801 NAP 10402 phenylephrine (ophthalmic formulations) 01/01/1940 5 years 01/01/2030 01/04/2030 No 24/09/2025 DLP was amended on 24/09/2025 PSUSA/00010402/203001 Eva Jirsová Czech Republic NAP 10403 pembrolizumab 04/09/2014 3 years 03/09/2027 02/12/2027 No 30/04/2025 PSUR frequency amended and DLP updated on 30/04/2025 PSUSA/00010403/202709 Bianca Mulder Netherlands CAP 10404 atazanavir / cobicistat 29/01/2015 5 years 28/01/2029 28/04/2029 No 19/09/2024 PSUSA/00010404/202901 Tiphaine Vaillant France CAP 10405 evolocumab 17/07/2015 3 years 17/07/2026 15/10/2026 No 27/03/2024 DLP was amended on 27/03/2024 PSUSA/00010405/202607 Kimmo Jaakkola Finland CAP 10406 1-propanol / isopropyl alcohol (covers other synonymous terms such as 2-propanol) / orthophenylphenol 23/10/1980 10 years 23/10/2029 21/01/2030 No 04/02/2026 Active substance name was amended on 04/02/2026 PSUR frequency and DLP were updated on 01/07/2020 Lead MS and PRAC Rapporteur name added on 03/04/2019 Entry name changed and Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended? Yes/No was updated on 07/05/2018 New substance added on 27/11/2015 PSUSA/00010406/202910 Adam Przybylkowski Poland NAP 10407 dibrompropamidine , propamidine 16/01/1959 11 years 02/04/2038 01/07/2038 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00010407/203804 Rhea Fitzgerald Ireland NAP 10408 sonidegib 30/06/2015 2 years 29/06/2026 27/09/2026 No 05/02/2025 PSUR frequency amended and DLP updated on 05/02/2025 PSUSA/00010408/202606 Petar Mas Croatia CAP 10409 panobinostat 23/02/2015 3 years 22/08/2026 20/11/2026 No 16/01/2025 PSUR frequency amended and DLP updated on 27/03/2024 PSUSA/00010409/202608 Georgia Gkegka Greece CAP 10410 human alfa1-proteinase inhibitor (centrally authorised product) 20/08/2015 5 years 31/12/2026 31/03/2027 No 22/10/2025 DLP was amended on 22/10/2025 PSUR frequency amended and DLP updated on 03/05/2023 PRAC Representative name was corrected on 29/07/2020 PSUR frequency and DLP were updated on 01/04/2020 DLP was updated on 03/04/2019 PRAC Representative updated on 26/09/2018 DLP was updated on 27/03/2018 PSUR Frequency amended and DLP updated on 17/10/2017 DLP was updated on 28/03/2017 Next DLP was updated on 22/09/2016 PRAC Representative amended on 28/06/2016 Entry name amended on 03/05/2016 New CAP was authorised on 20/08/2015 PSUSA/00010410/202612 Maria Martinez Gonzalez Spain CAP 10411 ceftolozane / tazobactam 19/12/2014 3 years 19/12/2026 19/03/2027 No 25/09/2024 DLP was amended on 25/09/2024 PSUSA/00010411/202612 Adam Przybylkowski Poland CAP 10412 idebenone (centrally authorised products) 08/09/2015 3 years 08/09/2027 07/12/2027 No 28/05/2025 PSUR frequency amended and DLP updated on 28/05/2025 DLP was amended on 30/04/2025 PSUSA/00010412/202709 Amelia Cupelli Italy CAP 10413 guanfacine 17/09/2015 3 years 17/03/2027 15/06/2027 No 20/11/2024 New CAP authorised on 26/02/2025 DLP was amended on 20/11/2024 PSUSA/00010413/202703 Maria del Pilar Rayon Spain CAP 10414 1-propanol / isopropyl alcohol (covers other synonymous terms such as 2-propanol) / lactic acid 07/09/1981 10 years 07/09/2029 06/12/2029 No 04/02/2026 Active substance name was amended on 04/02/2026 PSUR frequency and DLP were updated on 03/06/2020 LMS and PRAC representatives were added on 31/07/2019 Procedure number was corrected on 18/11/2016 New substance added on 27/11/2015 PSUSA/00010414/202909 Adam Przybylkowski Poland NAP 10415 demeclocycline / triamcinolone Not available* 13 years 13/07/2030 11/10/2030 No 27/11/2015 DLP was updated on 27/03/2018 Lead MS and PRAC Rapporteur name was added on 20/12/2016 New active substance added on 27/11/2015 PSUSA/00010415/203007 Eva Jirsová Czech Republic NAP 10416 ethanol / orthophenylphenol 05/02/1997 10 years 05/02/2029 06/05/2029 No 13/08/2025 PSUR frequency and DLP were updated on 23/10/2019 Lead MS and PRAC Rapporteur name added on 31/07/2018 Active substance name was amended on 20/12/2016 New active substance added on 27/11/2015 PSUSA/00010416/202902 Veronika Macurová Czech Republic NAP 10417 octenidine dihydrochloride / 1-propanol / isopropyl alcohol (covers other synonymous terms such as 2-propanol) 30/01/1987 10 years 30/01/2034 30/04/2034 No 04/02/2026 Active substance name was amended on 04/02/2026 PRAC Rapporteur updated on 15/11/2023 PSUSA/00010417/203401 Barbara Kovacic Bytyqi Croatia NAP 10421 asfotase alfa 03/07/2015 3 years 03/07/2026 01/10/2026 No 28/02/2024 PSUR frequency amended and DLP updated on 28/02/2024 PSUSA/00010421/202607 Eamon O Murchu Ireland CAP 10422 sebelipase alfa 28/08/2015 3 years 28/08/2027 26/11/2027 No 02/06/2026 PSUSA/00010422/202708 Karin Bolin Sweden CAP 10423 alirocumab 24/07/2015 3 years 24/07/2027 22/10/2027 No 06/10/2025 DLP was amended on 02/04/2025 PSUSA/00010423/202707 Dirk Mentzer Germany CAP 10424 glucose (apart from glucose1- phosphate), glucose in combination with calcium chloride and/or sodium chloride and/or magnesium chloride and/or sodium citrate and/or potassium chloride and/or sodium acetate (intravenous or parenteral use except haemodialysis, hemodiafiltration), potassium phosphate / sodium chloride / glucose / lactic acid / magnesium chloride / sodium lactate / potassium chloride 22/03/1971 10 years 02/09/2034 01/12/2034 Yes 17/12/2025 Active substance name was amended on 17/12/2025 Active substance name was amended on 05/06/2024 Information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?", PSUR frequency and DLP were amended on 26/07/2023 Active substance name, PSUR frequency and DLP were amended on 03/05/2023 Active substance name was amended on 23/10/2018 New active substance added on 21/12/2015 PSUSA/00010424/203409 none NAP 10425 inosine pranobex 01/08/1978 5 years 01/08/2028 30/10/2028 No 27/01/2026 DLP was amended on 27/03/2024 PSUSA/00010425/202808 Roxana Stefania Udrescu Romania NAP 10426 isavuconazole 06/09/2015 3 years 06/09/2027 05/12/2027 No 30/04/2025 DLP was amended on 30/04/2025 PSUSA/00010426/202709 Adam Przybylkowski Poland CAP 10427 linagliptin, linagliptin / metformin 24/08/2011 3 years 02/05/2027 31/07/2027 No 05/02/2025 DLP was amended on 05/02/2025 PSUSA/00010427/202705 Bianca Mulder Netherlands CAP NAP 10428 sterculia, frangula / sterculia 01/12/1955 10 years 28/02/2034 29/05/2034 No 31/07/2018 New active substances added to the entry on 31/07/2018 New Active Substance was added on 21/12/2015. PSUSA/00010428/203402 Guðrún Stefánsdóttir Iceland NAP 10429 levofloxacin (Inhalation use) 26/03/2015 5 years 26/05/2030 24/08/2030 No 04/02/2026 PSUR frequency amended and DLP updated on 04/02/2026 PSUSA/00010429/203005 Maria del Pilar Rayon Spain CAP 10430 phenylephrine / tropicamide Not available* 7 years 08/11/2032 06/02/2033 No 29/07/2026 PSUR frequency amended and DLP updated on 29/07/2026 PSUSA/00010430/203211 Karin Erneholm Denmark NAP 10431 amlodipine / atorvastatin / perindopril, amlodipine / atorvastatin / ramipril 31/07/2015 5 years 22/10/2030 20/01/2031 No 01/07/2026 DLP was amended on 01/07/2026 PSUSA/00010431/203010 Veronika Macurová Czech Republic NAP 10432 timolol (systemic use) 06/12/1990 7 years 13/10/2031 11/01/2032 No 12/09/2025 PSUR frequency amended and DLP updated on 25/06/2025 PSUSA/00010432/203110 Veronika Macurová Czech Republic NAP 10433 horse anti-T lymphocyte immunoglobulin for human use 17/11/1981 5 years 16/11/2027 14/02/2028 No 05/03/2025 Active substance name was amended on 05/03/2025 Next DLP was updated on 26/07/2023 PSUSA/00010433/202711 Zane Neikena Latvia NAP 10434 amlodipine / rosuvastatin, amlodipine / perindopril / rosuvastatin, rosuvastatin / perindopril / indapamide, rosuvastatin / perindopril, rosuvastatin / ramipril 29/07/2015 5 years 29/07/2029 27/10/2029 No 22/10/2025 Active substance name was amended on 22/10/2025 PSUR frequency amended and DLP updated on 02/04/2025 PSUSA/00010434/202907 Melinda Palfi Hungary NAP 10435 idarucizumab 16/10/2015 3 years 15/10/2027 13/01/2028 No 25/06/2025 DLP was amended on 25/06/2025 PSUSA/00010435/202710 Bianca Mulder Netherlands CAP 10438 sacubitril / valsartan 07/07/2015 2 years 31/07/2026 29/10/2026 No 05/03/2025 PSUR frequency amended and DLP updated on 05/03/2025 PSUSA/00010438/202607 Karin Erneholm Denmark CAP 10439 timolol (eye preparations) 01/12/1981 5 years 31/07/2026 29/10/2026 No 30/03/2022 DLP was updated on 30/03/2022 Next DLP was amended on 26/04/2017 EURD and DLP were amended on 07/04/2016 Active substance name was amended on 04/02/2016 Lead MS and PRAC Rapporteur name updated on 04/02/2016 PSUSA/00010439/202607 Dennis Lex Germany NAP 10440 estradiol (except cream/balm/emulsion for application in female genital area) 01/01/1946 5 years 31/08/2026 29/11/2026 No 31/01/2024 PRAC representative updated on 31/01/2024 PSUSA/00010440/202608 Bianca Mulder Netherlands NAP 10441 estradiol, estradiol /prednisolone (only cream/balm/emulsion for application in the female genital area) Not available* 3 years 24/04/2026 23/07/2026 Yes 05/08/2025 DLP was amended on 20/12/2023 PSUSA/00010441/202604 Lina Seibokiene Lithuania NAP 10442 levonorgestrel / ethinylestradiol, ethinylestradiol (combination pack) 29/01/2015 5 years 13/01/2029 13/04/2029 No 25/09/2024 PSUR frequency amended and DLP updated on 25/09/2024 PSUSA/00010442/202901 Zoubida Amimour France NAP 10443 dienogest / estradiol (HRT indication) 13/12/2000 5 years 13/06/2029 11/09/2029 No 05/02/2025 DLP was amended on 05/02/2025 PSUSA/00010443/202906 Bianca Mulder Netherlands NAP 10444 dienogest / estradiol (contraception indication) 03/11/2008 5 years 08/09/2028 07/12/2028 No 30/04/2024 DLP was amended on 30/04/2024 PSUSA/00010444/202809 Bianca Mulder Netherlands NAP 10445 asparaginase (centrally authorised product) 14/01/2016 3 years 14/01/2027 14/04/2027 No 25/09/2024 DLP was amended on 25/09/2024 PSUSA/00010445/202701 Jan Neuhauser Austria CAP 10446 birch bark extract (centrally authorised products) 14/01/2016 1 year 14/01/2026 25/03/2026 14/01/2027 25/03/2027 No 24/09/2025 DLP was amended on 24/09/2025 PSUSA/00010446/202601 PSUSA/00010446/202701 Zane Neikena Latvia CAP 10447 brivaracetam 14/01/2016 3 years 14/01/2027 14/04/2027 No 25/09/2024 DLP was amended on 25/09/2024 PSUSA/00010447/202701 Adam Przybylkowski Poland CAP 10448 carfilzomib 20/07/2012 3 years 19/07/2026 17/10/2026 No 28/02/2024 PSUR frequency amended and DLP updated on 28/02/2024 PSUSA/00010448/202607 Barbara Kovacic Bytyqi Croatia CAP 10449 cobicistat / elvitegravir / emtricitabine / tenofovir alafenamide 05/11/2015 3 years 04/11/2027 02/02/2028 No 25/06/2025 PSUR frequency amended and DLP updated on 25/06/2025 PSUSA/00010449/202711 Amelia Cupelli Italy CAP 10450 cobimetinib 24/08/2015 3 years 23/08/2026 21/11/2026 No 30/04/2024 DLP was amended on 30/04/2024 PSUSA/00010450/202608 Bianca Mulder Netherlands CAP 10451 efmoroctocog alfa 06/06/2014 1 year 05/06/2026 14/08/2026 05/06/2027 14/08/2027 No 04/02/2026 DLP was amended on 04/02/2026 PSUSA/00010451/202606 PSUSA/00010451/202706 Sonja Radowan Austria CAP 10454 glycerol phenylbutyrate 01/02/2013 3 years 31/01/2027 01/05/2027 No 27/07/2022 PRAC representative was updated on 27/07/2022 DLP and PSUR frequency were updated on 22/09/2021 DLP was updated on 23/09/2020 DLP and PRAC representative were updated on 25/09/2019 DLP and PRAC Representative updated on 04/07/2018 European Union reference date and Next DLP were updated on 07/05/2018 PSUR frequency amended and DLP updated on 31/01/2018 Next DLP was amended on 27/06/2017 Next DLP was amended on 30/01/2017 New CAP authorised on 27/11/2015 PSUSA/00010454/202701 Amelia Cupelli Italy CAP 10455 lumacaftor / ivacaftor 19/11/2015 3 years 19/05/2028 17/08/2028 No 04/02/2026 PSUR frequency amended and DLP updated on 04/02/2026 PSUSA/00010455/202805 Eamon O Murchu Ireland CAP 10456 mepolizumab 02/12/2015 3 years 23/09/2028 22/12/2028 No 29/04/2026 PSUR frequency amended and DLP updated on 29/04/2026 PSUSA/00010456/202809 Dirk Mentzer Germany CAP 10457 pegaspargase (centrally authorised product) 14/01/2016 5 years 14/07/2030 12/10/2030 No 02/06/2026 PSUSA/00010457/203007 Jenny-Maria Jönsson Sweden CAP 10458 susoctocog alfa 11/11/2015 3 years 11/11/2028 09/02/2029 No 29/07/2026 DLP was amended on 29/07/2026 PSUSA/00010458/202811 Dirk Mentzer Germany CAP 10459 talimogene laherparepvec 27/10/2015 3 years 26/10/2026 24/01/2027 No 06/10/2025 PSUR frequency amended and DLP updated on 05/06/2024 PSUSA/00010459/202610 Dirk Mentzer Germany CAP 10460 blinatumomab 03/12/2014 3 years 02/12/2028 02/03/2029 No 29/07/2026 DLP was amended on 29/07/2026 PSUSA/00010460/202812 Veronika Macurova Czech Republic CAP 10461 diclofenac / omeprazole Not available* 5 years 30/09/2026 29/12/2026 No 16/10/2023 PRAC Rapporteur name was amended on 18/10/2023 PSUSA/00010461/202609 Karin Erneholm Denmark NAP 10462 bisoprolol / perindopril 09/11/2015 7 years 22/10/2032 20/01/2033 No 01/07/2026 PSUR frequency amended and DLP updated on 01/07/2026 PRAC representative was updated on 22/12/2021 DLP was updated on 30/06/2021 PRAC representative and LMS were added on 01/04/2020 European Union reference date updated on 07/05/2018 New entry added on 04/03/2016 PSUSA/00010462/203210 Jana Pecherova Slovakia NAP 10463 fosinopril, fosinopril / hydrochlorothiazide 03/07/1990 5 years 02/07/2026 30/09/2026 No 02/03/2022 PRAC Representative updated on 16/11/2022 PSUR frequency and DLP were updated on 02/03/2022 Next DLP was updated on 06/03/2019 PRAC Representative updated on 26/09/2018 New merged entry added on 07/04/2016 Next DLP was amended on 07/04/2016 PSUSA/00010463/202607 Maria del Pilar Rayon Spain NAP 10464 thiocolchicoside, paracetamol / thiocolchicoside 04/07/1956 3 years 04/07/2027 02/10/2027 No 05/03/2025 DLP was amended on 05/03/2025 PSUSA/00010464/202707 Amelia Cupelli Italy NAP 10465 allergen for therapy: Dactylis Glomerata L., Phleum Pratense L., Anthoxanthum Odoratum L., Lolium Perenne L., Poa Pratensis L. (sublingual tablet) 10/08/2004 3 years 24/12/2025 24/03/2026 No 06/10/2025 Active substance name was amended on 28/02/2024 Active substance name was amended on 20/12/2023 DLP amended on 20/09/2023 PSUSA/00010465/202512 Dirk Mentzer Germany NAP 10466 allergen for diagnostic: grass pollen, tree pollen, house dust mites, moulds, weed pollen, vertebrates, animal epithelia (except for hymenoptera venoms) single or mixes, positive and negative controls 26/06/1983 10 years 31/10/2026 29/01/2027 No 16/10/2023 PRAC Rapporteur name was amended on 18/10/2023 PSUSA/00010466/202610 Karin Erneholm Denmark NAP 10467 cinchocaine hydrochloride / prednisolone caproate, cinchocaine hydrochloride / fluocortolone caproate / fluocortolone pivalate Not available* 9 years 03/11/2029 01/02/2030 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00010467/202911 NAP 10469 diphtheria / tetanus / pertussis (acellular, component) / hepatitis B (rDNA) / poliomyelitis (inactivated) / haemophilus type b conjugate vaccine (adsorbed) 15/02/2016 3 years 15/02/2026 16/05/2026 No 06/10/2025 Next DLP was updated on 18/10/2023 PSUSA/00010469/202602 Dirk Mentzer Germany CAP 10472 osimertinib 13/11/2015 3 years 12/11/2026 10/02/2027 No 31/07/2024 PSUR frequency amended and DLP updated on 31/07/2024 PSUSA/00010472/202611 Bianca Mulder Netherlands CAP 10473 varicella vaccine (live) 17/10/1994 3 years 16/03/2028 14/06/2028 No 19/11/2025 DLP was amended on 19/11/2025 PSUSA/00010473/202803 Jean-Michel Dogné Belgium NAP 10474 meloxicam 08/05/1995 5 years 09/07/2027 07/10/2027 No 05/04/2023 PSUR frequency amended and DLP updated on 05/04/2023 PRAC representative was updated on 26/05/2021 DLP was updated on 01/04/2020 PRAC Representative updated on 26/09/2018 PRAC Rapporteur name updated on 21/07/2017 DLP was updated on 28/03/2017 Lead MS and PRAC Rapporteur name was added on 28/07/2016 New active substance added on 07/04/2016 PSUSA/00010474/202707 Tiphaine Vaillant France NAP 10475 allergen for therapy: Phleum Pratense (oromucosal use, product authorised via mutually recognition procedure) 14/03/2006 5 years 13/03/2027 11/06/2027 No 02/06/2026 PSUSA/00010475/202703 Karin Bolin Sweden NAP 10476 ferric maltol 18/02/2016 3 years 18/02/2027 19/05/2027 No 18/10/2023 Next DLP was updated on 18/10/2023 PSUSA/00010476/202702 Adam Przybylkowski Poland CAP 10477 diflucortolone valerate / chlorquinaldol Not available* 13 years 30/09/2027 29/12/2027 No 07/04/2016 New active substance added on 07/04/2016 PSUSA/00010477/202709 NAP 10478 diflucortolone valerate / salicylic acid Not available* 13 years 04/04/2027 03/07/2027 No 07/04/2016 New active substance added on 07/04/2016 PSUSA/00010478/202704 NAP 10479 carbidopa / levodopa (for centrally authorised product) 19/11/2015 6 months 01/10/2026 10/12/2026 01/04/2027 10/06/2027 No 27/05/2026 Entry re-activated on 27/05/2026 New CAP authorised on 27/04/2026 Entry deleted as CAP surrendered 30/11/2019 PRAC Rapporteur name was amended on 31/07/2018 Next DLP was amended on 27/06/2017 PSUR Frequency amended and DLP updated on 20/12/2016 New CAP authorised on 19/11/2015 PSUSA/00010479/202610 PSUSA/00010479/202704 Barbara Kovacic Bytyqi Croatia CAP 10480 dexamethasone (centrally authorised product indicated in symptomatic multiple myeloma) 16/03/2016 3 years 16/09/2026 15/12/2026 No 05/06/2024 PSUR frequency amended and DLP updated on 05/06/2024 PSUSA/00010480/202609 Tiphaine Vaillant France CAP 10481 human coagulation factor X 16/03/2016 3 years 16/03/2027 14/06/2027 No 20/11/2024 DLP was amended on 20/11/2024 PSUSA/00010481/202703 Bianca Mulder Netherlands CAP 10482 rhubarb extract / salicylic acid Not available* 15 years 30/09/2030 29/12/2030 No 03/05/2016 New entry added on 03/05/2016 PSUSA/00010482/203009 NAP 10483 phenylpropanolamine 29/11/2005 5 years 10/06/2029 08/09/2029 No 05/02/2025 PSUR frequency amended and DLP updated on 05/02/2025 PSUSA/00010483/202906 Eva Jirsová Czech Republic NAP 10484 methoxyflurane 18/05/2015 3 years 17/05/2028 15/08/2028 No 04/02/2026 DLP was amended on 04/02/2026 PSUSA/00010484/202805 Karin Bolin Sweden NAP 10486 tauroselcholic [75Se] acid 25/06/1991 5 years 31/01/2028 30/04/2028 No 18/10/2023 Next DLP was updated on 18/10/2023 PSUSA/00010486/202801 Melinda Palfi Hungary NAP 10488 isotretinoin (oral formulations) 07/05/1982 1 year 06/05/2026 15/07/2026 06/05/2027 15/07/2027 Yes 18/12/2024 DLP was amended on 18/12/2024 PSUSA/00010488/202605 PSUSA/00010488/202705 Maia Uusküla Estonia NAP 10489 olodaterol / tiotropium 20/05/2015 5 years 19/05/2029 17/08/2029 No 05/02/2025 PSUR frequency amended and DLP updated on 05/02/2025 PSUSA/00010489/202905 Bianca Mulder Netherlands NAP 10490 pitolisant 31/03/2016 3 years 30/09/2027 29/12/2027 No 05/06/2024 DLP was amended on 05/06/2024 PSUSA/00010490/202709 Terhi Lehtinen Finland CAP 10491 azithromycin (systemic use formulations) 04/04/1991 3 years 30/04/2026 29/07/2026 No 31/01/2024 DLP was amended on 31/01/2024 PSUSA/00010491/202604 Kimmo Jaakkola Finland NAP 10492 azithromycin (ocular use formulations) Not available* 5 years 30/04/2028 29/07/2028 No 31/01/2024 PSUR frequency amended and DLP updated on 31/01/2024 PSUSA/00010492/202804 Kimmo Jaakkola Finland NAP 10493 ixekizumab 22/03/2016 3 years 22/03/2027 20/06/2027 No 06/10/2025 DLP was amended on 20/11/2024 PSUSA/00010493/202703 Dirk Mentzer Germany CAP 10494 calcium chloride / glucose / magnesium chloride / sodium chloride / sodium lactate, calcium chloride / glucose / magnesium chloride / sodium chloride / sodium lactate/ sodium bicarbonate, calcium chloride / amino acids blend / magnesium chloride / sodium chloride / sodium lactate, calcium chloride / icodextrin / magnesium chloride / sodium chloride / sodium lactate (peritoneal dialysis solutions) Not available* 15 years 01/01/2027 01/04/2027 No 09/07/2026 New entry added on 03/06/2016 PSUSA/00010494/202701 Benjamin Micallef Malta NAP 10495 immunocyanine 25/03/1997 15 years 30/06/2030 28/09/2030 No 03/06/2016 New active substance added on 03/06/2016 PSUSA/00010495/203006 NAP 10496 delapril / manidipine, delapril / indapamide 17/01/1989 5 years 30/06/2027 28/09/2027 No 01/03/2023 DLP was updated on 01/03/2023 PRAC representative was updated on 17/11/2021 PRAC representative was updated on 30/06/2021 PRAC Rapporteur name amended on 04/07/2018 DLP was updated on 27/03/2018 Lead MS and PRAC Rapporteur name was added on 20/12/2016 Entry 'delapril / manidipine' replaced with 'delapril / manidipine, delapril / indapamide' on 03/06/2016 PSUSA/00010496/202706 Amelia Cupelli Italy NAP 10497 albutrepenonacog alfa 26/01/2016 3 years 26/01/2027 26/04/2027 No 25/09/2024 DLP was amended on 25/09/2024 PSUSA/00010497/202701 Bianca Mulder Netherlands CAP 10498 daratumumab 16/11/2015 2 years 15/11/2026 13/02/2027 No 30/07/2025 DLP was amended on 30/07/2025 PSUSA/00010498/202611 Carla Torre Portugal CAP 10499 eftrenonacog alfa 20/03/2014 3 years 19/03/2026 17/06/2026 No 06/10/2025 DLP was amended on 15/11/2023 PSUSA/00010499/202603 Dirk Mentzer Germany CAP 10500 elotuzumab 30/11/2015 3 years 29/11/2027 27/02/2028 No 06/10/2025 DLP was amended on 30/07/2025 PSUSA/00010500/202711 Dirk Mentzer Germany CAP 10501 pandemic influenza vaccine (H5N1) (live attenuated, nasal) 20/05/2016 6 months 20/05/2026 29/07/2026 20/11/2026 29/01/2027 No 01/07/2026 DLP was amended on 01/07/2026 PSUSA/00010501/202605 PSUSA/00010501/202611 Sonja Radowan Austria CAP 10502 pitavastatin 17/07/2003 5 years 16/07/2030 14/10/2030 No 01/04/2026 PSUR frequency amended and DLP updated on 01/04/2026 PSUSA/00010502/203007 Bianca Mulder Netherlands NAP 10503 selexipag 21/12/2015 3 years 20/12/2026 20/03/2027 Yes 02/04/2025 Information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" was amended on 02/04/2025 DLP was amended on 25/09/2024 PSUSA/00010503/202612 Zoubida Amimour France CAP 10504 ascorbic acid / rutoside, ascorbic acid / rutoside / alfatocopherol Not available* 8 years 01/12/2033 01/03/2034 No 29/07/2026 DLP was amended on 29/07/2026 PSUSA/00010504/203312 Adam Przybylkowski Poland NAP 10505 autologous CD34+ enriched cell fraction that contains CD34+ cells transduced with retroviral vector that encodes for the human ADA cDNA sequence 26/05/2016 3 years 25/11/2028 23/02/2029 No 29/07/2026 DLP was amended on 29/07/2026 PSUSA/00010505/202811 Liana Martirosyan Netherlands CAP 10506 dutasteride, dutasteride / tamsulosine 20/11/2001 5 years 19/11/2027 17/02/2028 No 26/07/2023 Next DLP was updated on 26/07/2023 PSUSA/00010506/202711 Melinda Palfi Hungary NAP 10507 migalastat 26/05/2016 3 years 26/05/2027 24/08/2027 No 02/06/2026 PSUSA/00010507/202705 Karin Bolin Sweden CAP 10508 metronidazole / neomycin / nystatin 02/05/1997 5 years 02/09/2030 01/12/2030 No 29/04/2026 DLP was amended on 29/04/2026 PSUSA/00010508/203009 Zoubida Amimour France NAP 10509 pyridoxine / thiamine, arginine / pyridoxine / thiamine Not available* 9 years 03/05/2032 01/08/2032 No 11/06/2025 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00010509/203205 Guðrún Stefánsdóttir Iceland NAP 10510 beta-alanine 23/09/1991 3 years 23/01/2026 23/04/2026 No 15/11/2023 PRAC Rapporteur updated on 15/11/2023 PSUSA/00010510/202601 Barbara Kovacic Bytyqi Croatia NAP 10511 budesonide / salmeterol 23/07/2015 3 years 23/07/2027 21/10/2027 No 02/04/2025 DLP was amended on 02/04/2025 PSUSA/00010511/202707 Bianca Mulder Netherlands NAP 10512 amlodipine / losartan 06/01/2014 5 years 05/01/2029 05/04/2029 No 25/09/2024 DLP was amended on 25/09/2024 PSUSA/00010512/202901 Melinda Palfi Hungary NAP 10513 ceftazidime / avibactam 25/02/2015 3 years 24/02/2026 25/05/2026 No 18/10/2023 PSUR frequency amended and DLP updated on 18/10/2023 PSUSA/00010513/202602 Rugile Pilviniene Lithuania CAP 10514 emtricitabine / rilpivirine / tenofovir alafenamide 01/03/2016 3 years 28/02/2026 29/05/2026 No 15/11/2023 DLP was amended on 15/11/2023 PSUSA/00010514/202602 Ana Sofia Diniz Martins Portugal CAP 10515 emtricitabine / tenofovir alafenamide 04/04/2016 3 years 03/04/2026 02/07/2026 No 20/12/2023 DLP was amended on 20/12/2023 PSUSA/00010515/202604 Ana Sofia Diniz Martins Portugal CAP 10516 opicapone 24/06/2016 3 years 24/06/2027 22/09/2027 No 05/03/2025 DLP was amended on 05/03/2025 PSUSA/00010516/202706 Maria del Pilar Rayon Spain CAP 10517 trifluridine / tipiracil 24/03/2014 3 years 24/03/2026 22/06/2026 No 02/06/2026 PSUSA/00010517/202603 Jenny-Maria Jönsson Sweden CAP 10519 elbasvir / grazoprevir 19/01/2016 5 years 18/01/2030 18/04/2030 No 24/09/2025 PSUR frequency amended and DLP updated on 24/09/2025 PSUSA/00010519/203001 Ana Sofia Diniz Martins Portugal CAP 10521 technetium (99mTc) edda / hynic-octreotide 03/06/2016 15 years 02/06/2032 31/08/2032 Yes 25/09/2019 Active substance name corrected on 02/02/2022 PSUR frequency and DLP were updated on 25/09/2019 Entry name, PSUR frequency amended and DLP updated on 31/01/2018 Lead MS and PRAC Rapporteur name was added on 26/04/2017 New active substance added on 20/12/2016 PSUSA/00010521/203206 Adam Przybylkowski Poland NAP 10523 reslizumab 16/08/2016 3 years 16/02/2027 17/05/2027 No 06/10/2025 PRAC representative was updated on 01/03/2023 PSUR frequency and DLP were amended on 20/10/2021 DLP was updated on 21/10/2020 DLP was updated on 25/09/2019 PSUR frequency amended and DLP updated on 03/04/2019 DLP was updated on 26/09/2018 DLP was updated on 27/03/2018 DLP was updated on 17/10/2017 New CAP authorised on 22/09/2016 PSUSA/00010523/202702 Dirk Mentzer Germany CAP 10524 sofosbuvir / velpatasvir 28/06/2016 5 years 27/06/2030 25/09/2030 No 01/04/2026 DLP was corrected on 01/04/2026 PSUR frequency amended and DLP updated on 04/03/2026 PSUSA/00010524/203006 Ana Sofia Diniz Martins Portugal CAP 10525 deoxycholic acid 29/04/2015 3 years 29/04/2027 28/07/2027 No 05/02/2025 DLP was amended on 05/02/2025 PSUSA/00010525/202704 Karin Bolin Sweden NAP 10526 dequalinium, dequalinium / cinchocaine, dequalinium / lidocaine, dequalinium / enoxolone / tyrothricin/ hydrocortisone / lidocaine 01/06/1962 11 years 03/07/2039 01/10/2039 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00010526/203907 Amelia Cupelli Italy NAP 10527 diphenhydramine, ammonium chloride / diphenhydramine hydrochloride, diphenhydramine hydrochloride / levomenthol, ammonium chloride / diphenhydramine hydrochloride / levomenthol 05/03/1974 10 years 03/03/2035 01/06/2035 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00010527/203503 Rhea Fitzgerald Ireland NAP 10529 glycopyrronium (indicated for the treatment of severe sialorhoea) 15/09/2016 3 years 14/09/2027 13/12/2027 Yes 30/04/2025 PSUR frequency amended and DLP updated on 30/04/2025 PSUSA/00010529/202709 Zane Neikena Latvia CAP NAP 10532 lisinopril, lisinopril / hydrochlorothiazide 24/09/1987 5 years 23/09/2030 22/12/2030 No 27/05/2026 DLP was amended on 27/05/2026 PSUSA/00010532/203009 Carla Torre Portugal NAP 10533 etelcalcetide 11/11/2016 3 years 10/11/2027 08/02/2028 No 30/07/2025 DLP was amended on 30/07/2025 PSUSA/00010533/202711 Amelia Cupelli Italy CAP 10534 irinotecan (liposomal formulations) 22/10/2015 3 years 22/10/2028 20/01/2029 No 01/07/2026 DLP was amended on 01/07/2026 PSUSA/00010534/202810 David Olsen Norway CAP 10535 ixazomib 20/11/2015 3 years 19/11/2028 17/02/2029 No 29/07/2026 PSUR frequency amended and DLP updated on 29/07/2026 PSUSA/00010535/202811 Jenny-Maria Jönsson Sweden CAP 10536 lactic acid / urea, urea 21/11/1969 10 years 02/09/2034 01/12/2034 No 30/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00010536/203409 Polona Golmajer Slovenia NAP 10537 mesoglycan 22/12/1978 9 years 03/11/2028 01/02/2029 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00010537/202811 NAP 10539 empagliflozin / linagliptin 11/11/2016 3 years 10/11/2026 08/02/2027 No 03/07/2024 DLP was amended on 03/07/2024 PSUSA/00010539/202611 Maria del Pilar Rayon Spain CAP 10540 olanzapine 27/09/1996 3 years 31/03/2028 29/06/2028 No 21/12/2022 DLP was updated on 21/12/2022 DLP was updated on 18/12/2019 New entry created on 20/12/2016 PSUSA/00010540/202803 Kimmo Jaakkola Finland CAP NAP 10542 sulfogaiacol, sodium benzoate / sulfogaiacol, codeine / sodium benzoate, codeine sulfogaiacol, codeine / sulfogaiacol / grindelia soft extract 12/08/1996 5 years 31/12/2027 30/03/2028 No 27/03/2024 Active substance name was amended on 27/03/2024 PRAC Rapporteur updated on 15/11/2023 PSUSA/00010542/202712 Petar Mas Croatia NAP 10544 palbociclib 03/02/2015 3 years 02/08/2026 31/10/2026 No 27/03/2024 PSUR frequency amended and DLP updated on 27/03/2024 PSUSA/00010544/202608 Marie Louise Schougaard Christiansen Denmark CAP 10545 ascorbic acid / calcium, ascorbic acid / calcium / lysine Not available* 9 years 03/05/2029 01/08/2029 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00010545/202905 Roxana Dondera Romania NAP 10546 benzalkonium chloride / cetrimide, cetrimide / dimeticone Not available* 9 years 03/06/2029 01/09/2029 Yes 23/10/2024 Information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" was amended on 23/10/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00010546/202906 Rhea Fitzgerald Ireland NAP 10547 alfa-tocopherol / vaccinium myrtillus anthocyanosides, betacarotene / vaccinium myrtillus anthocyanosides Not available* 9 years 03/03/2029 01/06/2029 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00010547/202903 Maia Uusküla Estonia NAP 10549 morphine, morphine / cyclizine 14/04/1969 5 years 14/10/2027 12/01/2028 No 16/10/2023 PRAC Rapporteur name was amended on 18/10/2023 PSUSA/00010549/202710 Karin Erneholm Denmark NAP 10550 mycophenolate mofetil, mycophenolic acid 03/05/1995 3 years 02/05/2028 31/07/2028 No 04/02/2026 PSUR frequency amended and DLP updated on 04/02/2026 PSUSA/00010550/202805 Karin Erneholm Denmark CAP NAP 10551 mesterolone 25/05/1967 5 years 31/01/2030 01/05/2030 No 22/10/2025 PSUR frequency amended and DLP updated on 22/10/2025 PSUSA/00010551/203001 Petar Mas Croatia NAP 10552 edotreotide 08/12/2016 3 years 07/12/2028 07/03/2029 Yes 29/07/2026 DLP was amended on 29/07/2026 PSUSA/00010552/202812 Rhea Fitzgerald Ireland CAP NAP 10554 follitropin delta 12/12/2016 3 years 30/11/2026 28/02/2027 No 31/07/2024 DLP was amended on 31/07/2024 PSUSA/00010554/202611 Bianca Mulder Netherlands CAP 10556 venetoclax 05/12/2016 3 years 04/12/2027 03/03/2028 No 30/07/2025 DLP was amended on 30/07/2025 PSUSA/00010556/202712 Eva Jirsová Czech Republic CAP 10557 carbasalate calcium / metoclopramide, lysine acetylsalicylic acid / metoclopramide, paracetamol / metoclopramide 16/07/1981 15 years 16/07/2027 14/10/2027 No 30/01/2017 New entry added on 30/01/2017 PSUSA/00010557/202707 NAP 10558 cidofovir 23/04/1997 3 years 10/06/2027 08/09/2027 Yes 05/02/2025 DLP was amended on 05/02/2025 PSUSA/00010558/202706 Rugile Pilviniene Lithuania NAP 10559 lonoctocog alfa 04/01/2017 1 year 03/01/2026 14/03/2026 03/01/2027 14/03/2027 No 24/09/2025 DLP was amended on 24/09/2025 PSUSA/00010559/202601 PSUSA/00010559/202701 Sonja Radowan Austria CAP 10561 sulfamethizole 15/06/1955 10 years 15/06/2032 13/09/2032 Yes 01/03/2023 PSUR frequency and DLP were updated on 01/03/2023 PRAC Rapporteur name was amended on 28/04/2022 PRAC Rapporteur name was amended on 21/11/2018 DLP was updated on 28/02/2018 Lead MS and PRAC Rapporteur name was added on 26/04/2017 New entry added on 30/01/2017 PRAC Rapporteur name updated on 05/11/2018 PSUSA/00010561/203206 Marie Louise Schougaard Christiansen Denmark NAP 10563 calcium glycerophosphate / magnesium gluconate, calcium glycerophosphate / manganese glycerophosphate / potassium glycerophosphate / sodium glycerophosphate / thiamine 14/09/1959 11 years 03/05/2039 01/08/2039 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00010563/203905 NAP 10564 cetrimide, cetyltrimethylammonium naproxenate 07/12/1976 15 years 28/02/2030 29/05/2030 No 19/12/2017 Entry name amended on 19/12/2017 New active substance added on 28/02/2017 PSUSA/00010564/203002 NAP 10565 amino acid combinations / glucose / triglyceride combinations (e.g. olive oil, soya bean oil, fish oil)/ with or without electrolytes/ mineral compounds (i.v. application) - except the combination with procedure number 00010190 (drug Numeta) Not available* 5 years 03/06/2026 01/09/2026 No 02/02/2022 DLP was updated on 02/02/2022 PRAC representative and LMS were added on 23/09/2020 New active substance added on 28/02/2017 PSUSA/00010565/202606 Melinda Palfi Hungary NAP 10566 amino acid combinations/ glucose/ with or without electrolytes / mineral compounds (i.v. application) Not available* 5 years 03/06/2026 01/09/2026 No 02/02/2022 DLP was updated on 02/02/2022 PRAC representative was updated on 28/07/2021 PRAC representative was updated on 28/04/2021 PRAC representative and LMS were added on 23/09/2020 New active substance added on 28/02/2017 PSUSA/00010566/202606 Polona Golmajer Slovenia NAP 10569 Camellia sinensis, Leaf, Dry extract refined (derived from Camellia sinensis, L. O.KUNTZE) (topical use) 31/08/2009 5 years 31/12/2029 31/03/2030 No 24/09/2025 PSUR frequency amended and DLP updated on 24/09/2025 PSUSA/00010569/202912 Adam Przybylkowski Poland NAP 10570 landiolol 03/08/2016 3 years 02/02/2026 03/05/2026 No 31/01/2024 PRAC representative updated on 31/01/2024 PSUSA/00010570/202602 Bianca Mulder Netherlands NAP 10571 naphazoline, naphazoline / zinc sulphate 16/10/1946 12 years 31/07/2036 29/10/2036 No 02/04/2025 DLP was amended on 02/04/2025 PSUSA/00010571/203607 Karin Erneholm Denmark NAP 10572 nitrous oxide, nitrous oxide / oxygen Not available* 3 years 23/06/2028 21/09/2028 Yes 04/03/2026 DLP was amended on 04/03/2026 PSUSA/00010572/202806 John Joseph Borg Malta NAP 10573 mercaptamine (treatment of nephropathic cystinosis) 23/06/1997 5 years 23/10/2030 21/01/2031 No 01/07/2026 DLP was amended on 01/07/2026 PSUSA/00010573/203010 Maria Martinez Gonzalez Spain CAP 10574 mercaptamine (Indicated for the treatment of corneal cystine crystal deposit only) 19/01/2017 3 years 18/01/2027 18/04/2027 No 25/09/2024 DLP was amended on 25/09/2024 PSUSA/00010574/202701 Maria del Pilar Rayon Spain CAP 10575 tenofovir alafenamide 10/11/2016 3 years 09/11/2027 07/02/2028 No 30/07/2025 DLP was amended on 30/07/2025 PSUSA/00010575/202711 Amelia Cupelli Italy CAP 10576 bezlotoxumab 21/10/2016 5 years 20/10/2030 18/01/2031 No 01/07/2026 PSUR frequency amended and DLP updated on 01/07/2026 PSUR frequency amended and DLP updated on 31/05/2023 DLP was updated on 29/06/2022 DLP was updated on 30/06/2021 DLP was updated on 16/12/2020 PSUR frequency and DLP were updated on 03/06/2020 DLP was updated on 20/11/2019 DLP was updated on 05/06/2019 DLP was updated on 21/11/2018 DLP was updated on 06/06/2018 DLP was updated on 19/12/2017 EURD and DLP amended on 26/04/2017 New CAP authorised on 18/01/2017 PSUSA/00010576/203010 Adam Przybylkowski Poland CAP 10577 insulin glargine / lixisenatide 11/01/2017 3 years 21/11/2026 19/02/2027 No 03/07/2024 PSUR frequency amended and DLP updated on 03/07/2024 PSUSA/00010577/202611 Bianca Mulder Netherlands CAP 10578 baricitinib 13/02/2017 1 year 13/02/2026 24/04/2026 13/02/2027 24/04/2027 No 24/09/2025 DLP was amended on 24/09/2025 PSUSA/00010578/202602 PSUSA/00010578/202702 Adam Przybylkowski Poland CAP 10579 citrulline malate 31/10/1991 13 years 12/03/2034 10/06/2034 No 02/02/2022 Correction to PSUR frequency and DLP on 02/02/2022 DLP was updated on 17/11/2021 DLP was updated on 21/11/2018 PRAC representative and Lead Member State were added on 21/07/2017 New entry added on 28/03/2017 PSUSA/00010579/203403 Eva Jirsová Czech Republic NAP 10581 alectinib 04/07/2014 3 years 03/07/2028 01/10/2028 No 04/03/2026 DLP was amended on 04/03/2026 PSUSA/00010581/202807 Veronika Macurova Czech Republic CAP 10582 allergen for therapy: dermatophagoides pteronyssinus / dermatophagoides farina (oromucosal use, products authorised via mutually recognition procedure and decentralised procedure) 23/09/2015 3 years 22/09/2028 21/12/2028 No 27/05/2026 DLP was amended on 27/05/2026 PSUSA/00010582/202809 Dirk Mentzer Germany NAP 10583 bendroflumethiazide, bendroflumethiazide / potassium chloride 28/02/1960 6 years 01/01/2030 01/04/2030 No 25/09/2024 DLP was amended on 25/09/2024 PSUSA/00010583/203001 Eva Jirsová Czech Republic NAP 10584 benzyl nicotinate / camphor / dimethyl sulfoxide / nonivamide / turpentine oil, Nicoboxil/ Nonivamide 01/01/1994 5 years 31/03/2028 29/06/2028 No 20/12/2023 PSUR frequency amended and DLP updated on 20/12/2023 PSUSA/00010584/202803 Zane Neikena Latvia NAP 10585 budesonide / formoterol 25/08/2000 5 years 24/08/2030 22/11/2030 No 27/05/2026 DLP was corrected on 27/05/2026 PSUR frequency amended and DLP updated on 29/04/2026 PSUSA/00010585/203008 Marie Louise Schougaard Christiansen Denmark CAP NAP 10587 chlormethine 23/08/2013 3 years 22/08/2027 20/11/2027 No 30/04/2025 DLP was amended on 30/04/2025 PSUSA/00010587/202708 Tiphaine Vaillant France CAP 10588 tofacitinib 06/11/2012 3 years 05/11/2027 03/02/2028 No 25/06/2025 PSUR frequency amended and DLP updated on 25/06/2025 PSUSA/00010588/202711 Liana Martirosyan Netherlands CAP 10590 chenodeoxycholic acid (inborn error in primary bile acid synthesis, xanthomatosis - centrally authorised products only) 10/04/2017 1 year 09/10/2026 18/12/2026 09/10/2027 18/12/2027 No 27/05/2026 DLP was amended on 27/05/2026 PSUSA/00010590/202610 PSUSA/00010590/202710 Adam Przybylkowski Poland CAP 10593 sulfametrole / trimethoprim, sulfadiazine / trimethoprim, sulfamethoxazole / trimethoprim (co-trimoxazole) 01/04/1969 8 years 31/03/2027 29/06/2027 No 15/11/2023 PRAC Rapporteur updated on 15/11/2023 PSUSA/00010593/202703 Barbara Kovacic Bytyqi Croatia NAP 10594 fluciclovine (18F) 27/05/2016 3 years 27/05/2026 25/08/2026 No 31/01/2024 DLP was amended on 31/01/2024 PSUSA/00010594/202605 Rugile Pilviniene Lithuania CAP 10595 nusinersen 30/05/2017 3 years 30/05/2027 28/08/2027 No 05/02/2025 PSUR frequency amended and DLP updated on 05/02/2025 PSUSA/00010595/202705 Karin Bolin Sweden CAP 10596 cerliponase alfa 27/04/2017 3 years 26/04/2027 25/07/2027 No 02/06/2026 PSUSA/00010596/202704 Karin Bolin Sweden CAP 10597 dinutuximab beta 08/05/2017 1 year 08/11/2026 17/01/2027 08/11/2027 17/01/2028 No 01/07/2026 DLP was amended on 01/07/2026 PSUSA/00010597/202611 PSUSA/00010597/202711 Dirk Mentzer Germany CAP 10598 lactobacillus all subspecies and combinations of subspecies (oral and vaginal use) 14/07/1954 10 years 13/07/2034 11/10/2034 No 28/05/2025 PSUR frequency corrected and DLP corrected on 28/05/2025 PSUR frequency amended and DLP updated on 02/04/2025 PSUSA/00010598/203407 Dennis Lex Germany NAP 10599 choline alfoscerate 27/07/1987 8 years 30/08/2030 28/11/2030 No 03/05/2023 DLP was amended on 03/05/2023 Lead MS and PRAC Rapporteur name added on 29/06/2022 New active substance added on 27/06/2017 PSUSA/00010599/203008 Rugile Pilviniene Lithuania NAP 10600 deproteinised hemoderivative of calf blood, deproteinised hemoderivative of calf blood / macrogol 400 03/01/1957 8 years 31/03/2031 29/06/2031 No 12/09/2025 DLP was amended on 20/12/2023 PSUSA/00010600/203103 Veronika Macurová Czech Republic NAP 10601 irbesartan, irbesartan / hydrochlorothiazide 12/08/1997 5 years 12/08/2026 10/11/2026 No 28/04/2022 PRAC Representative updated on 16/11/2022 DLP was updated on 28/04/2022 Correction of active substance name on 30/03/2022 PRAC Representative updated on 26/09/2018 European Union reference date, DLP and Submission date were updated on 28/02/2018 New combination of active substances added following merge on 27/06/2017 *for irbesartan containing products the next PSUR (PSUSA/00010601/202109) will cover period of 6 years, form 12/08/2015 to 30/09/2021 PSUSA/00010601/202608 Maria del Pilar Rayon Spain CAP NAP 10603 benzocaine / chlorhexidine, benzocaine / chlorhexidine / tyrothricin Not available* 18 years 01/01/2030 01/04/2030 No 21/07/2017 New entry added on 21/07/2017 PSUSA/00010603/203001 NAP 10604 chlorhexidine / tetracaine 22/12/1969 8 years 22/12/2033 22/03/2034 No 23/10/2024 PSUR frequency amended and DLP updated on 23/10/2024 Active substance name was amended on 23/10/2024 Active substance amended on 19/12/2017 New entry added on 21/07/2017 PSUSA/00010604/203312 Miroslava Gocova Slovakia NAP 10605 human plasma proteins with no less than 95% albumin 01/07/1950 5 years 01/07/2029 29/09/2029 Yes 06/10/2025 DLP was amended on 05/03/2025 PSUSA/00010605/202907 Dirk Mentzer Germany NAP 10606 itopride 30/06/1995 5 years 30/06/2028 28/09/2028 Yes 04/03/2026 PSUR frequency amended and DLP updated on 04/03/2026 PSUSA/00010606/202806 Rugile Pilviniene Lithuania NAP 10607 meningococcal group B vaccine (recombinant, adsorbed) 29/10/2014 3 years 28/10/2027 26/01/2028 No 25/06/2025 DLP was amended on 25/06/2025 PSUSA/00010607/202710 Jean-Michel Dogné Belgium CAP 10608 nonacog beta pegol 31/05/2017 3 years 31/05/2026 29/08/2026 No 06/10/2025 PSUR frequency amended and DLP updated on 31/01/2024 PSUSA/00010608/202605 Dirk Mentzer Germany CAP 10609 sarilumab 12/01/2017 3 years 12/01/2026 12/04/2026 No 19/09/2025 DLP and PSUR frequency amended on 20/09/2023 PSUSA/00010609/202601 Maria Martinez Gonzalez Spain CAP 10610 shark liver oil / yeast extract, yeast extract (excluding saccharomyces boulardii) 01/01/1957 15 years 31/12/2031 30/03/2032 No 17/12/2025 Active substance name was amended on 17/12/2025 New entry added on 21/07/2017 PSUSA/00010610/203112 none NAP 10611 tripelennamine 04/04/1984 10 years 31/10/2026 29/01/2027 No 27/02/2026 New entry added on 21/07/2017 PSUSA/00010611/202610 Zane Neikena Latvia NAP 10612 sodium oxybate (oral use) 13/06/1961 1 year 12/10/2026 21/12/2026 12/10/2027 21/12/2027 Yes 27/05/2026 DLP was amended on 27/05/2026 PSUSA/00010612/202610 PSUSA/00010612/202710 Ana Sofia Diniz Martins Portugal CAP NAP 10613 sodium oxybate (intravenous use) 13/06/1961 5 years 12/10/2029 10/01/2030 No 25/06/2025 Information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" was amended on 25/06/2025 PSUR frequency amended and DLP updated on 25/06/2025 DLP was updated on 25/05/2022 PSUR frequency and DLP were updated on 05/06/2019 DLP was updated on 06/06/2018 PRAC representative added on 17/10/2017 New entry added on 21/07/2017 PSUSA/00010613/202910 Ana Sofia Diniz Martins Portugal NAP 10614 pentosan polysulfate sodium (for centrally authorised product) 02/06/2017 3 years 01/06/2027 30/08/2027 Yes 05/02/2025 DLP was amended on 05/02/2025 PSUSA/00010614/202706 Ana Sofia Diniz Martins Portugal CAP 10616 brodalumab 17/07/2017 3 years 16/07/2027 14/10/2027 No 19/09/2025 DLP was amended on 02/04/2025 PSUSA/00010616/202707 Maria Martinez Gonzalez Spain CAP 10617 beclometasone / formoterol / glycopyrronium bromide 17/07/2017 1 year 16/07/2026 24/09/2026 16/07/2027 24/09/2027 No 04/03/2026 DLP was amended on 04/03/2026 PSUSA/00010617/202607 PSUSA/00010617/202707 Jan Neuhauser Austria CAP 10618 patiromer 21/10/2015 3 years 20/10/2026 18/01/2027 No 03/07/2024 DLP was amended on 03/07/2024 PSUSA/00010618/202610 Terhi Lehtinen Finland CAP 10619 sofosbuvir / velpatasvir / voxilaprevir 18/07/2017 5 years 17/07/2030 15/10/2030 No 01/04/2026 PSUR frequency amended and DLP updated on 01/04/2026 PSUSA/00010619/203007 Ana Sofia Diniz Martins Portugal CAP 10620 glecaprevir / pibrentasvir 26/07/2017 5 years 25/07/2030 23/10/2030 No 01/04/2026 PSUR frequency amended and DLP updated on 01/04/2026 PSUSA/00010620/203007 Ana Sofia Diniz Martins Portugal CAP 10621 bismuth / lidocaine / zinc oxide, lidocaine / zinc oxide Not available* 8 years 01/01/2028 31/03/2028 Yes 23/09/2020 DLP was updated on 23/09/2020 LMS and PRAC representative were added on 31/07/2019 Information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" was amended on 06/02/2019 New entry introduced on 25/09/2017 PSUSA/00010621/202801 Rugile Pilviniene Lithuania NAP 10622 calcium chloride dihydrate / magnesium chloride hexahydrate / malic acid / sodium acetate trihydrate / sodium chloride / potassium chloride, calcium chloride dihydrate / sodium chloride / sodium lactate / potassium chloride, calcium chloride / sodium chloride / potassium chloride Not available* 13 years 01/01/2036 31/03/2036 No 20/09/2023 DLP amended on 20/09/2023 PSUSA/00010622/203601 Polona Golmajer Slovenia NAP 10623 cariprazine 13/07/2017 3 years 05/10/2027 03/01/2028 No 25/06/2025 PSUR frequency amended and DLP updated on 25/06/2025 PSUSA/00010623/202710 Ana Sofia Diniz Martins Portugal CAP 10624 cenegermin 06/07/2017 1 year 05/07/2026 13/09/2026 05/07/2027 13/09/2027 No 04/03/2026 DLP was amended on 04/03/2026 PSUSA/00010624/202607 PSUSA/00010624/202707 Jan Neuhauser Austria CAP 10625 mucopolysaccharide polysulfuric acid ester (chondroitin), mucopolysaccharide polysulfuric acid ester (chondroitin)/salicylic acid, mucopolysaccharide polysulfuric acid ester (chondroitin)/salicylic acid/flufenamic acid, mucopolysaccharide polysulfuric acid ester (chondroitin)/salicylic acid/suprarenal extract [cutaneous use] Not available* 9 years 02/12/2031 01/03/2032 No 23/10/2024 PSUR frequency amended and DLP updated on 23/10/2024 Active substance name was amended on 23/10/2024 New active sustance combination added following merge on 25/09/2017 PSUSA/00010625/203112 none NAP 10626 mucopolysaccharide polysulfuric acid ester (chondroitin), mucopolysaccharide polysulfuric acid ester (chondroitin)/ glucosamine [oral and intramuscular use] Not available* 9 years 02/12/2031 01/03/2032 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00010626/203112 NAP 10627 benzyl benzoate / disulfiram 22/10/1982 9 years 01/12/2028 01/03/2029 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00010627/202812 Sweden NAP 10628 gentamicin (implant) 28/02/1973 5 years 31/03/2027 29/06/2027 No 21/12/2022 DLP was updated on 21/12/2022 PRAC representative was updated on 19/10/2022 PRAC representative was updated on 27/07/2022 LMS and PRAC representative were added on 20/10/2021 New active substance added on 25/09/2017 PSUSA/00010628/202703 Amelia Cupelli Italy NAP 10629 hamamelis water Not available* 13 years 01/01/2040 31/03/2040 No 25/09/2017 New active substance added on 25/09/2017 PSUSA/00010629/204001 NAP 10630 spheroids of human autologous matrix-associated chondrocytes 10/07/2017 3 years 09/07/2027 07/10/2027 No 06/10/2025 PSUR frequency amended and DLP updated on 05/03/2025 PSUSA/00010630/202707 Dirk Mentzer Germany CAP 10631 testosterone (all formulations apart from topical use) 01/07/1978 3 years 31/12/2027 30/03/2028 No 24/09/2025 DLP was amended on 24/09/2025 PSUSA/00010631/202712 Maia Uusküla Estonia NAP 10632 zinc oxide, zinc oxide/calamine Not available* 9 years 03/11/2032 01/02/2033 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00010632/203211 Dennis Lex Germany NAP 10633 ribociclib 13/03/2017 3 years 12/03/2028 10/06/2028 No 22/10/2025 PSUR frequency amended and DLP updated on 22/10/2025 PSUSA/00010633/202803 Marie Louise Schougaard Christiansen Denmark CAP 10634 cladribine (multiple sclerosis) 08/07/2010 3 years 07/07/2027 05/10/2027 No 05/03/2025 PSUR frequency amended and DLP updated on 05/03/2025 PSUSA/00010634/202707 Carla Torre Portugal CAP 10635 avelumab 23/03/2017 3 years 22/03/2026 20/06/2026 No 15/11/2023 PSUR frequency amended and DLP updated on 15/11/2023 PSUSA/00010635/202603 Karin Erneholm Denmark CAP 10636 tivozanib 24/08/2017 3 years 23/02/2028 23/05/2028 No 22/10/2025 DLP was amended on 22/10/2025 PSUSA/00010636/202802 Rugile Pilviniene Lithuania CAP 10637 trientine 05/09/2017 3 years 05/09/2028 04/12/2028 No 27/05/2026 DLP was corrected on 27/05/2026 PSUR frequency amended and DLP updated on 29/04/2026 PSUSA/00010637/202809 Ana Sofia Diniz Martins Portugal CAP NAP 10638 midostaurin 28/04/2017 5 years 27/10/2029 25/01/2030 No 25/06/2025 PSUR frequency amended and DLP updated on 25/06/2025 PSUSA/00010638/202910 Carla Torre Portugal CAP 10639 telotristat 28/02/2017 3 years 27/02/2027 28/05/2027 No 18/10/2023 Next DLP was updated on 18/10/2023 PSUSA/00010639/202702 Adam Przybylkowski Poland CAP 10640 benzalkonium chloride / isopropyl myristate / paraffin liquid, benzalkonium chloride / chlorhexidine / isopropyl myristate / paraffin liquid Not available* 8 years 01/12/2033 01/03/2034 No 29/07/2026 DLP was amended on 29/07/2026 PSUSA/00010640/203312 Rhea Fitzgerald Ireland NAP 10641 eucalyptus oil Not available* 13 years 01/01/2030 01/04/2030 No 17/10/2017 New entry added on 17/10/2017 PSUSA/00010641/203001 NAP 10643 lutetium (177Lu) oxodotreotide 26/09/2017 3 years 19/12/2025 19/03/2026 No 26/07/2023 PSUR frequency amended and DLP updated on 26/07/2023 PSUSA/00010643/202512 Adam Przybylkowski Poland CAP 10644 atezolizumab 18/05/2016 2 years 17/05/2027 15/08/2027 No 04/02/2026 PSUR frequency amended and DLP updated on 04/02/2026 PSUSA/00010644/202705 Carla Torre Portugal CAP 10645 dupilumab 28/03/2017 1 year 28/03/2026 06/06/2026 28/03/2027 06/06/2027 No 19/11/2025 DLP was amended on 19/11/2025 PSUSA/00010645/202603 PSUSA/00010645/202703 Kimmo Jaakkola Finland CAP 10646 darunavir / cobicistat / emtricitabine / tenofovir alafenamide 21/09/2017 3 years 20/09/2027 19/12/2027 No 28/04/2022 PSUR frequency and DLP were updated on 28/04/2022 DLP was updated on 28/04/2021 DLP was updated on 06/05/2020 PSUR frequency amended on 20/11/2019 DLP was updated on 23/10/2019 DLP was updated on 30/04/2019 Lead MS and PRAC Rapporteur name updated on 23/10/2018 DLP was updated on 23/10/2018 New CAP authorised on 21/09/2017 PSUSA/00010646/202709 Ana Sofia Diniz Martins Portugal CAP 10647 dimethyl fumarate (psoriasis) 23/06/2017 3 years 23/03/2028 21/06/2028 No 19/11/2025 PSUR frequency amended and DLP updated on 19/11/2025 PSUSA/00010647/202803 Karin Bolin Sweden CAP 10648 triglyceride combinations (e.g. olive oil, soya bean oil, fish oil)/ with or without mineral compounds/electrolytes (i.v. application) 06/02/2014 5 years 03/06/2026 01/09/2026 No 15/11/2023 PRAC Rapporteur updated on 15/11/2023 PSUSA/00010648/202606 Petar Mas Croatia NAP 10649 ibuprofen, ibuprofen lysine (not indicated in ductus arteriosus), ibuprofen / caffeine 19/02/1969 3 years 18/02/2026 19/05/2026 No 18/10/2023 Next DLP was updated on 18/10/2023 PSUSA/00010649/202602 John Joseph Borg Malta NAP 10650 clodronic acid, clodronic acid / lidocaine 13/02/1985 5 years 28/02/2027 29/05/2027 Yes 16/11/2022 DLP was updated on 16/11/2022 PRAC Representative amended on 28/04/2022 New entry added following merge on 15/11/2017 PSUSA/00010650/202702 Jean-Michel Dogné Belgium NAP 10651 ozenoxacin 19/05/2017 5 years 18/05/2030 16/08/2030 No 04/02/2026 PSUR frequency amended and DLP updated on 04/02/2026 PSUSA/00010651/203005 Maria Martinez Gonzalez Spain NAP 10652 guselkumab 13/07/2017 1 year 12/07/2026 20/09/2026 12/07/2027 20/09/2027 No 04/03/2026 DLP was amended on 04/03/2026 PSUSA/00010652/202607 PSUSA/00010652/202707 Dirk Mentzer Germany CAP 10653 fluticasone furoate / umeclidinium / vilanterol 18/09/2017 3 years 17/03/2027 15/06/2027 No 02/06/2026 PSUSA/00010653/202703 Karin Bolin Sweden CAP 10654 padeliporfin 10/11/2017 3 years 09/11/2028 07/02/2029 No 29/07/2026 DLP was amended on 29/07/2026 PSUSA/00010654/202811 Maia Uusküla Estonia CAP 10655 niraparib 27/03/2017 1 year 26/03/2026 04/06/2026 26/03/2027 04/06/2027 No 19/11/2025 DLP was amended on 19/11/2025 PSUSA/00010655/202603 PSUSA/00010655/202703 Jan Neuhauser Austria CAP 10656 methohexital 24/01/1977 5 years 01/01/2027 01/04/2027 No 21/09/2022 DLP was updated on 21/09/2022 PRAC representative and LMS were added on 26/05/2021 New entry added on 19/17/2017 PSUSA/00010656/202701 Liana Martirosyan Netherlands NAP 10657 naloxone (for use in non-medical settings) 06/06/2016 2 years 09/05/2026 07/08/2026 No 05/02/2025 DLP was amended on 05/02/2025 PSUSA/00010657/202605 Liana Martirosyan Netherlands CAP NAP 10658 methyl salicylate, menthol / methyl salicylate, menthol / methyl salicylate / camphor, methyl salicylate/ camphor, methyl salicylate / menthol / camphor / tocopherol, methyl salicylate / camphor / menthol / turpentine (essence, oil), methyl salicylate / menthol / camphor / hydroxyethyl salicylate, methyl salicylate / menthol / camphor / hydroxyethyl salicylate / benzyl nicotinate 23/06/1989 5 years 20/04/2027 19/07/2027 No 31/01/2024 PRAC representative updated on 31/01/2024 PSUSA/00010658/202704 Carla Torre Portugal NAP 10659 inotuzumab ozogamicin 29/06/2017 3 years 28/12/2028 28/03/2029 No 29/07/2026 PSUR frequency amended and DLP updated on 29/07/2026 PSUSA/00010659/202812 Dirk Mentzer Germany CAP 10660 letermovir 01/11/2017 3 years 01/11/2027 30/01/2028 No 25/06/2025 DLP was amended on 25/06/2025 PSUSA/00010660/202711 Terhi Lehtinen Finland CAP 10661 benralizumab 14/11/2017 3 years 13/11/2028 11/02/2029 No 29/07/2026 DLP was amended on 29/07/2026 PSUSA/00010661/202811 David Olsen Norway CAP 10662 ocrelizumab 28/03/2017 3 years 27/03/2027 25/06/2027 No 06/10/2025 DLP was amended on 20/11/2024 PSUSA/00010662/202703 Dirk Mentzer Germany CAP 10663 rurioctocog alfa pegol 13/11/2018 3 years 12/11/2027 10/02/2028 No 25/06/2025 PSUR frequency amended and DLP updated on 25/06/2025 PSUSA/00010663/202711 Bianca Mulder Netherlands CAP 10664 budesonide (for centrally authorised products indicated for eosinophilic esophagitis only) 08/01/2018 3 years 07/07/2028 05/10/2028 No 01/04/2026 PSUR frequency amended and DLP updated on 01/04/2026 DLP was amended on 04/03/2026 PSUSA/00010664/202807 Zane Neikena Latvia CAP 10665 loperamide, loperamide / simeticone 31/05/1973 5 years 31/05/2029 29/08/2029 No 05/02/2025 PSUR frequency amended and DLP updated on 05/02/2025 PSUSA/00010665/202905 Adam Przybylkowski Poland NAP 10667 pseudoephedrine, acetylsalicylic acid / pseudoephedrine 01/02/1986 3 years 28/06/2026 26/09/2026 No 28/02/2024 PSUR frequency amended and DLP updated on 28/02/2024 PSUSA/00010667/202606 Maia Uusküla Estonia NAP 10668 emicizumab 16/11/2017 3 years 15/11/2027 13/02/2028 No 25/06/2025 PSUR frequency amended and DLP updated on 25/06/2025 PSUSA/00010668/202711 Amelia Cupelli Italy CAP 10669 burosumab 19/02/2018 1 year 18/02/2026 29/04/2026 18/02/2027 29/04/2027 No 22/10/2025 DLP was amended on 22/10/2025 PSUSA/00010669/202602 PSUSA/00010669/202702 Dirk Mentzer Germany CAP 10670 opium 01/10/1986 7 years 30/09/2031 29/12/2031 Yes 16/10/2023 PRAC Rapporteur name was amended on 18/10/2023 PSUSA/00010670/203109 Marie Louise Schougaard Christiansen Denmark NAP 10671 semaglutide (all other indications) 05/12/2017 2 years 31/05/2027 29/08/2027 No 02/06/2026 PSUSA/00010671/202705 Karin Bolin Sweden CAP 10672 prasterone (vaginal use/Pessary) 16/11/2016 5 years 15/11/2030 13/02/2031 No 29/07/2026 PSUR frequency amended and DLP updated on 29/07/2026 PSUSA/00010672/203011 Bianca Mulder Netherlands CAP 10673 sitagliptin, metformin / sitagliptin 21/03/2007 3 years 03/08/2026 01/11/2026 No 30/07/2025 Active substance name was amended on 30/07/2025 DLP was amended on 30/04/2024 PSUSA/00010673/202608 Bianca Mulder Netherlands CAP NAP 10674 hydrocortisone (centrally authorised products for adrenal insufficiency, paediatric use only) 09/02/2018 3 years 08/08/2026 06/11/2026 No 27/03/2024 PSUR frequency amended and DLP updated on 27/03/2024 PSUSA/00010674/202608 Karin Bolin Sweden CAP 10675 sodium zirconium cyclosilicate 22/03/2018 3 years 21/03/2028 19/06/2028 No 19/11/2025 DLP was amended on 19/11/2025 PSUSA/00010675/202803 Terhi Lehtinen Finland CAP 10677 velmanase alfa 23/03/2018 3 years 22/03/2028 20/06/2028 No 19/11/2025 PSUR frequency amended and DLP updated on 19/11/2025 PSUSA/00010677/202803 Jan Neuhauser Austria CAP 10678 herpes zoster vaccine (recombinant, adjuvanted) 13/10/2017 1 year 12/10/2026 21/12/2026 12/10/2027 21/12/2027 No 27/05/2026 DLP was amended on 27/05/2026 PSUSA/00010678/202610 PSUSA/00010678/202710 Sonja Radowan Austria CAP 10683 Krypton (81 mKr) 31/01/1995 10 years 30/01/2026 30/04/2026 No 20/06/2025 New active substance added on 06/06/2018 PSUSA/00010683/202601 Zane Neikena Latvia NAP 10684 coal tar, distilled coal tar, coconut oil / distilled coal tar / salicylic acid, coal tar solution / salicylic acid / sulfur, coal tar / salicylic acid, coal tar / menthol 16/02/1989 8 years 16/02/2033 17/05/2033 No 23/10/2024 PSUR frequency amended and DLP updated on 23/10/2024 Active substance name was amended on 23/10/2024 EURD added on 23/10/2024 New entry added on 06/06/2018 PSUSA/00010684/203302 Liana Martirosyan Netherlands NAP 10685 lisinopril / torasemide 12/12/2017 5 years 11/12/2028 11/03/2029 Yes 13/08/2025 DLP was amended on 31/07/2024 PSUSA/00010685/202812 Veronika Macurová Czech Republic NAP 10686 enterococcus faecium 27/07/1955 10 years 26/07/2026 24/10/2026 No 18/11/2025 New active substance added on 06/06/2018 PSUSA/00010686/202607 Polona Golmajer Slovenia NAP 10688 gemtuzumab ozogamicin 17/05/2000 3 years 16/05/2026 14/08/2026 No 31/01/2024 PSUR frequency amended and DLP updated on 31/01/2024 PSUSA/00010688/202605 Carla Torre Portugal CAP 10689 dolutegravir / rilpivirine 16/05/2018 3 years 15/05/2028 13/08/2028 No 04/02/2026 PSUR frequency amended and DLP updated on 04/02/2026 PSUSA/00010689/202805 Zoubida Amimour France CAP 10690 glibenclamide (for centrally authorised products only) 24/05/2018 3 years 23/05/2028 21/08/2028 No 04/02/2026 DLP was amended on 04/02/2026 PSUSA/00010690/202805 Maria del Pilar Rayon Spain CAP 10691 heparin / zinc sulphate 30/11/1998 12 years 29/11/2027 27/02/2028 No 31/07/2018 New combination of active substances added on 31/07/2018 PSUSA/00010691/202711 NAP 10693 allergen for therapy: Ambrosia Artemisiifolia (302) (sublingual use, products authorised via decentralised procedure)” 10/04/2014 3 years 09/04/2027 08/07/2027 No 06/10/2025 DLP was amended on 18/12/2024 PSUSA/00010693/202704 Dirk Mentzer Germany NAP 10694 rucaparib 19/12/2016 2 years 19/12/2025 19/03/2026 No 02/06/2026 PSUSA/00010694/202512 Jenny-Maria Jönsson Sweden CAP 10695 bictegravir / emtricitabine / tenofovir alafenamide 07/02/2018 3 years 06/02/2028 06/05/2028 No 22/10/2025 DLP was amended on 22/10/2025 PSUSA/00010695/202802 Liana Martirosyan Netherlands CAP 10696 iron dextran Not available* 3 years 01/01/2027 01/04/2027 Yes 25/09/2024 DLP was amended on 25/09/2024 PSUSA/00010696/202701 Zane Neikena Latvia NAP 10697 inotersen 06/07/2018 2 years 05/07/2027 03/10/2027 No 27/05/2026 DLP was corrected on 27/05/2026 PSUR frequency amended and DLP updated on 29/04/2026 DLP was amended on 04/03/2026 PSUSA/00010697/202707 Rhea Fitzgerald Ireland CAP 10698 brexpiprazole 10/07/2015 3 years 09/07/2027 07/10/2027 No 05/03/2025 DLP was amended on 05/03/2025 PSUSA/00010698/202707 Miroslava Gocova Slovakia CAP 10699 erenumab 17/05/2018 3 years 16/05/2027 14/08/2027 No 18/12/2024 PSUR frequency amended and DLP updated on 18/12/2024 PSUSA/00010699/202705 Terhi Lehtinen Finland CAP 10700 metreleptin 25/03/2013 1 year 24/01/2026 04/04/2026 24/01/2027 04/04/2027 No 24/09/2025 DLP was amended on 24/09/2025 PSUSA/00010700/202601 PSUSA/00010700/202701 Adam Przybylkowski Poland CAP 10701 daunorubicin / cytarabine 03/08/2017 3 years 02/08/2028 31/10/2028 No 01/04/2026 DLP was amended on 01/04/2026 PSUSA/00010701/202808 Carla Torre Portugal CAP 10702 tisagenlecleucel 30/08/2017 1 year 12/08/2026 21/10/2026 12/08/2027 21/10/2027 No 01/04/2026 DLP was amended on 01/04/2026 PSUSA/00010702/202608 PSUSA/00010702/202708 Dirk Mentzer Germany CAP 10703 axicabtagene ciloleucel 18/10/2017 1 year 17/10/2026 26/12/2026 17/10/2027 26/12/2027 No 01/07/2026 DLP was amended on 01/07/2026 PSUSA/00010703/202610 PSUSA/00010703/202710 Karin Erneholm Denmark CAP 10706 sodium fluoride (18F) 14/11/1994 5 years 13/11/2027 11/02/2028 Yes 26/07/2023 PSUR frequency amended and DLP updated on 26/07/2023 PSUSA/00010706/202711 Kimmo Jaakkola Finland NAP 10707 soybean phospholipids (oral use) 02/10/1957 5 years 01/10/2026 30/12/2026 No 15/11/2023 PRAC Rapporteur updated on 15/11/2023 PSUSA/00010707/202610 Petar Mas Croatia NAP 10708 fluorocholine (18F) 02/04/2010 3 years 01/04/2026 30/06/2026 No 23/08/2023 DLP was amended on 23/08/2023 DLP updated on 02/02/2022 LMS and PRAC representative were added on 25/09/2019 New entry added on 26/09/2018 PSUSA/00010708/202604 Eva Jirsová Czech Republic NAP 10709 vestronidase alfa 15/11/2017 3 years 14/11/2026 12/02/2027 No 03/07/2024 PSUR frequency amended and DLP updated on 03/07/2024 PSUSA/00010709/202611 Maria del Pilar Rayon Spain CAP 10710 alitretinoin (oral use) Not available* 1 year 18/01/2026 29/03/2026 18/01/2027 29/03/2027 No 24/09/2025 DLP was amended on 24/09/2025 PSUSA/00010710/202601 PSUSA/00010710/202701 Jan Neuhauser Austria NAP 10712 neratinib 17/07/2017 3 years 16/07/2026 14/10/2026 No 28/02/2024 PSUR frequency amended and DLP updated on 28/02/2024 PSUSA/00010712/202607 Bianca Mulder Netherlands CAP 10713 caplacizumab 31/08/2018 1 year 30/08/2026 08/11/2026 30/08/2027 08/11/2027 No 29/04/2026 DLP was amended on 29/04/2026 PSUSA/00010713/202608 PSUSA/00010713/202708 Jan Neuhauser Austria CAP 10714 vonicog alfa 08/12/2015 3 years 31/12/2026 31/03/2027 No 02/06/2026 PSUSA/00010714/202612 Karin Bolin Sweden CAP 10715 patisiran 10/08/2018 2 years 09/08/2027 07/11/2027 No 01/04/2026 PSUR frequency amended and DLP updated on 01/04/2026 PSUSA/00010715/202708 Rhea Fitzgerald Ireland CAP 10716 Symphytum officinale L., radix (comfrey root) 07/01/1966 13 years 31/12/2027 30/03/2028 No 23/10/2018 New active substance added on 23/10/2018 PSUSA/00010716/202712 NAP 10717 binimetinib 27/06/2018 3 years 26/06/2028 24/09/2028 No 04/02/2026 PSUR frequency amended and DLP updated on 04/02/2026 PSUSA/00010717/202806 Carla Torre Portugal CAP 10718 eravacycline 27/08/2018 3 years 26/08/2027 24/11/2027 No 02/04/2025 PSUR frequency amended and DLP updated on 02/04/2025 PSUSA/00010718/202708 Adam Przybylkowski Poland CAP 10719 encorafenib 27/06/2018 3 years 26/06/2028 24/09/2028 No 04/02/2026 PSUR frequency amended and DLP updated on 04/02/2026 PSUSA/00010719/202806 Rugile Pilviniene Lithuania CAP 10720 tildrakizumab 20/03/2018 1 year 19/03/2026 28/05/2026 19/03/2027 28/05/2027 No 22/10/2025 DLP was amended on 22/10/2025 PSUSA/00010720/202603 PSUSA/00010720/202703 Adam Przybylkowski Poland CAP 10721 allergen for diagnostic and/or therapy: Vespula SPP. (802) (with or without adjuvant), Wasp venom 03/07/1980 5 years 02/07/2027 30/09/2027 No 02/06/2026 PSUSA/00010721/202707 Karin Bolin Sweden NAP 10722 allergen for diagnostic and/or therapy: Apis mellifera (801) (with or without adjuvant), Apis mellifera venom 03/07/1980 5 years 02/07/2027 30/09/2027 No 02/06/2026 DLP was updated on 01/03/2023 PRAC Rapporteur name was amended on 22/09/2022 DLP was updated on 31/03/2021 PRAC representative and LMS were added on 18/11/2020 New active substance added on 21/11/2018 PSUSA/00010722/202707 Karin Bolin Sweden NAP 10723 durvalumab 01/05/2017 1 year 30/04/2026 09/07/2026 30/04/2027 09/07/2027 No 18/12/2024 DLP was amended on 18/12/2024 PSUSA/00010723/202604 PSUSA/00010723/202704 David Olsen Norway CAP 10724 abemaciclib 28/09/2017 3 years 28/09/2027 27/12/2027 No 30/04/2024 DLP was amended on 30/04/2024 PSUSA/00010724/202709 Carla Torre Portugal CAP 10725 interferon beta-1a (intramuscular use) 13/03/1997 5 years 03/05/2029 01/08/2029 No 05/02/2025 PSUR frequency amended and DLP updated on 05/02/2025 PSUSA/00010725/202905 Maria del Pilar Rayon Spain CAP 10726 interferon beta-1a (subcutaneous use) 04/05/1998 5 years 03/05/2026 01/08/2026 No 02/06/2026 PSUSA/00010726/202605 Karin Bolin Sweden CAP 10727 meropenem / vaborbactam 29/08/2017 3 years 28/08/2026 26/11/2026 No 30/04/2024 PSUR frequency amended and DLP updated on 30/04/2024 PSUSA/00010727/202608 Maria del Pilar Rayon Spain CAP 10728 brigatinib 28/04/2017 3 years 27/04/2026 26/07/2026 No 20/12/2023 PSUR frequency amended and DLP updated on 20/12/2023 PSUSA/00010728/202604 Carla Torre Portugal CAP 10729 doravirine 30/08/2018 5 years 29/08/2030 27/11/2030 No 27/05/2026 DLP was corrected on 27/05/2026 PSUR frequency amended and DLP updated on 29/04/2026 PSUSA/00010729/203008 Ana Sofia Diniz Martins Portugal CAP 10730 tezacaftor / ivacaftor 12/02/2018 1 year 11/02/2026 22/04/2026 11/02/2027 22/04/2027 No 24/09/2025 DLP was amended on 24/09/2025 PSUSA/00010730/202602 PSUSA/00010730/202702 Eamon O Murchu Ireland CAP 10731 doravirine / lamivudine / tenofovir disoproxil 30/08/2018 5 years 29/08/2030 27/11/2030 No 27/05/2026 DLP was corrected on 27/05/2026 PSUR frequency amended and DLP updated on 29/04/2026 PSUSA/00010731/203008 Ana Sofia Diniz Martins Portugal CAP 10732 damoctocog alfa pegol 29/08/2018 2 years 28/08/2027 26/11/2027 No 29/04/2026 DLP was amended on 29/04/2026 PSUSA/00010732/202708 Bianca Mulder Netherlands CAP 10733 galcanezumab 27/09/2018 3 years 27/09/2026 26/12/2026 No 30/04/2024 PSUR frequency amended and DLP updated on 30/04/2024 PSUSA/00010733/202609 Terhi Lehtinen Finland CAP 10734 ceftobiprole 20/11/2013 3 years 19/11/2027 17/02/2028 No 02/06/2026 PSUSA/00010734/202711 Jenny Jönsson Sweden NAP 10735 valsartan / rosuvastatin 12/10/2016 3 years 11/10/2028 09/01/2029 No 01/07/2026 DLP was amended on 01/07/2026 PSUSA/00010735/202810 Polona Golmajer Slovenia NAP 10736 activated attapulgite mormoiron, activated attapulgite / aluminium / pectin 30/03/1956 10 years 31/12/2026 31/03/2027 No 19/12/2018 New entry added on 19/12/18 PSUSA/00010736/202612 NAP 10737 influenza vaccine (surface antigen, inactivated, prepared in cell cultures) 12/12/2018 1 year 15/03/2026 24/05/2026 15/03/2027 24/05/2027 No 22/10/2025 DLP was amended on 22/10/2025 PSUSA/00010737/202603 PSUSA/00010737/202703 Dirk Mentzer Germany CAP 10738 mexiletine (centrally authorised products only) 18/12/2018 3 years 17/12/2025 17/03/2026 No 26/07/2023 Next DLP was updated on 26/07/2023 PSUSA/00010738/202512 Eva Jirsová Czech Republic CAP 10739 glycopyrronium bromide / formoterol 25/04/2016 3 years 24/04/2026 23/07/2026 No 20/12/2023 PSUR frequency amended and DLP updated on 20/12/2023 PSUSA/00010739/202604 Jan Neuhauser Austria CAP 10741 mogamulizumab 30/03/2012 3 years 29/03/2026 27/06/2026 No 15/11/2023 PSUR frequency amended and DLP updated on 15/11/2023 PSUSA/00010741/202603 Marie Louise Schougaard Christiansen Denmark CAP 10742 voretigene neparvovec 19/12/2017 1 year 23/07/2026 01/10/2026 23/07/2027 01/10/2027 No 04/03/2026 DLP was amended on 04/03/2026 PSUSA/00010742/202607 PSUSA/00010742/202707 Dirk Mentzer Germany CAP 10743 lanadelumab 23/08/2018 3 years 22/08/2026 20/11/2026 No 27/03/2024 PSUR frequency amended and DLP updated on 27/03/2024 PSUSA/00010743/202608 Terhi Lehtinen Finland CAP 10744 isopropyl alcohol , isopropyl alcohol (covers other synonymous terms such as 2-propanol) / benzalkonium 03/12/1982 10 years 02/12/2029 02/03/2030 No 04/02/2026 Active substance name was amended on 04/02/2026 Entry name updated on 22/10/2025 Entry name updated on 30/07/2025 New entry introduced on 06/03/2019 PSUSA/00010744/202912 none NAP 10745 apalutamide 14/02/2018 3 years 13/02/2028 13/05/2028 No 24/09/2025 PSUR frequency amended and DLP updated on 24/09/2025 PSUSA/00010745/202802 Tiphaine Vaillant France CAP 10746 macimorelin 11/01/2019 5 years 10/01/2030 10/04/2030 No 24/09/2025 PSUR frequency amended and DLP updated on 24/09/2025 PSUSA/00010746/203001 Liana Martirosyan Netherlands CAP NAP 10747 calcium dobesilate / lidocaine, 'calcium dobesilate / dexamethasone / lidocaine 30/12/1975 10 years 03/03/2035 01/06/2035 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00010747/203503 NAP 10748 octenidine 18/07/2018 10 years 17/07/2035 15/10/2035 No 01/04/2026 PSUR frequency amended and DLP updated on 01/04/2026 PSUSA/00010748/203507 Petar Mas Croatia NAP 10749 argipressin 01/04/1979 3 years 31/03/2027 29/06/2027 Yes 18/12/2024 DLP was amended on 18/12/2024 PSUSA/00010749/202703 Terhi Lehtinen Finland NAP 10750 magnesium / pyridoxine 24/07/1991 13 years 23/07/2026 21/10/2026 No 18/11/2025 New entry introduced on 06/03/2019 PSUSA/00010750/202607 Guðrún Stefánsdóttir Iceland NAP 10753 naldemedine 23/03/2017 2 years 22/03/2026 20/06/2026 No 20/11/2024 DLP was amended on 20/11/2024 PSUSA/00010753/202603 Eamon O Murchu Ireland CAP 10754 amidotrizoic acid and combination 05/03/1956 11 years 01/12/2036 01/03/2037 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00010754/203612 Karin Erneholm Denmark NAP 10755 lusutrombopag 28/09/2015 3 years 27/09/2026 26/12/2026 No 02/06/2026 PSUSA/00010755/202609 Mari Thorn Sweden CAP 10756 ropeginterferon alfa-2b 15/02/2019 3 years 14/02/2026 15/05/2026 No 18/10/2023 PSUR frequency amended and DLP updated on 18/10/2023 PSUSA/00010756/202602 Carla Torre Portugal CAP 10757 dacomitinib 27/09/2018 3 years 26/09/2027 25/12/2027 No 03/05/2023 PSUR frequency amended and DLP updated on 03/05/2023 DLP was updated on 25/05/2022 DLP was updated on 17/11/2021 PSUR frequency and DLP were updated on 26/05/2021 DLP was updated on 18/11/2020 DLP was updated on 06/05/2020 New CAP authorised on 02/04/2019 PSUSA/00010757/202709 Bianca Mulder Netherlands CAP 10758 fremanezumab 14/09/2018 3 years 13/09/2026 12/12/2026 No 30/04/2024 PSUR frequency amended and DLP updated on 30/04/2024 PSUSA/00010758/202609 Terhi Lehtinen Finland CAP 10759 infliximab 16/11/2000 3 years 23/08/2028 21/11/2028 No 29/04/2026 DLP was amended on 29/04/2026 PSUSA/00010759/202808 Karin Bolin Sweden CAP 10760 lorlatinib 21/09/2018 1 year 20/09/2026 29/11/2026 20/09/2027 29/11/2027 No 29/04/2026 DLP was amended on 29/04/2026 PSUSA/00010760/202609 PSUSA/00010760/202709 Barbara Kovacic Bytyqi Croatia CAP 10761 pegvaliase 24/05/2018 3 years 23/05/2028 21/08/2028 No 04/02/2026 DLP was amended on 04/02/2026 PSUSA/00010761/202805 Rhea Fitzgerald Ireland CAP 10762 volanesorsen 03/05/2019 6 months 02/05/2026 11/07/2026 02/11/2026 11/01/2027 No 01/07/2026 DLP was amended on 01/07/2026 PSUSA/00010762/202605 PSUSA/00010762/202611 Dennis Lex Germany CAP 10763 zanamivir (centrally authorised products only) 09/02/1999 3 years 31/01/2027 01/05/2027 No 02/06/2026 PSUSA/00010763/202701 Karin Bolin Sweden CAP 10764 andexanet alfa 26/04/2019 6 months 25/04/2026 04/07/2026 25/10/2026 03/01/2027 No 01/07/2026 DLP was amended on 01/07/2026 PSUSA/00010764/202604 PSUSA/00010764/202610 Bianca Mulder Netherlands CAP 10765 risankizumab 26/03/2019 5 years 25/03/2030 23/06/2030 No 19/11/2025 PSUR frequency amended and DLP updated on 19/11/2025 PSUSA/00010765/203003 Liana Martirosyan Netherlands CAP 10767 levofloxacin (intravenous and oral use) 01/10/1993 3 years 01/10/2026 30/12/2026 No 05/06/2024 PSUR frequency amended and DLP updated on 05/06/2024 PSUSA/00010767/202610 Dennis Lex Germany NAP 10768 levofloxacin (ocular use) 01/10/1993 5 years 01/10/2028 30/12/2028 No 05/06/2024 DLP was amended on 05/06/2024 PSUSA/00010768/202810 Dennis Lex Germany NAP 10771 anthrax vaccine 06/01/1994 3 years 31/12/2027 30/03/2028 No 06/10/2025 DLP was amended on 24/09/2025 PSUSA/00010771/202712 Dirk Mentzer Germany NAP 10772 metergoline 15/01/1990 5 years 31/08/2028 29/11/2028 No 03/07/2019 Lead MS and PRAC reperesentative were updated on 21/12/2022 New entry added on 03/07/2019 PSUSA/00010772/202808 Amelia Cupelli Italy NAP 10774 amlodipine / ramipril, amlodipine / hydrochlorothiazide / ramipril, hydrochlorothiazide / ramipril 31/03/2012 3 years 31/03/2027 29/06/2027 No 22/10/2025 Active substance name was amended on 22/10/2025 DLP was amended on 18/12/2024 PSUSA/00010774/202703 Jan Neuhauser Austria NAP 10775 ursodeoxycholic acid, tauroursodeoxycholic acid 27/11/1979 10 years 30/11/2026 28/02/2027 No 08/04/2026 Entry name updated on 03/07/2019 PSUSA/00010775/202611 Benjamin Micallef Malta NAP 10776 pramocaine, hydrocortisone / pramocaine 12/12/1965 11 years 02/12/2039 01/03/2040 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00010776/203912 NAP 10777 treosulfan (for centrally authorised product) 20/06/2019 3 years 19/06/2026 17/09/2026 No 31/01/2024 PSUR frequency amended and DLP updated on 31/01/2024 PSUSA/00010777/202606 Julia Pallos Hungary CAP 10779 avatrombopag 21/05/2018 3 years 20/05/2027 18/08/2027 No 19/09/2025 PSUR frequency amended and DLP updated on 05/02/2025 PSUSA/00010779/202705 Maria Martinez Gonzalez Spain CAP 10780 cemiplimab 28/09/2018 2 years 27/09/2026 26/12/2026 No 03/05/2023 PSUR frequency amended and DLP updated on 03/05/2023 PSUR frequency corrected on 21/12/2022 DLP was updated on 25/05/2022 PSUR frequency corrected on 30/03/2022 DLP was updated on 17/11/2021 PSUR frequency and DLP were updated on 26/05/2021 DLP was updated on 18/11/2020 DLP was updated on 06/05/2020 New CAP authorised on 28/06/2019 PSUSA/00010780/202609 Bianca Mulder Netherlands CAP 10781 talazoparib 16/10/2018 3 years 15/10/2027 13/01/2028 No 05/06/2024 DLP was amended on 05/06/2024 PSUSA/00010781/202710 Carla Torre Portugal CAP 10782 turoctocog alfa pegol 20/06/2019 3 years 19/06/2027 17/09/2027 No 06/10/2025 PSUR frequency amended and DLP updated on 05/02/2025 PSUSA/00010782/202706 Dirk Mentzer Germany CAP 10783 adalimumab 08/09/2003 3 years 31/12/2025 31/03/2026 No 20/09/2023 DLP amended on 20/09/2023 PSUSA/00010783/202512 Karin Bolin Sweden CAP 10784 ertugliflozin / metformin, ertugliflozin / sitagliptin, ertugliflozin 19/12/2017 2 years 18/12/2025 18/03/2026 No 25/09/2024 DLP was amended on 25/09/2024 PSUSA/00010784/202512 Bianca Mulder Netherlands CAP 10785 angiotensin II 21/12/2017 2 years 20/12/2025 20/03/2026 No 31/07/2024 PSUR frequency amended and DLP updated on 31/07/2024 PSUSA/00010785/202512 Bianca Mulder Netherlands CAP 10786 l-lysine hydrochloride / l-arginine hydrochloride 25/07/2019 3 years 24/07/2026 22/10/2026 Yes 28/02/2024 PSUR frequency amended and DLP updated on 28/02/2024 PSUSA/00010786/202607 Adam Przybylkowski Poland CAP 10787 ravulizumab 01/01/2019 3 years 31/12/2027 30/03/2028 No 30/07/2025 PSUR frequency amended and DLP updated on 30/07/2025 PSUSA/00010787/202712 Kimmo Jaakkola Finland CAP 10788 technetium (99mtc) N,N'-ethylene-(L,L)-dicysteine 28/09/2010 15 years 27/09/2033 26/12/2033 Yes 25/09/2019 New entry added on 25/09/2019 PSUSA/00010788/203309 NAP 10789 technetium (99mtc) 3,3-diphosphono-1,2-propanedicarboxylic acid 31/01/1995 15 years 30/01/2032 29/04/2032 Yes 25/09/2019 New entry added on 25/09/2019 PSUSA/00010789/203201 NAP 10790 aniracetam 20/08/1993 10 years 19/08/2031 17/11/2031 No 12/09/2025 PSUR frequency and DLP were updated on 28/04/2022 PRAC representative and LMS were added on 03/02/2021 New entry added on 25/09/2019 PSUSA/00010790/203108 Veronika Macurová Czech Republic NAP 10791 bovine lung phospholipid 22/12/1989 5 years 30/06/2026 28/09/2026 Yes 28/10/2025 PSUR frequency and DLP were updated on 02/03/2022 PRAC representative and LMS were added on 18/11/2020 New entry added on 25/09/2019 PSUSA/00010791/202606 Kimmo Jaakkola Finland NAP 10792 cod-liver oil (oral and parental use) Not available* 15 years 01/01/2034 01/04/2034 Yes 25/09/2019 New entry added on 25/09/2019 PSUSA/00010792/203401 NAP 10793 cod-liver oil (topical use), cod-liver oil/zinc oxide Not available* 15 years 01/01/2034 01/04/2034 Yes 25/09/2019 New entry added on 25/09/2019 PSUSA/00010793/203401 NAP 10794 ispaghula husk, ispaghula husk / ispaghula seed, ispaghula husk / ispaghula seed / senna Tinnervelly pod, psyllium, psyllium husk, psyllium seed 13/09/1954 10 years 12/09/2034 11/12/2034 No 27/05/2026 Entry re-activated on 27/05/2026 Active substance name was updated on 21/10/2020 New entry added on 25/09/2019 PSUSA/00010794/203409 none NAP 10795 etanercept 03/02/2000 5 years 02/02/2028 02/05/2028 No 19/09/2025 New CAP authorised on 23/04/2026 PSUR frequency amended and DLP updated on 18/10/2023 PSUSA/00010795/202802 Maria Martinez Gonzalez Spain CAP 10796 botulinum toxin type A (for centrally authorised products only) 01/02/2019 3 years 31/01/2027 01/05/2027 No 25/09/2024 PSUR frequency amended and DLP updated on 25/09/2024 PSUSA/00010796/202701 Adam Przybylkowski Poland CAP 10798 cannabidiol (for centrally authorised products only) 25/06/2018 3 years 24/06/2027 22/09/2027 No 05/02/2025 PSUR frequency amended and DLP updated on 05/02/2025 PSUSA/00010798/202706 Ana Sofia Diniz Martins Portugal CAP 10799 larotrectinib 26/11/2018 6 months 25/05/2026 03/08/2026 25/11/2026 03/02/2027 No 01/07/2026 DLP was amended on 01/07/2026 PSUSA/00010799/202605 PSUSA/00010799/202611 Rugile Pilviniene Lithuania CAP 10800 ethanol extracts of: Iberis amara L., planta tota recens / Angelica archangelica L., radix / Matricaria recutita L., flos / Carum carvi L., fructus / Silybum marianum (L.) Gaertn., fructus / Melissa officinalis L., folium / Mentha piperita L., folium / Chelidonium majus L., herba / Glycyrrhiza glabra L., radix 23/01/1968 3 years 30/11/2026 28/02/2027 No 31/07/2024 DLP was amended on 31/07/2024 PSUSA/00010800/202611 Dennis Lex Germany NAP 10801 poliovirus type 1 / poliovirus type 2 / poliovirus type 3 vaccine (oral, live, attenuated), poliovirus type 1 / poliovirus type 3 vaccine (oral, live, attenuated),poliovirus type 1 (oral, live, attenuated) vaccine, poliovirus type 2 (oral, live, attenuated) vaccine,poliovirus type 3 (oral, live, attenuated) vaccine 01/01/1964 3 years 26/07/2028 24/10/2028 Yes 01/04/2026 DLP was amended on 01/04/2026 PSUSA/00010801/202807 Jean-Michel Dogné Belgium NAP 10802 highly refined fish oil / glycerol / purified egg phosphatide 30/03/1998 5 years 29/03/2029 27/06/2029 No 20/11/2024 DLP was amended on 20/11/2024 PSUSA/00010802/202903 Polona Golmajer Slovenia NAP 10803 copper chloride dihydrate / manganese chloride tetrahydrate / potassium iodide / sodium fluoride / sodium selenite anhydrous / zinc chloride 05/02/1993 8 years 03/08/2033 01/11/2033 No 01/04/2026 DLP was amended on 01/04/2026 PSUSA/00010803/203308 Rugile Pilviniene Lithuania NAP 10805 docusate, docusate/sorbitol 01/01/1976 10 years 03/03/2035 01/06/2035 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00010805/203503 Zoubida Amimour France NAP 10806 rubidium (82Rb) chloride 22/11/2016 3 years 31/10/2026 29/01/2027 No 05/06/2024 PSUR frequency amended and DLP updated on 05/06/2024 PSUSA/00010806/202610 Dennis Lex Germany NAP 10807 thiamine / riboflavin/ pyridoxine / ascorbic acid / nicotinamide / glucose, thiamine / riboflavin / pyridoxine / ascorbic acid / nicotinamide, ascorbic acid / biotin / cyanocobalamin / folic acid / nicotinamide / pantothenic acid / pyridoxine hydrochloride / riboflavin / thiamine, riboflavin / thiamine / calcium folinate / cyanocobalamin / nicotinamide, calcium pantothenate / nicotinamide / pyridoxine / riboflavin / thiamine, dexpanthenol / nicotinamide / pyridoxine / riboflavin / thiamine, biotin / calcium pantothenate / cyanocobalamin / nicotinamide / pyridoxine / riboflavin / thiamine 27/09/1968 10 years 27/09/2027 26/12/2027 No 30/07/2025 Active substance name was amended on 30/07/2025 Active substance amended on 28/04/2022 Entry name was amended on 03/06/2020 EURD ID corrected on 05/02/2020 New entry following merge on 20/11/2019 PSUSA/00010807/202709 none NAP 10808 erythromycin (systemic use) 11/03/1954 3 years 11/03/2028 09/06/2028 No 19/11/2025 DLP was amended on 19/11/2025 PSUSA/00010808/202803 Eamon O'Murchu Ireland NAP 10809 erythromycin (topical use) 11/03/1954 5 years 11/03/2029 09/06/2029 No 20/11/2024 DLP was amended on 20/11/2024 PSUSA/00010809/202903 Eamon O'Murchu Ireland NAP 10810 lavender oil 26/06/2009 5 years 27/04/2028 26/07/2028 No 20/12/2023 DLP was amended on 20/12/2023 PSUSA/00010810/202804 Guðrún Stefánsdóttir Iceland NAP 10811 valine / histidine / isoleucine / leucine / lysine / methionine / phenylalanine / threonine / tyrosine / tryptophan 19/04/1991 10 years 01/08/2028 30/10/2028 No 05/02/2020 New entry added on 05/02/2020 PSUSA/00010811/202808 NAP 10812 sodium thiosulfate (except centrally authorised products) 11/11/2003 10 years 30/09/2027 29/12/2027 No 28/06/2023 Active substance name was amended on 28/06/2023 New entry added on 05/02/2020 PSUSA/00010812/202709 none NAP 10813 inactivated leptospire vaccine 04/04/1979 5 years 30/11/2027 28/02/2028 No 19/09/2024 PSUSA/00010813/202711 Zoubida Amimour France NAP 10814 aviptadil / phentolamine mesilate 10/07/1998 5 years 28/02/2027 29/05/2027 No 16/11/2022 DLP was updated on 16/11/2022 PRAC Rapporteur name was amended on 28/04/2022 LMS and PRAC representative were added on 28/07/2021 New entry added on 05/02/2020 PSUSA/00010814/202702 Marie Louise Schougaard Christiansen Denmark NAP 10815 allergen for therapy: betula verrucosa (sublingual use) 02/07/2019 3 years 02/07/2026 30/09/2026 No 28/02/2024 PSUR frequency amended and DLP updated on 28/02/2024 PSUSA/00010815/202607 Terhi Lehtinen Finland NAP 10816 lactic acid/oxalic acid / nitric acid / cupric nitrate/ acetic acid 27/09/1985 10 years 26/09/2029 25/12/2029 No 05/02/2020 New entry added on 05/02/2020 PSUSA/00010816/202909 NAP 10817 polatuzumab vedotin 10/06/2019 1 year 09/06/2026 18/08/2026 09/06/2027 18/08/2027 No 02/06/2026 PSUSA/00010817/202606 PSUSA/00010817/202706 Jenny-Maria Jönsson Sweden CAP 10818 siponimod 26/03/2019 3 years 25/03/2027 23/06/2027 No 20/11/2024 PSUR frequency amended and DLP updated on 20/11/2024 PSUSA/00010818/202703 Maria del Pilar Rayon Spain CAP 10819 fostamatinib 17/04/2018 3 years 16/04/2028 15/07/2028 No 19/11/2025 PSUR frequency amended and DLP updated on 19/11/2025 PSUSA/00010819/202804 Bianca Mulder Netherlands CAP 10820 osilodrostat 09/01/2020 3 years 08/01/2027 08/04/2027 No 25/09/2024 PSUR frequency amended and DLP updated on 25/09/2024 PSUSA/00010820/202701 Maria del Pilar Rayon Spain CAP 10822 delafloxacin 19/06/2017 2 years 18/06/2026 16/09/2026 No 05/02/2025 PSUR frequency amended and DLP updated on 05/02/2025 PSUSA/00010822/202606 Petar Mas Croatia CAP 10823 upadacitinib 16/08/2019 3 years 15/08/2028 13/11/2028 No 01/04/2026 PSUR frequency amended and DLP updated on 01/04/2026 PSUSA/00010823/202808 Petar Mas Croatia CAP 10824 romosozumab 08/01/2019 1 year 07/01/2026 18/03/2026 07/01/2027 18/03/2027 No 24/09/2025 DLP was amended on 24/09/2025 PSUSA/00010824/202601 PSUSA/00010824/202701 Tiphaine Vaillant France CAP 10825 esketamine (for centrally authorised product only) 05/03/2019 3 years 04/03/2027 02/06/2027 No 18/10/2023 Next DLP was updated on 18/10/2023 PSUSA/00010825/202703 Terhi Lehtinen Finland CAP 10826 glucagon (for centrally authorised product only) 24/07/2019 1 year 24/07/2026 02/10/2026 24/07/2027 02/10/2027 No 04/03/2026 DLP was amended on 04/03/2026 PSUSA/00010826/202607 PSUSA/00010826/202707 Rhea Fitzgerald Ireland CAP 10827 levonorgestrel (for emergency contraception only) 09/05/1990 5 years 08/05/2030 06/08/2030 No 04/02/2026 PSUR frequency amended and DLP updated on 04/02/2026 PSUSA/00010827/203005 Dennis Lex Germany NAP 10828 levonorgestrel (all indications except emergency contraception) 09/05/1990 3 years 08/05/2026 06/08/2026 No 31/01/2024 PSUR frequency amended and DLP updated on 31/01/2024 PSUSA/00010828/202605 Dennis Lex Germany NAP 10829 brolucizumab 07/10/2019 1 year 06/10/2026 15/12/2026 06/10/2027 15/12/2027 No 27/05/2026 DLP was amended on 27/05/2026 PSUSA/00010829/202610 PSUSA/00010829/202710 Dirk Mentzer Germany CAP 10830 imipenem / cilastatin / relebactam 16/07/2019 3 years 15/07/2027 13/10/2027 No 05/03/2025 PSUR frequency amended and DLP updated on 05/03/2025 PSUSA/00010830/202707 Adam Przybylkowski Poland CAP 10831 solriamfetol 20/03/2019 3 years 19/03/2028 17/06/2028 No 22/10/2025 PSUR frequency amended and DLP updated on 22/10/2025 PSUSA/00010831/202803 Julia Pallos Hungary CAP NAP 10832 gilteritinib 21/09/2018 3 years 20/09/2027 19/12/2027 No 30/04/2025 PSUR frequency amended and DLP updated on 30/04/2025 PSUSA/00010832/202709 Dennis Lex Germany CAP 10833 enoxaparin 15/09/2016 3 years 03/04/2027 02/07/2027 No 18/12/2024 DLP was amended on 18/12/2024 PSUSA/00010833/202704 Bianca Mulder Netherlands CAP NAP 10834 recombinant vesicular stomatitis virus - zaire ebolavirus vaccine (live) 11/11/2019 3 years 10/05/2028 08/08/2028 No 17/12/2025 PSUR frequency amended and DLP updated on 17/12/2025 PSUSA/00010834/202805 Liana Martirosyan Netherlands CAP 10835 allergen products for treatment: grass pollen, tree pollen, house dust mites, moulds, weed pollen, vertebrates, animal epithelia (except for hymenoptera venoms) single or mixes (subcutaneous use) 29/06/1984 8 years 31/07/2027 29/10/2027 No 01/04/2020 New entry added on 01/04/2020 PSUSA/00010835/202707 NAP 10836 human serum albumin (medical dilution) 25/11/1980 15 years 02/07/2035 30/09/2035 No 01/04/2020 New entry due to split on 01/04/2020 PSUSA/00010836/203507 NAP 10837 calcium carbonate/ magnesium carbonate/ simeticone 28/01/1988 10 years 01/01/2029 01/04/2029 No 01/04/2020 New entry added on 01/04/2020 PSUSA/00010837/202901 NAP 10839 givosiran 20/11/2019 1 year 19/05/2026 28/07/2026 19/05/2027 28/07/2027 No 04/02/2026 DLP was amended on 04/02/2026 PSUSA/00010839/202605 PSUSA/00010839/202705 Dennis Lex Germany CAP 10840 remdesivir (Veklury) 07/05/2020 3 years 06/05/2028 04/08/2028 No 17/12/2025 PSUR frequency amended and DLP updated on 17/12/2025 PSUSA/00010840/202805 Eva Jirsová Czech Republic CAP 10841 bempedoic acid, bempedoic acid / ezetimibe 21/02/2020 3 years 20/02/2028 20/05/2028 No 22/10/2025 PSUR frequency amended and DLP updated on 22/10/2025 PSUSA/00010841/202802 Kimmo Jaakkola Finland CAP 10843 darolutamide 30/07/2019 1 year 30/07/2026 08/10/2026 30/07/2027 08/10/2027 No 04/03/2026 DLP was amended on 04/03/2026 PSUSA/00010843/202607 PSUSA/00010843/202707 Jan Neuhauser Austria CAP 10844 dronabinol/cannabidiol 15/04/2005 5 years 14/04/2028 13/07/2028 No 20/12/2023 PSUR frequency amended and DLP updated on 20/12/2023 PSUSA/00010844/202804 Liana Martirosyan Netherlands NAP 10847 lidocaine hydrochloride / neomycin sulfate / polymyxin b, lidocaine hydrochloride monohydrate / fludrocortisone acetate / neomycin sulfate / polymyxin b Not available* 8 years 03/11/2026 01/02/2027 No 27/02/2026 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00010847/202611 Tiphaine Vaillant France NAP 10848 onasemnogene abeparvovec 24/05/2019 1 year 23/05/2026 01/08/2026 23/05/2027 01/08/2027 No 04/02/2026 DLP was amended on 04/02/2026 PSUSA/00010848/202605 PSUSA/00010848/202705 Karin Bolin Sweden CAP 10849 cefiderocol 14/11/2019 3 years 13/11/2027 11/02/2028 No 25/06/2025 PSUR frequency amended and DLP updated on 25/06/2025 PSUSA/00010849/202711 Dennis Lex Germany CAP 10850 indacaterol / mometasone furoate 30/05/2020 1 year 29/05/2026 07/08/2026 29/05/2027 07/08/2027 No 04/02/2026 DLP was amended on 04/02/2026 PSUSA/00010850/202605 PSUSA/00010850/202705 Jan Neuhauser Austria CAP 10851 isatuximab 02/03/2020 2 years 01/03/2027 30/05/2027 No 19/11/2025 DLP was amended on 19/11/2025 PSUSA/00010851/202703 Maria Martinez Gonzalez Spain CAP 10852 ozanimod 20/05/2020 3 years 19/05/2028 17/08/2028 No 04/02/2026 PSUR frequency amended and DLP updated on 04/02/2026 PSUSA/00010852/202805 Maria del Pilar Rayon Spain CAP 10853 drospirenone 12/11/2019 3 years 12/11/2027 10/02/2028 No 02/06/2026 PSUSA/00010853/202711 Jenny Jönsson Sweden NAP 10854 dexamethasone / netilmicin 08/04/2006 5 years 08/04/2026 07/07/2026 No 22/12/2021 DLP was updated on 22/12/2021 PRAC representative and LMS were added on 23/09/2020 New entry added on 29/07/2020 PSUSA/00010854/202604 Dennis Lex Germany NAP 10855 hydrocortisone (systemic formulations except for products indicated in adrenal insufficiency in a modified release tablet formulation and except for centrally authorised products for adrenal insufficiency in paediatric use only) 05/08/1952 5 years 31/08/2029 29/11/2029 No 25/06/2025 Active substance name was corrected on 25/06/2025 DLP was amended on 30/04/2025 PSUSA/00010855/202908 Barbara Kovacic Bytyqi Croatia NAP 10856 hydrocortisone (all formulations apart from systemic use) 05/08/1952 5 years 31/08/2029 29/11/2029 No 30/04/2025 DLP was amended on 30/04/2025 PSUSA/00010856/202908 Barbara Kovacic Bytyqi Croatia NAP 10859 glasdegib 21/11/2018 3 years 20/11/2027 18/02/2028 No 25/06/2025 PSUR frequency amended and DLP updated on 25/06/2025 PSUSA/00010859/202711 Bianca Mulder Netherlands CAP 10860 luspatercept 25/06/2020 1 year 24/06/2026 02/09/2026 24/06/2027 02/09/2027 No 04/02/2026 DLP was amended on 04/02/2026 PSUSA/00010860/202606 PSUSA/00010860/202706 Jo Robays Belgium CAP 10861 indacaterol / glycopyrronium / mometasone 03/07/2020 1 year 02/07/2026 10/09/2026 02/07/2027 10/09/2027 No 04/02/2026 DLP was amended on 04/02/2026 PSUSA/00010861/202607 PSUSA/00010861/202707 Jan Neuhauser Austria CAP 10862 cholera vaccine, oral, live 10/06/2016 3 years 09/06/2028 07/09/2028 No 04/02/2026 PSUR frequency amended and DLP updated on 04/02/2026 PSUSA/00010862/202806 Jean-Michel Dogné Belgium CAP 10863 pretomanid 14/08/2019 1 year 13/08/2026 22/10/2026 13/08/2027 22/10/2027 No 01/04/2026 DLP was amended on 01/04/2026 PSUSA/00010863/202608 PSUSA/00010863/202708 Liana Martirosyan Netherlands CAP 10864 iron sucrose (parenteral use) 06/12/1949 3 years 01/01/2027 01/04/2027 No 25/09/2024 DLP was amended on 25/09/2024 PSUSA/00010864/202701 Zane Neikena Latvia NAP 10865 ferric carboxymaltose (parenteral use) 06/12/1949 3 years 01/01/2027 01/04/2027 No 25/09/2024 DLP was amended on 25/09/2024 PSUSA/00010865/202701 Zane Neikena Latvia NAP 10866 ferric derisomaltose (parenteral use) 06/12/1949 3 years 01/01/2027 01/04/2027 No 25/09/2024 DLP was amended on 25/09/2024 PSUSA/00010866/202701 Zane Neikena Latvia NAP 10867 sodium iron gluconate (parenteral use) 06/12/1949 3 years 01/01/2027 01/04/2027 No 25/09/2024 DLP was amended on 25/09/2024 PSUSA/00010867/202701 Zane Neikena Latvia NAP 10868 ivacaftor / tezacaftor / elexacaftor 21/10/2019 1 year 20/10/2026 29/12/2026 20/10/2027 29/12/2027 No 01/07/2026 DLP was amended on 01/07/2026 PSUSA/00010868/202610 PSUSA/00010868/202710 Dennis Lex Germany CAP 10869 belantamab mafodotin 17/04/2025 6 months 16/04/2026 25/06/2026 16/10/2026 25/12/2026 No 01/07/2026 DLP was amended on 01/07/2026 PSUSA/00010869/202604 PSUSA/00010869/202610 Ulla Wändel Liminga Sweden CAP 10870 imlifidase 25/08/2020 6 months 25/02/2026 06/05/2026 25/08/2026 03/11/2026 No 01/04/2026 DLP was amended on 01/04/2026 PSUSA/00010870/202602 PSUSA/00010870/202608 Bianca Mulder Netherlands CAP 10871 alpelisib (Piqray) 24/05/2019 3 years 23/05/2028 21/08/2028 No 29/07/2026 Active substance name was amended on 29/07/2026 PSUR frequency amended and DLP updated on 04/02/2026 PSUSA/00010871/202805 Bianca Mulder Netherlands CAP 10872 lefamulin 19/08/2019 3 years 18/08/2028 16/11/2028 No 01/04/2026 PSUR frequency amended and DLP updated on 01/04/2026 PSUSA/00010872/202808 Eva Jirsová Czech Republic CAP 10873 bulevirtide 31/07/2020 1 year 30/07/2026 08/10/2026 30/07/2027 08/10/2027 No 04/03/2026 DLP was amended on 04/03/2026 PSUSA/00010873/202607 PSUSA/00010873/202707 Adam Przybylkowski Poland CAP 10874 entrectinib 18/06/2019 6 months 17/06/2026 26/08/2026 17/12/2026 25/02/2027 No 29/07/2026 DLP was amended on 29/07/2026 PSUSA/00010874/202606 PSUSA/00010874/202612 Bianca Mulder Netherlands CAP 10875 sodium oleate 06/09/1956 13 years 01/01/2033 01/04/2033 No 21/10/2020 New entry added on 21/10/2020 PSUSA/00010875/203301 NAP 10876 amlodipine/irbesartan 14/06/2020 5 years 14/06/2030 12/09/2030 No 04/03/2026 DLP was amended on 04/03/2026 PSUSA/00010876/203006 Maia Uusküla Estonia NAP 10877 leuprorelin (depot formulations) 31/07/1984 2 years 31/07/2027 29/10/2027 No 01/04/2026 DLP was amended on 01/04/2026 PSUSA/00010877/202707 Amelia Cupelli Italy CAP NAP 10878 avapritinib 09/01/2020 6 months 08/01/2026 19/03/2026 08/07/2026 16/09/2026 No 04/03/2026 DLP was amended on 04/03/2026 PSUSA/00010878/202601 PSUSA/00010878/202607 Bianca Mulder Netherlands CAP 10879 filgotinib 24/09/2020 1 year 23/09/2026 02/12/2026 23/09/2027 02/12/2027 No 29/04/2026 DLP was amended on 29/04/2026 PSUSA/00010879/202609 PSUSA/00010879/202709 Petar Mas Croatia CAP 10881 levofloxacin/dexamethasone (ocular use) 13/06/2020 3 years 12/06/2028 10/09/2028 No 04/02/2026 DLP was amended on 04/02/2026 PSUSA/00010881/202806 Amelia Cupelli Italy NAP 10882 amikacin (centrally authorised product only) 28/09/2018 1 year 27/09/2026 06/12/2026 27/09/2027 06/12/2027 No 27/05/2026 DLP was amended on 27/05/2026 PSUSA/00010882/202609 PSUSA/00010882/202709 Jean-Michel Dogné Belgium CAP 10883 carvedilol / ivabradine 25/04/2005 3 years 25/04/2028 24/07/2028 No 31/01/2024 PRAC representative updated on 31/01/2024 PSUSA/00010883/202804 Bianca Mulder Netherlands NAP 10884 lumasiran 19/11/2020 2 years 18/11/2026 16/02/2027 No 02/06/2026 PSUSA/00010884/202611 Karin Bolin Sweden CAP 10886 quadrivalent influenza vaccine (recombinant, prepared in cell culture) 16/01/2013 1 year 15/01/2026 26/03/2026 15/01/2027 26/03/2027 No 24/09/2025 DLP was amended on 24/09/2025 PSUSA/00010886/202601 PSUSA/00010886/202701 Zoubida Amimour France CAP 10887 acalabrutinib 31/10/2017 1 year 30/10/2026 08/01/2027 30/10/2027 08/01/2028 No 01/07/2026 DLP was amended on 01/07/2026 PSUSA/00010887/202610 PSUSA/00010887/202710 Barbara Kovacic Bytyqi Croatia CAP 10889 bupivacaine (liposomal formulations) 28/10/2011 1 year 27/10/2026 05/01/2027 27/10/2027 05/01/2028 No 01/07/2026 DLP was amended on 01/07/2026 PSUSA/00010889/202610 PSUSA/00010889/202710 Eamon O Murchu Ireland CAP 10890 serenoa repens 26/06/1981 5 years 26/06/2026 24/09/2026 No 28/10/2025 New entry added on 03/02/2021 PSUSA/00010890/202606 Gudrun Stefansdottir Iceland NAP 10891 methacholine 31/10/1986 5 years 31/10/2028 29/01/2029 No 12/09/2025 DLP was amended on 03/07/2024 PSUSA/00010891/202810 Veronika Macurová Czech Republic NAP 10892 ascorbic acid / acid folic / alfa-tocopherol / biotin / cholecalciferol / cyanocobalamin / nicotinamide / pantothenic acid / pyridoxine hydrochloride / retinol / riboflavin / thiamine 22/01/2001 8 years 22/01/2029 22/04/2029 No 28/04/2022 Active substance and DLP amended on 28/04/2022 New entry added on 03/02/2021 PSUSA/00010892/202901 NAP 10893 acetylsalicylic acid/rosuvastatin 26/06/2020 5 years 26/06/2028 24/09/2028 No 28/02/2024 DLP was amended on 28/02/2024 PSUSA/00010893/202806 Polona Golmajer Slovenia NAP 10894 trastuzumab deruxtecan 20/12/2019 6 months 19/06/2026 28/08/2026 19/12/2026 27/02/2027 No 29/07/2026 DLP was amended on 29/07/2026 PSUSA/00010894/202606 PSUSA/00010894/202612 Carla Torre Portugal CAP 10895 baloxavir marboxil 23/02/2018 3 years 22/02/2028 22/05/2028 No 22/10/2025 PSUR frequency amended and DLP updated on 22/10/2025 PSUSA/00010895/202802 Sonja Radowan Austria CAP 10896 tagraxofusp 21/12/2018 2 years 20/12/2025 20/03/2026 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 DLP was amended on 31/07/2024 PSUSA/00010896/202512 Bianca Mulder Netherlands CAP 10897 COVID-19 mRNA vaccine (Spikevax) 18/12/2020 2 years 17/12/2026 17/03/2027 No 30/07/2025 PSUR frequency amended and DLP updated on 30/07/2025 PSUSA/00010897/202612 Marie Louise Schougaard Christiansen Denmark CAP 10898 COVID-19 mRNA vaccine (Comirnaty) 19/12/2020 2 years 18/12/2026 18/03/2027 No 30/07/2025 PSUR frequency amended and DLP updated on 30/07/2025 PSUSA/00010898/202612 Liana Martirosyan Netherlands CAP 10899 atidarsagene autotemcel 17/12/2020 3 years 16/12/2027 15/03/2028 No 17/12/2025 PSUR frequency amended and DLP updated on 17/12/2025 DLP was amended on 30/07/2025 PSUSA/00010899/202712 Dirk Mentzer Germany CAP 10900 cabotegravir (for treatment of human immunodeficiency virus type 1 (HIV-1) 18/03/2020 1 year 17/03/2026 26/05/2026 17/03/2027 26/05/2027 No 22/10/2025 DLP was amended on 22/10/2025 PSUSA/00010900/202603 PSUSA/00010900/202703 Dennis Lex Germany CAP 10901 rilpivirine (for intramuscular use) 18/03/2020 1 year 17/03/2026 26/05/2026 17/03/2027 26/05/2027 No 22/10/2025 DLP was amended on 22/10/2025 PSUSA/00010901/202603 PSUSA/00010901/202703 Liana Martirosyan Netherlands CAP 10902 defatted powder of Arachis hypogaea L., semen (peanuts) 31/01/2020 3 years 30/01/2028 29/04/2028 No 24/09/2025 PSUR frequency amended and DLP updated on 24/09/2025 PSUSA/00010902/202801 Terhi Lehtinen Finland CAP 10903 brexucabtagene autoleucel 24/07/2020 6 months 23/01/2026 03/04/2026 23/07/2026 01/10/2026 No 04/03/2026 DLP was amended on 04/03/2026 PSUSA/00010903/202601 PSUSA/00010903/202607 Bianca Mulder Netherlands CAP 10904 inclisiran 09/12/2020 3 years 31/12/2028 31/03/2029 No 29/07/2026 PSUR frequency amended and DLP updated on 29/07/2026 PSUSA/00010904/202812 Kimmo Jaakkola Finland CAP 10905 latanoprost / netarsudil 07/01/2021 3 years 17/06/2028 15/09/2028 No 04/02/2026 PSUR frequency amended and DLP updated on 04/02/2026 PSUSA/00010905/202806 Adam Przybylkowski Poland CAP 10906 pertuzumab / trastuzumab 29/06/2020 1 year 28/06/2026 06/09/2026 28/06/2027 06/09/2027 No 04/02/2026 DLP was amended on 04/02/2026 PSUSA/00010906/202606 PSUSA/00010906/202706 Dirk Mentzer Germany CAP 10907 fenfluramine 25/06/2020 2 years 24/06/2027 22/09/2027 No 04/02/2026 PSUR frequency amended and DLP updated on 04/02/2026 PSUSA/00010907/202706 Dennis Lex Germany CAP 10908 formoterol fumarate dihydrate / glycopyrronium bromide / budesonide 18/06/2019 1 year 17/06/2026 26/08/2026 17/06/2027 26/08/2027 No 04/02/2026 DLP was amended on 04/02/2026 PSUSA/00010908/202606 PSUSA/00010908/202706 Jan Neuhauser Austria CAP 10909 fedratinib 16/08/2019 1 year 15/02/2026 26/04/2026 15/02/2027 26/04/2027 No 29/04/2026 PSUR frequency amended and DLP updated on 29/04/2026 DLP was amended on 01/04/2026 PSUSA/00010909/202602 PSUSA/00010909/202702 Sonja Radowan Austria CAP 10911 fostemsavir 04/02/2021 3 years 03/02/2027 04/05/2027 No 25/09/2024 PSUR frequency amended and DLP updated on 25/09/2024 PSUSA/00010911/202702 Liana Martirosyan Netherlands CAP 10913 oxytocin (systemic use) 02/06/1955 3 years 30/06/2026 28/09/2026 Yes 28/02/2024 DLP was amended on 28/02/2024 PSUSA/00010913/202606 Karen Pernille Harg Norway NAP 10914 oxytocin (nasal spray) 02/06/1955 3 years 30/06/2026 28/09/2026 Yes 28/02/2024 DLP was amended on 28/02/2024 PSUSA/00010914/202606 Karen Pernille Harg Norway NAP 10915 Rosuvastatin/ Omega-3-acid ethyl esters 15/01/2020 5 years 14/01/2030 14/04/2030 No 24/09/2025 DLP was amended on 24/09/2025 PSUSA/00010915/203001 Bianca Mulder Netherlands NAP 10917 selpercatinib 08/05/2020 6 months 08/05/2026 17/07/2026 08/11/2026 17/01/2027 No 01/07/2026 DLP was amended on 01/07/2026 PSUSA/00010917/202605 PSUSA/00010917/202611 Bianca Mulder Netherlands CAP 10918 tucatinib 17/04/2020 1 year 16/04/2026 25/06/2026 16/04/2027 25/06/2027 No 19/11/2025 DLP was amended on 19/11/2025 PSUSA/00010918/202604 PSUSA/00010918/202704 Jean-Michel Dogné Belgium CAP 10919 hepatitis B surface antigen, CpG 1018 adjuvant 09/11/2017 3 years 08/11/2027 06/02/2028 No 06/10/2025 PSUR frequency amended and DLP updated on 25/06/2025 PSUSA/00010919/202711 Dirk Mentzer Germany CAP 10920 somapacitan 28/08/2020 3 years 31/08/2027 29/11/2027 No 30/04/2025 PSUR frequency amended and DLP updated on 30/04/2025 PSUSA/00010920/202708 Dennis Lex Germany CAP 10921 cenobamate 21/11/2019 1 year 26/09/2026 05/12/2026 26/09/2027 05/12/2027 No 29/04/2026 DLP was amended on 29/04/2026 PSUSA/00010921/202609 PSUSA/00010921/202709 Jo Robays Belgium CAP 10922 icosapent ethyl 26/07/2012 3 years 25/07/2027 23/10/2027 No 05/03/2025 PSUR frequency amended and DLP updated on 05/03/2025 PSUSA/00010922/202707 Bianca Mulder Netherlands CAP 10923 pemigatinib 17/04/2020 1 year 16/04/2026 25/06/2026 16/04/2027 25/06/2027 No 17/12/2025 DLP was amended on 17/12/2025 DLP was amended on 19/11/2025 PSUSA/00010923/202604 PSUSA/00010923/202704 Bianca Mulder Netherlands CAP 10924 remimazolam 23/01/2020 1 year 22/07/2026 30/09/2026 22/07/2027 30/09/2027 No 04/03/2026 DLP was amended on 04/03/2026 PSUSA/00010924/202607 PSUSA/00010924/202707 Eamon O Murchu Ireland CAP 10925 risdiplam 07/08/2020 1 year 06/08/2026 15/10/2026 06/08/2027 15/10/2027 No 01/04/2026 DLP was amended on 01/04/2026 PSUSA/00010925/202608 PSUSA/00010925/202708 Jan Neuhauser Austria CAP 10926 selinexor 26/03/2021 3 years 25/03/2028 23/06/2028 No 19/11/2025 PSUR frequency amended and DLP updated on 19/11/2025 PSUSA/00010926/202803 Bianca Mulder Netherlands CAP 10927 ofatumumab 26/03/2021 1 year 25/09/2026 04/12/2026 25/09/2027 04/12/2027 No 29/04/2026 DLP was amended on 29/04/2026 PSUSA/00010927/202609 PSUSA/00010927/202709 Amelia Cupelli Italy CAP 10928 salmeterol / fluticasone propionate (for centrally authorised products) 27/01/2017 3 years 27/01/2028 26/04/2028 No 19/11/2025 Correction of DLP on 19/11/2025 PSUR frequency amended and DLP updated on 22/10/2025 DLP was amended on 24/09/2025 PSUSA/00010928/202801 Amelia Cupelli Italy CAP 10929 trifarotene 04/10/2019 3 years 03/10/2027 01/01/2028 No 29/06/2022 Next DLP was updated on 31/05/2023 PSUSA/00010929/202710 Karin Bolin Sweden NAP 10930 berotralstat 03/12/2020 3 years 02/12/2027 01/03/2028 No 30/07/2025 PSUR frequency amended and DLP updated on 30/07/2025 PSUSA/00010930/202712 Julia Pallos Hungary CAP 10931 dostarlimab 21/04/2021 1 year 20/04/2026 29/06/2026 20/04/2027 29/06/2027 No 18/12/2024 DLP was amended on 18/12/2024 PSUSA/00010931/202604 PSUSA/00010931/202704 Carla Torre Portugal CAP 10932 potassium citrate / potassium hydrogen carbonate 30/04/2021 3 years 29/04/2028 28/07/2028 No 17/12/2025 PSUR frequency amended and DLP updated on 17/12/2025 PSUSA/00010932/202804 Adam Przybylkowski Poland CAP 10933 lidocaine (topical use) 01/10/1948 8 years 30/09/2028 29/12/2028 No 30/06/2021 New active substance added on 30/06/2021 following split of previous entry PSUSA/00010933/202809 NAP 10934 lidocaine (systemic use) 01/10/1948 8 years 30/09/2028 29/12/2028 No 30/06/2021 New active substance added on 30/06/2021 following split of previous entry PSUSA/00010934/202809 NAP 10936 selumetinib 10/04/2020 6 months 09/04/2026 18/06/2026 09/10/2026 18/12/2026 No 02/06/2026 PSUSA/00010936/202604 PSUSA/00010936/202610 Karin Bolin Sweden CAP 10937 tralokinumab 17/06/2021 1 year 16/12/2026 24/02/2027 16/12/2027 24/02/2028 No 29/07/2026 DLP was amended on 29/07/2026 PSUSA/00010937/202612 PSUSA/00010937/202712 Kimmo Jaakkola Finland CAP NAP 10938 drospirenone / estetrol 19/05/2021 1 year 19/05/2026 28/07/2026 19/05/2027 28/07/2027 No 04/02/2026 DLP was amended on 04/02/2026 PSUSA/00010938/202605 PSUSA/00010938/202705 Dennis Lex Germany CAP 10940 ponesimod 18/03/2021 2 years 17/03/2027 15/06/2027 No 22/10/2025 PSUR frequency amended and DLP updated on 22/10/2025 PSUSA/00010940/202703 Karin Erneholm Denmark CAP 10941 setmelanotide 25/11/2020 1 year 24/11/2026 02/02/2027 24/11/2027 02/02/2028 No 01/07/2026 DLP was amended on 01/07/2026 PSUSA/00010941/202611 PSUSA/00010941/202711 Miroslava Gocova Slovakia CAP 10942 relugolix / estradiol / norethisterone acetate 26/05/2021 3 years 25/05/2028 23/08/2028 No 04/02/2026 PSUR frequency amended and DLP updated on 04/02/2026 PSUSA/00010942/202805 Dennis Lex Germany CAP 10943 tirbanibulin 14/12/2020 1 year 13/12/2026 21/02/2027 13/12/2027 21/02/2028 No 29/07/2026 DLP was amended on 29/07/2026 PSUSA/00010943/202612 PSUSA/00010943/202712 Jana Pecherova Slovakia CAP 10944 satralizumab (for centrally authorised products) 01/06/2020 1 year 31/05/2026 09/08/2026 31/05/2027 09/08/2027 No 04/02/2026 DLP was amended on 04/02/2026 PSUSA/00010944/202605 PSUSA/00010944/202705 Jan Neuhauser Austria CAP 10945 evinacumab 11/02/2021 1 year 11/02/2026 22/04/2026 11/02/2027 22/04/2027 No 02/06/2026 DLP was amended on 24/09/2025 PSUSA/00010945/202602 PSUSA/00010945/202702 Karin Bolin Sweden CAP 10946 glycerol / urea 18/03/2021 13 years 17/03/2034 15/06/2034 No 28/07/2021 New entry added on 28/07/2021 PSUSA/00010946/203403 NAP 10947 telmisartan / indapamide 08/02/2021 5 years 07/02/2026 08/05/2026 No 20/06/2025 New entry added on 28/07/2021 PSUSA/00010947/202602 Carla Torre Portugal NAP 10949 odevixibat 16/07/2021 1 year 15/07/2026 23/09/2026 15/07/2027 23/09/2027 No 29/07/2026 Reference to NAP removed on 29/07/2026 DLP was amended on 04/03/2026 PSUSA/00010949/202607 PSUSA/00010949/202707 Adam Przybylkowski Poland CAP 10950 vericiguat 19/01/2021 1 year 18/01/2026 29/03/2026 18/01/2027 29/03/2027 No 24/09/2025 DLP was amended on 24/09/2025 PSUSA/00010950/202601 PSUSA/00010950/202701 Kimmo Jaakkola Finland CAP 10951 tafasitamab 31/07/2020 6 months 30/01/2026 10/04/2026 30/07/2026 08/10/2026 No 02/06/2026 PSUSA/00010951/202601 PSUSA/00010951/202607 Jenny-Maria Jönsson Sweden CAP 10952 vosoritide 26/08/2021 1 year 25/08/2026 03/11/2026 25/08/2027 03/11/2027 No 01/04/2026 DLP was amended on 01/04/2026 PSUSA/00010952/202608 PSUSA/00010952/202708 Zane Neikena Latvia CAP 10953 bimekizumab 20/08/2021 3 years 19/08/2027 17/11/2027 No 02/04/2025 PSUR frequency amended and DLP updated on 02/04/2025 PSUSA/00010953/202708 Liana Martirosyan Netherlands CAP 10954 idecabtagene vicleucel 26/03/2021 1 year 25/03/2026 03/06/2026 25/03/2027 03/06/2027 No 02/06/2026 PSUSA/00010954/202603 PSUSA/00010954/202703 Jenny-Maria Jönsson Sweden CAP 10955 roxadustat 17/12/2018 1 year 16/12/2026 24/02/2027 16/12/2027 24/02/2028 No 29/07/2026 DLP was amended on 29/07/2026 PSUSA/00010955/202612 PSUSA/00010955/202712 Jana Pecherova Slovakia CAP 10956 phentermine/ topiramate 17/07/2012 3 years 17/07/2027 15/10/2027 No 05/03/2025 PSUR frequency amended and DLP updated on 05/03/2025 PSUSA/00010956/202707 Karin Bolin Sweden NAP 10957 mometasone furoate/olopatadine 26/04/2021 3 years 25/04/2026 24/07/2026 No 02/06/2026 PSUSA/00010957/202604 Karin Bolin Sweden NAP 10958 artesunate 23/06/2020 2 years 22/06/2027 20/09/2027 No 04/02/2026 PSUR frequency amended and DLP updated on 04/02/2026 PSUSA/00010958/202706 Dennis Lex Germany CAP 10959 sacituzumab govitecan 22/04/2020 3 years 21/04/2028 20/07/2028 No 18/12/2024 PSUR frequency amended and DLP updated on 18/12/2024 DLP was amended on 20/12/2023 PSUSA/00010959/202804 Bianca Mulder Netherlands CAP 10960 zanubrutinib 14/11/2019 1 year 13/11/2026 22/01/2027 13/11/2027 22/01/2028 No 01/07/2026 DLP was amended on 01/07/2026 PSUSA/00010960/202611 PSUSA/00010960/202711 Bianca Mulder Netherlands CAP 10962 ripretinib 15/05/2020 1 year 14/05/2026 23/07/2026 14/05/2027 23/07/2027 No 18/12/2024 DLP was amended on 18/12/2024 PSUSA/00010962/202605 PSUSA/00010962/202705 Barbara Kovacic Bytyqi Croatia CAP 10965 dexamethasone / tobramycin (systemic formulations) Not available* 5 years 31/03/2026 29/06/2026 No 19/10/2022 PRAC representative was updated on 19/10/2022 PRAC representative was updated on 27/07/2022 New entry due to splitting of entries on 22/12/2021 PSUSA/00010965/202603 Amelia Cupelli Italy NAP 10966 eptinezumab 21/02/2020 3 years 20/02/2028 20/05/2028 No 22/10/2025 PSUR frequency amended and DLP updated on 22/10/2025 PSUSA/00010966/202802 Liana Martirosyan Netherlands CAP 10967 avacopan 27/09/2021 1 year 26/09/2026 05/12/2026 26/09/2027 05/12/2027 No 01/07/2026 PSUR frequency amended and DLP updated on 01/07/2026 PSUR frequency amended and DLP updated on 19/11/2025 PSUSA/00010967/202609 PSUSA/00010967/202709 Liana Martirosyan Netherlands CAP 10968 glucarpidase 17/01/2012 3 years 16/07/2028 14/10/2028 No 01/04/2026 DLP was corrected on 01/04/2026 PSUR frequency amended and DLP updated on 04/03/2026 PSUSA/00010968/202807 Dennis Lex Germany CAP 10969 lonapegsomatropin 25/08/2021 3 years 25/08/2028 23/11/2028 No 01/04/2026 PSUR frequency amended and DLP updated on 01/04/2026 PSUSA/00010969/202808 Dennis Lex Germany CAP 10970 sotorasib 28/05/2021 6 months 27/05/2026 05/08/2026 27/11/2026 05/02/2027 No 01/07/2026 DLP was amended on 01/07/2026 PSUSA/00010970/202605 PSUSA/00010970/202611 Marie Louise Schougaard Christiansen Denmark CAP 10971 tecovirimat 13/07/2018 1 year 12/01/2026 23/03/2026 12/01/2027 23/03/2027 No 24/09/2025 DLP was amended on 24/09/2025 PSUSA/00010971/202601 PSUSA/00010971/202701 Dennis Lex Germany CAP 10972 COVID-19 Vaccine (recombinant, adjuvanted) (Nuvaxovid) 20/12/2021 1 year 19/12/2026 27/02/2027 19/12/2027 27/02/2028 No 29/07/2026 DLP was amended on 29/07/2026 PSUSA/00010972/202612 PSUSA/00010972/202712 Dirk Mentzer Germany CAP 10974 pegcetacoplan 14/05/2021 1 year 13/11/2026 22/01/2027 13/11/2027 22/01/2028 No 01/07/2026 DLP was amended on 01/07/2026 PSUSA/00010974/202611 PSUSA/00010974/202711 Kimmo Jaakkola Finland CAP 10975 pneumococcal polysaccharide conjugate vaccine (15 valent, adsorbed) 16/07/2021 1 year 15/01/2026 26/03/2026 15/01/2027 26/03/2027 No 06/10/2025 DLP was amended on 24/09/2025 PSUSA/00010975/202601 PSUSA/00010975/202701 Dirk Mentzer Germany CAP 10976 abrocitinib 08/09/2021 1 year 07/09/2026 16/11/2026 07/09/2027 16/11/2027 No 29/04/2026 DLP was amended on 29/04/2026 PSUSA/00010976/202609 PSUSA/00010976/202709 Petar Mas Croatia CAP 10977 amivantamab 21/05/2021 1 year 20/05/2026 29/07/2026 20/05/2027 29/07/2027 No 04/02/2026 DLP was amended on 04/02/2026 PSUSA/00010977/202605 PSUSA/00010977/202705 Dirk Mentzer Germany CAP 10978 finerenone 09/07/2021 1 year 08/07/2026 16/09/2026 08/07/2027 16/09/2027 No 04/03/2026 DLP was amended on 04/03/2026 PSUSA/00010978/202607 PSUSA/00010978/202707 Bianca Mulder Netherlands CAP 10979 tepotinib 25/03/2020 1 year 24/03/2026 02/06/2026 24/03/2027 02/06/2027 No 19/11/2025 DLP was amended on 19/11/2025 PSUSA/00010979/202603 PSUSA/00010979/202703 Bianca Mulder Netherlands CAP 10980 anifrolumab 30/07/2021 1 year 29/07/2026 07/10/2026 29/07/2027 07/10/2027 No 04/03/2026 DLP was amended on 04/03/2026 PSUSA/00010980/202607 PSUSA/00010980/202707 Liana Martirosyan Netherlands CAP 10981 pneumococcal polysaccharide conjugate vaccine (20-valent, adsorbed) 08/06/2021 1 year 07/06/2026 16/08/2026 07/06/2027 16/08/2027 No 29/07/2026 DLP was amended on 29/07/2026 PSUSA/00010981/202606 PSUSA/00010981/202706 Jean-Michel Dogné Belgium CAP 10982 somatrogon 26/10/2021 3 years 26/10/2027 24/01/2028 No 25/06/2025 PSUR frequency amended and DLP updated on 25/06/2025 PSUSA/00010982/202710 Liana Martirosyan Netherlands CAP 10983 voxelotor 14/02/2022 6 months 13/02/2026 24/04/2026 13/08/2026 22/10/2026 No 01/04/2026 DLP was amended on 01/04/2026 PSUSA/00010983/202602 PSUSA/00010983/202608 Jo Robays Belgium CAP 10984 nirmatrelvir / ritonavir 31/12/2021 3 years 30/12/2028 30/03/2029 No 29/07/2026 PSUR frequency amended and DLP updated on 29/07/2026 PSUSA/00010984/202812 Dennis Lex Germany CAP 10986 sodium citrate (extracorporeal use) 22/10/1990 8 years 31/01/2031 01/05/2031 Yes 18/10/2023 Next DLP was updated on 18/10/2023 PSUSA/00010986/203101 Polona Golmajer Slovenia NAP 10987 myristalkonium, benzalkonium (vaginal use only) 17/02/1986 13 years 01/01/2038 01/04/2038 No 24/09/2025 DLP was amended on 24/09/2025 PSUSA/00010987/203801 Lina Šeibokienė Lithuania NAP 10988 ascorbic acid / magnesium aspartate / leucine L / lysine L / phenylalanine L / valine L 09/11/2007 10 years 28/10/2034 26/01/2035 No 25/06/2025 PSUR frequency amended and DLP updated on 25/06/2025 PSUSA/00010988/203410 Guðrún Stefánsdóttir Iceland NAP 10989 enfortumab vedotin 18/12/2019 1 year 17/12/2026 25/02/2027 17/12/2027 25/02/2028 No 29/07/2026 DLP was amended on 29/07/2026 PSUSA/00010989/202612 PSUSA/00010989/202712 Eva Jirsová Czech Republic CAP 10990 lisocabtagene maraleucel / lisocabtagene maraleucel 05/02/2021 1 year 04/02/2026 15/04/2026 04/02/2027 15/04/2027 No 06/10/2025 DLP was amended on 24/09/2025 PSUSA/00010990/202602 PSUSA/00010990/202702 Dirk Mentzer Germany CAP 10991 tebentafusp 25/01/2022 1 year 24/01/2026 04/04/2026 24/01/2027 04/04/2027 No 05/03/2025 Next DLP was updated on 05/03/2025 PSUR frequency amended and DLP updated on 25/09/2024 PSUSA/00010991/202601 PSUSA/00010991/202701 Bianca Mulder Netherlands CAP 10993 daridorexant 07/01/2022 1 year 06/01/2026 17/03/2026 06/01/2027 17/03/2027 No 24/09/2025 DLP was amended on 24/09/2025 PSUSA/00010993/202601 PSUSA/00010993/202701 Ana Sofia Diniz Martins Portugal CAP 10994 relugolix 08/01/2019 1 year 07/01/2026 18/03/2026 07/01/2027 18/03/2027 No 24/09/2025 DLP was amended on 24/09/2025 PSUSA/00010994/202601 PSUSA/00010994/202701 Karin Erneholm Denmark CAP 10995 difelikefalin 23/08/2021 2 years 22/08/2027 20/11/2027 No 02/06/2026 PSUSA/00010995/202708 Karin Bolin Sweden CAP 10996 inebilizumab 11/06/2020 1 year 10/06/2026 19/08/2026 10/06/2027 19/08/2027 No 04/02/2026 DLP was amended on 04/02/2026 PSUSA/00010996/202606 PSUSA/00010996/202706 Amelia Cupelli Italy CAP 10997 rimegepant 27/02/2021 1 year 26/02/2026 07/05/2026 26/02/2027 07/05/2027 No 22/10/2025 DLP was amended on 22/10/2025 PSUSA/00010997/202602 PSUSA/00010997/202702 Karin Erneholm Denmark CAP 10998 linzagolix choline 14/06/2022 1 year 05/05/2026 14/07/2026 05/05/2027 14/07/2027 No 30/07/2025 DLP was corrected on 30/07/2025 PSUR frequency amended and DLP updated on 25/06/2025 DLP was amended on 18/12/2024 PSUSA/00010998/202605 PSUSA/00010998/202705 Dennis Lex Germany CAP 10999 mosunetuzumab 03/06/2022 6 months 02/06/2026 11/08/2026 02/12/2026 10/02/2027 No 29/07/2026 DLP was amended on 29/07/2026 PSUSA/00010999/202606 PSUSA/00010999/202612 Jenny-Maria Jönsson Sweden CAP 11000 ciltacabtagene autoleucel 28/02/2022 1 year 27/02/2026 08/05/2026 27/02/2027 08/05/2027 No 01/04/2026 PSUR frequency amended and DLP updated on 01/04/2026 PSUSA/00011000/202602 PSUSA/00011000/202702 Jo Robays Belgium CAP 11002 avalglucosidase alfa 06/08/2021 3 years 06/08/2027 04/11/2027 No 02/04/2025 PSUR frequency amended and DLP updated on 02/04/2025 PSUSA/00011002/202708 Liana Martirosyan Netherlands CAP 11003 olipudase alfa 28/03/2022 1 year 28/03/2026 06/06/2026 28/03/2027 06/06/2027 No 27/05/2026 DLP was amended on 27/05/2026 PSUSA/00011003/202603 PSUSA/00011003/202703 Dennis Lex Germany CAP 11004 eladocagene exuparvovec 18/07/2022 1 year 16/06/2026 25/08/2026 16/06/2027 25/08/2027 No 04/02/2026 DLP was amended on 04/02/2026 PSUSA/00011004/202606 PSUSA/00011004/202706 Dirk Mentzer Germany CAP 11005 lonafarnib 20/11/2020 1 year 19/11/2026 28/01/2027 19/11/2027 28/01/2028 No 01/07/2026 DLP was amended on 01/07/2026 PSUSA/00011005/202611 PSUSA/00011005/202711 Adam Przybylkowski Poland CAP 11006 eptacog beta (activated) 15/07/2022 2 years 14/07/2027 12/10/2027 No 29/04/2026 Correction of DLP on 29/04/2026 PSUR frequency amended and DLP updated on 04/03/2026 PSUSA/00011006/202707 Bianca Mulder Netherlands CAP 11007 budesonide (for centrally authorised products indicated for primary immunoglobulin A nephropathy only) 15/12/2021 1 year 14/12/2026 22/02/2027 14/12/2027 22/02/2028 No 29/07/2026 DLP was amended on 29/07/2026 PSUSA/00011007/202612 PSUSA/00011007/202712 Marie Louise Schougaard Christiansen Denmark CAP 11008 asciminib 29/10/2021 1 year 28/04/2026 07/07/2026 28/04/2027 07/07/2027 No 18/12/2024 DLP was amended on 18/12/2024 PSUSA/00011008/202604 PSUSA/00011008/202704 Eva Jirsová Czech Republic CAP 11010 teclistamab 23/08/2022 6 months 22/02/2026 03/05/2026 22/08/2026 31/10/2026 No 01/04/2026 DLP was amended on 01/04/2026 PSUSA/00011010/202602 PSUSA/00011010/202608 Veronika Macurova Czech Republic CAP 11011 lasmiditan 11/10/2019 1 year 11/10/2026 20/12/2026 11/10/2027 20/12/2027 No 27/05/2026 DLP was amended on 27/05/2026 PSUSA/00011011/202610 PSUSA/00011011/202710 Jana Pecherova Slovakia CAP 11012 lenacapavir 17/08/2022 1 year 16/08/2026 25/10/2026 16/08/2027 25/10/2027 No 01/04/2026 DLP was amended on 01/04/2026 PSUSA/00011012/202608 PSUSA/00011012/202708 Ana Sofia Diniz Martins Portugal CAP 11013 melphalan, melphalan flufenamide 06/02/2022 3 years 06/02/2028 06/05/2028 No 01/07/2026 Active substance name was amended on 01/07/2026 Reference to CAP added on 27/05/2026 Reference to NAP added on 01/04/2026 Active substance name was amended on 01/04/2026 PSUR frequency amended and DLP updated on 24/09/2025 PSUSA/00011013/202802 Dennis Lex Germany CAP NAP 11014 efgartigimod alfa 17/12/2021 1 year 16/12/2026 24/02/2027 16/12/2027 24/02/2028 No 29/07/2026 DLP was amended on 29/07/2026 PSUSA/00011014/202612 PSUSA/00011014/202712 Rhea Fitzgerald Ireland CAP 11015 tezepelumab 17/12/2021 1 year 16/12/2026 24/02/2027 16/12/2027 24/02/2028 No 29/07/2026 DLP was amended on 29/07/2026 PSUSA/00011015/202612 PSUSA/00011015/202712 Eva Jirsová Czech Republic CAP 11016 faricimab 28/01/2022 1 year 27/01/2026 07/04/2026 27/01/2027 07/04/2027 No 24/09/2025 DLP was amended on 24/09/2025 PSUSA/00011016/202601 PSUSA/00011016/202701 Carla Torre Portugal CAP 11017 fosdenopterin 26/02/2021 1 year 25/02/2026 06/05/2026 25/02/2027 06/05/2027 No 01/04/2026 PSUR frequency amended and DLP updated on 01/04/2026 PSUSA/00011017/202602 PSUSA/00011017/202702 Dennis Lex Germany CAP 11018 nivolumab / relatlimab 18/03/2022 1 year 17/03/2026 26/05/2026 17/03/2027 26/05/2027 No 22/10/2025 DLP was amended on 22/10/2025 PSUSA/00011018/202603 PSUSA/00011018/202703 Dirk Mentzer Germany CAP 11019 tirzepatide 13/05/2022 1 year 13/05/2026 22/07/2026 13/05/2027 22/07/2027 No 25/06/2025 PSUR frequency amended and DLP updated on 25/06/2025 DLP was amended on 18/12/2024 PSUSA/00011019/202605 PSUSA/00011019/202705 Bianca Mulder Netherlands CAP 11020 voclosporin 22/01/2021 1 year 21/01/2026 01/04/2026 21/01/2027 01/04/2027 No 24/09/2025 PSUR frequency amended and DLP updated on 24/09/2025 DLP was amended on 05/03/2025 PSUSA/00011020/202601 PSUSA/00011020/202701 Adam Przybylkowski Poland CAP 11021 vutrisiran 13/06/2022 3 years 12/06/2028 10/09/2028 No 29/07/2026 PSUR frequency amended and DLP updated on 29/07/2026 DLP was amended on 04/02/2026 PSUSA/00011021/202806 Liana Martirosyan Netherlands CAP 11022 capmatinib 06/05/2020 1 year 05/05/2026 14/07/2026 05/05/2027 14/07/2027 No 18/12/2024 DLP was amended on 18/12/2024 PSUSA/00011022/202605 PSUSA/00011022/202705 Carla Torre Portugal CAP 11023 sutimlimab 04/02/2022 1 year 04/02/2026 15/04/2026 04/02/2027 15/04/2027 No 24/09/2025 DLP was amended on 24/09/2025 PSUSA/00011023/202602 PSUSA/00011023/202702 Jan Neuhauser Austria CAP 11024 maribavir 23/11/2021 1 year 22/11/2026 31/01/2027 22/11/2027 31/01/2028 No 04/02/2026 DLP was amended on 04/02/2026 PSUSA/00011024/202611 PSUSA/00011024/202711 Adam Przybylkowski Poland CAP 11025 mitapivat 17/02/2022 1 year 16/02/2026 27/04/2026 16/02/2027 27/04/2027 No 22/10/2025 DLP was amended on 22/10/2025 PSUSA/00011025/202602 PSUSA/00011025/202702 Adam Przybylkowski Poland CAP 11026 nirsevimab 31/10/2022 1 year 30/04/2026 09/07/2026 30/04/2027 09/07/2027 No 25/06/2025 PSUR frequency amended and DLP updated on 25/06/2025 DLP was amended on 18/12/2024 PSUSA/00011026/202604 PSUSA/00011026/202704 Kimmo Jaakkola Finland CAP 11027 loncastuximab tesirine 23/04/2021 6 months 22/04/2026 01/07/2026 22/10/2026 31/12/2026 No 01/07/2026 DLP was amended on 01/07/2026 PSUSA/00011027/202604 PSUSA/00011027/202610 Eva Jirsová Czech Republic CAP 11028 tabelecleucel 16/12/2022 1 year 15/12/2026 23/02/2027 15/12/2027 23/02/2028 No 29/07/2026 DLP was amended on 29/07/2026 PSUSA/00011028/202612 PSUSA/00011028/202712 Amelia Cupelli Italy CAP 11029 abaloparatide 28/04/2017 1 year 27/04/2026 06/07/2026 27/04/2027 06/07/2027 No 01/04/2026 Correction of PSUR frequency on 01/04/2026 Correction of DLP on 04/02/2026 DLP was amended on 25/06/2025 PSUSA/00011029/202604 PSUSA/00011029/202704 Karin Erneholm Denmark CAP 11030 gozetotide 23/03/2022 1 year 22/03/2026 31/05/2026 22/03/2027 31/05/2027 No 19/11/2025 DLP was amended on 19/11/2025 PSUSA/00011030/202603 PSUSA/00011030/202703 John Joseph Borg Malta CAP NAP 11031 lutetium (177LU) vipivotide tetraxetan 23/03/2022 1 year 22/03/2026 31/05/2026 22/03/2027 31/05/2027 No 19/11/2025 DLP was amended on 19/11/2025 PSUSA/00011031/202603 PSUSA/00011031/202703 John Joseph Borg Malta CAP 11032 maralixibat 29/09/2021 6 months 28/03/2026 06/06/2026 28/09/2026 07/12/2026 No 27/05/2026 DLP was amended on 27/05/2026 PSUSA/00011032/202603 PSUSA/00011032/202609 Adam Przybylkowski Poland CAP 11033 spesolimab 01/09/2022 6 months 01/03/2026 10/05/2026 01/09/2026 10/11/2026 No 29/04/2026 DLP was amended on 29/04/2026 PSUSA/00011033/202603 PSUSA/00011033/202609 Zoubida Amimour France CAP 11034 dengue tetravalent vaccine (live, attenuated) 19/08/2022 1 year 18/08/2026 27/10/2026 18/08/2027 27/10/2027 No 01/04/2026 DLP was amended on 01/04/2026 PSUSA/00011034/202608 PSUSA/00011034/202708 Liana Martirosyan Netherlands CAP 11036 octreotide (for centrally authorised products) 30/06/2025 3 years 01/12/2028 01/03/2029 No 29/07/2026 PSUR frequency amended and DLP updated on 29/07/2026 PSUSA/00011036/202812 Eamon O Murchu Ireland CAP 11037 etranacogene dezaparvovec 22/11/2022 6 months 21/05/2026 30/07/2026 21/11/2026 30/01/2027 No 01/07/2026 DLP was amended on 01/07/2026 PSUSA/00011037/202605 PSUSA/00011037/202611 Bianca Mulder Netherlands CAP 11038 tremelimumab 21/10/2022 1 year 30/04/2026 09/07/2026 30/04/2027 09/07/2027 No 28/05/2025 PSUR frequency amended and DLP updated on 28/05/2025 DLP was amended on 18/12/2024 PSUSA/00011038/202604 PSUSA/00011038/202704 David Olsen Norway CAP 11039 donepezil / memantine 27/07/2020 5 years 26/07/2028 24/10/2028 No 12/09/2025 DLP was amended on 27/03/2024 PSUSA/00011039/202807 Veronika Macurová Czech Republic NAP 11041 ramipril / bisoprolol 11/05/2022 7 years 22/10/2032 20/01/2033 No 01/07/2026 PSUR frequency amended and DLP updated on 01/07/2026 New entry added on 03/05/2023 PSUSA/00011041/203210 Jana Pecherova Slovakia NAP 11042 meldonium 14/04/2003 8 years 13/04/2031 12/07/2031 Yes 03/05/2023 New entry added on 03/05/2023 PSUSA/00011042/203104 none NAP 11043 nifedipine / lidocaine 01/02/2004 10 years 03/03/2035 01/06/2035 Yes 03/05/2023 New entry added on 03/05/2023 PSUSA/00011043/203503 none NAP 11044 ipidacrine 12/05/2008 8 years 11/05/2031 09/08/2031 Yes 03/05/2023 New entry added on 03/05/2023 PSUSA/00011044/203105 none NAP 11045 COVID-19 Vaccine (recombinant, adjuvanted) (Bimervax) 30/03/2023 1 year 29/03/2026 07/06/2026 29/03/2027 07/06/2027 No 19/11/2025 DLP was amended on 19/11/2025 PSUSA/00011045/202603 PSUSA/00011045/202703 Zane Neikena Latvia CAP 11046 deucravacitinib 09/09/2022 1 year 08/09/2026 17/11/2026 08/09/2027 17/11/2027 No 29/04/2026 DLP was amended on 29/04/2026 PSUSA/00011046/202609 PSUSA/00011046/202709 Liana Martirosyan Netherlands CAP 11047 cipaglucosidase alfa 20/03/2023 1 year 19/03/2026 28/05/2026 19/03/2027 28/05/2027 No 02/06/2026 DLP was amended on 22/10/2025 PSUSA/00011047/202603 PSUSA/00011047/202703 Karin Bolin Sweden CAP 11048 ivosidenib 04/05/2023 1 year 03/05/2026 12/07/2026 03/05/2027 12/07/2027 No 25/06/2025 PSUR frequency amended and DLP updated on 25/06/2025 DLP was amended on 18/12/2024 PSUSA/00011048/202605 PSUSA/00011048/202705 Marie Louise Schougaard Christiansen Denmark CAP 11049 pegunigalsidase alfa 04/05/2023 3 years 03/11/2027 01/02/2028 No 25/06/2025 PSUR frequency amended and DLP updated on 25/06/2025 PSUSA/00011049/202711 Liana Martirosyan Netherlands CAP 11050 vadadustat 29/06/2020 1 year 28/06/2026 06/09/2026 28/06/2027 06/09/2027 No 29/07/2026 DLP was amended on 29/07/2026 PSUSA/00011050/202606 PSUSA/00011050/202706 Eva Jirsová Czech Republic CAP 11051 niraparib / abiraterone acetate 19/04/2023 6 months 19/04/2026 28/06/2026 19/10/2026 28/12/2026 No 01/07/2026 DLP was amended on 01/07/2026 PSUSA/00011051/202604 PSUSA/00011051/202610 Jan Neuhauser Austria CAP 11052 ruxolitinib (for non-segmental vitiligo) 21/09/2021 1 year 20/09/2026 29/11/2026 20/09/2027 29/11/2027 No 29/04/2026 DLP was amended on 29/04/2026 PSUSA/00011052/202609 PSUSA/00011052/202709 Adam Przybylkowski Poland CAP 11053 Insulin icodec 01/03/2024 6 months 28/02/2026 09/05/2026 28/08/2026 06/11/2026 No 29/04/2026 DLP was amended on 29/04/2026 PSUSA/00011053/202602 PSUSA/00011053/202608 Sonja Hrabcik Austria CAP 11054 iptacopan 05/12/2023 6 months 04/06/2026 13/08/2026 04/12/2026 12/02/2027 No 29/07/2026 DLP was amended on 29/07/2026 PSUSA/00011054/202606 PSUSA/00011054/202612 Lina Seibokiene Lithuania CAP 11055 aztreonam / avibactam 22/04/2024 6 months 21/04/2026 30/06/2026 21/10/2026 30/12/2026 No 01/07/2026 DLP was amended on 01/07/2026 PSUSA/00011055/202604 PSUSA/00011055/202610 Lina Seibokiene Lithuania CAP 11056 danicopan 18/01/2024 1 year 17/01/2026 28/03/2026 17/01/2027 28/03/2027 No 24/09/2025 PSUR frequency amended and DLP updated on 24/09/2025 DLP was amended on 05/03/2025 PSUSA/00011056/202601 PSUSA/00011056/202701 Dennis Lex Germany CAP 11057 pandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted, prepared in cell cultures), prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted, prepared in cell cultures) 31/01/2020 6 months 31/01/2026 11/04/2026 31/07/2026 09/10/2026 No 02/06/2026 PSUSA/00011057/202601 PSUSA/00011057/202607 Jenny Jönsson Sweden CAP 11058 chikungunya vaccine (live) 09/11/2023 6 months 08/05/2026 17/07/2026 08/11/2026 17/01/2027 No 01/07/2026 DLP was amended on 01/07/2026 PSUSA/00011058/202605 PSUSA/00011058/202611 Dirk Mentzer Germany CAP 11059 retifanlimab 22/03/2023 6 months 21/03/2026 30/05/2026 21/09/2026 30/11/2026 No 29/04/2026 DLP was amended on 29/04/2026 PSUSA/00011059/202603 PSUSA/00011059/202609 Dirk Mentzer Germany CAP 11060 sparsentan 17/02/2023 1 year 16/02/2026 27/04/2026 16/02/2027 27/04/2027 No 01/04/2026 PSUR frequency amended and DLP updated on 01/04/2026 PSUSA/00011060/202602 PSUSA/00011060/202702 Dennis Lex Germany CAP 11061 capivasertib 16/11/2023 6 months 15/05/2026 24/07/2026 15/11/2026 24/01/2027 No 01/07/2026 DLP was amended on 01/07/2026 PSUSA/00011061/202605 PSUSA/00011061/202611 Sonja Hrabcik Austria CAP 11062 efanesoctocog alfa 22/02/2023 1 year 22/02/2026 03/05/2026 22/02/2027 03/05/2027 No 01/04/2026 PSUR frequency amended and DLP updated on 01/04/2026 PSUSA/00011062/202602 PSUSA/00011062/202702 Amelia Cupelli Italy CAP 11063 dantrolene sodium hemiheptahydrate 29/05/2024 1 year 28/05/2026 06/08/2026 28/05/2027 06/08/2027 No 04/02/2026 DLP was amended on 04/02/2026 PSUSA/00011063/202605 PSUSA/00011063/202705 Liana Martirosyan Netherlands CAP NAP 11064 tofersen 25/04/2023 1 year 24/04/2026 03/07/2026 24/04/2027 03/07/2027 No 01/07/2026 New CAP authorised on 29/05/2024 PSUSA/00011064/202604 PSUSA/00011064/202704 Kimmo Jaakkola Finland CAP 11065 bevacizumab gamma 27/05/2024 1 year 26/05/2026 04/08/2026 26/05/2027 04/08/2027 No 01/07/2026 PSUR frequency amended and DLP updated on 01/07/2026 DLP was amended on 04/02/2026 PSUSA/00011065/202605 PSUSA/00011065/202705 Karin Erneholm Denmark CAP 11066 dopamine hydrochloride 27/05/2024 6 months 26/05/2026 04/08/2026 26/11/2026 04/02/2027 No 01/07/2026 DLP was amended on 01/07/2026 PSUSA/00011066/202605 PSUSA/00011066/202611 Maia Uusküla Estonia CAP 11067 aprocitentan 19/03/2024 1 year 18/03/2026 27/05/2026 18/03/2027 27/05/2027 No 29/04/2026 PSUR frequency amended and DLP updated on 29/04/2026 DLP was amended on 22/10/2025 PSUSA/00011067/202603 PSUSA/00011067/202703 Maria del Pilar Rayon Spain CAP 11068 vibegron 21/09/2018 6 months 20/03/2026 29/05/2026 20/09/2026 29/11/2026 No 29/04/2026 DLP was amended on 29/04/2026 PSUSA/00011068/202603 PSUSA/00011068/202609 Jan Neuhauser Austria CAP 11069 fruquintinib 04/09/2018 1 year 03/09/2026 12/11/2026 03/09/2027 12/11/2027 No 29/04/2026 DLP was amended on 29/04/2026 PSUSA/00011069/202609 PSUSA/00011069/202709 Bianca Mulder Netherlands CAP 11071 crovalimab 06/02/2024 6 months 05/02/2026 16/04/2026 05/08/2026 14/10/2026 No 01/04/2026 DLP was amended on 01/04/2026 PSUSA/00011071/202602 PSUSA/00011071/202608 Bianca Mulder Netherlands CAP 11072 erdafitinib 12/04/2019 1 year 11/04/2026 20/06/2026 11/04/2027 20/06/2027 No 19/11/2025 DLP was amended on 19/11/2025 PSUSA/00011072/202604 PSUSA/00011072/202704 Bianca Mulder Netherlands CAP 11073 flortaucipir (18F) 28/05/2020 6 months 28/05/2026 06/08/2026 28/11/2026 06/02/2027 No 29/07/2026 DLP was amended on 29/07/2026 PSUSA/00011073/202605 PSUSA/00011073/202611 Adam Przybylkowski Poland CAP 11074 odronextamab 22/08/2024 6 months 21/02/2026 02/05/2026 21/08/2026 30/10/2026 No 01/04/2026 DLP was amended on 01/04/2026 PSUSA/00011074/202602 PSUSA/00011074/202608 Veronika Macurová Czech Republic CAP 11075 respiratory syncytial virus mRNA vaccine 31/05/2024 6 months 30/05/2026 08/08/2026 30/11/2026 08/02/2027 No 26/08/2026 DLP was corrected on 26/08/2026 DLP was amended on 29/07/2026 PSUSA/00011075/202605 PSUSA/00011075/202611 Jean-Michel Dogné Belgium CAP 11076 sotatercept 26/03/2024 6 months 25/03/2026 03/06/2026 25/09/2026 04/12/2026 No 29/04/2026 DLP was amended on 29/04/2026 PSUSA/00011076/202603 PSUSA/00011076/202609 Zoubida Amimour France CAP 11077 rADAMTS13 09/08/2024 1 year 08/05/2026 17/07/2026 08/05/2027 17/07/2027 No 01/07/2026 PSUR frequency amended and DLP updated on 01/07/2026 DLP was amended on 25/06/2025 PSUSA/00011077/202605 PSUSA/00011077/202705 Maia Uusküla Estonia CAP 11080 sugemalimab 20/12/2021 6 months 19/06/2026 28/08/2026 19/12/2026 27/02/2027 No 29/07/2026 DLP was amended on 29/07/2026 PSUSA/00011080/202606 PSUSA/00011080/202612 Petar Mas Croatia CAP 11081 epinephrine (for nasal use) 09/08/2024 6 months 08/02/2026 19/04/2026 08/08/2026 17/10/2026 No 01/04/2026 DLP was amended on 01/04/2026 PSUSA/00011081/202602 PSUSA/00011081/202608 Terhi Lehtinen Finland CAP 11082 polihexanide 22/08/2024 6 months 21/02/2026 02/05/2026 21/08/2026 30/10/2026 No 01/04/2026 DLP was amended on 01/04/2026 PSUSA/00011082/202602 PSUSA/00011082/202608 Adam Przybylkowski Poland CAP 11083 fluoroethyltyrosine (18F) 23/12/2015 3 years 23/12/2027 22/03/2028 Yes 25/09/2024 New entry added on 25/09/2024 PSUSA/00011083/202712 not yet assigned none NAP 11084 dienogest / ethinylestradiol (prolonged-release tablet) 13/03/2024 1 year 15/03/2026 24/05/2026 15/03/2027 24/05/2027 No 02/06/2026 PSUSA/00011084/202603 PSUSA/00011084/202703 Jenny Jönsson Sweden NAP 11085 valsartan / indapamide 10/05/2024 5 years 10/05/2029 08/08/2029 No 25/09/2024 New entry added on 25/09/2024 PSUSA/00011085/202905 not yet assigned none NAP 11086 isothipendyl 12/08/2011 10 years 12/08/2034 10/11/2034 No 25/09/2024 PSUSA/00011086/203408 not yet assigned none NAP 11087 methylprednisolone (topical use) 18/12/1957 5 years 30/11/2028 28/02/2029 No 25/09/2024 New entry added on 25/09/2024 PSUSA/00011087/202811 not yet assigned none NAP 11088 nifurtimox 08/01/1970 3 years 08/01/2026 08/04/2026 No 26/05/2025 New entry added on 23/10/2024 PSUSA/00011088/202601 Maria del Pilar Rayon Spain NAP 11089 allergen for therapy: Dactylis Glomerata L., Phleum Pratense L., Anthoxanthum Odoratum L., Lolium Perenne L., Poa Pratensis L. Salsola Kali L., Blomia Tropicalis, Zea Mays L., Fraxinus Excelsior L., Arrhenatherum Elatius, Cynodon Dactylon (L.) pers., latex, Festuca Pratensis Hudson, Parietaria Officinalis L., Cat Epithelia, Dog Epithelia, Triticum Aestivum, Dermatophagoides Farinae, Juniperus Ashei Buchholz, Hordeum Vulgare L., Alnus Glutinosa L., Agrostis Capillaris L., Corylus Avellana L., Secale Cereale L., Avena Fatua whole., Holcus Lanatus, Artemisia Vulgaris L., Olea Europaea L., Ambrosia Artemisiifolia, Dermatophagoides Pteronyssinus, Carpinus Betulus L., Avena Sativa L., Bromus Inermis whole, Parietaria Judaica L., Betula single or mixes (Staloral) 10/08/2004 8 years 10/08/2033 08/11/2033 No 23/10/2024 New entry added on 23/10/2024 PSUSA/00011089/203308 not yet assigned none NAP 11090 macitentan / tadalafil 14/10/2024 1 year 13/10/2026 22/12/2026 13/10/2027 22/12/2027 No 27/05/2026 DLP was amended on 27/05/2026 PSUSA/00011090/202610 PSUSA/00011090/202710 Maria del Pilar Rayon Spain CAP 11091 delgocitinib 23/01/2020 1 year 22/01/2026 02/04/2026 22/01/2027 02/04/2027 No 24/09/2025 PSUR frequency amended and DLP updated on 24/09/2025 Reference to NAP added on 05/03/2025 New CAP authorised on 19/09/2024 PSUSA/00011091/202601 PSUSA/00011091/202701 Liana Martirosyan Netherlands CAP NAP 11092 elafibranor 10/06/2024 6 months 09/06/2026 18/08/2026 09/12/2026 17/02/2027 No 29/07/2026 DLP was amended on 29/07/2026 PSUSA/00011092/202606 PSUSA/00011092/202612 Rugile Pilviniene Lithuania CAP 11094 toripalimab 17/12/2018 1 year 16/12/2026 24/02/2027 16/12/2027 24/02/2028 No 29/07/2026 DLP was amended on 29/07/2026 PSUSA/00011094/202612 PSUSA/00011094/202712 Karin Erneholm Denmark CAP 11095 zolbetuximab 26/03/2024 1 year 25/03/2026 03/06/2026 25/03/2027 03/06/2027 No 17/12/2025 DLP was amended on 17/12/2025 PSUR frequency amended and DLP updated on 19/11/2025 PSUSA/00011095/202603 PSUSA/00011095/202703 Bianca Mulder Netherlands CAP 11097 mirvetuximab soravtansine 14/11/2022 1 year 13/11/2026 22/01/2027 13/11/2027 22/01/2028 No 01/07/2026 PSUR frequency amended and DLP updated on 01/07/2026 Correction of DLP on 18/12/2024 New CAP authorised on 14/11/2024 PSUSA/00011097/202611 PSUSA/00011097/202711 Maria del Pilar Rayon Spain CAP 11098 furazidine 24/10/2025 5 years 28/02/2026 29/05/2026 Yes 05/08/2025 New entry added on 18/12/2024 PSUSA/00011098/202602 Polona Golmajer Slovenia NAP 11099 magnesium chloride Not available* 20 years 02/09/2044 01/12/2044 Yes 18/12/2024 New entry added on 18/12/2024 PSUSA/00011099/204409 not yet assigned none NAP 11100 sodium acetate Not available* 20 years 02/09/2044 01/12/2044 Yes 18/12/2024 New entry added on 18/12/2024 PSUSA/00011100/204409 not yet assigned none NAP 11101 marstacimab 11/10/2024 1 year 10/04/2026 19/06/2026 10/04/2027 19/06/2027 No 01/07/2026 Correction of DLP on 01/07/2026 PSUR frequency amended and DLP updated on 27/05/2026 DLP was amended on 19/11/2025 PSUSA/00011101/202604 PSUSA/00011101/202704 Marie Louise Schougaard Christiansen Denmark CAP 11102 repotrectinib 15/11/2023 6 months 14/05/2026 23/07/2026 14/11/2026 23/01/2027 No 01/07/2026 DLP was amended on 01/07/2026 PSUSA/00011102/202605 PSUSA/00011102/202611 Barbara Kovacic Bytyqi Croatia CAP 11103 vilobelimab 04/04/2023 1 year 03/04/2026 12/06/2026 03/04/2027 12/06/2027 No 27/05/2026 PSUR frequency amended and DLP updated on 27/05/2026 DLP was amended on 19/11/2025 PSUSA/00011103/202604 PSUSA/00011103/202704 Liana Martirosyan Netherlands CAP 11104 rdESAT-6 / rCFP-10 09/05/2022 6 months 08/05/2026 17/07/2026 08/11/2026 17/01/2027 No 01/07/2026 DLP was amended on 01/07/2026 PSUSA/00011104/202605 PSUSA/00011104/202611 Sonja Hrabcik Austria CAP 11105 concizumab 10/03/2023 1 year 30/03/2026 08/06/2026 10/04/2027 19/06/2027 No 01/07/2026 Next DLP was updated on 01/07/2026 PSUR frequency amended and DLP updated on 27/05/2026 DLP was amended on 19/11/2025 PSUSA/00011105/202603 PSUSA/00011105/202704 Marie Louise Schougaard Christiansen Denmark CAP 11106 acoramidis 22/11/2024 6 months 21/05/2026 30/07/2026 21/11/2026 30/01/2027 No 01/07/2026 DLP was amended on 01/07/2026 PSUSA/00011106/202605 PSUSA/00011106/202611 Rhea Fitzgerald Ireland CAP 11107 belzutifan 13/08/2021 6 months 12/02/2026 23/04/2026 12/08/2026 21/10/2026 No 01/04/2026 DLP was amended on 01/04/2026 PSUSA/00011107/202602 PSUSA/00011107/202608 Dennis Lex Germany CAP 11108 catumaxomab 10/02/2025 6 months 09/02/2026 20/04/2026 09/08/2026 18/10/2026 No 01/04/2026 DLP was amended on 01/04/2026 PSUSA/00011108/202602 PSUSA/00011108/202608 Bianca Mulder Netherlands CAP 11109 garadacimab 14/01/2025 6 months 13/01/2026 24/03/2026 13/07/2026 21/09/2026 No 04/03/2026 DLP was amended on 04/03/2026 PSUSA/00011109/202601 PSUSA/00011109/202607 Marie Louise Schougaard Christiansen Denmark CAP 11110 lazertinib 21/05/2021 6 months 20/05/2026 29/07/2026 20/11/2026 29/01/2027 No 01/07/2026 DLP was amended on 01/07/2026 PSUSA/00011110/202605 PSUSA/00011110/202611 Petar Mas Croatia CAP 11111 nemolizumab 28/03/2022 1 year 27/09/2026 06/12/2026 27/09/2027 06/12/2027 No 27/05/2026 DLP was amended on 27/05/2026 PSUSA/00011111/202609 PSUSA/00011111/202709 Liana Martirosyan Netherlands CAP 11112 serplulimab 22/03/2022 6 months 21/03/2026 30/05/2026 21/09/2026 30/11/2026 No 29/04/2026 DLP was amended on 29/04/2026 PSUSA/00011112/202603 PSUSA/00011112/202609 Jan Neuhauser Austria CAP 11113 sipavibart 27/12/2024 1 year 26/12/2026 06/03/2027 26/12/2027 05/03/2028 No 29/07/2026 DLP was amended on 29/07/2026 PSUSA/00011113/202612 PSUSA/00011113/202712 Kimmo Jaakkola Finland CAP 11114 tiratricol 12/02/2025 6 months 11/02/2026 22/04/2026 11/08/2026 20/10/2026 No 01/04/2026 DLP was amended on 01/04/2026 PSUSA/00011114/202602 PSUSA/00011114/202608 Zoubida Amimour France CAP 11115 COVID-19 sa-mRNA Vaccine (Kostaive) 28/11/2023 1 year 27/11/2026 05/02/2027 27/11/2027 05/02/2028 No 01/07/2026 Active substance name was amended on 01/07/2026 DLP was amended on 04/02/2026 PSUSA/00011115/202611 PSUSA/00011115/202711 Dirk Mentzer Germany CAP 11117 imetelstat 06/06/2024 6 months 05/06/2026 14/08/2026 05/12/2026 13/02/2027 No 29/07/2026 DLP was amended on 29/07/2026 PSUSA/00011117/202606 PSUSA/00011117/202612 Bianca Mulder Netherlands CAP 11118 chikungunya vaccine (recombinant, adsorbed) 14/02/2025 6 months 13/02/2026 24/04/2026 13/08/2026 22/10/2026 No 01/04/2026 DLP was amended on 01/04/2026 Active substance name was amended on 01/04/2026 Correction of EURD and DLP on 30/04/2025 New CAP authorised on 28/02/2025 PSUSA/00011118/202602 PSUSA/00011118/202608 Liana Martirosyan Netherlands CAP 11119 seladelpar lysine dihydrate 14/08/2024 6 months 13/02/2026 24/04/2026 13/08/2026 22/10/2026 No 01/04/2026 DLP was amended on 01/04/2026 PSUSA/00011119/202602 PSUSA/00011119/202608 Amelia Cupelli Italy CAP 11120 eplontersen 21/12/2023 6 months 20/06/2026 29/08/2026 20/12/2026 28/02/2027 No 29/07/2026 DLP was amended on 29/07/2026 PSUSA/00011120/202606 PSUSA/00011120/202612 Jan Neuhauser Austria CAP 11121 pneumococcal polysaccharide conjugate vaccine (21-valent) 17/06/2024 6 months 16/06/2026 25/08/2026 16/12/2026 24/02/2027 No 29/07/2026 DLP was amended on 29/07/2026 PSUSA/00011121/202606 PSUSA/00011121/202612 Jean-Michel Dogné Belgium CAP 11122 indigo carmine 11/11/2003 13 years 10/11/2035 08/02/2036 Yes 02/04/2025 New entry added on 02/04/2025 PSUSA/00011122/203511 not yet assigned none NAP 11123 paraffin liquid / paraffin yellow soft 01/08/1977 12 years 28/12/2032 28/03/2033 Yes 25/06/2025 Active substance name was corrected on 25/06/2025 New entry added on 02/04/2025 PSUSA/00011123/203212 not yet assigned none NAP 11124 lactobacillus all subspecies and combinations of subspecies (intramuscular use) 14/07/1954 5 years 13/07/2029 11/10/2029 No 28/05/2025 PSUR frequency and DLP corrected on 28/05/2025 New entry added on 30/04/2025 PSUSA/00011124/202907 Dirk Mentzer Germany NAP 11127 tisotumab vedotin 20/09/2021 6 months 19/03/2026 28/05/2026 19/09/2026 28/11/2026 No 29/04/2026 DLP was amended on 29/04/2026 PSUSA/00011127/202603 PSUSA/00011127/202609 Jo Robays Belgium CAP 11129 datopotamab deruxtecan 27/12/2024 6 months 26/06/2026 04/09/2026 26/12/2026 06/03/2027 No 29/07/2026 DLP was amended on 29/07/2026 PSUSA/00011129/202606 PSUSA/00011129/202612 Jenny Jönsson Sweden CAP 11130 linvoseltamab 23/04/2025 6 months 22/04/2026 01/07/2026 22/10/2026 31/12/2026 No 01/07/2026 DLP was amended on 01/07/2026 PSUSA/00011130/202604 PSUSA/00011130/202610 Veronika Macurová Czech Republic CAP 11131 beremagene geperpavec 19/05/2023 6 months 18/05/2026 27/07/2026 18/11/2026 27/01/2027 No 01/07/2026 DLP was amended on 01/07/2026 PSUSA/00011131/202605 PSUSA/00011131/202611 Liana Martirosyan Netherlands CAP 11132 lecanemab 06/01/2023 6 months 05/01/2026 16/03/2026 05/07/2026 13/09/2026 No 04/03/2026 DLP was amended on 04/03/2026 PSUSA/00011132/202601 PSUSA/00011132/202607 Eva Jirsová Czech Republic CAP 11133 CARBO VEGETABILIS / RESINA PICEAE/ ROBINIA PSEUDOACACIA / STRYCHNOS NUX-VOMICA 19/12/2005 18 years 18/12/2043 17/03/2044 Yes 29/07/2026 Active substance name was amended on 29/07/2026 New active substance added on 28/05/2025 PSUSA/00011133/204312 none none NAP 11134 cinitapride 13/12/1989 13 years 12/12/2036 12/03/2037 Yes 28/05/2025 New active substance added on 28/05/2025 PSUSA/00011134/203612 none none NAP 11135 magnesium sulfate heptahydrate, potassium chloride, xylitol, procaine hydrochloride 04/04/2024 3 years 03/04/2027 02/07/2027 No 28/05/2025 New entry added on 28/05/2025 PSUSA/00011135/202704 none none NAP 11136 ATROPA BELLA-DONNA / VIBURNUM OPULUS / CHELIDONIUM MAJUS / ACONITUM NAPELLUS / CALENDULA OFFICINALIS / ABRUS PRECATORIUS 11/07/2008 18 years 10/07/2044 08/10/2044 Yes 29/07/2026 Active substance name was amended on 29/07/2026 New active substance added on 28/05/2025 PSUSA/00011136/204407 None none NAP 11137 papain / trypsin / chymotrypsin 25/11/2013 10 years 24/11/2035 22/02/2036 No 28/05/2025 New entry added on 28/05/2025 PSUSA/00011137/203511 none none NAP 11138 populi cortex et folium, extractum / fraxini cortex, extractum / european goldenrod extract 12/03/2015 13 years 11/03/2035 09/06/2035 No 28/05/2025 New entry added on 28/05/2025 PSUSA/00011138/203503 none none NAP 11139 bencyclane 23/11/1966 13 years 22/11/2035 20/02/2036 No 28/05/2025 New entry added on 28/05/2025 PSUSA/00011139/203511 none none NAP 11140 ferric citrate coordination complex 11/06/2025 6 months 10/06/2026 19/08/2026 10/12/2026 18/02/2027 No 29/07/2026 DLP was amended on 29/07/2026 PSUSA/00011140/202606 PSUSA/00011140/202612 Kimmo Jaakkola Finland CAP NAP 11141 givinostat 20/12/2024 6 months 20/06/2026 29/08/2026 20/12/2026 28/02/2027 No 29/07/2026 DLP was amended on 29/07/2026 PSUSA/00011141/202606 PSUSA/00011141/202612 Liana Martirosyan Netherlands CAP 11142 atropine (myopia indication) 31/08/1945 1 year 31/08/2026 09/11/2026 31/08/2027 09/11/2027 No 29/04/2026 DLP was amended on 29/04/2026 PSUSA/00011142/202608 PSUSA/00011142/202708 Dennis Lex Germany CAP NAP 11143 candesartan / indapamide 11/09/2024 5 years 10/09/2029 09/12/2029 No 30/07/2025 New entry added on 30/07/2025 PSUSA/00011143/202909 not yet assigned none NAP 11144 amino acid combinations (only combinations of pure amino acids or combination of amino acids with mineral compounds / electrolytes, oral use) 18/10/2006 7 years 17/10/2026 15/01/2027 No 27/02/2026 New entry added on 30/07/2025 PSUSA/00011144/202610 Polona Golmajer Slovenia NAP 11145 sepiapterin 19/06/2025 6 months 19/06/2026 28/08/2026 19/12/2026 27/02/2027 No 29/07/2026 DLP was amended on 29/07/2026 PSUSA/00011145/202606 PSUSA/00011145/202612 David Olsen Norway CAP 11146 deutivacaftor / tezacaftor / vanzacaftor 20/12/2024 6 months 19/06/2026 28/08/2026 19/12/2026 27/02/2027 No 29/07/2026 DLP was amended on 29/07/2026 PSUSA/00011146/202606 PSUSA/00011146/202612 Dennis Lex Germany CAP 11147 zanidatamab 20/11/2024 6 months 19/05/2026 28/07/2026 19/11/2026 28/01/2027 No 01/07/2026 DLP was amended on 01/07/2026 PSUSA/00011147/202605 PSUSA/00011147/202611 Jenny Jönsson Sweden CAP 11148 teprotumumab 21/01/2020 6 months 20/01/2026 31/03/2026 20/07/2026 28/09/2026 No 04/03/2026 DLP was amended on 04/03/2026 PSUSA/00011148/202601 PSUSA/00011148/202607 Sonja Radowan Austria CAP 11149 Glycine / L-ALANINE / L-ARGININE / L-ASPARTIC ACID / L-CYSTEINE HYDROCHLORIDE MONOHYDRATE / L-HISTIDINE / L-METHIONINE / L-PHENYLALANINE / L-PROLINE / L-SERINE / L-THREONINE / L-TRYPTOPHAN / L-TYROSINE / L-glutamic acid / L-lysine monohydrate / Taurine 28/07/2025 6 months 27/01/2026 07/04/2026 27/07/2026 05/10/2026 Yes 22/10/2025 DLP was amended on 22/10/2025 New CAP authorised on 28/07/2025 PSUSA/00011149/202601 PSUSA/00011149/202607 Amelia Cupelli Italy CAP 11150 diflunisal (for centrally authorised products) 03/11/2025 3 years 03/11/2028 01/02/2029 No 24/09/2025 PSUSA/00011150/202811 Karin Bolin Sweden CAP 11151 dorocubicel / allogeneic umbilical cord-derived CD34- cells, non-expanded 25/08/2025 6 months 24/02/2026 05/05/2026 24/08/2026 02/11/2026 No 02/06/2026 PSUSA/00011151/202602 PSUSA/00011151/202608 Karin Bolin Sweden CAP 11152 sargramostim 05/03/1991 6 months 04/03/2026 13/05/2026 04/09/2026 13/11/2026 No 02/06/2026 PSUSA/00011152/202603 PSUSA/00011152/202609 Jenny Jönsson Sweden CAP 11153 erysimum 12/11/1999 8 years 12/11/2030 10/02/2031 No 22/10/2025 New entry added on 22/10/2025 PSUSA/00011153/203011 not yet assigned none NAP 11154 sebetralstat 03/07/2025 6 months 02/01/2026 13/03/2026 02/07/2026 10/09/2026 No 22/10/2025 New CAP authorised on 17/09/2025 PSUSA/00011154/202601 PSUSA/00011154/202607 Zane Neikena Latvia CAP 11155 olezarsen 19/12/2024 6 months 18/06/2026 27/08/2026 18/12/2026 26/02/2027 No 29/07/2026 DLP was amended on 29/07/2026 PSUSA/00011155/202606 PSUSA/00011155/202612 Kimmo Jaakkola Finland CAP 11156 vimseltinib 14/02/2025 6 months 13/02/2026 24/04/2026 13/08/2026 22/10/2026 No 22/10/2025 New CAP authorised on 17/09/2025 PSUSA/00011156/202602 PSUSA/00011156/202608 Karin Erneholm Denmark CAP 11157 vorasidenib 06/08/2024 6 months 05/02/2026 16/04/2026 05/08/2026 14/10/2026 No 19/11/2025 EURD and DLP updated on 19/11/2025 New CAP authorised on 17/09/2025 PSUSA/00011157/202602 PSUSA/00011157/202608 Jo Robays Belgium CAP 11158 zuranolone 04/08/2023 6 months 03/02/2026 14/04/2026 03/08/2026 12/10/2026 No 22/10/2025 New CAP authorised on 17/09/2025 PSUSA/00011158/202602 PSUSA/00011158/202608 Guðrún Stefánsdóttir Iceland CAP 11159 resmetirom 14/03/2024 6 months 13/03/2026 22/05/2026 13/09/2026 22/11/2026 No 22/10/2025 New CAP authorised on 18/08/2025 PSUSA/00011159/202603 PSUSA/00011159/202609 Lina Seibokiene Lithuania CAP 11160 obecabtagene autoleucel 08/11/2024 6 months 07/05/2026 16/07/2026 07/11/2026 16/01/2027 No 01/07/2026 DLP was amended on 01/07/2026 PSUSA/00011160/202605 PSUSA/00011160/202611 Karin Erneholm Denmark CAP 11161 mirdametinib 11/02/2025 6 months 10/02/2026 21/04/2026 10/08/2026 19/10/2026 No 01/04/2026 DLP was amended on 01/04/2026 PSUSA/00011161/202602 PSUSA/00011161/202608 Bianca Mulder Netherlands CAP 11162 clascoterone 17/10/2025 6 months 16/04/2026 25/06/2026 16/10/2026 25/12/2026 No 19/11/2025 New CAP authorised on 17/10/2025 PSUSA/00011162/202604 PSUSA/00011162/202610 Zane Neikena Latvia CAP 11163 nirogacestat 27/11/2023 6 months 27/05/2026 05/08/2026 27/11/2026 05/02/2027 No 01/07/2026 DLP was amended on 01/07/2026 PSUSA/00011163/202605 PSUSA/00011163/202611 Terhi Lehtinen Finland CAP 11164 inavolisib 10/10/2024 6 months 09/04/2026 18/06/2026 09/10/2026 18/12/2026 No 27/05/2026 DLP was amended on 27/05/2026 PSUSA/00011164/202604 PSUSA/00011164/202610 Bianca Mulder Netherlands CAP 11165 donanemab 02/07/2024 6 months 02/01/2026 13/03/2026 02/07/2026 10/09/2026 No 04/02/2026 DLP was amended on 04/02/2026 New CAP authorised on 24/09/2025 PSUSA/00011165/202601 PSUSA/00011165/202607 Amelia Cupelli Italy CAP 11166 thiamine / cyanocobalamine / riboflavin / pyridoxine 27/09/1999 3 years 03/06/2028 01/09/2028 Yes 26/05/2026 PSUR frequency amended and DLP updated on 26/05/2026 New entry added on 17/12/2025 PSUSA/00011166/202806 not yet assigned none NAP 11167 gentian root / verbena herb / common sorrel herb / primula flower with calyx / sambucus nigra flower 27/06/2007 13 years 26/06/2036 24/09/2036 No 17/12/2025 New entry added 17/12/2025 PSUSA/00011167/203606 not yet assigned none NAP 11168 nipocalimab 29/04/2025 6 months 28/04/2026 07/07/2026 28/10/2026 06/01/2027 No 17/12/2025 New CAP authorised on 28/11/2025 PSUSA/00011168/202604 PSUSA/00011168/202610 Dirk Mentzer Germany CAP 11169 insulin icodec / semaglutide 05/12/2017 6 months 04/06/2026 13/08/2026 04/12/2026 12/02/2027 No 17/12/2025 New CAP authorised on 18/11/2025 PSUSA/00011169/202606 PSUSA/00011169/202612 Petar Mas Croatia CAP 11170 brensocatib 12/08/2025 6 months 11/02/2026 22/04/2026 11/08/2026 20/10/2026 No 17/12/2025 New CAP authorised on 18/11/2025 PSUSA/00011170/202602 PSUSA/00011170/202608 Zane Neikena Latvia CAP 11171 elinzanetant 08/07/2025 6 months 07/01/2026 18/03/2026 07/07/2026 15/09/2026 No 17/12/2025 New CAP authorised on 17/11/2025 PSUSA/00011171/202601 PSUSA/00011171/202607 Guðrún Stefánsdóttir Iceland CAP 11172 donidalorsen 21/08/2025 6 months 20/02/2026 01/05/2026 20/08/2026 29/10/2026 No 04/02/2026 New CAP authorised on 19/01/2026 PSUSA/00011172/202602 PSUSA/00011172/202608 Julia Pallos Hungary CAP 11173 etuvetidigene autotemcel 09/01/2026 6 months 08/07/2026 16/09/2026 08/01/2027 19/03/2027 No 04/02/2026 New CAP authorised on 09/01/2026 PSUSA/00011173/202607 PSUSA/00011173/202701 Jo Robays Belgium CAP 11174 levacetylleucine 24/09/2024 6 months 23/03/2026 01/06/2026 23/09/2026 02/12/2026 No 04/02/2026 New CAP authorised on 19/01/2026 PSUSA/00011174/202603 PSUSA/00011174/202609 Dennis Lex Germany CAP 11175 imlunestrant 25/09/2025 6 months 25/03/2026 03/06/2026 25/09/2026 04/12/2026 No 02/06/2026 DLP updated on 04/03/2026 New CAP authorised on 09/01/2026 PSUSA/00011175/202603 PSUSA/00011175/202609 Jenny Jönsson Sweden CAP 11176 pertussis vaccine (recombinant, acellular, component, adsorbed) 30/09/2016 6 months 29/03/2026 07/06/2026 29/09/2026 08/12/2026 No 04/02/2026 New CAP authorised on 09/01/2026 PSUSA/00011176/202603 PSUSA/00011176/202609 Amelia Cupelli Italy CAP 11177 deutetrabenazine 08/01/2026 1 year 31/03/2026 09/06/2026 31/03/2027 09/06/2027 No 01/04/2026 PSUR frequency corrected on 01/04/2026 New CAP authorised on 08/01/2026 PSUSA/00011177/202603 PSUSA/00011177/202703 Liana Martirosyan Netherlands CAP 11178 teplizumab 17/11/2022 6 months 16/05/2026 25/07/2026 16/11/2026 25/01/2027 No 04/02/2026 New CAP authorised on 08/01/2026 PSUSA/00011178/202605 PSUSA/00011178/202611 Terhi Lehtinen Finland CAP 11179 rilzabrutinib 19/06/2025 6 months 18/06/2026 27/08/2026 18/12/2026 26/02/2027 No 04/02/2026 New CAP authorised on 22/12/2025 PSUSA/00011179/202606 PSUSA/00011179/202612 Dennis Lex Germany CAP 11180 depemokimab 29/08/2017 6 months 28/02/2026 09/05/2026 28/08/2026 06/11/2026 No 04/03/2026 New CAP authorised on 12/02/2026 PSUSA/00011180/202602 PSUSA/00011180/202608 Dirk Mentzer Germany CAP 11181 aficamten 16/12/2025 6 months 15/06/2026 24/08/2026 15/12/2026 23/02/2027 No 04/03/2026 New CAP authorised on 12/02/2026 PSUSA/00011181/202606 PSUSA/00011181/202612 Eva Jirsová Czech Republic CAP 11182 aumolertinib 17/03/2020 6 months 16/03/2026 25/05/2026 16/09/2026 25/11/2026 No 04/03/2026 New CAP authorised on 12/02/2026 PSUSA/00011182/202603 PSUSA/00011182/202609 Bianca Mulder Netherlands CAP 11183 COVID-19 mRNA vaccine (mNEXSPIKE) 30/05/2025 1 year 29/05/2027 07/08/2027 29/05/2028 07/08/2028 No 01/07/2026 Active substance name was amended on 01/07/2026 Correction of PSUR frequency and DLP on 01/04/2026 New CAP authorised on 12/02/2026 PSUSA/00011183/202705 PSUSA/00011183/202805 Marie Louise Schougaard Christiansen Denmark CAP 11184 standardised bacterial culture suspension, standardised bacterial culture suspension / hydrocortisone, inactivated E. coli, inactivated E. coli / hydrocortisone 16/09/2008 15 years 16/09/2034 15/12/2034 No 01/04/2026 New entry added on 01/04/2026 PSUSA/00011184/203409 not yet assigned none NAP 11185 povidone, polyvinyl alcohol / povidone, dextran 70 / hypromellose, white soft paraffin / white soft paraffin combinations (ocular indications) 01/01/1981 13 years 30/06/2040 28/09/2040 No 01/04/2026 New entry added on 01/04/2026 PSUSA/00011185/204006 not yet assigned none NAP 11186 chlorhexidine / hydrocortisone 05/08/1952 8 years 03/03/2033 01/06/2033 Yes 01/04/2026 New entry added on 01/04/2026 PSUSA/00011186/203303 not yet assigned none NAP 11187 efinaconazole 19/03/2025 5 years 19/03/2029 17/06/2029 No 01/04/2026 New entry added on 01/04/2026 PSUSA/00011187/202903 not yet assigned none NAP 11188 penfluridol 05/11/2018 3 years 05/11/2027 03/02/2028 Yes 01/04/2026 New entry added on 01/04/2026 PSUSA/00011188/202711 not yet assigned none NAP 11189 ezetimibe / pitavastatin 17/04/2025 5 years 16/07/2030 14/10/2030 No 01/04/2026 New entry added on 01/04/2026 PSUSA/00011189/203007 not yet assigned none NAP 11190 anamirta cocculus / strychnos nux-vomica / petroleum / nicotiana tabacum 19/12/2001 18 years 19/12/2028 19/03/2029 Yes 01/04/2026 New entry added on 01/04/2026 PSUSA/00011190/202812 not yet assigned none NAP 11191 fenofibrate / rosuvastatin 26/08/2013 5 years 06/11/2027 04/02/2028 No 01/04/2026 New entry added on 01/04/2026 PSUSA/00011191/202711 not yet assigned none NAP 11192 ginkgo biloba L., folium (ginkgo leaf) 26/06/1986 10 years 25/06/2034 23/09/2034 No 01/04/2026 New entry added on 01/04/2026 PSUSA/00011192/203406 not yet assigned none NAP 11193 primaquine 12/04/1972 5 years 12/04/2031 11/07/2031 Yes 01/04/2026 New entry added on 01/04/2026 PSUSA/00011193/203104 not yet assigned none NAP 11194 nogapendekin alfa inbakicept 04/07/2025 6 months 03/07/2026 11/09/2026 03/01/2027 14/03/2027 No 01/04/2026 New CAP added on 01/04/2026 PSUSA/00011194/202607 PSUSA/00011194/202701 Jean-Michel Dogné Belgium CAP 11195 clesrovimab 09/06/2025 6 months 08/06/2026 17/08/2026 08/12/2026 16/02/2027 No 27/05/2026 DLP was amended on 27/05/2026 New CAP authorised on 15/04/2026 PSUSA/00011195/202606 PSUSA/00011195/202612 Dirk Mentzer Germany CAP 11196 doxecitine / doxribtimine 03/11/2025 6 months 02/05/2026 11/07/2026 02/11/2026 11/01/2027 No 29/04/2026 New CAP authorised on 26/03/2026 PSUSA/00011196/202605 PSUSA/00011196/202611 Barbara Kovacic Bytyqi Croatia CAP 11197 estetrol 26/03/2026 6 months 25/09/2026 04/12/2026 25/03/2027 03/06/2027 No 29/04/2026 New CAP authorised on 26/03/2026 PSUSA/00011197/202609 PSUSA/00011197/202703 Sonja Radowan Austria CAP 11198 belumosudil 16/07/2021 6 months 15/07/2026 23/09/2026 15/01/2027 26/03/2027 No 27/05/2026 DLP was corrected on 27/05/2026 New CAP authorised on 24/03/2026 PSUSA/00011198/202607 PSUSA/00011198/202701 Karin Erneholm Denmark CAP 11199 trivalent influenza vaccine (recombinant, prepared in cell culture) 30/03/2026 6 months 29/09/2026 08/12/2026 29/03/2027 07/06/2027 No 29/04/2026 New CAP authorised on 30/03/2026 PSUSA/00011199/202609 PSUSA/00011199/202703 Zoubida Amimour France CAP 11200 semaglutide (treatment of adults with non-cirrhotic metabolic dysfunction-associated steatohepatitis with liver fibrosis) 26/03/2026 6 months 25/09/2026 04/12/2026 25/03/2027 03/06/2027 No 03/06/2026 New CAP authorised on 26/03/2026 PSUSA/00011200/202609 PSUSA/00011200/202703 Karin Bolin Sweden CAP 11201 secale cereale L., phleum pratense, zea mays L. single or mixes (genitourinary therapy) 28/10/2004 5 years 28/10/2030 26/01/2031 No 27/05/2026 New entry added 27/05/2026 PSUSA/00011201/203010 not yet assigned none NAP 11202 salicylic acid (ocular use) Not available* 6 years 02/12/2029 02/03/2030 No 27/05/2026 New entry added on 27/05/2026 PSUSA/00011202/202912 not yet assigned none NAP 11203 viperae beri venenum / camphor / salicylic acid / turpentine oil Not available* 6 years 02/12/2029 02/03/2030 No 27/05/2026 New entry added on 27/05/2026 PSUSA/00011203/202912 not yet assigned none NAP 11204 tovorafenib 23/04/2024 6 months 22/10/2026 31/12/2026 22/04/2027 01/07/2027 No 27/05/2026 New CAP authorised on 20/04/2026 PSUSA/00011204/202610 PSUSA/00011204/202704 Marie Louise Schougaard Christiansen Denmark CAP 11205 influenza mRNA vaccine / COVID-19 mRNA vaccine (mCombriax) 20/04/2026 6 months 19/10/2026 28/12/2026 19/04/2027 28/06/2027 No 01/07/2026 Active substance name was amended on 01/07/2026 New CAP authorised on 20/04/2026 PSUSA/00011205/202610 PSUSA/00011205/202704 Georgia Gkegka Greece CAP 11206 remibrutinib 30/09/2025 6 months 29/09/2026 08/12/2026 29/03/2027 07/06/2027 No 27/05/2026 New CAP authorised on 23/04/2026 PSUSA/00011206/202609 PSUSA/00011206/202703 Terhi Lehtinen Finland CAP 11207 paltusotine 25/09/2025 6 months 31/08/2026 09/11/2026 28/02/2027 09/05/2027 No 27/05/2026 New CAP authorised on 23/04/2026 PSUSA/00011207/202608 PSUSA/00011207/202702 Liana Martirosyan Netherlands CAP 11208 mavorixafor 15/05/2015 6 months 14/05/2026 23/07/2026 14/11/2026 23/01/2027 No 27/05/2026 New CAP authorised on 27/04/2026 PSUSA/00011208/202605 PSUSA/00011208/202611 Karin Erneholm Denmark CAP 11210 lurbinectedin 15/06/2020 6 months 14/12/2026 22/02/2027 14/06/2027 23/08/2027 No 01/07/2026 New CAP authorised on 29/05/2026 PSUSA/00011210/202612 PSUSA/00011210/202706 Jenny-Maria Jönsson Sweden CAP 11211 tarlatamab 16/05/2024 6 months 15/11/2026 24/01/2027 15/05/2027 24/07/2027 No 01/07/2026 New CAP authorised on 29/05/2026 PSUSA/00011211/202611 PSUSA/00011211/202705 Sonja Radowan Austria CAP 11212 nadofaragene firadenovec 16/12/2025 6 months 15/06/2026 24/08/2026 15/12/2026 23/02/2027 No 01/07/2026 New CAP authorised on 28/05/2026 PSUSA/00011212/202606 PSUSA/00011212/202612 Amelia Cupelli Italy CAP 11213 leniolisib 24/03/2023 6 months 23/09/2026 02/12/2026 23/03/2027 01/06/2027 No 01/07/2026 New CAP authorised on 21/05/2026 PSUSA/00011213/202609 PSUSA/00011213/202703 Petar Mas Croatia CAP 11214 plozasiran 18/11/2025 6 months 31/07/2026 09/10/2026 31/01/2027 11/04/2027 No 01/07/2026 New CAP authorised on 19/06/2026 PSUSA/00011214/202607 PSUSA/00011214/202701 Terhi Lehtinen Finland CAP 11215 pridinol 29/12/2014 3 years 29/12/2027 28/03/2028 Yes 29/07/2026 New entry added on 29/07/2026 PSUSA/00011215/202712 not yet assigned none NAP 11216 benzyl alcohol / ethanol / isopropyl alcohol (covers other synonymous terms such as 2-propanol) 02/06/1995 7 years 02/06/2032 31/08/2032 Yes 29/07/2026 New entry added on 29/07/2026 PSUSA/00011216/203206 not yet assigned none NAP 11217 erbium 25/11/2003 5 years 25/11/2030 23/02/2031 Yes 29/07/2026 New entry added on 29/07/2026 PSUSA/00011217/203011 not yet assigned none NAP 11218 ferric ferrocyanide 15/05/2009 5 years 15/05/2030 13/08/2030 No 29/07/2026 New entry added on 29/07/2026 PSUSA/00011218/203005 not yet assigned none NAP 11219 physostigmine 28/12/2000 5 years 28/12/2030 28/03/2031 No 29/07/2026 New entry added on 29/07/2026 PSUSA/00011219/203012 not yet assigned none NAP 11220 iberidis amarae herba recens / matricariae flos / menthae piperitae folium / melissae folium / glycyrrhizae radix / carvi fructus 04/08/2015 18 years 04/08/2044 02/11/2044 No 29/07/2026 New entry added on 29/07/2026 PSUSA/00011220/204408 not yet assigned none NAP 11221 arnica montana / arum triphyllum / belladonna, bromum / bryonia / mercurius solubilis / phytolacca decandra / pulsatilla / spongia testa 24/03/2009 18 years 24/03/2044 22/06/2044 Yes 29/07/2026 New entry added on 29/07/2026 PSUSA/00011221/204403 not yet assigned none NAP 11222 chamomilla vulgaris / phytolacca decandra / rheum 19/05/2003 18 years 19/05/2044 17/08/2044 Yes 29/07/2026 New entry added 29/07/2026 PSUSA/00011222/204405 not yet assigned none NAP 11223 tolebrutinib 21/07/2025 6 months 20/07/2026 28/09/2026 20/01/2027 31/03/2027 No 29/07/2026 New CAP authorised on 19/06/2026 PSUSA/00011223/202607 PSUSA/00011223/202701 Amelia Cupelli Italy CAP 11224 alpelisib (Vijoice) 15/07/2026 6 months 14/01/2027 25/03/2027 14/07/2027 22/09/2027 No 29/07/2026 New CAP authorised on 15/07/2026 PSUSA/00011224/202701 PSUSA/00011224/202707 Bianca Mulder Netherlands CAP 11225 nerandomilast 07/10/2025 6 months 06/10/2026 15/12/2026 06/04/2027 15/06/2027 No 26/08/2026 EURD and DLP corrected on 26/08/2026 New CAP authorised on 15/07/2026 PSUSA/00011225/202610 PSUSA/00011225/202704 Barbara Kovacic Bytyqi Croatia CAP 11226 trenibotulinumtoxinE 22/06/2026 6 months 21/12/2026 01/03/2027 21/06/2027 30/08/2027 No 26/08/2026 EURD and DLP updated on 26/08/2026 New CAP authorised on 15/07/2026 PSUSA/00011226/202612 PSUSA/00011226/202706 Guðrún Stefánsdóttir Iceland CAP 11227 camizestrant 29/05/2025 6 months 28/11/2026 06/02/2027 28/05/2027 06/08/2027 No 26/08/2026 New CAP authorised on 20/07/2026 PSUSA/00011227/202611 PSUSA/00011227/202705 Karin Bolin Sweden CAP 107800 levodopa 21/12/2018 1 year 20/12/2026 28/02/2027 20/12/2027 28/02/2028 No 29/07/2026 DLP was amended on 29/07/2026 PSUSA/00107800/202612 PSUSA/00107800/202712 Barbara Kovacic Bytyqi Croatia CAP NAP 107812 netarsudil 18/12/2017 3 years 17/06/2027 15/09/2027 No 04/03/2026 PSUR frequency amended and DLP updated on 04/03/2026 PSUSA/00107812/202706 Maria del Pilar Rayon Spain CAP &"Calibri"&11&K000000&"Verdana,Regular"&6© European Medicines Agency, 2011. Reproduction is authorised provided the source is acknowledged._x000D_&1#&"Verdana"&7&K737373 Classified as internal/staff & contractors by the Europ &"Verdana,Regular"&9Page &P / &N An agency of the European Union https://www.ema.europa.eu/documents/template-form/template-request-amendments-addition-active-substances-combinations-active-substances-european-union_en-1.docxhttps://www.ema.europa.eu/documents/other/timetable-periodic-safety-update-report-psur-psur-single-assessment-psusa_en.pdfhttp://www.ema.europa.eu/ema/index.jsp?curl=pages/contacts/PRAC/people_listing_000112.jsp&mid=WC0b01ac058058f328https://www.ema.europa.eu/documents/other/introductory-cover-note-list-european-union-reference-dates-frequency-submission-periodic-safety_en.pdf Removed entries Active substances and combinations of active substances removed from the EURD list Comments Month removed ebola vaccine (Ad26.ZEBOV-GP [recombinant], MVA-BN-Filo [recombinant]) Entry deleted due to CAPs (MVABEA and ZABDENO) withdrawn Aug-26 benzocaine / cetylpyridinium chloride Entry deleted due to merge (see EURD ID: 636) Jul-26 cefoperazone / sulbactam Entry deleted due to merge (See EURD ID: 597) Jul-26 ceftriaxone sodium / lidocaine hydrochloride Entry deleted due to merge (See EURD ID: 613) Jul-26 choline salicylate Entry deleted due to merge (See EURD ID: 626) Jul-26 cyanocobalamin / l-arginine l-2 pyrrolidone-5-carboxylate Entry removed as only authorised in 1 MS Jul-26 epitizide / triamterene Entry deleted due to no products in scope Jul-26 fenoprofen Entry removed as only authorised in 1 MS Jul-26 glutathione Entry removed as only authorised in 1 MS Jul-26 glycerol / paraffin liquid / vaselin Entry removed as only authorised in 1 MS Jul-26 acetylsalicylic acid / paracetamol Entry deleted due to merge (See EURD ID: 252) Jul-26 diphenhydramine / racemic camphor / zinc oxide Entry removed as only authorised in 1 MS Jul-26 dithranol Entry removed as only authorised in 1 MS Jul-26 dectaflur / olaflur Entry removed as only authorised in 1 MS Jul-26 aminosalicylic acid Entry removed as only authorised in 1 MS Jun-26 cocaine Entry deleted due to no products in scope Jun-26 ergometrine Entry deleted due to no products in scope Jun-26 fludrocortisone / gramicidin / neomycin Entry deleted due to no products in scope Jun-26 furazolidone Entry deleted due to no products in scope Jun-26 plasma protein fraction Entry removed as only authorised in 1 MS Jun-26 glutaral Entry deleted due to no products in scope Jun-26 chloroquine phosphate / proguanil hydrochloride Entry deleted due to no products in scope Jun-26 insulin degludec / liraglutide Entry deleted due to merge (See EURD ID: 1892) Jun-26 tilmanocept Entry deleted due to no products in scope Jun-26 ivabradine / metoprolol Entry deleted due to no products in scope Jun-26 sodium benzoate / grindelia tincture / polygala syrup Entry deleted due to no products in scope Jun-26 parathyroid hormone Entry deleted as Natpar (CAP) withdrawn Jun-26 hydroxyprogesterone caproate Entry deleted due to no products in scope Jun-26 dasiglucagon Entry deleted as Zegalogue (CAP) withdrawn Jun-26 melphalan Entry deleted due to merge (see EURD ID: 11013) May-26 copper sulfate / zinc oxide Entry removed as only authorised in 1 MS May-26 calcium carbonate / sodium alginate / sodium bicarbonate, sodium alginate / sodium bicarbonate, sodium alginate/ potassium hydrogen carbonate, sodium alginate/magnesium alginate Entry deleted due to merge (see entry ID 123 and/or 500) May-26 duvelisib Entry deleted as Copiktra (CAP) withdrawn May-26 casirivimab / imdevimab (Ronapreve) Entry deleted as Ronapreve (CAP) withdrawn May-26 valoctocogene roxaparvovec Entry deleted as Roctavian (CAP) withdrawn May-26 clotrimazole / zinc oxide Entry removed as only authorised in 1 MS Apr-26 codeine / erysimum Entry removed as only authorised in 1 MS Apr-26 codeine / ethylmorphine hydrochloride Entry removed as only authorised in 1 MS Apr-26 disodium phosphate dodecahydrate / sodium dihydrogen phosphate dihydrate Entry deleted - Art 57 has no products/products covered by other entry (See EURD ID: 2737) Apr-26 ibritumomab tiuxetan Entry deleted as Zevalin (CAP) expired Apr-26 levamisole Entry deleted due to revocation of all levamisole-containing products from the EU market Apr-26 bendroflumethiazide / timolol maleate Entry removed as only authorised in 1 MS Apr-26 chymotrypsin / trypsin Entry deleted - Art 57 has no products Apr-26 benzocaine / tyrothricin Entry removed as only authorised in 1 MS Apr-26 bromelain Entry removed as only authorised in 1 MS Apr-26 acetic acid Entry removed as only authorised in 1 MS Mar-26 atropine sulfate / hyoscine hydrobromide / hyoscyamine sulfate / phenobarbital Entry deleted - Art 57 has no products Mar-26 benzoxonium chloride Entry removed as only authorised in 1 MS Mar-26 carbutamide Entry deleted - Art 57 has no products Mar-26 dextran 70 / hypromellose Entry deleted due to merge (See EURD IDs 11185 or 9280) Mar-26 dextromethorphan hydrobromide / pseudoephedrine hydrochloride Entry deleted - Art 57 has no products Mar-26 dichlorobenzyl alcohol Entry deleted - Art 57 has no products Mar-26 dropropizine Entry removed as only authorised in 1 MS Mar-26 doederlein bacillus selected strain (lactobacillus casei ssp rhamnosus) / estriol / progesterone Entry removed as only authorised in 1 MS Mar-26 melarsoprol Entry removed as only authorised in 1 MS Mar-26 panthenol Entry deleted - Art 57 has no products Mar-26 dicyclomine hydrochloride / paracetamol Entry deleted due to active substance(s) already covered by EURD ID 1051 Mar-26 sodium chromate (51cr) Entry deleted - Art 57 has no products Mar-26 salicylate / triethanolamine Entry deleted - Art 57 has no products Mar-26 arginine glutamate Entry deleted - Art 57 has no products Mar-26 ascorbic acid / cyanocobalamin / folic acid / nicotinamide Entry removed as only authorised in 1 MS Mar-26 gentamicin sulfate / indometacin Entry removed as only authorised in 1 MS Mar-26 chlorpheniramine / dextromethorphan / paracetamol / pseudoephedrine Entry removed as only authorised in 1 MS Mar-26 ascorbic acid / potassium bicarbonate Entry removed as only authorised in 1 MS Mar-26 fluorescein sodium / proxymetacaine hydrochloride Entry deleted - Art 57 has no products Mar-26 sargramostim Entry deleted - Art 57 has no products Mar-26 cinacalcet Entry removed as Mimpara (CAP) withdrawn Feb-26 idebenone (non centrally authorised products) Entry removed as only authorised in 1 MS Feb-26 mometasone / salicylic acid Entry removed as only authorised in 1 MS Feb-26 pranoprofen Entry removed as only authorised in 1 MS Feb-26 aluminium phosphate Entry deleted as other entry covers same products (See EURD ID: 500) Feb-26 ocriplasmin Entry removed as Jetrea (CAP) withdrawn Feb-26 rabbit anti-human thymocyte immunoglobulin Entry deleted due to merge (see EURD ID: 10252) Feb-26 phenylephrine / ketorolac Entry removed as Omidria (CAP) withdrawn Feb-26 atorvastatin / perindopril Entry deleted - Art 57 has no products Feb-26 13C-methacetin Entry deleted - Art 57 has no products Feb-26 sotrovimab Entry removed as XEVUDY (CAP) withdrawn Feb-26 eptifibatide Entry removed as Integrilin (CAP) withdrawn Jan-26 lixisenatide Entry deleted - Art 57 has no products Jan-26 cytidine / uridine triphosphate sodium Entry deleted - Art 57 has no products Dec-25 trandolapril / verapamil Entry deleted due to merge (see EURD ID: 3004) Nov-25 dengue tetravalent vaccine (live, attenuated) [Chimeric yellow fever dengue virus serotype 1 (live, attenuated) / Chimeric yellow fever dengue virus serotype 2 (live, attenuated) / Chimeric yellow fever dengue virus serotype 3 (live, attenuated) / Chimeric yellow fever dengue virus serotype 4 (live, attenuated)] Entry removed as Dengavia (CAP) withdrawn Nov-25 dirithromycin Entry deleted - Art 57 has no products Oct-25 etofylline Entry deleted due to merge (see EURD ID: 1329) Oct-25 moexipril Entry deleted - Art 57 has no products Oct-25 nisoldipine Entry deleted - Art 57 has no products Oct-25 parnaparin Entry removed as only authorised in 1 MS Oct-25 dihydroergocristine / etofylline Entry deleted due to merge (see EURD ID: 1329) Oct-25 ephedrine hydrochloride / resorcinol Entry deleted - Art 57 has no products Oct-25 amlexanox Entry deleted - Art 57 has no products Oct-25 rosuvastatin/ perindopril /indapamide Entry removed due to merge (see EURD ID:10434) Oct-25 tixagevimab / cilgavimab (Evusheld) Entry deleted as Evusheld (CAP) withdrawn Oct-25 rosuvastatin / ramipril Entry removed due to merge (see EURD ID:10434) Sep-25 gemeprost Entry deleted - Art 57 has no products Sep-25 human leucocyte interferon-alfa Entry deleted as there are no products in Art 57 Sep-25 ascorbic acid / paracetamol / pheniramine hydrogenomaleate / phenylephrine hydrochloride Entry removed as only authorised in 1 MS Sep-25 dexketoprofen / tramadol Entry removed due to merge (see EURD ID: 997) Sep-25 cefotiam Entry deleted as there are no products in Art 57 Jul-25 cefpirome Entry deleted as there are no products in Art 57 Jul-25 codeine / diclofenac Entry deleted as there are no products in Art 57 Jul-25 etizolam Entry removed as only authorised in 1 MS Jul-25 methocarbamol / paracetamol Entry deleted due to merge (see EURD ID: 2011) Jul-25 nizatidine Entry removed as only authorised in 1 MS Jul-25 propyphenazone Entry deleted as there are no products in Art 57 Jul-25 sulfafurazole Entry removed as only authorised in 1 MS Jul-25 buprenorphine (implant) Entry deleted due to Sixmo (CAP) withdrawal Jul-25 josamycin Entry removed as only authorised in 1 MS Jun-25 pralsetinib Entry deleted due to product(s) withdrawn Jun-25 alverine / simeticone Entry deleted due to merge (see EURD ID: 124) May-25 amylmetacresol / dichlorobenzyl alcohol Entry deleted due to merge (see EURD ID: 204) May-25 cyanocobalamin / folic acid Entry deleted due to merge (see EURD ID: 892) May-25 dextromethorphan / guaifenesin Entry deleted due to merge (see EURD ID: 1009) May-25 ammonium chloride / codeine phosphate hemihydrate / guaifenesin / thyme oil Entry deleted due to merge (see EURD ID: 1576) May-25 isoniazid / pyridoxine hydrochloride Entry deleted due to merge (see EURD ID: 1789) May-25 isoniazid / rifampicin Entry deleted due to merge (see EURD ID: 1789) May-25 bromelain / trypsin Entry deleted as there are no products in Art 57 May-25 isoniazid / pyrazinamide / rifampicin, ethambutol / isoniazid / pyrazinamide / rifampicin Entry deleted due to merge (see EURD ID: 1789) May-25 dapagliflozin / metformin Entry deleted due to merge (see EURD ID: 10029) May-25 saxagliptin / dapagliflozin Entry deleted due to merge (see EURD ID: 10029) May-25 fidanacogene elaparvovec Entry deleted due to BEQVEZ (CAP) withdrawal May-25 cocarboxylase Entry deleted as there are no products in Art 57 Apr-25 dextromethorphan hydrobromide / dichlorobenzyl alcohol Entry removed as only authorised in 1 MS Apr-25 diethylstilbestrol Entry removed as only authorised in 1 MS Apr-25 dimethyl sulfoxide Entry removed as only authorised in 1 MS Apr-25 diphenhydramine hydrochloride / zinc oxide Entry deleted as there are no products in Art 57 Apr-25 misoprostol / naproxen Entry deleted as there are no products in Art 57 Apr-25 oxaprozin Entry removed as only authorised in 1 MS Apr-25 guaifenesin / oxolamine citrate Entry deleted as there are no products in Art 57 Apr-25 pentobarbital Entry deleted as there are no products in Art 57 Apr-25 phenindione Entry removed as only authorised in 1 MS Apr-25 codeine phosphate hemihydrate / fenpiverinium bromide / paracetamol / pitofenone hydrochloride Entry deleted as there are no products in Art 57 Apr-25 magnesium chloride hexahydrate / potassium chloride / procaine hydrochloride Entry removed as only authorised in 1 MS Apr-25 ephedrine hydrochloride / sulfathiazole Entry removed as only authorised in 1 MS Apr-25 nitrofural / phenazone / tetracaine hydrochloride Entry removed as only authorised in 1 MS Apr-25 shingles (herpes zoster) vaccine (live) Entry deleted due to Zostavax (CAP) withdrawal Apr-25 regdanvimab (Regkirona) Entry deleted due to Regkirona(CAP) withdrawal Apr-25 nifurtimox Entry deleted due to duplicate entry (see EURD ID: 11088) Apr-25 dectaflur / olaflur / sodium fluoride Entry deleted due to merge (See EURD ID: 863) Mar-25 enflurane Entry deleted as there are no products in Art 57 Mar-25 etynodiol Entry deleted as there are no products in Art 57 Mar-25 hydrocortisone / propanocaine Entry removed as only authorised in 1 MS Mar-25 norgestimate Entry deleted as there are no products in Art 57 Mar-25 phenylephrine / zinc sulfate Entry deleted as there are no products in Art 57 Mar-25 pidotimod Entry removed as only authorised in 1 MS Mar-25 epinephrine / prilocaine hydrochloride Entry removed as only authorised in 1 MS Mar-25 doxylamine hydrogen succinate / paracetamol / pseudoephedrine hydrochloride Entry removed as only authorised in 1 MS Mar-25 trifluridine Entry removed as only authorised in 1 MS Mar-25 octreotide (for centrally authorised products) Entry deleted as Mycapssa (CAP) is withdrawn Mar-25 allantoin / aminoacridine / peru balsam / prednisolone Entry deleted as there are no products in Art 57 Feb-25 dextromethorphan hydrobromide / triprolidine hydrochloride Entry deleted as there are no products in Art 57 Feb-25 latanoprost (products with paediatric indication) Entry deleted due to merge with EURD ID: 1832 Feb-25 allantoin / aminoacridine / hydrocortisone hemisuccinate / lidocaine hydrochloride Entry deleted as there are no products in Art 57 Feb-25 mequitazine Entry removed as only authorised in 1 MS Feb-25 phenylephrine hydrochloride / prednisolone acetate Entry deleted as there are no products in Art 57 Feb-25 meningococcal group A, B, C, W and Y vaccine Entry deleted as Penbraya (CAP) is withdrawn Feb-25 quinidine Entry (EURD ID 2595) deleted as there is a duplicate entry EURD ID: 1688 "quinidine, hydroquinidine" Jan-25 obeticholic acid Entry deleted as the marketing authorisation for Ocaliva is revoked by the Commission Implementing Decision of 30 August Jan-25 darvadstrocel Entry deleted as Alofisel (CAP) is withdrawn Jan-25 azacitidine (oral formulations) Entry (EURD ID: 10935) deleted due to merge with EURD ID: 274 Jan-25 chlortalidone / metoprolol Entry removed as only authorised in 1 MS Dec-24 dextromethorphan hydrobromide / mepyramine maleate Entry deleted as there are no products in Art 57 Dec-24 dextromethorphan hydrobromide / guaifenesin / mepyramine maleate Entry deleted as there are no products in Art 57 Dec-24 dextromethorphan hydrobromide / guaifenesin / mepyramine maleate / phenylephrine hydrochloride Entry deleted as there are no products in Art 57 Dec-24 magnesium oxide Entry deleted due to merge (See EURD ID: 1929) Dec-24 pixantrone Entry deleted as Pixuvri (CAP) withdrawn Nov-24 pralsetinib Entry deleted as Gavreto (CAP) withdrawn Nov-24 acetylsalicylic acid / calcium carbonate Entry deleted as there are no products in Art 57 Oct-24 amitriptyline hydrochloride / chlordiazepoxide Entry deleted due to merge (See EURD ID: 661) Oct-24 ascorbic acid / dextromethorphan / paracetamol / pseudoephedrine Entry deleted due to merge (See EURD ID: 2307) Oct-24 alum / benzalkonium chloride Entry removed as only authorised in 1 MS Oct-24 benzalkonium chloride / dimethicone Entry deleted as there are no products in Art 57 Oct-24 benzalkonium chloride / dimethicone / hydrocortisone / nystatin Entry deleted as there are no products in Art 57 Oct-24 benzalkonium chloride / hexylresorcinol Entry deleted due to merge (See EURD ID: 332) Oct-24 benzalkonium chloride / lidocaine Entry removed as only authorised in 1 MS Oct-24 benzalkonium chloride / tolnaftate Entry removed as only authorised in 1 MS Oct-24 chlorhexidine / neomycin Entry removed as only authorised in 1 MS Oct-24 chlorocresol combinations Entry removed as only authorised in 1 MS Oct-24 acetylsalicylic acid / ascorbic acid / caffeine / chlorphenamine maleate Entry removed as only authorised in 1 MS Oct-24 cinchocaine hydrochloride / esculin / framycetin sulfate / hydrocortisone acetate Entry deleted as there are no products in Art 57 Oct-24 clopamide / pindolol Entry removed as only authorised in 1 MS Oct-24 clopamide / reserpine Entry deleted as there are no products in Art 57 Oct-24 codeine polysulfonate / phenyltoloxamine polysulfonate Entry removed as only authorised in 1 MS Oct-24 dextromethorphan / paracetamol Entry deleted due to merge (See EURD ID 2307) Oct-24 dextromethorphan hydrobromide / paracetamol / pseudoephedrine hydrochloride Entry deleted due to merge (See EURD ID 2307) Oct-24 caffeine / codeine phosphate / doxylamine succinate / paracetamol Entry removed as only authorised in 1 MS Oct-24 guaifenesin / pseudoephedrine Entry deleted due to merge (See EURD ID: 1580) Oct-24 measles vaccine (live attenuated) Entry deleted as there are no products in Art 57 Oct-24 menadiol Entry deleted due to merge (See EURD ID: 2400) Oct-24 miglitol Entry deleted as there are no products in Art 57 Oct-24 neomycin sulfate / polymyxin b sulfate Entry removed as only authorised in 1 MS Oct-24 orphenadrine Entry deleted due to merge (See EURD ID: 2224) Oct-24 acetylsalicylic acid / caffeine / codeine / paracetamol Entry deleted due to merge (See EURD ID: 2312) Oct-24 caffeine / codeine / paracetamol Entry deleted due to merge (See EURD ID: 448) Oct-24 quinidine / verapamil hydrochloride Entry deleted as there are no products in Art 57 Oct-24 acetylsalicylic acid / citric acid / sodium hydrogen carbonate Entry deleted due to merge (See EURD ID: 241) Oct-24 ketoprofen / sucralfate Entry removed as only authorised in 1 MS Oct-24 zaleplon Entry removed as only authorised in 1 MS Oct-24 acetylsalicylic acid / codeine phosphate / paracetamol Entry deleted due to merge (See EURD ID: 448) Oct-24 dihydrocodeine / paracetamol Entry removed as only authorised in 1 MS Oct-24 ferrimanitol ovoalbumin Entry removed as only authorised in 1 MS Oct-24 neomycin sulphate / polymyxin b sulfate / prednisolone acetate Entry deleted as there are no products in Art 57 Oct-24 calcium folinate / iron succinyl-protein complex Entry deleted due to merge (See EURD ID 10234) Oct-24 macrogol 3350 combinations (oral use) Entry deleted due to merge (See EURD ID: 1924) Oct-24 dasabuvir, ombitasvir / paritaprevir / ritonavir Entry deleted as Exviera & Viekirax (CAPs) withdrawn on 25/09/2024 Oct-24 dibromotyrosine Entry deleted as there are no products in Art 57 Sep-24 dihydroxyaluminum sodium carbonate Entry deleted due to merge (see EURD ID: 1098) Sep-24 hydrocortisone / oxytetracycline Entry deleted due to merge (see EURD ID: 2262) Sep-24 hydrocortisone acetate / oxytetracycline hydrochloride / polymyxin b Entry deleted due to merge (see EURD ID: 2262) Sep-24 sodium citrate / sodium lauryl sulfoacetate Entry deleted due to merge (see EURD ID: 2735) Sep-24 dibromotyrosine / thiamazole Entry deleted as there are no products in Art 57 Sep-24 magnesium citrate / magnesium lactate Entry deleted dut to merge (see EURD ID 1928) Sep-24 ulipristal acetate (treatment of moderate to severe symptoms of uterine fibroids) Entry deleted as CAP (Esmya) withdrawn on 18/07/2024 Sep-24 obiltoxaximab Entry deleted as CAP (NYXTHRACIS) withdrawn on 02/08/2024 Sep-24 COVID-19 vaccine (Ad26.COV2-S [recombinant]) (JCOVDEN) Entry deleted as CAP (JCOVDEN) withdrawn on 26/07/2024 Sep-24 ethambutol / isoniazid / pyrazinamide / rifampicine Entry deleted as there are no products in Art 57 Jul-24 amifostine Entry deleted as there are no products in Art 57 Jul-24 clemastine / dexamethasone Entry removed as only authorised in 1 MS Jul-24 azidamfenicol Entry removed as only authorised in 1 MS Jun-24 benzalkonium chloride / benzyl alcohol / chlorhexedine Entry removed as only authorised in 1 MS Jun-24 benzododecinium / polysorbate 80, benzododecinium Entry removed as only authorised in 1 MS Jun-24 beractant Entry removed as only authorised in 1 MS Jun-24 chloroxylenol / edetic acid / triclosan Entry deleted as there are no products in Art 57 Jun-24 eberconazole Entry removed as only authorised in 1 MS Jun-24 fluocortolone Entry deleted as there are no products in Art 57 Jun-24 lofexidine Entry deleted as there are no products in Art 57 Jun-24 talinolol Entry deleted as there are no products in Art 57 Jun-24 tiopronin Entry removed as only authorised in 1 MS Jun-24 lamivudine / tenofovir disoproxil Entry removed as only authorised in 1 MS Jun-24 citric acid / potassium / sodium Entry deleted as there are no products in Art 57 May-24 dexamethasone / neomycin Entry deleted due to merge (See EURD ID: 977) May-24 dexamethasone acetate / hydroxyethyl salicylate / salicylamide Entry deleted as there are no products in Art 57 May-24 piretanide Entry deleted due to merge (See EURD ID: 2434) May-24 proguanil Entry deleted as there are no products in Art 57 May-24 tazarotene Entry deleted as there are no products in Art 57 May-24 dexamethasone sodium / framycetin sulfate Entry removed as only authorised in 1 MS May-24 caffeine / chlorphenamine maleate / paracetamol Entry removed as only authorised in 1 MS Apr-24 acetylsalicylic acid / ascorbic acid / chlorphenamine maleate / phenylephrine hydrochloride Entry deleted as there are no products in Art 57 Apr-24 biclotymol / chlorphenamine maleate / phenylephrine hydrochloride Entry deleted as there are no products in Art 57 Apr-24 chlorphenamine / paracetamol / phenylephrine Entry deleted due to merge (See EURD ID: 693) Apr-24 chlorphenamine maleate / codeine phosphate / pseudoephedrine hydrochloride Entry deleted as there are no products in Art 57 Apr-24 acetic acid glacial / dexamethasone / neomycin Entry removed as only authorised in 1 MS Apr-24 mephenesin Entry deleted as there are no products in Art 57 Apr-24 mephenesin / methyl nicotinate Entry deleted as there are no products in Art 57 Apr-24 naloxone / tilidine Entry removed as only authorised in 1 MS Apr-24 glucose anhydrous / nikethamide Entry removed as only authorised in 1 MS Apr-24 chlorphenamine / phenylephrine Entry deleted due to merge (See EURD ID: 710) Apr-24 pirenzepine Entry removed as only authorised in 1 MS Apr-24 propantheline Entry removed as only authorised in 1 MS Apr-24 acetylsalicylic acid / ascorbic acid / chlorphenamine / colae semen Entry deleted as there are no products in Art 57 Apr-24 caffeine / chlorphenamine / paracetamol / phenylephrine Entry removed as only authorised in 1 MS Apr-24 belantamab mafodotin Entry deleted as Blenrep (CAP) expired Apr-24 COVID-19 Vaccine (ChAdOx1-S [recombinant]) (Vaxzevria) Entry deleted as Vaxzevria (CAP) withdrawn Apr-24 benzathine benzylpenicillin, benzathine benzylpenicillin / lidocaine Entry deleted due to merge with EURD ID: 383 Mar-24 cetylpyridinium / menthol Entry deleted as there are no products in Art 57 Mar-24 ciprofloxacin hydrochloride / dexamethasone acetate Entry deleted as already covered under EURD ID: 10012 Mar-24 homatropine Entry removed as only authorised in 1 MS Mar-24 lauromacrogol / lidocaine / matricariae tinctura Entry removed as only authorised in 1 MS Mar-24 mezlocillin Entry deleted as there are no products in Art 57 Mar-24 orciprenaline Entry deleted as there are no products in Art 57 Mar-24 procaine benzylpenicillin Entry deleted due to merge with EURD ID: 383 Mar-24 sulfogaiacol Entry deleted due to merge with EURD ID: 10542 Mar-24 codeine phosphate / sulfogaiacol Entry deleted due to merge with EURD ID: 10542 Mar-24 SARS-CoV-2, B.1.351 variant, prefusion Spike delta TM protein, recombinant Entry deleted as Vidprevtyn Beta (CAP) withdrawn on 11 March 2024 Mar-24 ascorbic acid / caffeine citrate / chlorphenamine maleate / dextromethorphan hydrobromide / paracetamol Entry removed as only authorised in 1 MS Mar-24 chlorphenamine maleate / diphenhydramine hydrochloride / phenylephrine hydrochloride Entry removed as only authorised in 1 MS Mar-24 chlortalidone / clonidine hydrochloride Entry removed as only authorised in 1 MS Mar-24 calcium pantothenate / cystine / keratin / p-aminobenzoic acid / thiamine / yeast Entry deleted as there are no products in Art 57 Mar-24 demoxytocin Entry removed as only authorised in 1 MS Mar-24 diclofenamide Entry deleted as there are no products in Art 57 Mar-24 pandemic influenza vaccine (H5N1) (whole virion, Vero cell derived, inactivated) Entry deleted as there are no products in Art 57 Mar-24 dichlorobenzyl alcohol / sodium benzoate Entry removed as only authorised in 1 MS Mar-24 dextropropoxyphene hydrochloride Entry removed as only authorised in 1 MS Mar-24 benzododecinium bromide Entry deleted due to merge with EURD ID: 369 Feb-24 chorionic gonadotrophin Entry deleted due to merge with EURD ID: 736 Feb-24 dihydralazine Entry deleted due to merge with EURD ID: 1646 Feb-24 dihydralazine / hydrochlorothiazide / reserpine Entry deleted as there are no products in Art 57 Feb-24 dimethoxanate Entry deleted as there are no products in Art 57 Feb-24 framycetin sulfate / lidocaine hydrochloride / salicylates / triamcinolone acetonide Entry deleted as there are no products in Art 57 Feb-24 hydralazine hydrochloride / hydrochlorothiazide / metoprolol tartrate Entry deleted as there are no products in Art 57 Feb-24 chlortalidone / hydralazine hydrochloride / oxprenolol hydrochloride Entry deleted as there are no products in Art 57 Feb-24 hydralazine hydrochloride / propranolol hydrochloride Entry deleted as there are no products in Art 57 Feb-24 polyvinyl alcohol / povidone Entry 2477 deleted due to merge with EURD ID: 2475 Feb-24 reteplase Entry deleted as Rapilysin (CAP) withdrawn on 26 Jan 2024 Feb-24 copper (64Cu) chloride Entry deleted as Cuprymina (CAP) withdrawn on 25 Jan 2024 Feb-24 estradiol / medroxyprogesterone acetate Entry deleted due to merge with EURD ID: 582 Jan-24 ornithine Entry deleted due to merge with EURD ID: 10187 Jan-24 perazine Entry deleted due to merge with EURD ID: 2426 & 2536 Jan-24 thiethylperazine Entry deleted due to merge with EURD ID: 2426 & 2536 Jan-24 trifluoperazine Entry deleted due to merge with EURD ID: 2426 & 2536 Jan-24 caffeine / indomethacin / proclorperazine maleate Entry removed as no products identified in Art 57 Jan-24 acetylsalicylic acid / dipyridamole Entry removed as only authorised in 1 MS Jan-24 abciximab Entry removed as no products identified in Art 57 Dec-23 acrivastine / pseudoephedrine Deletion of entry due to merge with EURD ID 54 Dec-23 altretamine Entry removed as only authorised in 1 MS Dec-23 aluminium hydroxide gel / calcium carbonate Entry removed as no products identified in Art 57 Dec-23 amiloride Deletion due to merge entries EURD ID: 145, 146, 147, 149 and 151 with entry EURD ID: 148 Dec-23 amiloride / bumetanide Deletion due to merge entries EURD ID: 145, 146, 147, 149 and 151 with entry EURD ID: 148 Dec-23 amiloride / chlortalidone Deletion due to merge entries EURD ID: 145, 146, 147, 149 and 151 with entry EURD ID: 148 Dec-23 amiloride / hydrochlorthiazide Deletion due to merge entries EURD ID: 145, 146, 147, 149 and 151 with entry EURD ID: 148 Dec-23 amiloride / hydrochlorthiazide / timolol Deletion due to merge entries EURD ID: 145, 146, 147, 149 and 151 with entry EURD ID: 148 Dec-23 amitriptyline hydrochloride / medazepam Entry removed as only authorised in 1 MS Dec-23 bacitracin / neomycin Entry deleted due to merge all the bacitracin containing entries (EURD ID: 288, 289, 291, 292 and 9072) in a single one (EURD ID: 285) Dec-23 bacitracin / hydrocortisone / neomycin Entry deleted due to merge all the bacitracin containing entries (EURD ID: 288, 289, 291, 292 and 9072) in a single one (EURD ID: 285) Dec-23 bacitracin zinc / cystein / glycine / neomycin sulfate / threonine Entry deleted due to merge all the bacitracin containing entries (EURD ID: 288, 289, 291, 292 and 9072) in a single one (EURD ID: 285) Dec-23 bacitracin zinc / neomycin sulfate / polymyxin b sulfate Entry deleted due to merge all the bacitracin containing entries (EURD ID: 288, 289, 291, 292 and 9072) in a single one (EURD ID: 285) Dec-23 bisacodyl combinations Entry deleted due to merge with EURD ID: 416 Dec-23 canrenone Entry removed as only authorised in 1 MS Dec-23 chloroxine Entry removed as only authorised in 1 MS Dec-23 colecalciferol Entry deleted due to merge entries EURD ID: 862, 1249 and 9089 with entry EURD ID: 10386 Dec-23 cyanamide Entry removed as no products identified in Art 57 Dec-23 caffeine / cyclizine / ergotamine Entry removed as only authorised in 1 MS Dec-23 dimemorfan Entry removed as no products identified in Art 57 Dec-23 efavirenz / emtricitabine / tenofovir Entry removed as Atripla (CAP) surrendered Dec-23 ergocalciferol Entry deleted due to merge entries EURD ID: 862, 1249 and 9089 with entry EURD ID: 10386 Dec-23 lomefloxacin Entry removed as only authorised in 1 MS Dec-23 neostigmine Entry deleted due to merge with EURD ID: 1557 Dec-23 nilvadipine Entry removed as only authorised in 1 MS Dec-23 pneumococcal polysaccharide conjugate vaccine (adsorbed) - 7 valent Entry removed as Prevenar (CAP) surrendered Dec-23 quazepam Entry removed as no products identified in Art 57 Dec-23 cinchonidine / cinchonine / quinidine / quinine Entry removed as only authorised in 1 MS Dec-23 saquinavir Entry removed as Invirase (CAP) surrendered Dec-23 bacitracin / polymyxine Entry deleted due to merge all the bacitracin containing entries (EURD ID: 288, 289, 291, 292 and 9072) in a single one (EURD ID: 285) Dec-23 calcium / ergocalciferol Entry deleted due to merge entries EURD ID: 862, 1249 and 9089 with entry EURD ID: 10386 Dec-23 bupivacaine/meloxicam Entry removed as Zynrelef (CAP) withdrawn on 05.10.23 Nov-23 chlorphenamine maleate / pholcodine Entry removed due to referral 107i/1521 adopted in Dec 2022: CMDh AR conclusions: The Committee, as a consequence, considers that the benefit-risk balance of pholcodine-containing medicinal products is not favourable. Therefore, pursuant to Article 116 of Directive 2001/83/EC, the Committee recommends the revocation of the marketing authorisations for pholcodine-containing medicinal products. Nov-23 paracetamol / pholcodine / pseudoephedrine Entry removed due to referral 107i/1521 adopted in Dec 2022: CMDh AR conclusions: The Committee, as a consequence, considers that the benefit-risk balance of pholcodine-containing medicinal products is not favourable. Therefore, pursuant to Article 116 of Directive 2001/83/EC, the Committee recommends the revocation of the marketing authorisations for pholcodine-containing medicinal products. Nov-23 pholcodine / biclotymol / chlorphenamine maleate Entry removed due to referral 107i/1521 adopted in Dec 2022: CMDh AR conclusions: The Committee, as a consequence, considers that the benefit-risk balance of pholcodine-containing medicinal products is not favourable. Therefore, pursuant to Article 116 of Directive 2001/83/EC, the Committee recommends the revocation of the marketing authorisations for pholcodine-containing medicinal products. Nov-23 SARS-CoV-2 virus, strain wuhan hCoV-19/Italy/INMI1-isl/2020, inactivated (Valneva) Entry removed as COVID-19 Vaccine (inactivated, adjuvanted) Valneva was withdrawn on 12.10.23 Nov-23 dimenhydrinate Entry removed due to merge (See EURD ID: 1088) Oct-23 hydrochlorothiazide / propranolol / triamterene Entry removed due to merge (See EURD ID: 1644) Oct-23 metildigoxin Entry removed due to merge (See EURD ID: 1065) Oct-23 nitrofurantoin / pyridoxine hydrochloride Entry removed due to merge (See EURD ID: 2174) Oct-23 pancreatic enzymes, pancreatic extracts, pancreatin (except for the centrally authorised product) Entry removed due to merge (See EURD ID: 2705) Oct-23 pancreatin / simeticone Entry removed due to merge (See EURD ID: 2705) Oct-23 dimethicone / pancreatin Entry removed due to merge (See EURD ID: 2705) Oct-23 selenite sodium Entry removed due to merge (See EURD ID: 2690) Oct-23 hydrochlorothiazide / triamterene / verapamil hydrochloride Entry removed due to merge (See EURD ID: 3107) Oct-23 xipamide Entry removed due to merge (See EURD ID: 3133) Oct-23 crizanlizumab Entry for deletion as Adakveo (CAP) is revoked Oct-23 iodohippurate sodium (123i) Entry removed as no products identified in Art 57 Sep-23 elivaldogene autotemcel Entry for deletion as Skysona (CAP) is withdrawn Sep-23 naphazoline nitrate / prednisolone Entry removed as only authorised in 1 MS Aug-23 dextromethorphan hydrobromide / quinidine sulfate Entry removed as no products identified in Art 57 Aug-23 neridronic acid Entry removed as no products identified in Art 57 Aug-23 penfluridol Entry removed as only authorised in 1 MS Aug-23 chlorphenoxamine Entry removed as only authorised in 1 MS Aug-23 acrivastine / pseudoephedrine Entry removed due to merge with EURD ID 54 “Acrivastine, acrivastine / pseudoephedrine” Jul-23 pholcodine Entry removed due to products' revocation (following Referral procedure) Jul-23 rufloxacin Entry removed as only authorised in 1 MS Jul-23 risperidone (centrally authorised products only) Entry removed due to merge with EURD ID: 2649 Jul-23 iodohippurate sodium (123i) Entry removed as no products identified in Art 57 Jun-23 betamethasone / diprophylline / guaifenesin Entry removed as only authorised in 1 MS Jun-23 ioxaglic acid Entry removed as no products identified in Art 57 Jun-23 lysine acetylsalicylate Entry removed due to merge with EURD ID: 39 (acetylsalicylic acid) Jun-23 lidocaine / norepinephrine Entry removed as only authorised in 1 MS Jun-23 sodium benzoate / grindelia tincture / polygala syrup Entry removed as only authorised in 1 MS Jun-23 calcium chloride / glucose monohydrate / magnesium chloride hexahydrate Entry removed due to merge (see EURD ID: 10424) Apr-23 piretanide Entry removed due to merge (see EURD ID: 2434) Apr-23 peppermint oil Entry removed as no longer fulfils requirements for inclusion in EURD list Apr-23 nilvadipine Entry removed as only authorised in 1 MS Mar-23 sulbactam Entry removed as only authorised in 1 MS Mar-23 xenon Entry removed as only authorised in 1 MS Mar-23 indinavir Entry removed as Crixivan (CAP) was withdrawn Jan-23 metformin / saxagliptin Entry removed due to merge with EURD ID: 2685 (saxagliptin) Jan-23 telbivudine Entry removed as Sebivo (CAP) was withdrawn Jan-23 telithromycin Entry removed as Ketek (CAP) was withdrawn Jan-23 ibalizumab Entry removed as Trogarzo (CAP) was withdrawn Jan-23 equine tetanus immunoglobulin Entry removed as no products identified in Art 57 Jan-23 adefovir Entry removed as Hepsera (CAP) was withdrawn Dec-22 peginterferon alpha-2b Entry removed as PegIntron & ViraferonPeg (CAP) were withdrawn Dec-22 botulinum toxin type b Entry removed as NeuroBloc (CAP) was withdrawn Dec-22 aminotridecane adipate Entry removed as no products identified in Art 57 Nov-22 strontium [89sr] chloride Entry removed as only authorised in 1 MS Nov-22 atenolol / nifedipine Entry removed as only authorised in 1 MS Nov-22 diphtheria / tetanus / pertussis (acellular, component) / haemophilus type b conjugate vaccine (adsorbed) Entry removed as no products identified in Art 57 Oct-22 leuprorelin (except for depot formulations) Entry removed as only authorised in 1 MS Oct-22 hydrochlorothiazide / moexipril Entry removed as only authorised in 1 MS Oct-22 halofantrine Entry removed as no products identified in Art 57 Sep-22 ertugliflozin Entry ID removed due to merge (see entry ID: 10784) Sep-22 ceftibuten Entry removed as only authorised in 1 MS Jul-22 interferon alpha-2a Entry removed as only authorised in 1 MS Jul-22 calcium chloride / glucose / magnesium chloride hexahydrate / sodium chloride / sodium hydrogen carbonate Entry removed as no products identified in Art 57 (Products covered/moved to EURD ID: 2724) Jul-22 cloxazolam Entry removed as only authorised in 1 MS Jul-22 sotagliflozin Entry removed as Zynquista (CAP) was withdrawn Jun-22 nateglinide Entry removed as Starlix (CAP) was withdrawn May-22 moxetumomab pasudotox Entry removed as Lumoxiti (CAP) was withdrawn May-22 cefodizime Entry removed as only authorised in 1 MS May-22 benzalkonium chloride (incl ocular) Entry removed due to merge. See EURD ID: 10987 Apr-22 sodium aurothiomalate Entry removed as no products identified in Art 57 Apr-22 calcium pantothenate / nicotinamide / pyridoxine / riboflavin / thiamine Entry removed due to merge. See EURD ID: 10807 Apr-22 dicobalt edetate Entry removed as only authorised in 1 MS Apr-22 betibeglogene autotemcel Entry removed as Zynteglo (CAP) was withdrawn Apr-22 flubendazole Entry removed as only authorised in 1 MS Mar-22 oxatomide Entry removed as only authorised in 1 MS Mar-22 pergolide Entry removed as only authorised in 1 MS Mar-22 lesinurad Entry removed as Zurampic (CAP) was withdrawn Mar-22 naltrexone Entry removed as only authorised in 1 MS Feb-22 crisaborole Entry removed as Staquis (CAP) was withdrawn Feb-22 didanosine Entry removed as no products identified in Art 57 Jan-22 fenoterol (obsteric indications) Entry removed as only authorised in 1 MS Jan-22 influenza vaccine (split virion, inactivated, prepared in cell cultures) Entry removed as no products identified in Art 57 Jan-22 benzoyl peroxide hydrous / potassium hydroxyquinoline sulphate Entry removed as only authorised in 1 MS Jan-22 allogeneic T cells genetically modified with a retroviral vector encoding for a truncated form of the human low affinity nerve growth factor receptor (ΔLNGFR) and the herpes simplex I virus thymidine kinase (HSV-TK Mut2) Entry removed as Zalmoxis (CAP) was withdrawn Jan-22 allopurinol / lesinurad Entry removed as no products identified in Art 57 Jan-22 cinoxacin Entry removed as only authorised in 1 MS Dec-21 enoxacin Entry removed as no products identified in Art 57 Dec-21 fluocinolone acetonide / framycetin Entry ID removed due to merge (see entry ID: 1952) Dec-21 fluocinolone acetonide / ketocaine hydrochloride Entry ID removed due to merge (see entry ID: 1952) Dec-21 interferon alpha-2b Entry removed as IntronA (CAP) was withdrawn Dec-21 erythromycin / isotretinoin, isotretinoin (topical formulations) Entry removed as only authorised in 1 MS Dec-21 nalidixic acid Entry removed as no products identified in Art 57 Dec-21 pipemidic acid Entry removed as no products identified in Art 57 Dec-21 dihydroergocryptine Entry removed as no products identified in Art 57 Oct-21 dihydroergotoxine Entry removed as only authorised in 1 MS Oct-21 ispaghula husk, ispaghula husk/ ispaghula seed, ispaghula husk/ispaghula seed/senna Tinnervelly pod, psyllium, psyllium husk, psyllium seed Entry removed as GPAG outcome adopted by PRAC Oct-21 senna glycosides standardised 60% Entry removed as GPAG outcome adopted by PRAC Oct-21 eluxadoline Entry removed due to Truberzi (CAP) surrendered Aug-21 necitumumab Entry removed due to Portrazza (CAP) expiry of MA Jul-21 lidocaine Entry removed due to split (see entry ID: 10933 and 10934) Jun-21 collagenase clostridium histolyticum (treatment of Dupuytren’s contracture and treatment of Peyronie’s disease) Entry removed due to Xiapex (CAP) withdrawal Jun-21 methionine Entry removed as only authorised in 1 MS May-21 meningococcal group a and c polysaccharide vaccine Entry removed as only authorised in 1 MS May-21 benzathine benzylpenicillin / procaine benzylpenicillin Entry removed as only products authorised under WEU May-21 furosemide / ramipril Entry removed as only authorised in 1 MS Apr-21 cholic acid (CTX, AMACR or cholesterol 7α-hydroxylase deficiency indication) Entry removed as Kolbam was withdrawn Mar-21 meningococcal group a, c, w135, y polysaccharide vaccine Entry removed as no products identified in Art 57 Mar-21 alendronate / alfacalcidol Entry removed as only authorised in 1 MS Mar-21 peramivir Entry removed as Alpivab was withdrawn Mar-21 alitretinoin (cutaneous use) Entry removed as Panretin was withdrawn Feb-21 oxytocin Entry removed due to split (see entry ID: 10913 and 10914) Feb-21 indoramin Entry removed as only authorised in 1 MS Jan-21 quizartinib Entry removed as no products identified in Art 57 Jan-21 fluticasone / salmeterol (for centrally authorised products) Entry removed as product no longer authrorised Jan-21 ivabradine Entry ID removed due to merge (see entry ID: 10883) Dec-20 carvedilol / ivabradine Entry ID removed due to merge (see entry ID: 10883) Dec-20 strontium ranelate Entry removed as Protelos and Osseor were withdrawn in April 2020 Nov-20 benzocain / neomycin sulfate Entry removed as only authorised in 1 MS Oct-20 stavudine Entry removed as Zerit was withdrawn in June 2020 Sep-20 iron (parenteral preparations, except for iron dextran) Entry removed due to split (see entry ID: 10864, 10865, 10866 and 10867) Sep-20 ingenol mebutate Entry removed as product no longer authrorised Jul-20 hydrocortisone (except for products indicated in adrenal insufficiency in a modified release tablet formulation) Entry removed due to split (See entries ID: 10855, 10856) Jul-20 rubella vaccine (live, attenuated) Entry removed as only authorised in 1 MS Jun-20 technetium (99mtc) tiatide Entry removed as no products identified in Art 57 Jun-20 rolapitant Entry removed as Varuby was withdrawn in Jan 2020 Jun-20 rimexolone Entry removed as no products identified in Art 57 May-20 ferric citrate coordination complex Entry removed as product no longer authrorised May-20 chlorpropamide Entry removed as no products identified in Art 57 May-20 lidocaine hydrochloride monohydrate / fludrocortisone acetate / neomycin sulfate / polymyxin b Entry removed due to merge (See entry ID: 10847) May-20 lidocaine / paraformaldehyde Entry removed as no products identified in Art 57 May-20 lidocaine / pentosan polysulfate sodium / triamcinolone, lidocaine / triamcinolone Entry removed as no products identified in Art 57 May-20 lidocaine hydrochloride / neomycin sulfate / polymyxin b Entry removed due to merge (See entry ID: 10847) May-20 pheniramine maleate / tetryzoline hydrochloride Entry removed as only authorised in 1 MS May-20 ergocalciferol / retinol acetate Entry removed as no products identified in Art 57 May-20 a-tocopherol / ergocalciferol / phytomenadion / retinol palmitate Entry removed as no products identified in Art 57 May-20 calcium carbonate / sodium alginate / sodium bicarbonate Entry removed due to merge (See entry ID: 10845) May-20 sodium alginate / sodium bicarbonate Entry removed due to merge (See entry ID: 10845) May-20 sulfanilamide Entry removed as no products identified in Art 57 May-20 adenosine 5' triphosphate / disodium salt Entry removed as only authorised in 1 MS Apr-20 125i-human serum albumin Entry removed as only authorised in 1 MS Mar-20 acetyldigoxin combinations Entry removed as only authorised in 1 MS Mar-20 adenosine / cytochrome c / nicotinamide / sodium succinate / sorbitol Entry removed as no products identified in Art 57 Mar-20 adenosine 5' triphosphate / disodium salt / glycine Entry removed as no products identified in Art 57 Mar-20 alpha amylase / bacitracin Entry removed as no products identified in Art 57 Mar-20 alpha chymotrypsin Entry removed as no products identified in Art 57 Mar-20 aluminium / calcium / sodium Entry removed as no products identified in Art 57 Mar-20 aminocaproic acid / esculina / hesperidina metil chalcona / menadiona / menadione sodium bisulfite Entry removed as no products identified in Art 57 Mar-20 amylsalicylate / levomenthol / methylnicotinate Entry removed as no products identified in Art 57 Mar-20 anatoxin staphylococcal native mixed alpha / beta and delta Entry removed as no products identified in Art 57 Mar-20 benzalkonium chloride / oxymetazoline Entry removed as no products identified in Art 57 Mar-20 benzylnicotinate / hydroxyethyl salicylate Entry removed as no products identified in Art 57 Mar-20 dihydroergocristine / esculinum / rutoside Entry removed as only authorised in 1 MS Mar-20 dihydroergocristine mesilate / raubasine Entry removed as no products identified in Art 57 Mar-20 caffeine / dihydroergotamine / propyphenazone Entry removed as no products identified in Art 57 Mar-20 dihydroergotoxin / hydrochlorothiazide / reserpine Entry removed as no products identified in Art 57 Mar-20 anthracene glycosides / glycosides hidroxiantracénicos / iodine Entry removed due to merge (See entry ID: 10838) Mar-20 lidocaine / matricariae extract Entry removed as no products identified in Art 57 Mar-20 potassium / sodium / triclosan Entry removed as no products identified in Art 57 Mar-20 codeine phosphate / promethazine hydrochloride Entry removed as no products identified in Art 57 Mar-20 ascorbic acid / calcium hydrogenphosphate / calcium panthotenate / colecalciferol / cyanocobalamin / folic acid / nicotinamide / pyridoxine hydrochloride / retinol / riboflavine / thiamin nitrate, ascorbic acid / cyanocobalamin / ergocalciferol / nicotinamide / pyridoxine / retinol / riboflavin / thiamine hydrochloride, ascorbic acid / colecalciferol / dexpanthenol / nicotinamide / pyridoxine / retinol / riboflavin / thiamine Entry removed as only authorised in 1 MS Mar-20 a-tocopheryl acetate / retinol acetate Entry removed as only authorised in 1 MS Mar-20 pyridoxine hydrochloride / retinol acetate / tocopheryl acetate Entry removed as no products identified in Art 57 Mar-20 a-tocoferol acetate / aurantii aetheroleum / citri aetheroleum / retinol palmitate / terpineol Entry removed as no products identified in Art 57 Mar-20 sacarose / trioxymethylene Entry removed as no products identified in Art 57 Mar-20 saccharomyces cerevisiae / sodium sulfate Entry removed as no products identified in Art 57 Mar-20 sulfabenzamide / sulfacetamide / sulfathiazole Entry removed as no products identified in Art 57 Mar-20 pyrimethamine / sulfalene Entry removed as only authorised in 1 MS Mar-20 aminopropylone / sulodexide Entry removed as no products identified in Art 57 Mar-20 sulphur / triclosan Entry removed as no products identified in Art 57 Mar-20 oxydation product / terebenthin essential oil Entry removed as no products identified in Art 57 Mar-20 calcium carbonate / magnesium carbonate / sodium bicarbonate Entry removed due to merge (See entry ID: 10837) Mar-20 allethrin (isomers and mixtures of isomers) / piperonyl butoxide Entry removed as only authorised in 1 MS Mar-20 cibenzoline Entry removed as only authorised in 1 MS Feb-20 formaldehyde Entry removed as only authorised in 1 MS Feb-20 pristinamycin Entry removed as only authorised in 1 MS Feb-20 guanosine / inosine / miconazole nitrate / vitamin f Entry removed due to merge (See entry ID: 10425) Jan-20 levonorgestrel Entry removed due to split (See entry ID: 107831 and 107832) Jan-20 nilvadipine Entry removed as it no longer fulfills the criteria for remaining on the list Jan-20 phentermine Entry removed as it no longer fulfills the criteria for remaining on the list Jan-20 charcoal activated / sodium thiosulphate Entry removed due to merge (See entry ID: 107816) Jan-20 androstanolone Entry removed as only authorised in 1 MS Dec-19 acetyldigoxin Entry removed as only authorised in 1 MS Nov-19 allobarbital / aminophenazone Entry removed as no products identified in Art 57 Nov-19 allopurinol / benzbromarone Entry removed as only authorised in 1 MS Nov-19 ambucetamide Entry removed as no products identified in Art 57 Nov-19 amiloride / hydrochlorthiazide / methyldopa Entry removed as no products identified in Art 57 Nov-19 aminaftone Entry removed as only authorised in 1 MS Nov-19 amlodipine / benazepril Entry removed as no products identified in Art 57 Nov-19 amoxicillin / metronidazole Entry removed as no products identified in Art 57 Nov-19 amoxicillin trihydrate / clarithromycin / lansoprazole Entry removed as no products identified in Art 57 Nov-19 amphetamine Entry removed as no products identified in Art 57 Nov-19 amphetamine / dextroamfetamine Entry removed as no products identified in Art 57 Nov-19 ascorbic acid / biotin / cyanocobalamin / folic acid / niacinamide / pantothenic acid / pyridoxine hydrochloride / riboflavin / thiamine mononitrate, biotine / cyanocobalamin / nicotinamide / pantothenic acid / pyridoxine / riboflavin / thiamine Entry removed due to merge (See entry ID: 107808) Nov-19 auranofin Entry removed as only authorised in 1 MS Nov-19 azepentacene polysulfonate sodium Entry removed as no products identified in Art 57 Nov-19 bacitracin / neomycin / prednisolone Entry removed as no products identified in Art 57 Nov-19 benfotiamine / biotin / cyanocobalamin / pantothenic acid / pyridoxine / retinol Entry removed as no products identified in Art 57 Nov-19 benfotiamine / cyanocobalamin Entry removed as only authorised in 1 MS Nov-19 benfotiamine / cyanocobalamin / pyridoxine Entry removed as only authorised in 1 MS Nov-19 benfotiamine / caffeine / codeine / paracetamol / propyphenazone Entry removed as no products identified in Art 57 Nov-19 benfotiamine / pyridoxine Entry removed as only authorised in 1 MS Nov-19 benidipine Entry removed as no products identified in Art 57 Nov-19 benzalkonium chloride / chloroxylenol / disodium edetate Entry removed as no products identified in Art 57 Nov-19 benzatropine Entry removed as no products identified in Art 57 Nov-19 benzonatate Entry removed as no products identified in Art 57 Nov-19 brompheniramine maleate / codeine phosphate / guaifenesin Entry removed as no products identified in Art 57 Nov-19 buclizine hydrochloride / cyanocobalamin / lysine hydrochloride / pyridoxine hydrochloride / tryptophan Entry removed as no products identified in Art 57 Nov-19 bupranolol Entry removed as no products identified in Art 57 Nov-19 buprenorphine hydrochloride / salicylic acid Entry removed as no products identified in Art 57 Nov-19 butalbital / paracetamol Entry removed as no products identified in Art 57 Nov-19 butalbital / caffeine / paracetamol Entry removed as no products identified in Art 57 Nov-19 butalbital / caffeine / codeine phosphate / paracetamol Entry removed as no products identified in Art 57 Nov-19 butenafine Entry removed as no products identified in Art 57 Nov-19 butriptyline Entry removed as no products identified in Art 57 Nov-19 cafedrine Entry removed as no products identified in Art 57 Nov-19 calamine Entry removed as no products identified in Art 57 Nov-19 calcium / magnesium / phosphorus Entry removed as only authorised in 1 MS Nov-19 cannabidiol (except for centrally authorised product) Entry removed as no products identified in Art 57 Nov-19 carbenicillin Entry removed as no products identified in Art 57 Nov-19 carbimide Entry removed as no products identified in Art 57 Nov-19 carbinoxamine maleate / phenylephrine hydrochloride Entry removed as no products identified in Art 57 Nov-19 carmellose (except for eye preparation) Entry removed as no products identified in Art 57 Nov-19 adenine / benfotiamine / carnitine orotate / fructose / nicotinamide / pantothenic acid / potassium orotate / pyridoxine / riboflavin / xanthine Entry removed as no products identified in Art 57 Nov-19 cefcapene Entry removed as no products identified in Art 57 Nov-19 cefpiramide Entry removed as no products identified in Art 57 Nov-19 cefsulodin Entry removed as no products identified in Art 57 Nov-19 cefteram Entry removed as no products identified in Art 57 Nov-19 ceftezole Entry removed as no products identified in Art 57 Nov-19 cefapirin Entry removed as no products identified in Art 57 Nov-19 cerivastatin Entry removed as no products identified in Art 57 Nov-19 benzoyl peroxide / cetylpyridinium chloride Entry removed as no products identified in Art 57 Nov-19 chlormadinone / estradiol Entry removed as no products identified in Art 57 Nov-19 chlornitrofenol Entry removed as no products identified in Art 57 Nov-19 chlorobutanol / levomenthol / pine oils / terpineol / thymol Entry removed as only authorised in 1 MS Nov-19 chlorothiazide Entry removed as no products identified in Art 57 Nov-19 chloroxylenol / disodium edetate Entry removed as no products identified in Art 57 Nov-19 chlorphenamine maleate / hydrocodone bitartrate / phenylephrine hydrochloride Entry removed as no products identified in Art 57 Nov-19 chlorphenamine maleate / hydrocodone polistirex Entry removed as no products identified in Art 57 Nov-19 chlorphenamine maleate / paracetamol / phenylephrine hydrochloride / phenyltoloxamine citrate Entry removed as no products identified in Art 57 Nov-19 chlorproethazine Entry removed as no products identified in Art 57 Nov-19 chlortetracycline / demeclocycline / tetracycline Entry removed as no products identified in Art 57 Nov-19 chlorxylenol / cinchocaine Entry removed as no products identified in Art 57 Nov-19 chlorzoxazone / paracetamol Entry removed as no products identified in Art 57 Nov-19 cilastatin Entry removed as no products identified in Art 57 Nov-19 bismuth subgallate / cinchocaine hydrochloride / oxidised cellulose calcium salt Entry removed as no products identified in Art 57 Nov-19 clofibrate Entry removed as no products identified in Art 57 Nov-19 clorazepate / pyridoxine Entry removed as no products identified in Art 57 Nov-19 codeine / creosote Entry removed as no products identified in Art 57 Nov-19 codeine / diphenhydramine Entry removed as no products identified in Art 57 Nov-19 codeine / ephedrine hydrochloride / guaifenesin Entry removed as no products identified in Art 57 Nov-19 codeine polysulfonate / guaifenesin / phenyltoloxamine Entry removed as no products identified in Art 57 Nov-19 codeine polysulfonate / guaifenesin / phenyltoloxamine / thyme Entry removed as no products identified in Art 57 Nov-19 codeine polysulfonate resin Entry removed as no products identified in Art 57 Nov-19 cyanocobalamin / folic acid / nicotinamide / pantothenic acid / pyridoxine hydrochloride / riboflavin / thiamine nitrate Entry deleted due to merge (see Entry ID: 107808) Nov-19 cyproheptadine hydrochloride / dimethylaminoethanol acetylglutamate / metoclopramide hydrochloride Entry removed as no products identified in Art 57 Nov-19 dantrone / poloxamer Entry removed as no products identified in Art 57 Nov-19 delavirdine Entry removed as no products identified in Art 57 Nov-19 dexbudesonide Entry removed as no products identified in Art 57 Nov-19 dexetimide Entry removed as no products identified in Art 57 Nov-19 dextranomer Entry removed as no products identified in Art 57 Nov-19 dextromethorphan hydrobromide / phenylpropanolamine hydrochloride Entry removed as no products identified in Art 57 Nov-19 dextromethorphan hydrobromide / guaifenesin / pseudoephedrine hydrochloride Entry removed as no products identified in Art 57 Nov-19 dextromethorphan hydrobromide / guaifenesin / paracetamol / pseudoephedrine hydrochloride Entry removed as only authorised in 1 MS Nov-19 chlorphenamine / dextromethorphan hydrochloride / phenylephrine hydrochloride Entry removed as no products identified in Art 57 Nov-19 dibenzepine Entry removed as no products identified in Art 57 Nov-19 diclofenac / gentamicin Entry removed as no products identified in Art 57 Nov-19 diclofenac / tobramycin Entry removed as no products identified in Art 57 Nov-19 diclofenac sodium / lidocaine Entry removed as no products identified in Art 57 Nov-19 dipivefrine Entry removed as no products identified in Art 57 Nov-19 dipivefrine hydrochloride / guanethidine Entry removed as no products identified in Art 57 Nov-19 docusate Entry deleted due to merge (See Entry ID: 107806) Nov-19 doxercalciferol Entry removed as no products identified in Art 57 Nov-19 erythromycin Entry removed due to split (See entry ID: 10808 and 10809) Nov-19 ethambutol / isoniazid Entry removed as no products identified in Art 57 Nov-19 ethambutol / isoniazid / rifampicine Entry removed as no products identified in Art 57 Nov-19 etoperidone Entry removed as no products identified in Art 57 Nov-19 etynodiol / mestranol Entry removed as no products identified in Art 57 Nov-19 fenbufen Entry removed as no products identified in Art 57 Nov-19 fendiline Entry removed as no products identified in Art 57 Nov-19 flurithromycin Entry removed as no products identified in Art 57 Nov-19 guaifenesin / hydrocodone Entry removed as no products identified in Art 57 Nov-19 guaifenesin / pentoxyverine Entry removed as no products identified in Art 57 Nov-19 hyaluronate zinc Entry removed as no products identified in Art 57 Nov-19 hydrochlorothiazide / methyldopa Entry removed as no products identified in Art 57 Nov-19 hydrochlorothiazide / reserpine / triamterene Entry removed as no products identified in Art 57 Nov-19 hydrocodone Entry removed as no products identified in Art 57 Nov-19 homatropine methylbromide / hydrocodone bitartrate Entry removed as no products identified in Art 57 Nov-19 hydrocodone bitartrate / ibuprofen Entry removed as no products identified in Art 57 Nov-19 hydrocodone bitartrate / paracetamol Entry removed as no products identified in Art 57 Nov-19 guaifenesin / hydrocodone bitartrate / phenylephrine hydrochloride Entry removed as no products identified in Art 57 Nov-19 hydrocodone bitartrate / phenyltoloxamine citrate Entry removed as no products identified in Art 57 Nov-19 escherichia coli / hydrocortisone acetate Entry removed as no products identified in Art 57 Nov-19 atropine / hydromorphone Entry removed as no products identified in Art 57 Nov-19 calcium oxide / ichthammol / potassium aluminium sulfate / salicylic acid / sodium perborate Entry removed as no products identified in Art 57 Nov-19 iodamide Entry removed as no products identified in Art 57 Nov-19 acidum malicum levogirum / calcium chloride dihydrate / glucose monohydrate / glycine / l proline / l-alanine / l-arginine / l-histidine / l-isoleucine / l-leucine / l-lysine hydrochloride / l-methionine / l-phenylalanine / l-threonine / l-tryptophane / l-valine / magnesium chloride hexahydrate / potassium chloride / sodium chloride / sodium glycerophosphate pentahydrate / zinc chloride Entry removed as no products identified in Art 57 Nov-19 lovastatin / nicotinic acid Entry removed as no products identified in Art 57 Nov-19 lumiracoxib Entry removed as no products identified in Art 57 Nov-19 meclofenamate Entry removed as no products identified in Art 57 Nov-19 mepenzolate Entry removed as no products identified in Art 57 Nov-19 mesuximide Entry removed as it no longer fulfills the criteria for remaining on the list Nov-19 methenamine / methylene blue Entry removed as no products identified in Art 57 Nov-19 methenamine / phenazopyridine Entry removed as no products identified in Art 57 Nov-19 acetylsalicylic acid / methocarbamol Entry removed as no products identified in Art 57 Nov-19 methyl diethylacetylsalicylate Entry removed as no products identified in Art 57 Nov-19 methylprednisolone acetate / neomycin sulfate Entry removed as no products identified in Art 57 Nov-19 metipamide Entry removed as no products identified in Art 57 Nov-19 metizoline Entry removed as no products identified in Art 57 Nov-19 metronidazole / minocycline / nystatine Entry removed as no products identified in Art 57 Nov-19 mitiglinide Entry removed as no products identified in Art 57 Nov-19 mofebutazone Entry removed as no products identified in Art 57 Nov-19 morphine sulfate / naltrexone hydrochloride Entry removed as no products identified in Art 57 Nov-19 nafcillin Entry removed as no products identified in Art 57 Nov-19 naloxone hydrochloride / pentazocine hydrochloride Entry removed as no products identified in Art 57 Nov-19 neomycin / phenylephrine / polymyxin b Entry removed as no products identified in Art 57 Nov-19 norfenefrine Entry removed as no products identified in Art 57 Nov-19 nystatin / triamcinolone Entry removed as no products identified in Art 57 Nov-19 oxiglutatione Entry removed as no products identified in Art 57 Nov-19 parethoxycaine Entry removed as no products identified in Art 57 Nov-19 pentosan polyester / phenylephrine Entry removed as no products identified in Art 57 Nov-19 pentoxyverine hydrogen citrate / terpine hydrate Entry removed as no products identified in Art 57 Nov-19 phenazone / tetracaine Entry removed as no products identified in Art 57 Nov-19 oxytetracycline / phenazopyridine hydrochloride / sulfamethizole Entry removed as no products identified in Art 57 Nov-19 phendimetrazine Entry removed as no products identified in Art 57 Nov-19 glibenclamide / phenformin hydrochloride Entry removed as no products identified in Art 57 Nov-19 guaifenesin / phenylephrine hydrochloride Entry removed as no products identified in Art 57 Nov-19 isoprenaline / phenylephrine hydrochloride Entry removed as no products identified in Art 57 Nov-19 phenylephrine hydrochloride / promethazine hydrochloride Entry removed as no products identified in Art 57 Nov-19 phenylsalicylate Entry removed as only authorised in 1 MS Nov-19 paracetamol / phenyltoloxamine citrate Entry removed as no products identified in Art 57 Nov-19 phosphorus (32p) sodium phosphate / sodium carbonate Entry removed as no products identified in Art 57 Nov-19 betaxolol / pilocarpine Entry removed as no products identified in Art 57 Nov-19 poliovirus type 1 (oral, live, attenuated) vaccine Entry deleted due to merge (see Entry ID: 107802) Nov-19 poliovirus type 1 / poliovirus type 2 / poliovirus type 3 vaccine (oral, live, attenuated) Entry deleted due to merge (see Entry ID: 107802) Nov-19 poliovirus type 2 (oral, live, attenuated) vaccine Entry deleted due to merge (see Entry ID: 107802) Nov-19 poliovirus type 3 (oral, live, attenuated) vaccine Entry deleted due to merge (see Entry ID: 107802) Nov-19 pranlukast Entry removed as no products identified in Art 57 Nov-19 prenoxdiazine Entry removed as no products identified in Art 57 Nov-19 progabide Entry removed as no products identified in Art 57 Nov-19 quinaprilat Entry removed as no products identified in Art 57 Nov-19 rebamipide Entry removed as no products identified in Art 57 Nov-19 reserpine Entry removed as no products identified in Art 57 Nov-19 rofecoxib Entry removed as no products identified in Art 57 Nov-19 rokitamycin Entry removed as no products identified in Art 57 Nov-19 rosoxacin Entry removed as no products identified in Art 57 Nov-19 sermorelin Entry removed as no products identified in Art 57 Nov-19 streptodornase Entry removed as no products identified in Art 57 Nov-19 tegaserod Entry removed as no products identified in Art 57 Nov-19 thenoate sodium Entry removed as no products identified in Art 57 Nov-19 teprenone Entry removed as no products identified in Art 57 Nov-19 terconazole Entry removed as no products identified in Art 57 Nov-19 terguride Entry removed as no products identified in Art 57 Nov-19 thyroglobulin Entry removed as no products identified in Art 57 Nov-19 tiotixene Entry removed as no products identified in Art 57 Nov-19 tolazamide Entry removed as no products identified in Art 57 Nov-19 tolmetin Entry removed as no products identified in Art 57 Nov-19 vidarabine Entry removed as no products identified in Art 57 Nov-19 boceprevir Entry for removal: Victrelis (CAP) surrendered. No other products in Art 57. Nov-19 carbidopa / levodopa (for centrally authorised product) Entry deleted as Numient (CAP) surrendered Nov-19 olaratumab Entry deleted as Lartruvo (CAP) revoked following Referral in July 2019 Nov-19 enoxaparin (biosimilars) Entry deleted due to merge (see Entry ID: 107810) Nov-19 enoxaparin (except for biosimilars) Entry deleted due to merge (see Entry ID: 107810) Nov-19 poliovirus type 1 / poliovirus type 3 (oral, live, attenuated) vaccine Entry deleted due to merge (see Entry ID: 107802) Nov-19 F(ab’)2 fragments of equine antirabies immunoglobulin Entry to be removed: produtcts authorised in only 1 MS Sep-19 fenspiride Entry to be removed as no products identified in Art 57 Sep-19 benzathine phenoxymethylpenicillin Entry deleted as medicinal products containing ‘benzathine phenoxymethylpenicillin’ are covered by the ‘phenoxymethylpenicillin’ entry Sep-19 daclatasvir Entry to be removed due to MA expiry Sep-19 dihydroergotamine / etilefrine Entry to be removed as no products identified in Art 57 Sep-19 etanercept (except for biosimilars) Entry deleted due to merge Sep-19 ertugliflozin / metformin Entry deleted due to merge Sep-19 ertugliflozin / sitagliptin Entry deleted due to merge Sep-19 etanercept (biosimilars) Entry deleted due to merge Sep-19 zafirlukast Entry to be removed as no products identified in Art 57 Sep-19 adalimumab (biosimilars) Entry deleted due to merge Jul-19 adalimumab (except for biosimilars) Entry deleted due to merge Jul-19 ursodeoxycholic acid Entry to be removed as no products identified in Art 57 Jun-19 pramocaine Entry deleted due to merge Jun-19 amlodipine besilate / ramipril Entry deleted due to merge Jun-19 chenodeoxycholic acid (for gallstone dissolution) Entry deleted due to merge Jun-19 dasabuvir Entry deleted due to merge Jun-19 hydrochlorothiazide / ramipril Entry deleted due to merge Jun-19 hydrocortisone acetate / pramocaine hydrochloride Entry deleted due to merge Jun-19 malathion / permethrin / piperonyl butoxide Entry to be removed as no products identified in Art 57 Jun-19 ombitasvir / paritaprevir / ritonavir Entry deleted due to merge Jun-19 tauroursodeoxycholic acid Entry deleted due to merge Jun-19 antithrombin alpha Entry to be removed due to MA withdrawal May-19 ethinylestradiol / gestodene (transdermal application) Entry removed from the EURD list since products containing this active substance are authorised only in one MS May-19 levofloxacin (except for the centrally authorised product) Entry deleted due to merge May-19 ofatumumab Entry to be removed due to MA withdrawal May-19 acetylcysteine / tuaminoheptane Entry deleted due to merge Apr-19 colchicine / dicycloverine hydrochloride GPAG outcome adopted by PRAC April 2019 entry removed Apr-19 colchicine / probenecid GPAG outcome adopted by PRAC April 2019 entry removed Apr-19 dicycloverine hydrochloride / metochalcone / procaine hydrochloride GPAG outcome adopted by PRAC April 2019 entry removed Apr-19 aluminium oxide hydrated / dicycloverine hydrochloride / magnesium oxide light / simeticone GPAG outcome adopted by PRAC April 2019 entry removed Apr-19 fluorometholone / tetryzoline GPAG outcome adopted by PRAC April 2019 entry removed Apr-19 fluorometholone / urea GPAG outcome adopted by PRAC April 2019 entry removed Apr-19 retapamulin Entry removed due to withdrawal of CAP (only authorisation) Apr-19 infliximab (biosimilars) Entry merged with 'infliximab (except biosimilars). New entry named "Infliximab". Apr-19 infliximab (except for biosimilars) Entry merged with 'infliximab (biosimilars). New entry named "Infliximab". Apr-19 lubiprostone Entry removed: no products in the procedure Apr-19 amidotrizoic acid Entry to be removed because covered by "amidotrizoic acid and combination" Feb-19 aluminium salicylate / sulfaguanidine Entry removed since no products have been identified containing this combination of active substances Feb-19 amfetamine aspartate / amfetamine sulfate / dexamfetamine saccharate / dexamfetamine sulfate Entry removed since no products have been identified containing this combination of active substances Feb-19 biodastase / dehydrocholic acid / lipase / papain / procaine hydrochloride Entry removed since no products have been identified containing this combination of active substances Feb-19 calcium / dexamethasone / lidocaine Entry to be removed: duplicate of "calcium dobesilate / dexamethasone / lidocaine" Feb-19 calcium / lidocaine Entry to be removed: duplicate of "calcium dobesilate / lidocaine" Feb-19 calcium carbonate / simeticone Entry removed since no products have been identified containing this combination of active substances Feb-19 calcium dobesilate / dexamethasone / lidocaine Entry removed because merged with "calcium dobesilate / lidocaine" Feb-19 calcium dobesilate / lidocaine Entry removed because merged with "calcium dobesilate / dexamethasone / lidocaine" Feb-19 pegaptanib Entry to be removed due to MA withdrawal Feb-19 ibuprofen / isopropyl myristate Entry removed since no products have been identified containing this combination of active substances Feb-19 lysine amidotrizoate / sodium amidotrizoate Entry removed because covered by "amidotrizoic acid and combination" Feb-19 meglumine amidotrizoate / sodium amidotrizoate Entry removed because covered by "amidotrizoic acid and combination" Feb-19 metaxalone Entry removed since no products have been identified containing this active substance Feb-19 metoxybutropate Entry removed since no products have been identified containing this active substance Feb-19 pipobroman Entry removed from the EURD list since product containing this active substance is authorised only in one MS Feb-19 polycarbophil Entry removed since no products have been identified containing this combination of active substances Feb-19 acetylsalicylic acid / magnesium hydroxide Entry removed since no products have been identified containing this active substance Jan-19 albiglutide Entry removed since no products have been identified containing this active substance Jan-19 amrinone Entry removed since no products have been identified containing this active substance Jan-19 calcium pantothenate / dimeticone / magnesium polygalacturonate Entry removed since no products have been identified containing this active substance Jan-19 chloramphenicol / medroxyprogesterone / tetryzoline Entry removed since no products have been identified containing this active substance Jan-19 chloramphenicol / methyluracil Entry removed from the EURD list since products containing this active substance are authorised only in one MS Jan-19 choline magnesium trisalicylate Entry removed since no products have been identified containing this active substance Jan-19 coprecipitate of aluminium hydroxide / magnesium carbonate Entry to be removed because covered by "antacids: combinations or monocomponents of aluminium / calcium / magnesium / potassium / sodium salts" Jan-19 cromoglicate sodium / tetryzoline hydrochloride Entry removed since no products have been identified containing this active substance Jan-19 dienestrol Entry removed since no products have been identified containing this active substance Jan-19 diphenhydramine hydrochloride / naphazoline hydrochloride / neomycin sulfate Entry removed from the EURD list since products containing this active substance are authorised only in one MS Jan-19 estradiol / gestodene Entry removed since no products have been identified containing this active substance Jan-19 estrogen / methyltestosterone Entry removed since no products have been identified containing this active substance Jan-19 estrone sodium sulfate Entry removed since no products have been identified containing this active substance Jan-19 ethinylestradiol / etynodiol Entry removed since no products have been identified containing this active substance Jan-19 ethinylestradiol / lynestrenol Entry removed since no products have been identified containing this active substance Jan-19 ethinylestradiol / norgestrel Entry removed since no products have been identified containing this active substance Jan-19 fluorometholone / gentamicin Entry removed since no products have been identified containing this active substance Jan-19 fluorometholone / miconazole nitrate / neomycin sulfate Entry removed since no products have been identified containing this active substance Jan-19 fluorometholone acetate / tobramycin Entry removed since no products have been identified containing this active substance Jan-19 heptaminol Entry removed from the EURD list since products containing this active substance are authorised only in one MS Jan-19 magnesium peroxide Entry removed since no products have been identified containing this active substance Jan-19 mebhydroline Entry removed since no products have been identified containing this active substance Jan-19 medroxyprogesterone acetate / tetryzoline hydrochloride Entry removed since no products have been identified containing this active substance Jan-19 metipranolol Entry removed since no products have been identified containing this active substance Jan-19 metipranolol hydrochloride / pilocarpine hydrochloride Entry removed since no products have been identified containing this active substance Jan-19 oxamniquine Entry removed since no products have been identified containing this active substance Jan-19 oxandrolone Entry removed since no products have been identified containing this active substance Jan-19 oxymetholone Entry removed since no products have been identified containing this active substance Jan-19 pegademase Entry removed since no products have been identified containing this active substance Jan-19 pimethixene Entry removed from the EURD list since products containing this active substance are authorised only in one MS Jan-19 polyestradiol Entry removed since no products have been identified containing this active substance Jan-19 polythiazide Entry removed since no products have been identified containing this active substance Jan-19 polythiazide / reserpine Entry removed since no products have been identified containing this active substance Jan-19 pramocaine hydrochloride / zinc sulfate Entry removed since no products have been identified containing this active substance Jan-19 prednisolone acetate / sulfacetamide sodium Entry removed since no products have been identified containing this active substance Jan-19 sodium bicarbonate / sodium citrate / sodium fluoride Entry removed since no products have been identified containing this active substance Jan-19 sodium bromide Entry removed from the EURD list since products containing this active substance are authorised only in one MS Jan-19 ribavirin (aerosol application) Entry to be removed: no products authorised in Art.57. The last product which was authorised, Virazole in Spain, was withdrawn on 19/10/2018. Dec-18 fentanyl (transdermal system - centrally authorised product) Entry to be removed: no products authorised , as the CAP Ionsys belonging to the procedure has now been withdrawn. Dec-18 aluminium lactate / benzydamine Entry removed since no products have been identified containing this active substance Nov-18 bacitracin / colistimethate sodium / hydrocortisone acetate Entry removed from the EURD list since products containing this active substance are authorised only in one MS Nov-18 cobamamide / cyproheptadine Entry removed from the EURD list since products containing this active substance are authorised only in one MS Nov-18 copper acetate / lactic acid / salicylic acid Entry removed from the EURD list since products containing this active substance are authorised only in one MS Nov-18 olpadronic acid Entry removed since no products have been identified containing this active substance Nov-18 ticarcillin Entry removed from the EURD list since products containing this active substance are authorised only in one MS Nov-18 amyl nitrite Entry removed since no products have been identified containing this active substance Oct-18 chloramphenicol / collagenase Entry removed from the EURD list since products containing this active substance are authorised only in one MS Oct-18 chlorcyclizine hydrochloride / cinnarizine Entry removed from the EURD list since products containing this active substance are authorised only in one MS Oct-18 cilnidipine Entry removed since no products have been identified containing this active substance Oct-18 clemastine fumarate / phenylpropanolamine hydrochloride Entry removed since no products have been identified containing this active substance Oct-18 clocinizine / phenylpropanolamine hydrochloride Entry removed from the EURD list since products containing this active substance are authorised only in one MS Oct-18 co-danthrusate Entry removed from the EURD list since products containing this active substance are authorised only in one MS Oct-18 desipramine Entry removed since no products have been identified containing this active substance Oct-18 eptotermin alpha Entry removed since no products have been identified containing this active substance Oct-18 fructose Entry removed since no products have been identified containing this active substance Oct-18 ibacitabine Entry removed from the EURD list since products containing this active substance are authorised only in one MS Oct-18 influenza vaccine (split virion, inactivated) (centrally authorised products only) The marketing authorisation has expired on 1 July 2018. Oct-18 acebutolol / mefruside Entry removed since no products have been identified containing this active substance Sep-18 acebutolol / nifedipine Entry removed since no products have been identified containing this active substance Sep-18 acepromazine / aceprometazine / clorazepate dipotassium Entry removed since no products have been identified containing this active substance Sep-18 acetylsalicylic acid / carisoprodol Entry removed since no products have been identified containing this active substance Sep-18 actinoquinol / oxedrine tartrate Entry removed since no products have been identified containing this active substance Sep-18 activated attapulgite / attapulgite / morphine hydrochloride Entry removed since no products have been identified containing this active substance Sep-18 aluminium hydroxide / attapulgite / kaolin / pectin Entry removed since no products have been identified containing this active substance Sep-18 amineptine Entry removed since no products have been identified containing this active substance Sep-18 amylocaine hydrochloride / dodeclonium bromide Entry removed since no products have been identified containing this active substance Sep-18 avobenzone / ensulizole / octisalate Entry removed since no products have been identified containing this active substance Sep-18 azintamide / hyoscine Entry removed since no products have been identified containing this active substance Sep-18 benzalkonium chloride / furazolidone Entry removed since no products have been identified containing this active substance Sep-18 bile-dispert / pancreatin Entry removed since no products have been identified containing this active substance Sep-18 bretylium Entry removed since no products have been identified containing this active substance Sep-18 broxaterol Entry removed since no products have been identified containing this active substance Sep-18 buformin Entry removed since no products have been identified containing this active substance Sep-18 butorphanol Entry removed since no products have been identified containing this active substance Sep-18 buzepide metiodide / haloperidol Entry removed since no products have been identified containing this active substance Sep-18 caffeine / carisoprodol / diclofenac sodium / paracetamol Entry removed since no products have been identified containing this active substance Sep-18 calcium pidolate Entry removed since no products have been identified containing this active substance Sep-18 camostat Entry removed since no products have been identified containing this active substance Sep-18 carisoprodol Entry removed since no products have been identified containing this active substance Sep-18 carisoprodol / paracetamol Entry removed since no products have been identified containing this active substance Sep-18 carmofur Entry removed since no products have been identified containing this active substance Sep-18 carmoisine Entry removed since no products have been identified containing this active substance Sep-18 carmoisine / paracetamol Entry removed since no products have been identified containing this active substance Sep-18 centella extract / hydrocortisone acetate / neomycine Entry removed since no products have been identified containing this active substance Sep-18 cetylpyridinium / dequalinium chloride Entry removed since no products have been identified containing this active substance Sep-18 cevimeline Entry removed since no products have been identified containing this active substance Sep-18 chymopapain Entry removed since no products have been identified containing this active substance Sep-18 cinnarizine / heptaminol acefylline Entry removed since no products have been identified containing this active substance Sep-18 corticotropin Entry removed since no products have been identified containing this active substance Sep-18 cyanocobalamin / hydroxocobalamin Entry removed since no products have been identified containing this active substance Sep-18 cyclandelate Entry removed since no products have been identified containing this active substance Sep-18 d,l-1-(p-hydroxyphenyl)-propylamine hydroiodide / muramidase hydrochloride / thonzylamine hydrochloride Entry removed since no products have been identified containing this active substance Sep-18 dalfopristin / quinupristin Entry removed since no products have been identified containing this active substance Sep-18 denileukin diftitox Entry removed since no products have been identified containing this active substance Sep-18 deslanoside Entry removed since no products have been identified containing this active substance Sep-18 dextromoramide Entry removed since no products have been identified containing this active substance Sep-18 dimefline Entry removed since no products have been identified containing this active substance Sep-18 diphemanil Entry removed since no products have been identified containing this active substance Sep-18 dipivefrine hydrochloride / pilocarpine hydrochloride Entry removed since no products have been identified containing this active substance Sep-18 dipotassium clorazepate / gabob / pyridoxine hydrochloride Entry removed since no products have been identified containing this active substance Sep-18 diprophylline / oxidation product / terebenthin essential oil Entry removed since no products have been identified containing this active substance Sep-18 diprophylline / proxyphylline / theophylline Entry removed since no products have been identified containing this active substance Sep-18 disodium inosinate Entry removed since no products have been identified containing this active substance Sep-18 dixyrazine Entry removed since no products have been identified containing this active substance Sep-18 domiphen Entry removed since no products have been identified containing this active substance Sep-18 drofenine / propyphenazone Entry removed since no products have been identified containing this active substance Sep-18 dronabinol Entry removed since no products have been identified containing this active substance Sep-18 eledoisin Entry removed since no products have been identified containing this active substance Sep-18 embramine Entry removed since no products have been identified containing this active substance Sep-18 emetine Entry removed since no products have been identified containing this active substance Sep-18 epervudine Entry removed since no products have been identified containing this active substance Sep-18 equilin sulfate sodium / estrone sodium sulfate Entry removed since no products have been identified containing this active substance Sep-18 estropipate Entry removed since no products have been identified containing this active substance Sep-18 eszopiclone Entry removed since no products have been identified containing this active substance Sep-18 ethylmorphine hydrochloride / indometacin Entry removed since no products have been identified containing this active substance Sep-18 etofylline / hexobendine Entry removed since no products have been identified containing this active substance Sep-18 etretinate Entry removed since no products have been identified containing this active substance Sep-18 fluocortin Entry removed since no products have been identified containing this active substance Sep-18 framycetin sulfate / oxedrine / polymyxin b sulphate Entry removed since no products have been identified containing this active substance Sep-18 fursultiamine / riboflavin Entry removed since no products have been identified containing this active substance Sep-18 gastric mucin Entry removed since no products have been identified containing this active substance Sep-18 glibornuride Entry removed since no products have been identified containing this active substance Sep-18 gramicidin / neomycin Entry removed since no products have been identified containing this active substance Sep-18 gramicidin s / framycetin sulfate / polymyxin b sulfate Entry removed since no products have been identified containing this active substance Sep-18 ibudilast Entry removed since no products have been identified containing this active substance Sep-18 iopanoic acid Entry removed since no products have been identified containing this active substance Sep-18 edrophonium Entry removed since no products have been identified containing this active substance Sep-18 prenoxdiazine Entry removed since no products have been identified containing this active substance Sep-18 propacetamol Entry removed since no products have been identified containing this active substance Sep-18 proscillaridin Entry removed since no products have been identified containing this active substance Sep-18 quinfamide Entry removed since no products have been identified containing this active substance Sep-18 resorcinol / sulphur Entry removed since no products have been identified containing this active substance Sep-18 sibutramine Entry removed since no products have been identified containing this active substance Sep-18 sivelestat Entry removed since no products have been identified containing this active substance Sep-18 sodium aurothiosulfate Entry removed since no products have been identified containing this active substance Sep-18 sodium bromebrate Entry removed since no products have been identified containing this active substance Sep-18 sodium medronate / stannous fluoride Entry removed since no products have been identified containing this active substance Sep-18 sodium pidolate Entry removed since no products have been identified containing this active substance Sep-18 stannous fluoride Entry removed since no products have been identified containing this active substance Sep-18 sulesomab Entry removed since no products have been identified containing this active substance Sep-18 tedisamil Entry removed since no products have been identified containing this active substance Sep-18 tinidazole / tioconazole Entry removed since no products have been identified containing this active substance Sep-18 ascorbic acid / macrogol 3350 / potassium chloride / sodium ascorbate / sodium chloride / sodium sulphate Entry was merged with "macrogol 3350 combinations (oral use)", therefore it had to be deleted from the list Sep-18 hydroxocobalamin (except for products for chemical poisoning) Entry was merged with "cobamamide"ID 838 due to the similarity in therapeutical indication, therefore it had to be deleted from the list Sep-18 macrogol 3350 / potassium chloride / sodium bicarbonate / sodium chloride Entry was merged with "macrogol 3350 combinations (oral use)", therefore it had to be deleted from the list Sep-18 macrogol 3350 / potassium chloride / sodium sulphate anhydrous / sodium chloride / sodium hydrogen carbonate Entry was merged with "macrogol 3350 / potassium chloride / sodium bicarbonate / sodium chloride ; ascorbic acid / macrogol 3350 / potassium chloride / sodium ascorbate / sodium chloride / sodium sulphate" in new entry "macrogol 3350 combinations (oral use)", therefore it had to be deleted from the list Sep-18 retigabine Entry removed due to product withdrawal on 19 July 2018 Sep-18 sodium fluoride Entry removed because this substance is covered by the general "fluoride" entry Sep-18 amylocaine hydrochloride / sodium benzoate Entry removed from the EURD list since products containing this active substance are authorised only in one MS Sep-18 catalase Entry removed from the EURD list since products containing this active substance are authorised only in one MS Sep-18 catalase / neomycin Entry removed from the EURD list since products containing this active substance are authorised only in one MS Sep-18 cellulase Entry removed from the EURD list since products containing this active substance are authorised only in one MS Sep-18 cetalkonium / lidocaine Entry removed from the EURD list since products containing this active substance are authorised only in one MS Sep-18 chlorquinaldol / hydrocortisone butyrate Entry removed from the EURD list since products containing this active substance are authorised only in one MS Sep-18 cicletanine Entry removed from the EURD list since products containing this active substance are authorised only in one MS Sep-18 clofoctol Entry removed from the EURD list since products containing this active substance are authorised only in one MS Sep-18 desoxycortone acetate Entry removed from the EURD list since products containing this active substance are authorised only in one MS Sep-18 dimecrotate magnesium Entry removed from the EURD list since products containing this active substance are authorised only in one MS Sep-18 eperisone Entry removed from the EURD list since products containing this active substance are authorised only in one MS Sep-18 ephedrine hydrochloride / naphazoline nitrate Entry removed from the EURD list since products containing this active substance are authorised only in one MS Sep-18 ethionamide Entry removed from the EURD list since products containing this active substance are authorised only in one MS Sep-18 fenoldopam Entry removed from the EURD list since products containing this active substance are authorised only in one MS Sep-18 fluoride sodium / strontium acetate hemihydrate Entry removed from the EURD list since products containing this active substance are authorised only in one MS Sep-18 gramicidin / naphazoline / neomycin / phenylephrine Entry removed from the EURD list since products containing this active substance are authorised only in one MS Sep-18 halcinonide Entry removed from the EURD list since products containing this active substance are authorised only in one MS Sep-18 hydroxocobalamin / pyridoxine / thiamine Entry removed from the EURD list since products containing this active substance are authorised only in one MS Sep-18 ibopamine Entry removed from the EURD list since products containing this active substance are authorised only in one MS Sep-18 metixene Entry removed from the EURD list since products containing this active substance are authorised only in one MS Sep-18 naphazoline nitrate / thonzylamine hydrochloride Entry removed from the EURD list since products containing this active substance are authorised only in one MS Sep-18 procaterol Entry removed from the EURD list since products containing this active substance are authorised only in one MS Sep-18 rociverine Entry removed from the EURD list since products containing this active substance are authorised only in one MS Sep-18 takadiastase Entry removed from the EURD list since products containing this active substance are authorised only in one MS Sep-18 alitretinoin Entry removed from the EURD list due to splitting existing entry into two separate entries: alitretinoin (cutaneous use) and alitretinoin (oral use) Sep-18 rabbit anti-human T-lymphocyte immunoglobulin (powder for solution for infusion) Entry removed from the EURD list due to procedure scope change and merging with "rabbit anti-humanT-lymphocyte immunoglobulin (concentrate for solution for infusion)" entry. New entry: "rabbit anti-humanT-lymphocyte immunoglobulin". Sep-18 acetylaminonitropropoxybenzene Entry to be removed since no products have been identified containing this active substance Jul-18 acetylleucine Entry to be removed from the EURD list since only one product in one MS identified containing this active substance. Jul-18 aconitine / histamine disalicylate Entry to be removed since no products have been identified containing this combination of active substances Jul-18 acriflavinium chloride / menthol / resorcinol Entry to be removed from the EURD list since only one product in one MS identified containing this combination of active substances. Jul-18 algeldrate, algeldrate / magnesium hydroxide Removal from EURD list; Entry: "antacids: combinations or monocomponents of aluminium / calcium / magnesium / potassium / sodium salts" to be followed (PSUSA/00000500) Jul-18 alibendole Entry to be removed since no products have been identified containing this active substance Jul-18 altizide Entry to be removed since no products have been identified containing this active substance Jul-18 amezinium Entry to be removed from the EURD list since only one product in one MS identified containing this active substance. Jul-18 amilomer Entry to be removed since no products have been identified containing this active substance Jul-18 aminoglutethimide Entry to be removed since no products have been identified containing this active substance Jul-18 aminohippurate Entry to be removed since no products have been identified containing this active substance Jul-18 aminotridecane undecylenate Entry to be removed since no products have been identified containing this active substance Jul-18 ampicillin / flucloxacillin Entry to be removed from the EURD list since only products in one MS identified containing this combination of active substances. Jul-18 azulenolum Entry to be removed since no products have been identified containing this active substance Jul-18 barbexaclone Entry to be removed since no products have been identified containing this active substance Jul-18 benexate Entry to be removed since no products have been identified containing this active substance Jul-18 benorilate Entry to be removed since no products have been identified containing this active substance Jul-18 bopindolol Entry to be removed since no products have been identified containing this active substance Jul-18 buclizine Entry to be removed since no products have been identified containing this active substance Jul-18 cadralazine Entry to be removed since no products have been identified containing this active substance Jul-18 calcium carbonate / magnesium carbonate Removal from EURD list; Entry: "antacids: combinations or monocomponents of aluminium / calcium / magnesium / potassium / sodium salts" to be followed (PSUSA/00000500) Jul-18 cortivazol Entry to be removed from the EURD list since only one product in one MS identified containing this active substance. Jul-18 detajmium Entry to be removed since no products have been identified containing this active substance Jul-18 ditazole Entry to be removed since no products have been identified containing this active substance Jul-18 flavodate Entry to be removed from the EURD list since only one product in one MS identified containing this active substance. Jul-18 glycol salicylate / methyl nicotinate Entry to be removed from the EURD list since only products in one MS identified containing this combination of active substances. Jul-18 idrocilamide Entry to be removed from the EURD list since only one product in one MS identified containing this active substance. Jul-18 iotrolan Entry to be removed since no products have been identified containing this active substance Jul-18 lidoflazine Entry to be removed since no products have been identified containing this active substance Jul-18 limaprost Entry to be removed since no products have been identified containing this active substance Jul-18 linsidomine Entry to be removed since no products have been identified containing this active substance Jul-18 mabuprofen Entry to be removed since no products have been identified containing this active substance Jul-18 matrix-applied characterised autologous cultured chondrocytes The marketing authorisation has expired on 1 July 2018, therefore this entry is deleted. Jul-18 mitoguazone Entry to be removed since no products have been identified containing this active substance Jul-18 nimorazole Entry to be removed since no products have been identified containing this active substance Jul-18 nitrogen Entry to be removed from the EURD list since only one product in one MS identified containing this active substance. Jul-18 nonivamide Entry to be removed from the EURD list since only one product in one MS identified containing this active substance. Jul-18 oxilofrine Entry to be removed since no products have been identified containing this active substance Jul-18 oxitropium Entry to be removed from the EURD list since only one product in one MS identified containing this active substance. Jul-18 oxymetazoline hydrochloride / prednisolone sodium phosphate Entry to be removed from the EURD list since only products in one MS identified containing this combination of active substances. Jul-18 pemoline Entry to be removed since no products have been identified containing this active substance Jul-18 pipazetate Entry to be removed since no products have been identified containing this active substance Jul-18 pipotiazine Entry to be removed from the EURD list since only one product in one MS identified containing this active substance. Jul-18 pitofenone Entry to be removed since no products have been identified containing this active substance Jul-18 ramelteon Entry to be removed since no products have been identified containing this active substance Jul-18 stanozolol Entry to be removed since no products have been identified containing this active substance Jul-18 thioproperazine Entry to be removed since no products have been identified containing this active substance Jul-18 triclabendazole Entry to be removed since no products have been identified containing this active substance Jul-18 trimethobenzamide Entry to be removed from the EURD list since only products in one MS identified containing this combination of active substances. Jul-18 tropatepine Entry to be removed from the EURD list since only one product in one MS identified containing this active substance. Jul-18 troxipide Entry to be removed since no products have been identified containing this active substance Jul-18 tulobuterol Entry to be removed since no products have been identified containing this active substance Jul-18 unoprostone Entry to be removed since no products have been identified containing this active substance Jul-18 valethamate Entry to be removed since no products have been identified containing this active substance Jul-18 vasopressin Entry to be removed since no products have been identified containing this active substance Jul-18 viloxazine Entry to be removed since no products have been identified containing this active substance Jul-18 viminol Entry to be removed from the EURD list since only products in one MS identified containing this combination of active substances. Jul-18 voglibose Entry to be removed since no products have been identified containing this active substance Jul-18 vorinostat Entry to be removed since no products have been identified containing this active substance Jul-18 xantinol nicotinate Entry to be removed from the EURD list since only products in one MS identified containing this combination of active substances. Jul-18 zalcitabine Entry to be removed since no products have been identified containing this active substance Jul-18 simeprevir Product was withdrawn on 05/03/2018, therefore entry is deleted Jun-18 flupirtine Marketing authorisations for flupirtine containing priducts have been revoked with the CMDh position dated 21 March 2018, therefore entry to be removed Jun-18 acetylsalicylic acid / ibuprofen Entry to be removed since no products have been identified containing this combination of active substances Jun-18 benzathine benzylpenicillin / lidocaine hydrochloride Entry to be removed since no products have been identified containing this combination of active substances Jun-18 cefonicid / lidocaine hydrochloride Entry to be removed since no products have been identified containing this combination of active substances Jun-18 cetylpyridinium chloride / dichlorobenzyl alcohol / lidocaine hydrochloride Entry to be removed since no products have been identified containing this combination of active substances Jun-18 indometacin / methocarbamol Entry to be removed since no products have been identified containing this combination of active substances Jun-18 lidocaine hydrochloride / metacresol / paraformaldehyde Entry to be removed since no products have been identified containing this combination of active substances Jun-18 lidocaine hydrochloride / phenylbutazone Entry to be removed since no products have been identified containing this combination of active substances Jun-18 lidocaine hydrochloride / phenylephrine hydrochloride / sodium propionate Entry to be removed since no products have been identified containing this combination of active substances Jun-18 lidocaine hydrochloride / piperacillin sodium Entry to be removed since no products have been identified containing this combination of active substances Jun-18 lidocaine hydrochloride / tolperisone hydrochloride Entry to be removed since no products have been identified containing this combination of active substances Jun-18 pheniramine Entry to be removed since no products have been identified containing this combination of active substances Jun-18 acediasulfone Entry to be removed since no products have been identified containing this active substance May-18 acediasulfone / cinchocaine / dihydroxymethyl carbamide Entry to be removed since no products have been identified containing this active substance May-18 alfoscerate olamine Entry to be removed since no products have been identified containing this active substance May-18 aloxiprin Entry to be removed since no products have been identified containing this active substance May-18 benzethonium chloride Entry to be removed since no products have been identified containing this active substance May-18 benzfetamine Entry to be removed since no products have been identified containing this active substance May-18 calcium phosphate / cyanocobalamin / cyproheptadine hydrochloride Entry to be removed since no products have been identified containing this combination of active substances May-18 coal tar, distilled coal tar Removal from EURD list following merge. Entry: "coal tar, distilled coal tar, distilled coal tar / lecithin, coconut oil / distilled coal tar / salicylic acid, coal tar solution / salicylic acid / sulfur, coal tar / salicylic acid, coal tar / menthol, coal tar solution / salicylic acid / benzalkonium chloride solution / polyoxyethylene 4 lauryl ether / polyoxyethylene 23 lauryl ether" to be followed (PSUSA/00010684) May-18 coal tar / menthol Removal from EURD list following merge. Entry: "coal tar, distilled coal tar, distilled coal tar / lecithin, coconut oil / distilled coal tar / salicylic acid, coal tar solution / salicylic acid / sulfur, coal tar / salicylic acid, coal tar / menthol, coal tar solution / salicylic acid / benzalkonium chloride solution / polyoxyethylene 4 lauryl ether / polyoxyethylene 23 lauryl ether" to be followed (PSUSA/00010684) May-18 coconut oil / distilled coal tar / salicylic acid, coal tar solution / salicylic acid / sulfur Removal from EURD list following merge. Entry: "coal tar, distilled coal tar, distilled coal tar / lecithin, coconut oil / distilled coal tar / salicylic acid, coal tar solution / salicylic acid / sulfur, coal tar / salicylic acid, coal tar / menthol, coal tar solution / salicylic acid / benzalkonium chloride solution / polyoxyethylene 4 lauryl ether / polyoxyethylene 23 lauryl ether" to be followed (PSUSA/00010684) May-18 cholecalciferol concentrate / sodium fluoride Entry to be removed from the EURD list since only one product in one MS identified containing this combination of active substances. May-18 colchicine / opium / tiemonium Entry to be removed from the EURD list since only one product in one MS identified containing this combination of active substances. May-18 delapril Entry to be removed from the EURD list since only one product in one MS identified containing this active substance. May-18 distilled coal tar / lecithin Removal from EURD list following merge. Entry: "coal tar, distilled coal tar, distilled coal tar / lecithin, coconut oil / distilled coal tar / salicylic acid, coal tar solution / salicylic acid / sulfur, coal tar / salicylic acid, coal tar / menthol, coal tar solution / salicylic acid / benzalkonium chloride solution / polyoxyethylene 4 lauryl ether / polyoxyethylene 23 lauryl ether" to be followed (PSUSA/00010684) May-18 mebutizide Entry to be removed since no products have been identified containing this active substance May-18 reviparin Entry to be removed since no products have been identified containing this active substance May-18 trilostane Entry to be removed since no products have been identified containing this active substance May-18 abarelix Entry to be removed since no products have been identified containing this active substance Apr-18 peramivir Entry to be removed since no products have been identified containing this active substance Apr-18 prasterone Products currently authorised only in PL, therefore entry is deleted Apr-18 tiemonium Entry to be removed since no products have been identified containing this active substance Apr-18 telavancin Product was withdrawn on 23/03/2018, therefore entry is deleted Apr-18 ipecacuanha / potassium sulfoguaiacolate / promethazine Products currently authorised only in NL and as generic, therefore entry is deleted Apr-18 nesiritide Entry to be removed since no products have been identified containing this active substance Apr-18 aceclidine Entry to be removed since no products have been identified containing this active substance Apr-18 ammonium chloride / dextromethorphan hydrobromide / diphenhydramine hydrochloride / pseudoephedrine hydrochloride Entry to be removed since no products have been identified containing this active substance Apr-18 benzocaine / chlorobutanol Entry to be removed since no products have been identified containing this active substance Apr-18 caffeine / propyphenazone Products currently authorised only in ES and under WEU, therefore entry is deleted Apr-18 calcium carbonate / vitamin d / zinc Entry to be removed since no products have been identified containing this active substance Apr-18 chlorphenamine maleate / hyoscine methobromide / pseudoephedrine hydrochloride Entry to be removed since no products have been identified containing this active substance Apr-18 cimetidine / sodium alginate Entry to be removed since no products have been identified containing this active substance Apr-18 cineole / codeine phosphate Product currently authorised only in FR, therefore entry is deleted Apr-18 cineole / thymol Entry to be removed since no products have been identified containing this active substance Apr-18 clorprenaline / codeine / pseudoephedrine Entry to be removed since no products have been identified containing this active substance Apr-18 colistimethate sodium / erythromycin lactobionate Entry to be removed since no products have been identified containing this active substance Apr-18 daclizumab Entry should be removed as the Marketing Authorisation has been withdrawn on 27 March 2018 Apr-18 caffeine (apnea, centrally authorised product only) Removal from EURD list; Entry: "caffeine (apnea)" to be followed (PSUSA/0000482) Mar-18 estradiol (17-beta) / trimegestone Entry to be removed since no products have been identified containing this active substance combination Mar-18 lactobacillus acidophilus Removal from EURD list; Entry: "lactobacillus all subspecies and combinations of subspecies" to be followed (PSUSA/00010598) Mar-18 metformin hydrochloride / sitagliptin Removal from EURD list following merge. Entry: "sitagliptin, metformin hydrochloride / sitagliptin" to be followed (PSUSA/00010673) Mar-18 sitagliptin Removal from EURD list following merge. Entry: "sitagliptin, metformin hydrochloride / sitagliptin" to be followed (PSUSA/00010673) Mar-18 triglyceride combinations (e.g.  olive oil, soya bean oil, fish oil)/ with or without mineral compounds/electrolytes (i.v. application) Removal from EURD list; Entry: "triglyceride combinations (e.g. olive oil, soya bean oil, fish oil)/ with or without mineral compounds/electrolytes (i.v. application) to be followed (PSUSA/00010648) Mar-18 acetylsalicylic acid / pseudoephedrine hydrochloride Entry was merged with "pseudoephedrine" and "acetylsalicylic acid / pseudoephedrine hydrochloride" entries, therefore it had to be deleted from the list Feb-18 pseudoephedrine MERGED with "pseudoephedrine" and "acetylsalicylic acid / pseudoephedrine hydrochloride" in a new entry, therefore entry is deleted Feb-18 a-tocopherol / ascorbic acid / cupric oxide / sodium selenate / vitamin a / zinc oxide Entry to be removed since no products have been identified containing this active substance combination. Feb-18 boric acid / guaiazulen / ichthammol / zinc oxide Entry to be removed since no products have been identified containing this active substance combination. Feb-18 brompheniramine / pseudoephedrine Entry to be removed since no products have been identified containing this active substance combination. Feb-18 calcium levomefolate / mecobalamin / pyridoxal phosphate Entry to be removed since no products have been identified containing this active substance combination. Feb-18 carbethopendecinium bromide / ephedrine hydrochloride Entry to be removed since no products have been identified containing this active substance combination. Feb-18 carbinoxamine maleate / pseudoephedrine hydrochloride Entry to be removed since no products have been identified containing this active substance combination. Feb-18 cefdinir Entry to be removed since no products have been identified containing this active substance combination. Feb-18 clocortolone hexanoate / clocortolone pivalate Entry to be removed since no products have been identified containing this active substance combination. Feb-18 estradiol / norgestimate Entry to be removed since no products have been identified containing this active substance combination. Feb-18 glaucine hydrobromide / pseudoephedrine hydrochloride Entry to be removed since no products have been identified containing this active substance combination. Feb-18 insulin porcine Products currently authorised only in UK and under WEU, therefore entry is deleted Feb-18 iotalamic acid Entry to be removed since no products have been identified containing this active substance combination. Feb-18 lisuride Product authorised in 1 MS (FR), therefore should be deleted Feb-18 loperamide MERGED with "loperamide hydrochloride/simeticon" in a new entry, therefore entry is deleted Feb-18 loperamide hydrochloride / simeticone MERGED with "loperamide" in a new entry, therefore entry is deleted Feb-18 macrogol 3350 / potassium chloride / sodium chloride / sodium bicarbonate / potassium sulfate Entry to be removed since no products have been identified containing this active substance combination. Feb-18 chlorphenesin Entry to be removed since no products have been identified containing this active substance combination. Feb-18 adenosine / allopurinol / glutathione / lactobionic acid / magnesium sulphate / poly (0-2-hydroxyethyl) starch (pentafraction) / potassium dihydrogen phosphate / potassium hydroxide / raffinose / sodium hydroxide Entry to be removed from the EURD list since only one product in one MS identified containing this combination of active substances. Jan-18 azoximer bromide Entry to be removed from the EURD list since only one product in one MS identified containing this active substances. Jan-18 brompheniramine Entry to be removed from the EURD list since only one product in one MS identified containing this active substances. Jan-18 dolasetron Entry to be removed from the EURD list since only one product in one MS identified containing this active substances. Jan-18 ketanserin Entry to be removed from the EURD list since only one product in one MS identified containing this active substances. Jan-18 methyl salicylate / levomenthol Removal from EURD list following merge: Entry: "menthol / methyl salicylate / camphor, menthol / methyl salicylate" to be followed (PSUSA/00010658) Jan-18 methyl salicylate / levomenthol / DL-camphor Removal from EURD list following merge: Entry: "menthol / methyl salicylate / camphor, menthol / methyl salicylate" to be followed (PSUSA/00010658) Jan-18 catumaxomab Entry should be removed as the Marketing Authorisation has been withdrawn on 2nd June 2017. Dec-17 desirudin Entry should be removed as the Marketing Authorisation was withdrawn on 29/07/2014. Dec-17 alipogene tiparvovec Entry should be removed as the marketing authorisation expired on 25/10/2017. No additional PSURs are required to be submitted. Dec-17 gadoversetamide Entry should be removed as the marketing authorisation has expired on has expired on 23/07/2017. Dec-17 influenza vaccine (surface antigen, inactivated, prepared in cell cultures) Entry should be removed as the marketing authorisation has expired on has expired on 01/06/2017. Dec-17 influenza vaccine (surface antigen, inactivated, virosome) Entry should be removed as no products are currently authorised in EU with this active substance. Dec-17 mestranol / norethisterone Entry to be removed from the EURD list since only one product in one MS identified containing this combination of active substances. Dec-17 hepatitis A vaccine (inactivated, virosome) Entry to be removed from the EURD list as there are currently no products authorised in the EU Dec-17 dihydroergocristine Entry to be removed from the EURD list since only one product in one MS identified containing this active substance. Nov-17 bemetizide / triamterene Entry to be removed from the EURD list since only one product in one MS identified containing this combination of active substances. Nov-17 ebastine / pseudoephedrine Entry to be removed from the EURD list since only one product in one MS identified containing this combination of active substances. Nov-17 fish oil / olive oil / soybean oil / triglycerides medium-chain Removal from EURD list following merge: Entry: "triglyceride combinations (e.g. olive oil, soya bean oil, fish oil)/ with or without mineral compounds/electrolytes (i.v. application)" to be followed (PSUSA/00010648) Nov-17 clodronic acid Removal from EURD list following merge: Entry: "clodronic acid, clodronic acid / lidocaine" to be followed (PSUSA/00010650) Nov-17 ibuprofen, ibuprofen lysine (not indicated in ductus arteriosus) Removal from EURD list following merge: Entry: "ibuprofen, ibuprofen lysine (not indicated in ductus arteriosus), ibuprofen / caffeine" to be followed (PSUSA/00010649) Nov-17 vorapaxar Product withdrawn, therefore entry should be removed. Nov-17 roxatidine Entry to be removed from the EURD list since only one product in one MS identified containing this active substance. Oct-17 tiludronic acid Entry to be removed from the EURD list since only one product in one MS identified containing this active substance. Oct-17 eucalyptol Entry "eucalyptol" is deleted as there a no products authorised in Art 57. New entry "eucalyptus oil" is created as per MAH request Oct-17 tropisetron Only 1 valid generic product identified in ES. Products in FR expired due to sunset clause, products in other MSs are withdrawn. Therefore entry is deleted. Oct-17 calcium chloride dihydrate / lactic acid / magnesium chloride hexahydrate / sodium chloride / sodium hydrogen carbonate All Products currently authorised in EU are authorised under WEU, therefore entry is deleted Oct-17 benzalkonium chloride / isopropyl myristate / paraffin liquid The entry will be merged with 'benzalkonium chloride / chlorhexidine / isopropyl myristate / paraffin liquid' therfore the current entry is deleted Oct-17 pancreas powder (centrally authorised product only) Product withdrawn on 27 July 2017, therefore entry should be removed. Oct-17 buflomedil Entry removed, as only 2 generic products identified in Art. 57 DB. No submissions have been received. Oct-17 influenza vaccine (H1N1)ν (split virion, inactivated, adjuvanted) Entry removed, as this medicine is withdrawn from use in the European Union Oct-17 alcium chloride dihydrate / magnesium chloride hexahydrate / malic acid / sodium acetate trihydrate / sodium chloride / potassium chloride Removal from EURD list following merge: Entry: "calcium chloride dihydrate / magnesium chloride hexahydrate / malic acid / sodium acetate trihydrate / sodium chloride / potassium chloride, calcium chloride dihydrate / sodium chloride / sodium lactate / potassium chloride" to be followed (PSUSA/00010622) Sep-17 bismuth subnitrate / lidocaine / zinc oxide Removal from EURD list following merge: Entry: "bismuth / lidocaine / zinc oxide, lidocaine / zinc oxide" to be followed (PSUSA/00010621) Sep-17 cefminox Entry to be removed from the EURD list since only one product in one MS identified containing this active substance. Sep-17 chondroitin Removal from EURD list following merge: Entries to be followed: PSUSA/00010625 or PSUSA/00010626 accordingly Sep-17 chondroitin / glucosamine Removal from EURD list following merge: Entries to be followed PSUSA/00010625 or PSUSA/00010626 accordingly Sep-17 D-camphor / hydroxyethyl salicylate / levomenthol / methyl salicylate Entry to be removed from the EURD list since only one product in one MS identified containing this active substance. Sep-17 dornase alpha / fibrinolysin Entry to be removed since no products have been identified containing this active substance combination. Sep-17 fructose / glycerin Entry to be removed since no products have been identified containing this active substance combination. Sep-17 glycerine Entry to be removed from the EURD list due to duplication with "glycerol" entry. Sep-17 hexamidine / tetravacaine Entry to be removed since no products have been identified containing this active substance. Sep-17 icodextrin Entry to be removed since no products have been identified containing this active substance. Sep-17 methysergide Entry to be removed since no products have been identified containing this active substance. Sep-17 testosterone undecanoate (injection) Removal from EURD list: Entry: "testosterone (all formulations apart from topical use)" to be followed (PSUSA/00010631) Sep-17 testosterone (all formulations apart from topical use and testosterone undecanoate injection) Removal from EURD list: Entry: "testosterone (all formulations apart from topical use)" to be followed (PSUSA/00010631) Sep-17 tetrazepam Entry to be removed from the EURD list following suspension of the products. Sep-17 zinc oxide Removal from EURD list following merge: Entry: "zinc oxide, zinc oxide/calamine" to be followed (PSUSA/00010632) Sep-17 caffeine / ephedrine sulfate / promethazine hydrochloride Entry to be removed from the EURD list since only one product in one MS identified containing this combination of active substances. Jul-17 sodium oxybate Removal from EURD list: Entry deleted due to merging of sodium oxybate (oral use) and sodium oxybate (intravenous use) Jul-17 acetic acid / calcium chloride / glucose anhydrous / magnesium chloride / potassium chloride / sodium chloride Entry to be removed since no products have been identified containing this active substance combination. Jul-17 acetic acid glacial / calcium chloride dihydrate / glucose monohydrate / magnesium chloride hexahydrate / potassium chloride / sodium chloride / sodium dihydrogen phosphate dihydrate / sodium hydrogen carbonate Entry to be removed since only 2 WEU products in CZ identified. Jul-17 acetylsalicylic acid / pravastatin Entry to be removed since no products have been identified containing this active substance combination. Jul-17 arsenic trioxide / ephedrine hydrochloride / lidocaine Entry to be removed since no products are authorised containing this active substance combination. Jul-17 benzocaine / chlorhexidine Removal from EURD list: Entry deleted due to merging 'benzocaine / chlorhexidine' with 'benzocaine / chlorhexidine / tyrothricin'. Jul-17 benzocaine / chlorhexidine / tyrothricin Removal from EURD list: Entry deleted due to merging 'benzocaine / chlorhexidine' with 'benzocaine / chlorhexidine / tyrothricin'. Jul-17 calcium chloride / glucose / potassium chloride / sodium chlorid / sodium lactate / sodium saccharin Entry to be removed since no products are authorised containing this active substance combination. Jul-17 chlorhexidine gluconate / oxybuprocaine hydrochloride Removal from EURD list: Entry deleted due to merging ‘chlorhexidine gluconate / oxybuprocaine hydrochloride’ with ‘chlorhexidine gluconate / tetracaine hydrochloride'. Jul-17 chlorhexidine gluconate / tetracaine hydrochloride Removal from EURD list: Entry deleted due to merging ‘chlorhexidine gluconate / oxybuprocaine hydrochloride’ with ‘chlorhexidine gluconate / tetracaine hydrochloride'. Jul-17 chondroitin sulphate sodium / sodium hyaluronate Entry to be removed since no products are authorised containing this active substance combination. Jul-17 fexofenadine combinations Entry to be removed since no products are authorised containing this active substance combination. Jul-17 glucosamine / lidocaine Entry to be removed since product is only authorised in 1 MS (PL). Jul-17 human albumin solution Entry to be removed. The products of this entry will fall into the scope of the newly introduced entry "human plasma proteins with not less than 95% albumin". Jul-17 human plasma proteins with not less than 96% albumin Entry to be removed. The products of this entry will fall into the scope of the newly introduced entry "human plasma proteins with not less than 95% albumin". Jul-17 mangafodipir Product withdrawn on 21 June 2012, therefore entry should be removed. Jul-17 methyl salicylate bp / octafonium chloride / phenol / zinc oxide Entry to be removed since no products have been identified containing this active substance combination. Jul-17 lactobacillus rhamnosus Removal from EURD list: Entry: "lactobacillus all subspecies and combinations of subspecies" to be followed (PSUSA/00010598) Jun-17 lactobacillus acidophilus Removal from EURD list: Entry: "lactobacillus all subspecies and combinations of subspecies" to be followed (PSUSA/00010598) Jun-17 lactobacillus fermentum / lactobacillus rhamnosus / lactobacillus salivarius / lactobacillus vaginalis Removal from EURD list: Entry: "lactobacillus all subspecies and combinations of subspecies" to be followed (PSUSA/00010598) Jun-17 guaifenesin / salbutamol sulfate Entry to be removed from the EURD list since only one product in one MS identified containing this combination of active substances. Jun-17 hydrochlorothiazide / irbesartan Removal from EURD list: Entry: "hydrochlorothiazide / irbesartan, irbesartan" to be followed (PSUSA/00010601) Jun-17 irbesartan Removal from EURD list: Entry: "hydrochlorothiazide / irbesartan, irbesartan" to be followed (PSUSA/00010601) Jun-17 propiomazine Entry to be removed from the EURD list since only one product in one MS identified containing this combination of active substances. Jun-17 sulfametrole / trimethoprim, sulfadiazine trimethoprim New entry was created by merging 'sulfametrole / trimethoprim, sulfadiazine / trimethoprim’ with ‘sulfamethoxazole / trimethoprim (co-trimoxazole), therefore entry for “'sulfametrole / trimethoprim, sulfadiazine / trimethoprim” should be deleted. May-17 palifermin Product withdrawn on 24.02.2016, therefore entry is removed. May-17 hetastarch / sodium chloride The entry removed from the list as a duplicate (to 1694 'hydroxyethyl starch'). May-17 elvitegravir Product withdrawn on 03.11.2016, therefore entry is removed. May-17 co-trimoxazole New entry was created by merging 'sulfametrole / trimethoprim, sulfadiazine / trimethoprim’ with ‘sulfamethoxazole / trimethoprim (co-trimoxazole), therefore entry for “co-trimoxazole” should be deleted. May-17 bendroflumethiazide / hydralazine / propanolol Entry to be removed since only one product identified in Art. 57 DB in one MSs (DE). Entry to be deleted. May-17 clarithromycin / lansoprazole / tinidazole Entry to be removed since only one generic product identified in Art. 57 DB in one MSs (LV). May-17 amyleine / chlorhexidine Entry to be removed since no products have been identified containing this active substance combination. Apr-17 bacitracin / chlorhexidine Entry to be removed since no products have been identified containing this active substance combination. Apr-17 bendroflumethiazide Removal from EURD list: New entry: "bendroflumethiazide, bendroflumethiazide / potassium chloride" to be followed (PSUSA/00010583) Apr-17 benzalkonium chloride / chlorhexidine dihydrochloride / isopropyl myristate / paraffin liquid Entry to be removed from the EURD list since products in only one MS identified containing this combination of active substances. Apr-17 collagen Entry to be removed since no products have been identified containing this active substance combination. Apr-17 collagenase clostridium histolyticum (all indications except for treatment of Dupuytren’s contracture and Peyronie’s disease) Entry to be removed since no products have been identified containing this active substance combination. Apr-17 characterised viable autologous cartilage cells expanded ex vivo expressing specific marker proteins Entry to be removed following withdrawal of marketing authorisation Apr-17 benzylnicotine / camphora / dimethyl sulphate / turpentine oil Entry to be removed since no products have been identified containing this active substance combination. Apr-17 dinutuximab Entry to be removed following withdrawal of marketing authorisation Apr-17 budesonide / formoterol (apart from centrally authorised products) Removal from EURD list: New entry: "budesonide / formoterol" to be followed (PSUSA/00010585) Apr-17 budesonide / formoterol (only centrally authorised products) Removal from EURD list: New entry: "budesonide / formoterol" to be followed (PSUSA/00010585) Apr-17 chlorhexidine / hydrocortisone Entry to be removed since no products have been identified containing this active substance combination. Apr-17 chlorhexidine / sodium fluoride Entry to be removed since no products have been identified containing this active substance combination. Apr-17 chlorhexidine / tolnaftate Entry to be removed since no products have been identified containing this active substance combination. Apr-17 chlorhexidine hydrochloride / hydrocortisone acetate / nystatin Entry to be removed since no products have been identified containing this active substance combination. Apr-17 chlorhexidine hydrochloride / nystatin Entry to be removed since no products have been identified containing this active substance combination. Apr-17 mycobacterium bovis Removal from EURD list: Entry: "BCG vaccine (freeze-dried)" to be followed (PSUSA/00000304) Apr-17 dextromethorphan hydrobromide / salbutamol sulfate Entry to be removed since no products have been identified containing this fixed dose active substance combination. Mar-17 oagulation factor ii / human coagulation factor ix / human coagulation factor vii / human coagulation factor x / protein c Entry to be removed since no products are authorised in EU containing this fixed dose active substance combination. Mar-17 calcium carbonate / etidronate disodium Entry to be removed since no products have been identified containing this fixed dose active substance combination. Mar-17 chelidonium majus L., herba Entry to be removed from the EURD list since only one product in one MS identified containing this combination of active substances. Mar-17 cyanocobalamin / dexamethasone / lidocaine hydrochloride / thiamine Entry to be removed from the EURD list since this fixed dose combination is authorised only in one Member State. Mar-17 dehydrocholic acid / homatropine / papaverine Entry to be removed from the EURD list since this fixed dose combination is authorised only in one Member State. Mar-17 ferucarbotran Entry to be removed since no products have been identified containing this active substance. Mar-17 fusafungine Entry to be removed since no products are authorised in EU containing this active substance. Mar-17 rimantadine Entry to be removed as all products containing this active substance are authorised under Article 10(a). Mar-17 nicotinic acid Entry to be removed from the EURD list since products with this active substance are authorised only in one Member State. Mar-17 oxedrine Entry to be removed from the EURD list since products with this active substance are authorised only in one Member State. Mar-17 oxybuprocaine hydrochloride / tetracaine hydrochloride Entry to be removed from the EURD list since only one WEU product is authorised in only one Member State. Mar-17 penamecillin Entry to be removed from the EURD list since products with this active substance are authorised only in one Member State. Mar-17 phenolphthalein Entry to be removed from the EURD list since products with this active substance are authorised only in one Member State. Mar-17 poliovirus type 1 / poliovirus type 3 (oral, live, attenuated) vaccine Entry to be removed since no products have been identified containing this fixed dose active substance combination. Mar-17 sulfamethoxazole Entry to be removed since no products have been identified containing this combination of active substances. Mar-17 aluminium oxide / hydrated / magnesium hydroxide / oxetacaine Entry to be removed since the combination of active substances is only authorised in 1 MS Feb-17 antazoline phosphate / naphazoline hydrochloride / zinc sulfate Entry to be removed since no products have been identified containing this active substance combination. Feb-17 biclotymol / cineole / pholcodine Entry to be removed since no products have been identified containing this active substance combination. Feb-17 charcoal activated / magnesium hydroxide Entry to be removed since the combination of active substances is only authorised in 1 MS Feb-17 chlorhexidine gluconate / oxedrine tartrate Entry to be removed since no products have been identified containing this active substance combination. Feb-17 chlorhexidine hydrochloride / phenobarbital / valerian extract Entry to be removed since no products have been identified containing this active substance combination. Feb-17 enterococcus faecalis / escherichia coli / klebsiella pneumoniae / morganella morganii / proteus mirabilis Entry to be removed since the combination of active substances is only authorised in 1 MS Feb-17 ethanolic extracts of camellia sinensis (L.) kuntze, non fermentatum folium Entry to be removed since no products have been identified containing this active substance combination. Feb-17 influenza vaccine (H1N1)ν (split virion, inactivated) Entry to be removed following withdrawal of marketing authorisation Feb-17 meprobamate Entry to be removed since the combination of active substances is only authorised in 1 MS Feb-17 mercaptamine Removal from EURD list: Entry split to two entries: "mercaptamine (treatment of nephropathic cystinosis)" to be followed (PSUSA/00010573) Feb-17 oxetacaine Entry to be removed since no products have been identified containing this active substance. Feb-17 influenza vaccine (H1N1)ν (whole virion, inactivated, prepared in cell culture) Entry removed from the list due to withdrawal of the product. Feb-17 nitrous oxide Removal from EURD list: Entry merged with combination of active substances containing nitrous oxide / oxygen. New entry: "nitrous oxide, nitrous oxide/oxygen" to be followed (PSUSA/00010572) Feb-17 naphazoline hydrochloride / pheniramine maleate Entry to be removed since no products have been identified containing this active substance combination. Feb-17 naphazoline Removal from EURD list: Entry merged with combination of active substances containing naphazoline/zinc sulphate. New entry: "naphazoline, naphazoline/zinc sulphate" to be followed (PSUSA/00010571) Feb-17 methotrexate (for centrally authorised product) Removal from EURD list: This entry was wrongly updated in the previous version of the EURDlist Jan-17 calcium glycerophosphate / magnesium gluconate Removal from EURD list: Entry merged with an existing entry “calcium glycerophosphate / magnesium gluconate”, therefore entry for “calcium glycerophosphate / magnesium gluconate” is deleted Jan-17 carbasalate calcium / metoclopramide Removal from EURD list: Entry merged with with other combination of active substances containing metoclopramide Jan-17 enoxaparin Removal from EURD list: Entry split to two entries: one entry only for biosimilar products and another entry for all products except for biosimilars. Jan-17 lysine acetylsalicylic acid / metoclopramide Removal from EURD list: Entry merged with with other combination of active substances containing metoclopramide Jan-17 sulfametrole / trimethoprim Removal from EURD list: Entry to be removed following merging with sulfadiazine trimethoprim Jan-17 phenothrin / piperonyl butoxide Removal from EURD list: Entry to be removed from the EURD list since no products have been identified containing this active substance combination. Dec-16 betamethasone sodium phosphate / framycetin sulfate Removal from EURD list: Entry to be removed from the EURD list since no products have been identified containing this active substance combination. Dec-16 sulpiride Removal from EURD list: substance was merged with levosulpiride, in line with the principles set in the EURDlist introductory cover note. Entry: "levosulpiride, sulpiride" to be followed (PSUSA/00001859) Dec-16 mycophenolate mofetil Removal from the EURD List: New entry "'mycophenolate mofetil, mycophenolic acid" to be followed (PSUSA/00010550) Dec-16 mycophenolic acid (apart from mycophenolate mofetil) Removal from the EURD List: New entry "'mycophenolate mofetil, mycophenolic acid" to be followed (PSUSA/00010550) Dec-16 morphine Removal from the EURD List: New entry "morphine, morphine / cyclizine" to be followed (PSUSA/00010549) Dec-16 ascorbic acid / calcium Removal from EURD list: ascorbic acid / calcium / lysine” was merged with the entry “ascorbic acid / calcium”, therefore the existing entry “ascorbic acid / calcium” should be deleted. Dec-16 benzalkonium chloride / cetrimide Removal from EURD list: “cetrimide/dimeticone” was merged with an existing entry “benzalkonium chloride/cetrimide”, therefore entry for “benzalkonium chloride/cetrimide” should be deleted. Dec-16 betacarotene / vaccinium myrtillus anthocyanosides Removal from EURD list: New entry: "alpha-tocopherol / vaccinium myrtillus anthocyanosides, betacarotene / vaccinium myrtillus anthocyanosides" to be followed (PSUSA/00010547) Dec-16 factor x / human coagulation factor ix / human coagulation factor vii / protein c / protein s / prothrombin Removal from EURD list: Entry: “human prothrombin complex" to be followed (PSUSA/00001638) Dec-16 ferumoxsil (siloxane coated superparamagnetic ironoxide) Entry to be removed since the active substance is only authorised in 1 MS Dec-16 itopride Entry to be removed from the EURD list since only one product authorised in 1 MS has been identified. Dec-16 olanzapine Removal from EURD list: olanzapine and olanzapine pamoate entries were merged. New entry to be followed: "olanzapine" (PSUSA/0010540) Dec-16 olanzapine pamoate Removal from EURD list: olanzapine and olanzapine pamoate entries were merged. Entry to be followed: "olanzapine" (PSUSA/0010540) Dec-16 coconut oil / distilled coal tar / salicylic acid Removal from EURD list: New entry: coconut oil / distilled coal tar / salicylic acid, coal tar solution / salicylic acid / sulfur to be followed (PSUSA/00010548) Dec-16 diazepam / sulpiride Entry to be removed from the EURD list since only one product authorised in 1 MS has been identified. Dec-16 urea Removal from the EURD List: New entry "'lactic acid / urea, urea" to be followed (PSUSA/00010536) Dec-16 lisinopril Removal from EURD list: merge of lisonopril with lisinopril / hydrochlorothiazide Nov-16 pegloticase Removal from EURD list: the product has not been renewed and Rapporteur notified us that no more PSUR are expected for this product. Nov-16 hydrochlorothiazide / lisinopril Removal from EURD list: merge of lisonopril with lisinopril / hydrochlorothiazide Nov-16 telaprevir Removal from EURD list: entry to be removed from the EURD List following PRAC AR in October 2016 and the MAH's wish to not renew the MA Nov-16 acidic acid / nitric acid / oxolinic acid / zinc nitrate Entry to be removed since no products have been identified containing this active substance combination. Oct-16 ajmaline Entry to be removed from the EURD list since only one product authorised in 1 MS has been identified. Oct-16 ammonium chloride / diphenhydramine hydrochloride Entry removed and merged with diphenhydramine, diphenhydramine hydrochloride / levomenthol. Entry to be followed: "diphenhydramine, ammonium chloride / diphenhydramine hydrochloride, diphenhydramine hydrochloride / levomenthol, ammonium chloride / diphenhydramine hydrochloride / levomenthol" Oct-16 borax / calcium carbonate / cholecalciferol / copper oxide / magnesium oxide / manganese sulfate / zinc oxide Entry to be removed since no products have been identified containing this active substance combination. Oct-16 calcium levulinate / cetylpyridinium chloride / diphenhydramine hydrochloride / essential sage oil / panthenol / phenylephrine hydrochloride Entry to be removed since no products have been identified containing this active substance combination. Oct-16 cineole / gaiacol / pholcodine Entry to be removed since no products have been identified containing this active substance combination. Oct-16 codeine phosphate / ibuprofen / paracetamol Entry to be removed since no products have been identified containing this active substance combination. Oct-16 hypericin Entry to be removed since no products have been identified containing this active substance. Additionally, a duplicate entry "hypericum perforatum L., herba" has been identified. Oct-16 lidocaine / zinc oxide Entry to be removed since no products have been identified containing this active substance combination. Oct-16 nicotinic acid / simvastatin Entry to be removed since no products have been identified containing this active substance combination. Oct-16 tegafur / uracil Entry to be removed since no products have been identified containing this active substance combination. Oct-16 dequalinium Removal from EURD list: new entry "dequalinium, dequalinium / cinchocaine, dequalinium / lidocaine" (PSUSA/00010526) should be followed Oct-16 dequalinium chloride / lidocaine Removal from EURD list: new entry "dequalinium, dequalinium / cinchocaine, dequalinium / lidocaine" (PSUSA/00010526) should be followed Oct-16 diphenhydramine Removal from EURD list: new entry "diphenhydramine, ammonium chloride / diphenhydramine hydrochloride, diphenhydramine hydrochloride / levomenthol, ammonium chloride / diphenhydramine hydrochloride / levomenthol" (PSUSA/00010527) should be followed Oct-16 diphenhydramine hydrochloride / levomenthol Removal from EURD list: new entry "diphenhydramine, ammonium chloride / diphenhydramine hydrochloride, diphenhydramine hydrochloride / levomenthol, ammonium chloride / diphenhydramine hydrochloride / levomenthol" (PSUSA/00010527) should be followed Oct-16 levobunolol Removal from EURD list: entry "levobunolol (ophthalmic indication)" (PSUSA/00010109) should be followed Oct-16 magnesium / potassium / sodium / water for injection Entry to be removed since no products have been identified containing this active substance combination. Jul-16 spirapril Entry to be removed from the EURD list since only one product authorised in 1 MS has been identified. Jul-16 dutasteride / tamsulosin hydrochloride Entry removed due to merging the entries for dutasteride and dutasteride/tamsulosine Jun-16 sodium molybdate [99mo] / sodium pertechnetate [99mtc] Entry removed due to it being duplicate to entry 'technetium (99mTc) pertechnetate' Jun-16 pyridoxin / thiamine Entry removed from the EURD List following the merging with another combination of active substances Jun-16 dutasteride Entry removed due to merging the entries for dutasteride and dutasteride/tamsulosine Jun-16 ascorbic acid / rutoside This product is only authorised in France under Article 8(3) of Directive 2001/83/EC, therefore it should be removed from the list Jun-16 artemether / lumefantrin (dispersible tablet) Product authorised only in 1 Member State, therefore it should be removed from the list Jun-16 delapril / manidipine Removal from EURD list: new entry 'delapril / manidipine, delapril / indapamide' (PSUSA/00010496) should be followed. May-16 calcium chloride / icodextrin / magnesium chloride / sodium chloride / sodium lactate Entry removed and merged with 3 other combinations of active substances for peritoneal dialysis. New entry: 'calcium chloride / glucose / magnesium chloride / sodium chloride / sodium lactate, calcium chloride / glucose / magnesium chloride / sodium chloride / sodium lactate/ sodium bicarbonate, calcium chloride / amino acids blend / magnesium chloride / sodium chloride / sodium lactate, calcium chloride / icodextrin / magnesium chloride / sodium chloride / sodium lactate’ to be followed May-16 azithromycin Removal from EURD list: new entries “azithromycin (systemic use formulations)”(PSUSA/00010491/) and azithromycin (ocular use formulations)” (PSUSA/00010492) should be followed. May-16 ambroxol / doxycycline Entry to be removed since products identified in Art. 57 are only authorised in 1 MS (DE) Apr-16 ascorbic acid / cyanocobalamin / ergocalciferol / nicotinamide / pyridoxine / retinol / riboflavin / thiamine hydrochloride This entry should be removed from the EURD List since this combination of active substance is already covered by the following entry: 'ascorbic acid / calcium hydrogenphosphate / calcium panthotenate / colecalciferol / cyanocobalamin / folic acid / nicotinamide / pyridoxine hydrochloride / retinol / riboflavine / thiamin nitrate, ascorbic acid / cyanocobalamin / ergocalciferol / nicotinamide / pyridoxine / retinol / riboflavin / thiamine hydrochloride, ascorbic acid / colecalciferol / dexpanthenol / nicotinamide / pyridoxine / retinol / riboflavin / thiamine Apr-16 bromhexine / oxymetazoline Entry to be removed since products identified in Art. 57 are only authorised in 1 MS (HU) Apr-16 citric acid / epoetin alpha / human albumin / sodium chloride / sodium citrate Entry to be removed since no products containing this particular combination have been identified in the Article 57 database Apr-16 histrelin Entry to be removed from the EURD list as no products containing the active substance histrelin have been identified in article 57. In addition, no submissions were received during the reconcilliation process for PSUSA/00001611/201511 Apr-16 human coagulation factor xiii / human fibrinogen Entry to be removed since no authorised products were identified in Article 57 Apr-16 influenza vaccine (H1N1)ν (surface antigens, inactivated, adjuvanted) Entry to be removed following withdrawal of marketing authorisation for CAP Focetria on 11/02/2016 Apr-16 influenza vaccine (H1N1)ν (surface antigens, inactivated, prepared in cell cultures, adjuvanted) Entry to be removed since only the product Celtura (authorised in DE) was identified in Article 57 Apr-16 lansoprazole / metronidazole / tetracycline Entry to be removed since no authorised products were identified in Article 57 Apr-16 leucocytes dialysate Entry to be removed since no authorised products were identified in Article 57 Apr-16 selenomethionine (75Se) Entry to be removed since no authorised products were identified in Article 57 Apr-16 thrombin Entry to be removed since no products were identified in Article 57 referencing “thrombin” as standalone active substance, apart from 2 products containing bovine thrombin (only authorised in PL)) Apr-16 almagate Removal from EURD List: only authorised in one Member State (ES). Therefore the active substance almagate should be removed from the EURDlist. Apr-16 erythromycin / isotretinoin Removal from EURD list: new entries “erythromycin / isotretinoin, isotretinoin (topical formulations)”(PSUSA/00010487/) and “isotretinoin (oral formulations)” (PSUSA/00010488) should be followed. Apr-16 isotretinoin Removal from EURD list: new entries “erythromycin / isotretinoin, isotretinoin (topical formulations)”(PSUSA/00010487/) and “isotretinoin (oral formulations)” (PSUSA/00010488) should be followed. Apr-16 dextromethorphan hydrobromide / quinidine sulfate (treatment of pseudobulbar affect (PBA)) CAP Nuedexta no longer authorised. MA has been withdrawn on 02/03/2016 Mar-16 fosinopril Entry "fosinopril, fosinopril / hydrochlorothiazide" should be followed Mar-16 fosinopril / hydrochlorothiazide Entry "fosinopril, fosinopril / hydrochlorothiazide" should be followed Mar-16 thiocolchicoside Entry "thiocolchicoside, paracetamol / thiocolchicoside" should be followed Mar-16 paracetamol / thiocolchicoside Entry "thiocolchicoside, paracetamol / thiocolchicoside" should be followed Mar-16 metopimazine Not authorised in EEA or in more than 1 Member state. Mar-16 estradiol The estradiol entry has been split into the following 2 new entries: -estradiol (without cream/balm/emulsion for application in the female genital area) -estradiol, estradiol / prednisolone (only cream/balm/emulsion for application in the female genital area) Feb-16 terfenadine Not authorised in EEA or in more than 1 Member state. Feb-16 parathyroid hormone (rdna) CAP Preotact no longer authorised. MA has been withdrawn on 16/05/2014. Feb-16 dienogest / estradiol Entry dienogest / estradiol split into 2 new entries with a different scope based on the different indication. The 2 new entries to be followed are: dienogest / estradiol (HRT indication) dienogest / estradiol (contraception indication) Feb-16 alfatradiol Not authorised in EEA or in more than 1 Member state Jan-16 almitrine Not authorised in EEA or in more than 1 Member state Dec-15 betamethasone / dexchlorpheniramine maleate Not authorised in EEA or in more than 1 Member state Dec-15 butizide / spironolactone Not authorised in EEA or in more than 1 Member state Dec-15 calcium chloride dihydrate / glucose / potassium chloride / sodium chloride Entry "glucose (apart from glucose1- phosphate) / glucose in combination with calcium chloride and/or sodium chloride and/or magnesium chloride and/or sodium citrate and/or potassium chloride (intravenous or parenteral use)" should be followed. Dec-15 calcium chloride dihydrate / glucose monohydrate Entry "glucose (apart from glucose1- phosphate) / glucose in combination with calcium chloride and/or sodium chloride and/or magnesium chloride and/or sodium citrate and/or potassium chloride (intravenous or parenteral use)" should be followed. Dec-15 calcium chloride dihydrate / glucose monohydrate / sodium chloride Entry "glucose (apart from glucose1- phosphate) / glucose in combination with calcium chloride and/or sodium chloride and/or magnesium chloride and/or sodium citrate and/or potassium chloride (intravenous or parenteral use)" should be followed. Dec-15 calcium chloride dihydrate / potassium chloride / sodium chloride Entry "glucose (apart from glucose1- phosphate) / glucose in combination with calcium chloride and/or sodium chloride and/or magnesium chloride and/or sodium citrate and/or potassium chloride (intravenous or parenteral use)" should be followed. Dec-15 chlortalidone / spironolactone Not authorised in EEA or in more than 1 Member state Dec-15 'dexbrompheniramine / pseudoephedrine Not authorised in EEA or in more than 1 Member state Dec-15 dexchlorpheniramine / guaiafenesin / pseudoephedrine Not authorised in EEA or in more than 1 Member state Dec-15 dexchlorpheniramine / pseudoephedrine Not authorised in EEA or in more than 1 Member state Dec-15 galactose Not authorised in EEA or in more than 1 Member state Dec-15 glucose Entry "glucose (apart from glucose1- phosphate) / glucose in combination with calcium chloride and/or sodium chloride and/or magnesium chloride and/or sodium citrate and/or potassium chloride (intravenous or parenteral use)" should be followed. Dec-15 glucose / potassium chloride Entry "glucose (apart from glucose1- phosphate) / glucose in combination with calcium chloride and/or sodium chloride and/or magnesium chloride and/or sodium citrate and/or potassium chloride (intravenous or parenteral use)" should be followed. Dec-15 glucose / potassium chloride / sodium chloride / sodium citrate Entry "glucose (apart from glucose1- phosphate) / glucose in combination with calcium chloride and/or sodium chloride and/or magnesium chloride and/or sodium citrate and/or potassium chloride (intravenous or parenteral use)" should be followed. Dec-15 glucose / sodium chloride Entry "glucose (apart from glucose1- phosphate) / glucose in combination with calcium chloride and/or sodium chloride and/or magnesium chloride and/or sodium citrate and/or potassium chloride (intravenous or parenteral use)" should be followed. Dec-15 linagliptin Entry "linagliptin, linagliptin / metformin" should be followed. Dec-15 linagliptin / metformin Entry "linagliptin, linagliptin / metformin" should be followed. Dec-15 dibrompropamidine Entry "dibrompropamidine , propamidine" should be followed. Nov-15 trapidil Not authorised in EEA or in more than 1 Member state Nov-15 empagliflozin Entry "empagliflozin, empagliflozin / metformin" should be followed. Nov-15 tacrolimus (systemic formulations) - for CAP Envarsus Entry "tacrolimus (systemic formulations)" should be followed. Nov-15 tocopherol / tretinoin Not authorised in EEA or in more than 1 Member state Oct-15 tioconazole Entry "tioconazole, tioconazole / hydrocortisone" should be followed. Oct-15 phenylephrine Entry divided according to indication. Entry "phenylephrine (IV, nasal or oral formulations )" or "phenylephrine (ophthalmic formulations)" should be followed. Oct-15 nystatin / tinidazole Entry "tinidazole / nystatin, tinidazole" should be followed Oct-15 tinidazole Entry "tinidazole / nystatin, tinidazole" should be followed Oct-15 beclometasone dipropionate / formoterol fumarate Entry "beclometasone / formoterol (inhalative application)" should be followed Sep-15 calcium carbonate / colecalciferol Entry "calcium salts / colecalciferol" should be followed Sep-15 calcium phosphate / colecalciferol Entry "calcium salts / colecalciferol" should be followed Sep-15 macrogol 4000 Entry "macrogol 4000 and combinations (systemic use)" to be followed Sep-15 'macrogol 4000 and combinations Entry "macrogol 4000 and combinations (systemic use)" to be followed Sep-15 macrogol 4000 / potassium chloride / sodium bicarbonate / sodium chloride / sodium sulfate anhydrous Entry "macrogol 4000 and combinations (systemic use)" to be followed Sep-15 rosiglitazone Not authorised in EEA or in more than 1 Member state Sep-15 valsartan Entry "valsartan, hydrochlorothiazide / valsartan" to be followed Sep-15 hydrochlorothiazide / valsartan Entry "valsartan,/ hydrochlorothiazide / valsartan" to be followed Sep-15 budipine Not authorised in EEA or in more than 1 Member state Jul-15 cidofovir Not authorised in EEA or in more than 1 Member state Jul-15 ferumoxytol Not authorised in EEA or in more than 1 Member state Jul-15 floctafenine Not authorised in EEA or in more than 1 Member state Jul-15 human fibrinogen / human thrombin (all pharmaceutical dose forms except for sealant matrix) Entry "human fibrinogen / human thrombin" should be followed Jul-15 raltegravir Entry "raltegravir, lamivudine / raltegravir " should be followed Jul-15 amitriptyline Entry "amitriptyline, amitriptyline / amitriptylinoxide, amitriptylinoxide" should be followed Jun-15 amitriptylinoxide Entry "amitriptyline, amitriptyline / amitriptylinoxide, amitriptylinoxide" should be followed Jun-15 amitriptyline / amitriptylinoxide Entry "amitriptyline, amitriptyline / amitriptylinoxide, amitriptylinoxide" should be followed Jun-15 colestilan Not authorised in EEA or in more than 1 Member state Jun-15 bacterial lysate Entry “bacterial lysates” removed and more specific entries are introduced Jun-15 allergen diagnostics: all prick and provocation tests of all species; intracutan tests (allergens) Allergen group entry is temporarily removed from the EURD list. For more details regarding this decision please refer to the PRAC minutes (May 2015 - Item 12.10.4.) http://www.ema.europa.eu/ema/index.jsp?curl=pages/about_us/document_listing/document_listing_000353.jsp May-15 allergen products for treatment: epithelia and feathers, single or mixes (parenteral preparations) native Allergen group entry is temporarily removed from the EURD list. For more details regarding this decision please refer to the PRAC minutes (May 2015 - Item 12.10.4.) http://www.ema.europa.eu/ema/index.jsp?curl=pages/about_us/document_listing/document_listing_000353.jsp May-15 allergen products for treatment: grass and cereal pollen, single or mixes (oral preparations, solid forms) native Allergen group entry is temporarily removed from the EURD list. For more details regarding this decision please refer to the PRAC minutes (May 2015 - Item 12.10.4.) http://www.ema.europa.eu/ema/index.jsp?curl=pages/about_us/document_listing/document_listing_000353.jsp May-15 allergen products for treatment: grass and cereal pollen, single or mixes (parenteral preparations) allergoid Allergen group entry is temporarily removed from the EURD list. For more details regarding this decision please refer to the PRAC minutes (May 2015 - Item 12.10.4.) http://www.ema.europa.eu/ema/index.jsp?curl=pages/about_us/document_listing/document_listing_000353.jsp May-15 allergen products for treatment: grass and cereal pollen, single or mixes (parenteral preparations) native Allergen group entry is temporarily removed from the EURD list. For more details regarding this decision please refer to the PRAC minutes (May 2015 - Item 12.10.4.) http://www.ema.europa.eu/ema/index.jsp?curl=pages/about_us/document_listing/document_listing_000353.jsp May-15 allergen products for treatment: insects venoms (parenteral preparations) native Allergen group entry is temporarily removed from the EURD list. For more details regarding this decision please refer to the PRAC minutes (May 2015 - Item 12.10.4.) http://www.ema.europa.eu/ema/index.jsp?curl=pages/about_us/document_listing/document_listing_000353.jsp May-15 allergen products for treatment: mites, single or mixes (oral presentation- liquid and semi-solid forms) native Allergen group entry is temporarily removed from the EURD list. For more details regarding this decision please refer to the PRAC minutes (May 2015 - Item 12.10.4.) http://www.ema.europa.eu/ema/index.jsp?curl=pages/about_us/document_listing/document_listing_000353.jsp May-15 allergen products for treatment: mites, single or mixes (parenteral preparations) allergoid Allergen group entry is temporarily removed from the EURD list. For more details regarding this decision please refer to the PRAC minutes (May 2015 - Item 12.10.4.) http://www.ema.europa.eu/ema/index.jsp?curl=pages/about_us/document_listing/document_listing_000353.jsp May-15 allergen products for treatment: mites, single or mixes (parenteral preparations) native Allergen group entry is temporarily removed from the EURD list. For more details regarding this decision please refer to the PRAC minutes (May 2015 - Item 12.10.4.) http://www.ema.europa.eu/ema/index.jsp?curl=pages/about_us/document_listing/document_listing_000353.jsp May-15 allergen products for treatment: moulds, single or mixes (parenteral preparations) native Allergen group entry is temporarily removed from the EURD list. For more details regarding this decision please refer to the PRAC minutes (May 2015 - Item 12.10.4.) http://www.ema.europa.eu/ema/index.jsp?curl=pages/about_us/document_listing/document_listing_000353.jsp May-15 allergen products for treatment: tree pollen, single or mixes (oral presentation – liquid and semi-solid forms) native Allergen group entry is temporarily removed from the EURD list. For more details regarding this decision please refer to the PRAC minutes (May 2015 - Item 12.10.4.) http://www.ema.europa.eu/ema/index.jsp?curl=pages/about_us/document_listing/document_listing_000353.jsp May-15 allergen products for treatment: tree pollen, single or mixes (parenteral preparations) allergoid Allergen group entry is temporarily removed from the EURD list. For more details regarding this decision please refer to the PRAC minutes (May 2015 - Item 12.10.4.) http://www.ema.europa.eu/ema/index.jsp?curl=pages/about_us/document_listing/document_listing_000353.jsp May-15 allergen products for treatment: tree pollen, single or mixes (parenteral preparations) native Allergen group entry is temporarily removed from the EURD list. For more details regarding this decision please refer to the PRAC minutes (May 2015 - Item 12.10.4.) http://www.ema.europa.eu/ema/index.jsp?curl=pages/about_us/document_listing/document_listing_000353.jsp May-15 allergen products for treatment: weed pollen, single or mixes (oral presentation – liquid) native Allergen group entry is temporarily removed from the EURD list. For more details regarding this decision please refer to the PRAC minutes (May 2015 - Item 12.10.4.) http://www.ema.europa.eu/ema/index.jsp?curl=pages/about_us/document_listing/document_listing_000353.jsp May-15 allergen products for treatment: weed pollen, single or mixes (parenteral preparations) allergoid Allergen group entry is temporarily removed from the EURD list. For more details regarding this decision please refer to the PRAC minutes (May 2015 - Item 12.10.4.) http://www.ema.europa.eu/ema/index.jsp?curl=pages/about_us/document_listing/document_listing_000353.jsp May-15 allergen products for treatment: weed pollen, single or mixes (parenteral preparations) native Allergen group entry is temporarily removed from the EURD list. For more details regarding this decision please refer to the PRAC minutes (May 2015 - Item 12.10.4.) http://www.ema.europa.eu/ema/index.jsp?curl=pages/about_us/document_listing/document_listing_000353.jsp May-15 allergens from vertebrates, single or mixes (parenteral presentations) native Allergen group entry is temporarily removed from the EURD list. For more details regarding this decision please refer to the PRAC minutes (May 2015 - Item 12.10.4.) http://www.ema.europa.eu/ema/index.jsp?curl=pages/about_us/document_listing/document_listing_000353.jsp May-15 products used in connection with allergen diagnostics: products for positive and negative control for allergy prick tests and negative control for allergy provocation tests; diluents (no active substance) for prick test and treatment products; positive and negative control for intracutan tests Allergen group entry is temporarily removed from the EURD list. For more details regarding this decision please refer to the PRAC minutes (May 2015 - Item 12.10.4.) http://www.ema.europa.eu/ema/index.jsp?curl=pages/about_us/document_listing/document_listing_000353.jsp May-15 guanfacine Not authorised in EEA or in more than 1 Member state May-15 dimethyl fumarate / ethyl fumarate calcium / ethyl fumarate magnesium / ethyl fumarate zinc Not authorised in EEA or in more than 1 Member state May-15 autologous peripheral-blood mononuclear cells activated with prostatic acid phosphatase granulocyte-macrophage colony-stimulating factor (sipuleucel-T) Not authorised in EEA or in more than 1 Member state May-15 amlodipine / indapamide Entry "'amlodipine / indapamide, amlodipine / indapamide / perindopril" should be followed May-15 amlodipine / indapamide / perindopril Entry "'amlodipine / indapamide, amlodipine / indapamide / perindopril" should be followed May-15 budipine Not authorised in EEA or in more than 1 Member state May-15 adrafinil Not authorised in EEA or in more than 1 Member state May-15 human fibrinogen / human thrombin (sealant matrix) Entry "human fibrinogen / human thrombin" should be followed Apr-15 phloroglucinol / trimethylphloroglucinol Entry "phloroglucinol, phloroglucinol / trimethylphloroglucinol" should be followed Apr-15 phloroglucinol Entry "phloroglucinol, phloroglucinol / trimethylphloroglucinol" should be followed Apr-15 niaprazine Not authorised in EEA or in more than 1 Member state Apr-15 misoprostol (gynaecological indication) Entries "misoprostol (gynaecological indication - labor induction)" and "misoprostol (gynaecological indication - termination of pregnancy)" should be followed accordingly Apr-15 mazindol Not authorised in EEA or in more than 1 Member state Apr-15 human spongiosa Not authorised in EEA or in more than 1 Member state Apr-15 human fascia lata collagen Not authorised in EEA or in more than 1 Member state Apr-15 ferumoxtran-10 (superparamagnetic ironoxide) Not authorised in EEA or in more than 1 Member state Apr-15 ferumoxides Not authorised in EEA or in more than 1 Member state Apr-15 chlorphenamine / dexchlorpheniramine / pseudoephedrine Not authorised in EEA or in more than 1 Member state Apr-15 carmustine Entries "carmustine (powder and solvent for solution for infusion)" and "carmustine (implant)" should be followed accordingly Apr-15 caffeine / dexchlorpheniramine / dextromethorphan Not authorised in EEA or in more than 1 Member state Apr-15 atorvastatin (paediatric indication) Entry "atorvastatin" should be followed Apr-15 atorvastatin (adult indication) Entry "atorvastatin" should be followed Apr-15 aprotinin / human fibrinogen / thrombin (calcium chloride) Entry "aprotinin / calcium chloride / human factor xiii / human fibrinogen / human thrombin, aprotinin / fibrinogen / fibronectin / human coagulation factor XIII / plasma protein fraction / plasminogen / thrombin, aprotinin / human fibrinogen / thrombin (calcium chloride)" should be followed Apr-15 aprotinin / fibrinogen / fibronectin / human coagulation factor XIII / plasma protein fraction / plasminogen / thrombin Entry "aprotinin / calcium chloride / human factor xiii / human fibrinogen / human thrombin, aprotinin / fibrinogen / fibronectin / human coagulation factor XIII / plasma protein fraction / plasminogen / thrombin, aprotinin / human fibrinogen / thrombin (calcium chloride)" should be followed Apr-15 aprotinin / calcium chloride / human factor xiii / human fibrinogen / human thrombin Entry "aprotinin / calcium chloride / human factor xiii / human fibrinogen / human thrombin, aprotinin / fibrinogen / fibronectin / human coagulation factor XIII / plasma protein fraction / plasminogen / thrombin, aprotinin / human fibrinogen / thrombin (calcium chloride)" should be followed Apr-15 codergocrine mesilate Entry "dihydroergotoxine" should be followed Mar-15 ibuprofen lysine Entry "ibuprofen, ibuprofen lysine (not indicated in ductus arteriosus)" should be followed Mar-15 ibuprofen Entry "ibuprofen, ibuprofen lysine (not indicated in ductus arteriosus)" should be followed Mar-15 sodium bicarbonate Entry "'sodium hydrogen carbonate" should be followed Mar-15 diclofenac (ophtalmic formulations) Entry "diclofenac (topical formulations)" should be followed Mar-15 diclofenac (cutaneous formulations) Entry "diclofenac (topical formulations)" should be followed Mar-15 amlodipine / valsartan Entry "'amlodipine / valsartan, amlodipine / hydrochlorothiazide, valsartan" should be followed Mar-15 amlodipine / hydrochlorothiazide / valsartan Entry "'amlodipine / valsartan, amlodipine / hydrochlorothiazide, valsartan" should be followed Mar-15 aluminium / calcium or aluminium / magnesium Not authorised in EEA or in more than 1 Member state Feb-15 acidic acid / nitric acid / oxalic acid / zinc nitrate Not authorised in EEA or in more than 1 Member state Feb-15 pegaspargase Entry "asparaginase" should be followed Jan-15 crisantaspase (erwinia L-asparaginase) Entry "asparaginase" should be followed Jan-15 cilazapril / hydrochlorothiazide Entry "'cilazapril, cilazapril / hydrochlorothiazide" should be followed Jan-15 bromhexine / ephedrine Not authorised in EEA or in more than 1 Member state Jan-15 anise oil / bromhexine / fennel oil / levomenthol Not authorised in EEA or in more than 1 Member state Jan-15 ambroxol hydrochloride / theophylline Not authorised in EEA or in more than 1 Member state Jan-15 canagliflozin / metformin Entry "'canagliflozin, canagliflozin / metformin" should be followed Dec-14 acethylthyrosine / acetylcysteine / alanine / arginine / asparagine monohydrate / aspartic acid / glutamic acid / glycine / histidine / isoleucine / leucine / lysine acetate / methionine / ornithine hydrochloride / phenylalanine / proline / serine / threonine / tryptophane / valine Entry "'amino acid combinations (only combinations of pure amino acids or combination of amino acids with mineral compounds/electrolytes, i.v. application)" should be followed Dec-14 metformin / vildagliptin Entry "'vildagliptin, metformin / vildagliptin" should be followed Nov-14 caffeine / opium / paracetamol Not authorised in EEA or in more than 1 Member state Nov-14 hydroxyzine Entry removed as duplicate to "hydroxyzine chloride / hydroxyzine pamoate and all fixed combination, hydroxyzine" Nov-14 doripenem Not authorised in EEA or in more than 1 Member state Nov-14 camphor / eucalyptus oil / menthol / thymol / turpentine oil Entry "'camphor, camphor and other terpene derivates" should be followed Nov-14 camphor / eucalyptus oil / menthol / turpentine oil Entry "'camphor, camphor and other terpene derivates" should be followed Nov-14 camphor / menthol Entry "'camphor, camphor and other terpene derivates" should be followed Nov-14 camphor / ichtamol Entry "'camphor, camphor and other terpene derivates" should be followed Nov-14 sodium salt of gamma-hydroxybutyric acid Entry "sodium oxybate" should be followed Oct-14 bendroflumethiazide / spironolactone Not authorised in EEA or in more than 1 Member state Sep-14 nelfinavir Not authorised in EEA or in more than 1 Member state Sep-14 chlorazepate Entry clorazepate in the EURD list to be followed Sep-14 cetylpyridinium chloride / muramidase hydrochloride Entry cetylpyridinium, lysozyme in the EURD list to be followed Sep-14 calcium pantothenate / dl-methionine / l-cystine / pa / pyridoxine hcl / thiamine hcl Not authorised in EEA or in more than 1 Member state Sep-14 benztropine mesylate Entry benztropine in the EURD list to be followed Sep-14 benfotiamine / calcium hydrogen phosphate dihydrate / magnesium estearate Entry benfotiamine in the EURD list to be followed Sep-14 benfotiamine / calcium hydrogen phosphate dihydrate / cyanocobalamin / magnesium estearate / pyridoxine Entry benfotiamine, cyanocobalamin, pyridoxine in the EURD list to be followed Sep-14 ammonium salt / glycine / glycyrrhizic acid / l-station sun cysteine hydrochloride hydrate Not authorised in EEA or in more than 1 Member state Sep-14 aluminium hydroxide dried / magnesium hydroxide / simeticone Entry aluminium oxide, magnesium hydroxide, simeticone in the EURD list to be followed Sep-14 benzalkonium chloride / potassium alum Entry alum, benzalkonium chloride in the EURD list to be followed Sep-14 sodium ferrous citrate Entry iron, oral preparations in the EURD list to be followed Jul-14 sodium ferric gluconate complex Entry iron, parenteral preparations in the EURD list to be followed Jul-14 iron / sodium feredetate Entry sodium feredetate in the EURD list to be followed Jul-14 folic acid / iron Entry iron in combination with folic acid and other substances in the EURD list to be followed Jul-14 ferrous sulphate / folic acid Entry iron in combination with folic acid and other substances in the EURD list to be followed Jul-14 ferrous sulfate / serine Entry iron in combination with folic acid and other substances in the EURD list to be followed Jul-14 ferrous sulfate Entry iron, oral preparations in the EURD list to be followed Jul-14 ferrous salts Entry iron, oral preparations in the EURD list to be followed Jul-14 ferrous lactate Entry iron, oral preparations in the EURD list to be followed Jul-14 ferrous glycine sulfate Entry iron, oral preparations in the EURD list to be followed Jul-14 ferrous gluconate Entry iron, oral preparations in the EURD list to be followed Jul-14 ferrous fumarate Entry iron, oral preparations in the EURD list to be followed Jul-14 ferrous aspartate Entry iron, oral preparations in the EURD list to be followed Jul-14 ferric polymaltose / folic acid Entry iron in combination with folic acid and other substances in the EURD list to be followed Jul-14 ferric hydroxide sucrose complex Entry iron, parenteral preparations in the EURD list to be followed Jul-14 dextriferron Entry iron, parenteral preparations in the EURD list to be followed Jul-14 cyanocobalamin / ferrous sulfate / folic acid Entry iron in combination with folic acid and other substances in the EURD list to be followed Jul-14 cyanocobalamin / dl-serine / ferrous sulfate / folic acid Entry iron in combination with folic acid and other substances in the EURD list to be followed Jul-14 copper gluconate / ferrous gluconate / manganese gluconate Entry iron in any combination including one or more of the following: multivitamins, minerals, aminoacids, herbal extracts, lecithine (except for combinations with folic acid)to be followed Jul-14 chromium trichloride hexahydrate / copper chloride dihydrate / ferric chloride hexahydrate / manganese chloride tetrahydrate / potassium iodide / sodium fluoride / sodium molybdate dihydrate / sodium selenite / water for injection / zinc chloride Entry iron in any combination including one or more of the following: multivitamins, minerals, aminoacids, herbal extracts, lecithine (except for combinations with folic acid)to be followed Jul-14 calcium panthotenate / copper / d /l-methionine / faex medicinalis / iron / l-cystine / milium semen extract / paraaminobenzoic acid / pyridoxine hydrochloride / thiamine hydrochloride / triticum germs extract / zinc Entry iron in any combination including one or more of the following: multivitamins, minerals, aminoacids, herbal extracts, lecithine (except for combinations with folic acid)to be followed Jul-14 calcium folinate / iron protein succinylate Entry calcium folinate, iron succinyl-protein complex in the EURD list to be followed Jul-14 ascorbic acid / ferrous sulfate Entry iron in any combination including one or more of the following: multivitamins, minerals, aminoacids, herbal extracts, lecithine (except for combinations with folic acid)to be followed Jul-14 ascorbic acid / calcium hydrogenphosphate / calcium panthotenate / colecalciferol / copper sulfate / cyanocobalamin / ferrous fumarate / folic acid / magnesium lactate / manganese sulfate / nicotinamide / pyridoxine hydrochloride / retinol / riboflavine / sodium molybdenate / thiamin nitrate / tocopherol acetate / zinc sulfate Entry iron in combination with folic acid and other substances in the EURD list to be followed Jul-14 ascorbic acid / betacarotene / biotine / calcium hydrogenphosphate / colecalciferol / copper sulfate / cyanocobalamin / ferrous sulfate / folic acid / ginseng radix extract / magnesium oxide / manganese sulfate / nicotinamide / pyridoxine hydrochloride / riboflavine / sodium selenate / thiamin nitrate / tocopherol alpha dl acetate / zinc sulfate Entry iron in combination with folic acid and other substances in the EURD list to be followed Jul-14 ascorbic acid / calcium hydrogenphosphate / calcium lactate / calcium panthotenate / colecalciferol / cyanocobalamin / ferrous fumarate / folic acid / nicotinamide / pyridoxine hydrochloride / retinol palmitate / riboflavine / thiamin nitrate / tocoferol acetate Entry iron in combination with folic acid and other substances in the EURD list to be followed Jul-14 ascorbic acid / calcium fluoride / calcium hydrogenphosphate / calcium panthotenate / copper sulfate / cyanocobalamin / deanol hydrogentartrate / ergocalciferol / ferrous sulfate / ginseng radix extract / lecithine / magnesium sulfate / manganese sulfate / nicotinamide / potassium sulfate / pyridoxine hydrochloride / retinol palmitate / riboflavine / rutoside / soy lecithine / thiamine nitrate / tocopherol alpha dl acetate / zinc oxide Entry iron in any combination including one or more of the following: multivitamins, minerals, aminoacids, herbal extracts, lecithine (except for combinations with folic acid) in the EURD list to be followed Jul-14 ammonium molybdate tetrahydrate / chromium trichloride hexahydrate / cobalt gluconate / copper gluconate / ferrous gluconate / manganese gluconate / sodium fluoride / sodium iodide / sodium selenite / zinc gluconate Entry iron in any combination including one or more of the following: multivitamins, minerals, aminoacids, herbal extracts, lecithine (except for combinations with folic acid) in the EURD list to be followed Jul-14 valpromide Entry valproic acid / sodium valproate / valproate pivoxil / valproate semisodium / valpriomide / valproate bismuth / calcium valproate / valproate magnesium in the EURD list to be followed Jul-14 divalproex sodium Entry valproic acid / sodium valproate / valproate pivoxil / valproate semisodium / valpriomide / valproate bismuth / calcium valproate / valproate magnesium in the EURD list to be followed Jul-14 valproic acid Entry valproic acid / sodium valproate / valproate pivoxil / valproate semisodium / valpriomide / valproate bismuth / calcium valproate / valproate magnesium in the EURD list to be followed Jul-14 alphatocopherol / ascorbic acid / betacarotene / cyanocobalamin / extractum ginseng / ferrous fumarate / nicotinamide / pyridoxine hydrochloride / thiamine mononitrate Entry iron in any combination including one or more of the following: multivitamins, minerals, aminoacids, herbal extracts, lecithine (except for combinations with folic acid) in the EURD list to be followed Jul-14 methotrimeprazine Entry levomepromazine in the EURD list to be followed May-14 diacethyl-midecamycin Entry midecamycin acetate in the EURD list to be followed May-14 aliskiren / amlodipine / hydrochlorothiazide Not authorised in EEA or in more than 1 Member state Feb-14 anti-human t-lymphocyte immunoglobulin from rabbits Moved temporarily to the “List of substances under PSUR Work Sharing scheme and other substances contained in Nationally Authorised Products with DLP synchronised” Feb-14 desvenlafaxine Not authorised in EEA or in more than 1 Member state Feb-14 diphtheria / tetanus / pertussis (whole cell) and hepatitis B(Rdna) (Hbv) vaccine (adsorbed) Not authorised in EEA or in more than 1 Member state Feb-14 iobitridol Moved temporarily to the “List of substances under PSUR Work Sharing scheme and other substances contained in Nationally Authorised Products with DLP synchronised” Feb-14 prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) Merged entry with pandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) Feb-14 docosahexaenoic acid / eicosapentanoic acid Entry omega-3-acid-ethyl esters in the PSUR WS List to be followed Feb-14 human albumin solution Moved temporarily to the “List of substances under PSUR Work Sharing scheme and other substances contained in Nationally Authorised Products with DLP synchronised” Feb-14 laropiprant / nicotinic acid Not authorised in EEA or in more than 1 Member state Feb-14 metformin hydrochloride / rosiglitazone Not authorised in EEA or in more than 1 Member state Feb-14 rilonacept Not authorised in EEA or in more than 1 Member state Feb-14 tetrofosmin Merged entry with technetium (99mTc) tetrofosmin Feb-14 articaine hydrochloride / ephedrine Not authorised in EEA or in more than 1 Member state Jan-14 alogliptin / metformin Included in shared entry "alogliptin, alogliptin / metformin, alogliptin / pioglitazone" Jan-14 porfimer Moved temporarily to the “List of substances under PSUR Work Sharing scheme and other substances contained in Nationally Authorised Products with DLP synchronised” Jan-14 flupirtine Moved temporarily to the “List of substances under PSUR Work Sharing scheme and other substances contained in Nationally Authorised Products with DLP synchronised” Nov-13 clarithromycin Moved temporarily to the “List of substances under PSUR Work Sharing scheme and other substances contained in Nationally Authorised Products with DLP synchronised” Oct-13 doconexent / eicosapentaenoic acid / omega-3 acid ethyl esters Replaced with "omega-3-acid-ethyl esters" which is placed temporarily in the “List of substances under PSUR Work Sharing scheme and other substances contained in Nationally Authorised Products with DLP synchronised” Oct-13 testosterone enantate injection Replaced with "testosterone (all formulations apart from transdermal application and testosterone undecylate injection)" Oct-13 carbamoylphenoxyacetic acid / theophylline Not authorised in EEA or in more than 1 Member state Sep-13 cilostazol Moved temporarily to the “List of substances under PSUR Work Sharing scheme and other substances contained in Nationally Authorised Products with DLP synchronised” Sep-13 quinine combinations Entry too general, specific combinations will be specified in the EURD List if those are authorised in EEA or in more than 1 Member state. Sep-13 defibrotide Not authorised in EEA or in more than 1 Member state Jul-13 diphtheria / tetanus / pertussis (acellular, component) / hepatitis b (rdna) / poliomyelitis (inactivated) vaccines (adsorbed) Not authorised in EEA or in more than 1 Member state Jul-13 alemtuzumab Not authorised in EEA or in more than 1 Member state Jul-13 chlorhexidine gluconate / tixocortol pivalate Moved temporarily to the “List of substances under PSUR Work Sharing scheme and other substances contained in Nationally Authorised Products with DLP synchronised” Jul-13 aloe barbadensis miller / aloe ferox miller, folium Products which do not fall in the scope of Article 10(1), 10a, 16, 14a of Directive 2001/83/EC as amended should follow national requirements for the submission of PSURs May-13 aloe barbadensis miller / aloe ferox miller, folium Products which do not fall in the scope of Article 10(1), 10a, 16, 14a of Directive 2001/83/EC as amended should follow national requirements for the submission of PSURs May-13 arctostaphylos uva-ursi (L.) spreng., folium Products which do not fall in the scope of Article 10(1), 10a, 16, 14a of Directive 2001/83/EC as amended should follow national requirements for the submission of PSURs May-13 capsicum annuum L. var. minimum (Miller) heiser, fructus Products which do not fall in the scope of Article 10(1), 10a, 16, 14a of Directive 2001/83/EC as amended should follow national requirements for the submission of PSURs May-13 cassia senna L.; cassia angustifolia vahl, fructus // cassia senna L.; cassia angustifolia vahl, folium Products which do not fall in the scope of Article 10(1), 10a, 16, 14a of Directive 2001/83/EC as amended should follow national requirements for the submission of PSURs May-13 cephaelis ipecacuanha (brot.) a. rich.; cephaelis acuminata karsten, radix Products which do not fall in the scope of Article 10(1), 10a, 16, 14a of Directive 2001/83/EC as amended should follow national requirements for the submission of PSURs May-13 echinacea pallida (nutt.) nutt.; echinacea purpurea (L.) moench; echinacea angustifolia dc, radix // echinacea purpurea (L.) moench, herba Products which do not fall in the scope of Article 10(1), 10a, 16, 14a of Directive 2001/83/EC as amended should follow national requirements for the submission of PSURs May-13 eucalyptus globulus labill., aetheroleum Products which do not fall in the scope of Article 10(1), 10a, 16, 14a of Directive 2001/83/EC as amended should follow national requirements for the submission of PSURs May-13 ginkgo biloba L., folium Products which do not fall in the scope of Article 10(1), 10a, 16, 14a of Directive 2001/83/EC as amended should follow national requirements for the submission of PSURs May-13 glycyrrhiza glabra L.; glycyrrhiza inflata bat.; glycyrrhiza uralensis fisch., radix Products which do not fall in the scope of Article 10(1), 10a, 16, 14a of Directive 2001/83/EC as amended should follow national requirements for the submission of PSURs May-13 melaleuca alternifolia (maiden and betche) cheel, aetheroleum Products which do not fall in the scope of Article 10(1), 10a, 16, 14a of Directive 2001/83/EC as amended should follow national requirements for the submission of PSURs May-13 melaleuca viridiflora, (melaleuca quinquenervia) Broad-leaved paperbark, aetheroleum Products which do not fall in the scope of Article 10(1), 10a, 16, 14a of Directive 2001/83/EC as amended should follow national requirements for the submission of PSURs May-13 mentha x piperita l., aetheroleum Products which do not fall in the scope of Article 10(1), 10a, 16, 14a of Directive 2001/83/EC as amended should follow national requirements for the submission of PSURs May-13 pinus sylvestris L., aetheroleum Products which do not fall in the scope of Article 10(1), 10a, 16, 14a of Directive 2001/83/EC as amended should follow national requirements for the submission of PSURs May-13 plantago ovata forssk., semen Products which do not fall in the scope of Article 10(1), 10a, 16, 14a of Directive 2001/83/EC as amended should follow national requirements for the submission of PSURs May-13 plantago ovata forssk., seminis tegumentum Products which do not fall in the scope of Article 10(1), 10a, 16, 14a of Directive 2001/83/EC as amended should follow national requirements for the submission of PSURs May-13 rhamnus purshianus dc, cortex Products which do not fall in the scope of Article 10(1), 10a, 16, 14a of Directive 2001/83/EC as amended should follow national requirements for the submission of PSURs May-13 rheum palmatum L.; rheum officinale baillon, radix Products which do not fall in the scope of Article 10(1), 10a, 16, 14a of Directive 2001/83/EC as amended should follow national requirements for the submission of PSURs May-13 serenoa repens (bartram) small (sabal serrulata (michaux) nichols, fructus Products which do not fall in the scope of Article 10(1), 10a, 16, 14a of Directive 2001/83/EC as amended should follow national requirements for the submission of PSURs May-13 symphytum officinale L. radix Products which do not fall in the scope of Article 10(1), 10a, 16, 14a of Directive 2001/83/EC as amended should follow national requirements for the submission of PSURs May-13 thymus vulgaris L.; thymus zygis loefl. ex L., aetheroleum Products which do not fall in the scope of Article 10(1), 10a, 16, 14a of Directive 2001/83/EC as amended should follow national requirements for the submission of PSURs May-13 valeriana officinalis L., radix Products which do not fall in the scope of Article 10(1), 10a, 16, 14a of Directive 2001/83/EC as amended should follow national requirements for the submission of PSURs May-13 xysmalobium undulatum L. Aiton f. var. undulatatum, radix Products which do not fall in the scope of Article 10(1), 10a, 16, 14a of Directive 2001/83/EC as amended should follow national requirements for the submission of PSURs May-13 paracetamol (IV formulation) Moved temporarily to the “List of substances under PSUR Work Sharing scheme and other substances contained in Nationally Authorised Products with DLP synchronised” May-13 cyproterone / ethinylestradiol Moved temporarily to the “List of substances under PSUR Work Sharing scheme and other substances contained in Nationally Authorised Products with DLP synchronised” May-13 gentamicin / zyrconium Not authorised in EEA or in more than 1 Member state Apr-13 amcinonide / neomycin Not authorised in EEA or in more than 1 Member state Apr-13 ascorbic acid / cetylpyridinium Not authorised in EEA or in more than 1 Member state Apr-13 deltamethrin Not authorised in EEA or in more than 1 Member state Apr-13 human plasma protease C1 inhibitor Moved temporarily to the “List of substances under PSUR Work Sharing scheme and other substances contained in Nationally Authorised Products with DLP synchronised” Apr-13 doxylamine Moved temporarily to the “List of substances under PSUR Work Sharing scheme and other substances contained in Nationally Authorised Products with DLP synchronised” Apr-13 almitrine dimesilate / raubasine Not authorised in EEA or in more than 1 Member state Feb-13 amylase / lipase / protease Please refer to entry: pancreatic enzymes / pancreatic extracts / pancreatin Jan-13 grepafloxacin hydrochloride Not authorised in EEA or in more than 1 Member state Dec-12 _x000D_&1#&"Verdana"&7&K737373 Classified as internal/staff & contractors by the European Medicines Agency

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Report Form Field Safety Corrective Action Medical Devices Vigilance System 1 Administrative information 1.2 Type of report in format YYYY-MM-DD 2 Submitter of the report Status of submitter 3 Manufacturer information 4 Authorised representative information 5 National contact point information 6 Medical device information Risk class(es) of device(s) when placed on the market 6.1 6.2 MDD/AIMDD IVDD 6.3 MDR Type (Multiple choice) IVDR Type (Multiple choice) 6.4       Does the device fulfil any of the following cases:       - “for this device a scientific opinion has been asked in accordance with Article 52(9) MDR or Article 52(10) MDR”,        - “for companion diagnostic a competent authority or European Medicines Agency (EMA) was consulted in accordance with           section 5.2 of Annex IX IVDR or section 3.k of Annex X IVDR." Competent authority name or European Medicines Agency  which delivered the scientific opinion or was consulted by the notified body Name(s) of the medicinal substance(s) / product(s), tissue(s), cell(s) of human origin or their derivative(s) associated with the device Unique Device Identification (UDI) Categorisation of device Description of device and commercial information in format YYYY-MM-DD in format YYYY-MM-DD 7 Description of the FSCA Coding with IMDRF terms is a mandatory requirement 7.2 Is there suspicion or confirmation of a relationship between the FSCA and the medicinal substance(s) / product(s), tissue(s), cell(s) of human origin or their derivative(s) associated with the device? 7.3 IMDRF Medical device problem codes Choice 1 (most relevant) Choice 2 Choice 3 Choice 4 Choice 5 Choice 6 IMDRF 'Medical device problem codes'                                              ( Annex A) 7.4 IMDRF Cause Investigation findings Choice 1 (most relevant) Choice 2 Choice 3 Choice 4 Choice 5 Choice 6 IMDRF 'Cause Investigation findings'                                              ( Annex C) 7.5 IMDRF Cause investigation conclusions  Choice 1 (most relevant) Choice 2 Choice 3 Choice 4 Choice 5 Choice 6 IMDRF 'Cause Investigation conclusions'                          ( Annex D) 7.6 IMDRF Health impact codes Choice 1 (most relevant) Choice 2 Choice 3 Choice 4 Choice 5 Choice 6 IMDRF 'Health impact codes'                                              ( Annex F) 7.11 Attached please find FSN Status 7.12 Market distribution of device (region/country) The code XI is used for Northern Ireland Candidate Countries 8 Comments Submission of this report does not, in itself, represent a conclusion by the manufacturer and/or authorised representative or the National Competent Authority that the content of this report is complete or accurate, that the medical device(s) listed failed in any manner and/or that the medical device(s) caused or contributed to the alleged death or deterioration in the state of the health of any person. I affirm that the information given above is correct to the best of my knowledge. NOTE: Please do not print this form but send it electronically by clicking the 'Send XML-data by E-Mail' and attach a copy of the form on this email. By hitting the button 'Send XML data by E-Mail' the data will be extracted, written into an XML file and attached on a pre-filled email. Please check your out box whether the email has been sent as the time stamp on this form IS NOT an indicator for correct sending of the email. You should save the form within your system before hitting the button 'Send XML data by E-Mail' as after that the form is write-protected and cannot be used for the submission of follow-up or final reports. Textfields printable summary SB-11371-RC1 4.0 2000-02-24 FSCA Report Form SANTE-BI@ec.europa.eu SANTE BI 2026-08-12 Version 4.0 - SB-11371-RC1 Version 4.0 - SB-xxxxx Link all fields of Section 3 with the XSD + update code 07-03-25 Update the links and code of all fields of section 1 & 2 06-03-25 Repair the XSL file (IN & OUT) - 05-03-25 Starting project version 4: 24-02-2025 SANTE.R.4 btnImport: btnExportXml: btnNewCase: btnTestData: btnFixSave: XMLVersion: formVersion: SB_NBR: ncaName: reportType: reportDate: mfrInternalNo: ncaReportNo: ncaIncidenceReportNo: ncaCoordinating: statusReporter: reporterOtherText: delete manufacturer information: mfrName: mfrSRN: mfrContactName: mfrAddress: mfrPostcode: mfrCity: mfrPhone: mfrFax: mfrEmailAddress: mfrCountry: delete Authorised Representative Information: ARName: ARSRN: ARContactPerson: ARAddress: ARPostCode: ARCity: ARPhone: ARFax: AREmailAddress: pg 2 - S1.3.3.g: AR Country ISO 3166-1 alpha-2: delete submitter’s information: National Contact Point: ncpContactPerson: ncpOrgAddress: ncpOrgPostcode: ncpOrgCity: ncpOrgPhone: ncpOrgFax: ncpOrgEmail: pg 2 - S1.3.2.g: Country ISO 3166-1 alpha-2: delete device information: deviceClassMarket_Y: deviceClassMDD: deviceClassIVDD: deviceClassMDR: deviceClassMDRType1: deviceClassMDRType2: deviceClassMDRType3: deviceClassMDRType4: deviceClassMDRType5: deviceClassMDRType6: deviceClassMDRType7: deviceClassMDRType8: deviceClassMDRType9: deviceClassMDRType10: deviceClassMDRType11: deviceClassIVDR: deviceClassIVDRType1: deviceClassIVDRType2: deviceClassIVDRType3: deviceClassIVDRType4: deviceClassIVDRType5: deviceClassIVDRType6: deviceClassIVDRType7: deviceClassIVDRType8: DeviceFulfill: CompetentAuthName: RelevantName: udiDI: udiPI: udiDIBasic: udiDIUnitUse: nomenclatureSystem: nomenclatureCode: nomenclatureCodeDefinedInText: brandName: modelNum: catalogNum: serialNum: batchNum: deviceMfrDate: deviceExpiryDate: nbIdNum: deviceSoftwareVer: deviceAccessories: fscaBackground: RelationShip_Y: RelationShip_N: imdrfCodeChoice1: imdrfCodeChoice2: imdrfCodeChoice3: imdrfCodeChoice4: imdrfCodeChoice5: imdrfCodeChoice6: imdrfInvestigationFindingsCodeChoice1: imdrfInvestigationFindingsCodeChoice2: imdrfInvestigationFindingsCodeChoice3: imdrfInvestigationFindingsCodeChoice4: imdrfInvestigationFindingsCodeChoice5: imdrfInvestigationFindingsCodeChoice6: imdrfInvestigationConclusionCodeChoice1: imdrfInvestigationConclusionCodeChoice2: imdrfInvestigationConclusionCodeChoice3: imdrfInvestigationConclusionCodeChoice4: imdrfInvestigationConclusionCodeChoice5: imdrfInvestigationConclusionCodeChoice6: imdrfHealthImpactCodeChoice1: imdrfHealthImpactCodeChoice2: imdrfHealthImpactCodeChoice3: imdrfHealthImpactCodeChoice4: imdrfHealthImpactCodeChoice5: imdrfHealthImpactCodeChoice6: fscaDescription: fscaAdvice: fscaProgress: fscaTimeSchedule: fscaAttachmentFSNEnglish: 0 fscaAttachmentFSNNational: 0 fscaAttachmentFSNOther: 0 fscaAttachmentStatus: fscaAttachmentOtherText: distribution_all: Austria: Belgium: Bulgaria: Switzerland: Cyprus: Czech Republic: Germany: Denmark: Estonia: Spain: Finland: France: Greece: Croatia: Hungary: Ireland: Iceland: Italy: Liechtenstein: Lithuania: Luxembourg: Latvia: Malta: Netherlands: Norway: Poland: Portugal: Romania: Sweden: Slovenia: Slovakia: Turkey: Northern Ireland: distributionOutsideEU: Serbia: Macedonia: Montenegro: Albania: additionalComments: Signaturesfeld1: bt_Print: bt_Email: bt_Check: TF_06_04a: TF_06_04b: TF_06_05: TF_06_06: TF_06_07: TF_06_08: TF_06_11: TF_06_12: TF_06_13: TF_06_14: TF_06_16: TF_06_21: TF_07_01: TF_07_07: TF_07_08: TF_07_09: TF_07_10: TF_07_11: TF_07_12: TF_08_00: