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31 August 2026
EMA/PRAC/164465/2026
Human Medicines Division
Pharmacovigilance Risk Assessment Committee (PRAC)
Draft agenda for the meeting on 31 August-03 September 2026
Chair: Ulla Wändel Liminga – Vice-Chair: Liana Martirosyan
31 August 2026, 09:30 – 19:30, virtual meeting/room 2D
01 September 2026, 08:30 – 19:30, virtual meeting/room 2D
02 September 2026, 08:30 – 19:30, virtual meeting/room 2D
03 September 2026, 08:30 – 16:00, virtual meeting/room 2D
Disclaimers
Some of the information contained in this agenda is considered commercially confidential or sensitive
and therefore not disclosed. With regard to intended therapeutic indications or procedure scopes listed
against products, it must be noted that these may not reflect the full wording proposed by applicants
and may also change during the course of the review. Additional details on some of these procedures
will be published in the PRAC meeting highlights once the procedures are finalised.
Of note, this agenda is a working document primarily designed for PRAC members and the work the
Committee undertakes.
Note on access to documents
Some documents mentioned in the agenda cannot be released at present following a request for
access to documents within the framework of Regulation (EC) No 1049/2001 as they are subject to on-
going procedures for which a final decision has not yet been adopted. They will become public when
adopted or considered public according to the principles stated in the Agency policy on access to
documents (EMA/127362/2006 Rev.1).
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Pharmacovigilance Risk Assessment Committee (PRAC)
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Table of contents
1. Introduction 12
1.1. Welcome and declarations of interest of members, alternates and experts .......... 12
1.2. Agenda of the meeting on 31 August-03 September 2026 .................................... 12
1.3. Minutes of the previous meeting on 06-09 July 2026 ........................................... 12
2. EU referral procedures for safety reasons: urgent EU procedures 12
2.1. Newly triggered procedures ................................................................................. 12
2.2. Ongoing procedures ............................................................................................. 12
2.3. Procedures for finalisation.................................................................................... 12
3. EU referral procedures for safety reasons: other EU referral
procedures 12
3.1. Newly triggered procedure ................................................................................... 12
3.1.1. Ferric carboxymaltose, ferric derisomaltose, ferric gluconate, iron sucrose, iron dextran (NAP) -
EMA/REF/0000369747 ............................................................................................. 12
3.2. Ongoing procedures ............................................................................................. 13
3.3. Procedures for finalisation.................................................................................... 13
3.4. Re-examination procedures .................................................................................. 13
3.5. Others .................................................................................................................. 13
4. Signals assessment and prioritisation 13
4.1. New signals detected from EU spontaneous reporting systems and/or other sources
............................................................................................................................. 13
4.1.1. Acitretin (NAP) ........................................................................................................ 13
4.1.2. Anakinra - KINERET (CAP) ........................................................................................ 14
4.1.3. Deucravacitinib – SOTYKTU (CAP) .............................................................................. 14
4.1.4. Fentanyl (transdermal patches) (NAP) ........................................................................ 14
4.1.5. Gefitinib - IRESSA (CAP) .......................................................................................... 14
4.1.6. Idarucizumab - PRAXBIND (CAP) ............................................................................... 14
4.1.7. Infliximab - FLIXABI (CAP), REMICADE (CAP), REMSIMA (CAP), ZESSLY (CAP) ................ 15
4.1.8. Lazertinib - LAZCLUZE (CAP) ..................................................................................... 15
4.1.9. Progestogens (NAP) ................................................................................................. 15
4.2. Signals follow-up and prioritisation ...................................................................... 16
4.2.1. Oxacillin (NAP) ........................................................................................................ 16
4.3. Variation procedure(s) resulting from signal evaluation ...................................... 16
5. Risk management plans (RMPs) 16
5.1. Medicines in the pre-authorisation phase ............................................................. 16
5.1.1. Anselamimab (CAP MAA) - EMEA/H/C/006422, Orphan ................................................ 16
5.1.2. Apixaban (CAP MAA) - EMEA/H/C/006752 ................................................................... 16
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5.1.3. Baxdrostat (CAP MAA) - EMEA/H/C/006597 ................................................................ 16
5.1.4. Bevacizumab (CAP MAA) - EMEA/H/C/005995 ............................................................. 16
5.1.5. Ensartinib (CAP MAA) - EMEA/H/C/006757 ................................................................. 17
5.1.6. Filgrastim (CAP MAA) - EMEA/H/C/007009 .................................................................. 17
5.1.7. Fondaparinux sodium (CAP MAA) - EMEA/H/C/006824 ................................................. 17
5.1.8. Gadoquatrane (CAP MAA) - EMEA/H/C/006443 ............................................................ 17
5.1.9. Insulin aspart (CAP MAA) - EMEA/H/C/006677 ............................................................ 17
5.1.10. Insulin aspart (CAP MAA) - EMEA/H/C/006864 ............................................................ 17
5.1.11. Lunsotogene parvec (CAP MAA) - EMEA/H/C/006802, Orphan ....................................... 17
5.1.12. Orforglipron (CAP MAA) - EMEA/H/C/006632 ............................................................... 18
5.1.13. Pimicotinib (CAP MAA) - EMEA/H/C/006383, PRIME, Orphan ......................................... 18
5.1.14. Ruxolitinib (CAP MAA) - EMEA/H/C/006793 ................................................................. 18
5.1.15. Sintilimab (CAP MAA) - EMEA/H/C/006743.................................................................. 18
5.1.16. Zopapogene imadenovec (CAP MAA) - EMEA/H/C/006508, Orphan ................................ 18
5.2. Medicines in the post-authorisation phase – PRAC-led procedures ....................... 18
5.2.1. Dimethyl fumarate – DIMETHYL FUMARATE MYLAN (CAP); NAP – EMA/VR/0000344712 ... 18
5.2.2. Emtricitabine / Tenofovir disoproxil - EMTRICITABINE/TENOFOVIR DISOPROXIL ZENTIVA
(CAP); NAP – EMA/VR/0000335678 ........................................................................... 19
5.2.3. Fosdenopterin – NULIBRY (CAP) – EMA/VR/0000347997 .............................................. 19
5.2.4. Sonidegib – ODOMZO (CAP) – EMA/VR/0000357142 .................................................... 19
5.2.5. Pomalidomide - POMALIDOMIDE KRKA (CAP); NAP - EMA/VR/0000361252 ..................... 20
5.3. Medicines in the post-authorisation phase – CHMP-led procedures ...................... 20
5.3.1. Abiraterone acetate – ABIRATERONE MYLAN (CAP); NAP – EMA/VR/0000291298 ............ 20
5.3.2. Abrocitinib – CIBINQO (CAP) – EMA/VR/0000350662 ................................................... 20
5.3.3. Afamelanotide – SCENESSE (CAP) – EMA/VR/0000325360 ........................................... 21
5.3.4. Aflibercept – OPUVIZ (CAP) – EMA/VR/0000357444 ..................................................... 21
5.3.5. Apixaban – ELIQUIS (CAP) – EMA/VR/0000327005 ...................................................... 21
5.3.6. Asciminib – SCEMBLIX (CAP) – EMA/VR/0000342126 ................................................... 21
5.3.7. Atidarsagene autotemcel – LIBMELDY (CAP) – EMA/VR/0000334917 .............................. 22
5.3.8. Atropine sulfate – RYJUNEA (CAP) – EMA/VR/0000357137 ............................................ 22
5.3.9. Cabotegravir – APRETUDE (CAP) – EMA/VR/0000331993 .............................................. 22
5.3.10. Cabotegravir – VOCABRIA (CAP) – EMA/VR/0000332087 .............................................. 23
5.3.11. Capivasertib – TRUQAP (CAP) – EMA/VR/0000293735 .................................................. 23
5.3.12. Dabigatran etexilate – PRADAXA (CAP) – EMA/VR/0000347421 ..................................... 23
5.3.13. Dapivirine – DAPIVIRINE VAGINAL RING 25 MG (CAP) – EMA/X/0000314697.................. 24
5.3.14. Dasatinib – SPRYCEL (CAP) – EMA/VR/0000356665 ..................................................... 24
5.3.15. Deferasirox – EXJADE (CAP) – EMA/VR/0000333352 .................................................... 24
5.3.16. Delgocitinib – ANZUPGO (CAP) – EMA/VR/0000315280 ................................................ 24
5.3.17. Dolutegravir – TIVICAY (CAP) – EMA/VR/0000351003 .................................................. 25
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5.3.18. Enfortumab vedotin – PADCEV (CAP) – EMA/VR/0000336191........................................ 25
5.3.19. Epcoritamab – TEPKINLY (CAP) – EMA/VR/0000358245 ............................................... 25
5.3.20. Exagamglogene autotemcel – CASGEVY (CAP) – EMA/VR/0000356719 ........................... 26
5.3.21. Fenfluramine – FINTEPLA (CAP) – EMA/VR/0000350597 ............................................... 26
5.3.22. Fenfluramine – FINTEPLA (CAP) – EMA/VR/0000350494 ............................................... 26
5.3.23. Filgotinib – JYSELECA (CAP) – EMA/VR/0000350853 .................................................... 27
5.3.24. Florbetapir (18F) – AMYVID (CAP) – EMA/VR/0000333287 ............................................. 27
5.3.25. Givinostat – DUVYZAT (CAP) – EMA/VR/0000343703 ................................................... 27
5.3.26. Givinostat – DUVYZAT (CAP) – EMA/VR/0000343737 ................................................... 27
5.3.27. Glofitamab – COLUMVI (CAP) – EMA/VR/0000327100 .................................................. 28
5.3.28. Glofitamab – COLUMVI (CAP) – EMA/VR/0000348695 .................................................. 28
5.3.29. Ivacaftor – KALYDECO (CAP) – EMA/VR/0000343903 ................................................... 28
5.3.30. Ivacaftor / Tezacaftor / Elexacaftor – KAFTRIO (CAP) – EMA/X/0000343848 ................... 29
5.3.31. Levacetylleucine – AQNEURSA (CAP) – EMA/VR/0000354947 ........................................ 29
5.3.32. Maralixibat – LIVMARLI (CAP) – EMA/VR/0000320544 .................................................. 29
5.3.33. Melphalan flufenamide – PEPAXTI (CAP) – EMA/VR/0000350278 ................................... 30
5.3.34. Metreleptin – MYALEPTA (CAP) – EMA/VR/0000356904 ................................................ 30
5.3.35. Mirabegron – BETMIGA (CAP) – EMA/VR/0000349861 .................................................. 30
5.3.36. Naloxone – NYXOID (CAP) – EMA/VR/0000325329 ...................................................... 31
5.3.37. Obinutuzumab – GAZYVARO (CAP) – EMA/VR/0000350995........................................... 31
5.3.38. Obinutuzumab – GAZYVARO (CAP) – EMA/VR/0000327013........................................... 31
5.3.39. Obinutuzumab – GAZYVARO (CAP) – EMA/VR/0000349826........................................... 31
5.3.40. Ocrelizumab – OCREVUS (CAP) – EMA/VR/0000313041................................................ 32
5.3.41. Ocrelizumab – OCREVUS (CAP) – EMA/VR/0000357152................................................ 32
5.3.42. Pneumococcal polysaccharide conjugate vaccine (15 valent, adsorbed) – VAXNEUVANCE (CAP)
– EMA/VR/0000356991 ............................................................................................ 32
5.3.43. Radium-223 – XOFIGO (CAP) – EMA/VR/0000350998 .................................................. 33
5.3.44. Radium-223 – XOFIGO (CAP) – EMA/VR/0000351078 .................................................. 33
5.3.45. Respiratory syncytial virus mRNA vaccine (nucleoside modified) – MRESVIA (CAP) –
EMA/VR/0000320244 ............................................................................................... 33
5.3.46. Rilzabrutinib – WAYRILZ (CAP) – EMA/VR/0000357430 ................................................ 34
5.3.47. Selumetinib – KOSELUGO (CAP) – EMA/VR/0000347385 .............................................. 34
5.3.48. Somapacitan – SOGROYA (CAP) – EMA/VR/0000350795 .............................................. 34
5.3.49. Sulfur hexafluoride – SONOVUE (CAP) – EMA/VR/0000355106 ...................................... 35
5.3.50. Talazoparib – TALZENNA (CAP) – EMA/VR/0000350865 ................................................ 35
5.3.51. Trastuzumab – HERZUMA (CAP) – EMA/X/0000343856 ................................................ 35
5.3.52. Ustekinumab – IMULDOSA (CAP) – EMA/VR/0000347840 ............................................. 35
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6. Periodic safety update reports (PSURs) 36
6.1. PSUR single assessment (PSUSA) procedures including centrally authorised products
(CAPs) only .......................................................................................................... 36
6.1.1. Abacavir – ZIAGEN (CAP) – EMA/PSUR/0000344374 .................................................... 36
6.1.2. Abatacept – ORENCIA (CAP) – EMA/PSUR/0000344377 ................................................ 36
6.1.3. Adalimumab – AMGEVITA (CAP); AMSPARITY (CAP); HEFIYA (CAP); HUKYNDRA (CAP); HULIO
(CAP); HUMIRA (CAP); HYRIMOZ (CAP); IDACIO (CAP); IMRALDI (CAP); LIBMYRIS (CAP);
YUFLYMA (CAP) – EMA/PSUR/0000344425 .................................................................. 36
6.1.4. Amino acids – MAAPLIV (CAP) – EMA/PSUR/0000344441.............................................. 36
6.1.5. Angiotensin II – GIAPREZA (CAP) – EMA/PSUR/0000344429 ......................................... 37
6.1.6. Avapritinib – AYVAKYT (CAP) – EMA/PSUR/0000344431 ............................................... 37
6.1.7. Belzutifan – WELIREG (CAP) – EMA/PSUR/0000344453 ................................................ 37
6.1.8. Birch bark extract – FILSUVEZ (CAP) – EMA/PSUR/0000344404 .................................... 37
6.1.9. Brensocatib – BRINSUPRI (CAP) – EMA/PSUR/0000344438 ........................................... 37
6.1.10. Brexucabtagene autoleucel – TECARTUS (CAP) – EMA/PSUR/0000344416 ...................... 37
6.1.11. Catumaxomab – KORJUNY (CAP) – EMA/PSUR/0000344454 ......................................... 38
6.1.12. Crovalimab – PIASKY (CAP) – EMA/PSUR/0000344450 ................................................. 38
6.1.13. Danicopan – VOYDEYA (CAP) – EMA/PSUR/0000344446 ............................................... 38
6.1.14. Dapivirine – DAPIVIRINE VAGINAL RING 25 MG (Art 58) – EMA/PSUR/0000339021 ......... 38
6.1.15. Daridorexant – QUVIVIQ (CAP) – EMA/PSUR/0000344443 ............................................ 38
6.1.16. Delgocitinib – ANZUPGO (CAP) – EMA/PSUR/0000344461............................................. 39
6.1.17. Donanemab – KISUNLA (CAP) – EMA/PSUR/0000344439 ............................................. 39
6.1.18. Elinzanetant – LYNKUET (CAP) – EMA/PSUR/0000344463 ............................................. 39
6.1.19. Epinephrine – EURNEFFY (CAP) – EMA/PSUR/0000344451 ............................................ 39
6.1.20. Eptacog alfa (activated) – NOVOSEVEN (CAP) – EMA/PSUR/0000344447 ........................ 39
6.1.21. Ertugliflozin – STEGLATRO (CAP); Ertugliflozin / Metformin hydrochloride – SEGLUROMET
(CAP); Ertugliflozin / Sitagliptin – STEGLUJAN (CAP) – EMA/PSUR/0000344430 .............. 39
6.1.22. Evinacumab – EVKEEZA (CAP) – EMA/PSUR/0000344420 ............................................. 40
6.1.23. Faricimab – VABYSMO (CAP) – EMA/PSUR/0000344426 ............................................... 40
6.1.24. Garadacimab – ANDEMBRY (CAP) – EMA/PSUR/0000344455 ......................................... 40
6.1.25. Gefapixant – LYFNUA (CAP) – EMA/PSUR/0000344383 ................................................. 40
6.1.26. Ivacaftor – KALYDECO (CAP) – EMA/PSUR/0000344411 ............................................... 40
6.1.27. Lamivudine / Abacavir – KIVEXA (CAP) – EMA/PSUR/0000344375 ................................. 41
6.1.28. Lecanemab – LEQEMBI (CAP) – EMA/PSUR/0000344458 .............................................. 41
6.1.29. Lisocabtagene maraleucel / Lisocabtagene maraleucel – BREYANZI (CAP) –
EMA/PSUR/0000344421 ........................................................................................... 41
6.1.30. Lonoctocog alfa – AFSTYLA (CAP) – EMA/PSUR/0000344406 ......................................... 41
6.1.31. Lutetium (177Lu) oxodotreotide – LUTATHERA (CAP) – EMA/PSUR/0000344414 ............... 41
6.1.32. Metreleptin – MYALEPTA (CAP) – EMA/PSUR/0000344434............................................. 41
6.1.33. Mexiletine – NAMUSCLA (CAP) – EMA/PSUR/0000344427 ............................................. 42
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6.1.34. Mirdametinib – EZMEKLY (CAP) – EMA/PSUR/0000344444 ............................................ 42
6.1.35. Omalizumab – OMLYCLO (CAP); XOLAIR (CAP) – EMA/PSUR/0000344391 ...................... 42
6.1.36. Pandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted, prepared in cell
cultures) – INCELLIPAN (CAP); Zoonotic influenza vaccine (H5N1) (surface antigen,
inactivated, adjuvanted, prepared in cell cultures) – CELLDEMIC (CAP) –
EMA/PSUR/0000344449 ........................................................................................... 42
6.1.37. Pirtobrutinib – JAYPIRCA (CAP) – EMA/PSUR/0000344380 ............................................ 42
6.1.38. Plerixafor – MOZOBIL (CAP) – EMA/PSUR/0000344390 ................................................ 43
6.1.39. Pneumococcal polysaccharide conjugate vaccine (15 valent, adsorbed) – VAXNEUVANCE (CAP)
– EMA/PSUR/0000344419 ........................................................................................ 43
6.1.40. Quadrivalent influenza vaccine (recombinant, prepared in cell culture) – SUPEMTEK TETRA
(CAP) – EMA/PSUR/0000344432 ............................................................................... 43
6.1.41. Relugolix – ORGOVYX (CAP) – EMA/PSUR/0000344433 ................................................ 43
6.1.42. Romosozumab – EVENITY (CAP) – EMA/PSUR/0000344428 .......................................... 43
6.1.43. Rucaparib – RUBRACA (CAP) – EMA/PSUR/0000344413 ............................................... 43
6.1.44. Sarilumab – KEVZARA (CAP) – EMA/PSUR/0000344412 ............................................... 44
6.1.45. Sebetralstat – EKTERLY (CAP) – EMA/PSUR/0000344437 ............................................. 44
6.1.46. Sutimlimab – ENJAYMO (CAP) – EMA/PSUR/0000344445 .............................................. 44
6.1.47. Tafasitamab – MINJUVI (CAP) – EMA/PSUR/0000344435 .............................................. 44
6.1.48. Tagraxofusp – ELZONRIS (CAP) – EMA/PSUR/0000344436 ........................................... 44
6.1.49. Talquetamab – TALVEY (CAP) – EMA/PSUR/0000344393 .............................................. 45
6.1.50. Tebentafusp – KIMMTRAK (CAP) – EMA/PSUR/0000344442 .......................................... 45
6.1.51. Tecovirimat – TECOVIRIMAT SIGA (CAP) – EMA/PSUR/0000344448 ............................... 45
6.1.52. Teprotumumab – TEPEZZA (CAP) – EMA/PSUR/0000344456 ......................................... 45
6.1.53. Tezacaftor / Ivacaftor – SYMKEVI (CAP) – EMA/PSUR/0000344423 ................................ 45
6.1.54. Tiratricol – EMCITATE (CAP) – EMA/PSUR/0000344457 ................................................ 45
6.1.55. Ustekinumab – FYMSKINA (CAP); IMULDOSA (CAP); OTULFI (CAP); PYZCHIVA (CAP);
QOYVOLMA (CAP); STELARA (CAP); STEQEYMA (CAP); USGENA (CAP); USRENTY (CAP);
USYMRO (CAP); UZPRUVO (CAP); WEZENLA (CAP); YESINTEK (CAP) – EMA/PSUR/0000344407
............................................................................................................................. 46
6.1.56. Vericiguat – VERQUVO (CAP) – EMA/PSUR/0000344417 ............................................... 46
6.1.57. Voclosporin – LUPKYNIS (CAP) – EMA/PSUR/0000344422 ............................................. 46
6.1.58. Vorasidenib – VORANIGO (CAP) – EMA/PSUR/0000344440 ........................................... 46
6.1.59. Zuranolone – ZURZUVAE (CAP) – EMA/PSUR/0000344462 ............................................ 46
6.2. PSUR single assessment (PSUSA) procedures including centrally authorised products
(CAPs) and nationally authorised products (NAPs) .............................................. 47
6.2.1. Alendronic acid / Colecalciferol – ADROVANCE (CAP); FOSAVANCE (CAP); VANTAVO (CAP),
NAP; alendronic acid / calcium / colecalciferol (NAP) – EMA/PSUR/0000344382 ............... 47
6.2.2. Lamivudine / Abacavir / Zidovudine - TRIZIVIR (CAP), NAP – EMA/PSUR/0000344408 ..... 47
6.2.3. Lenalidomide - LENALIDOMIDE ACCORD (CAP); LENALIDOMIDE KRKA (CAP); LENALIDOMIDE
MYLAN (CAP); REVLIMID (CAP), NAP – EMA/PSUR/0000344392 .................................... 47
6.2.4. Repaglinide - NOVONORM (CAP); PRANDIN (CAP); NAP – EMA/PSUR/0000344399 .......... 47
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6.3. PSUR single assessment (PSUSA) procedures including nationally authorised
products (NAPs) only ........................................................................................... 48
6.3.1. 5 fluorouracil (topical application) – EMA/PSUR/0000344410 ........................................ 48
6.3.2. Alendronate – EMA/PSUR/0000344376 ....................................................................... 48
6.3.3. Alitretinoin (oral use) – EMA/PSUR/0000344424 .......................................................... 48
6.3.4. Alizapride – EMA/PSUR/0000344378 .......................................................................... 48
6.3.5. Allergen for therapy: Dactylis Glomerata L., Phleum Pratense L., Anthoxanthum Odoratum L.,
Lolium Perenne L., Poa Pratensis L. (sublingual tablet) – EMA/PSUR/0000344403 ............ 48
6.3.6. Amino acid combinations (only combinations of pure amino acids or combination of amino
acids with mineral compounds/electrolytes, i.v. application) – EMA/PSUR/0000344409 .... 49
6.3.7. Aminophylline – EMA/PSUR/0000344384 .................................................................... 49
6.3.8. Amisulpride – EMA/PSUR/0000344386 ....................................................................... 49
6.3.9. Antithrombin III – EMA/PSUR/0000344418 ................................................................. 49
6.3.10. Atropine / diphenoxylate – EMA/PSUR/0000344381 ..................................................... 49
6.3.11. Benzydamine / cetylpyridine – EMA/PSUR/0000344385 ................................................ 49
6.3.12. Beta-alanine – EMA/PSUR/0000344401 ...................................................................... 50
6.3.13. Bezafibrate – EMA/PSUR/0000344389 ........................................................................ 50
6.3.14. Biotin – EMA/PSUR/0000344397................................................................................ 50
6.3.15. Calcitriol – EMA/PSUR/0000344379 ........................................................................... 50
6.3.16. Carboprost – EMA/PSUR/0000344396 ........................................................................ 50
6.3.17. Cilostazol – EMA/PSUR/0000344415 .......................................................................... 51
6.3.18. Diacerein – EMA/PSUR/0000344398 .......................................................................... 51
6.3.19. Estriol – EMA/PSUR/0000344405 ............................................................................... 51
6.3.20. Exemestane – EMA/PSUR/0000344395 ...................................................................... 51
6.3.21. Famciclovir – EMA/PSUR/0000344387 ........................................................................ 51
6.3.22. Nifurtimox – EMA/PSUR/0000344452 ......................................................................... 51
6.3.23. Sertindole – EMA/PSUR/0000344394 ......................................................................... 52
6.4. Follow-up to PSUR/PSUSA procedures ................................................................. 52
6.5. Variation procedure(s) resulting from PSUSA evaluation ..................................... 52
6.6. Expedited summary safety reviews ...................................................................... 52
7. Post-authorisation safety studies (PASS) 52
7.1. Protocols of PASS imposed in the marketing authorisation(s) .............................. 52
7.1.1. Cabotegravir – VOCABRIA (CAP); Rilpivirine – REKAMBYS (CAP) – EMA/PASS/000035884852
7.1.2. Lonafarnib – ZOKINVY (CAP) – EMA/PASS/0000357585 ............................................... 53
7.1.3. Mirdametinib - Ezmekly (CAP) - EMA/PASS/0000340654 .............................................. 53
7.1.4. Sodium valproate (NAP) – EMA/PASS/0000328174 ...................................................... 53
7.2. Protocols of PASS non-imposed in the marketing authorisation(s) ...................... 53
7.2.1. Aficamten – MYQORZO (CAP) – EMA/PAM/0000347918 ................................................ 53
7.2.2. Cladribine – MAVENCLAD (CAP) – EMA/PAM/0000357455 ............................................. 54
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7.2.3. Delgocitinib – ANZUPGO (CAP) – EMA/PAM/0000291999 .............................................. 54
7.2.4. Deucravacitinib – SOTYKTU (CAP) – EMA/PAM/0000357688 .......................................... 54
7.2.5. Efgartigimod alfa – VYVGART (CAP) – EMA/PAM/0000358653 ....................................... 54
7.2.6. Efgartigimod alfa – VYVGART (CAP) – EMA/PAM/0000358063 ....................................... 55
7.2.7. Etrasimod – VELSIPITY (CAP) – EMA/PAM/0000357465 ................................................ 55
7.2.8. Inebilizumab – UPLIZNA (CAP) – EMA/PAM/0000357017 .............................................. 55
7.2.9. Inebilizumab – UPLIZNA (CAP) – EMA/PAM/0000357209 .............................................. 55
7.2.10. Mavacamten – CAMZYOS (CAP) - EMA/PAM/0000343701 ............................................. 56
7.2.11. Naltrexone hydrochloride / Bupropion hydrochloride – MYSIMBA (CAP) –
EMA/PAM/0000349763 ............................................................................................. 56
7.2.12. Nipocalimab – IMAAVY (CAP) – EMA/PAM/0000357528 ................................................ 56
7.2.13. Nipocalimab – IMAAVY (CAP) – EMA/PAM/0000358639 ................................................ 56
7.3. Results of PASS imposed in the marketing authorisation(s) ................................. 56
7.4. Results of PASS imposed and non-imposed in the marketing authorisation(s) ..... 57
7.4.1. Baricitinib – OLUMIANT (CAP) – EMA/VR/0000345885 .................................................. 57
7.4.2. COVID-19 mRNA vaccine – COMIRNATY (CAP) – EMA/VR/0000343925 .......................... 57
7.4.3. COVID-19 mRNA vaccine – COMIRNATY (CAP) – EMA/VR/0000334558 .......................... 57
7.4.4. Elosulfase alfa – VIMIZIM (CAP) – EMA/VR/0000268096 .............................................. 58
7.4.5. Fexinidazole – FEXINIDAZOLE WINTHROP (CAP) – EMA/VR/0000356314 ........................ 58
7.4.6. Ponesimod – PONVORY (CAP) – EMA/VR/0000320506 .................................................. 58
7.4.7. Tacrolimus - ADVAGRAF (CAP); MODIGRAF (CAP); NAP – EMA/VR/0000315125 .............. 58
7.4.8. Voretigene neparvovec – LUXTURNA (CAP) – EMA/VR/0000357435 ............................... 59
7.5. Interim results and other post-authorisation measures for imposed and non-imposed
studies .................................................................................................................. 59
7.5.1. Abaloparatide – ELADYNOS (CAP) – EMA/PAM/0000357990 .......................................... 59
7.5.2. Beclometasone / Formoterol / Glycopyrronium bromide - TRIMBOW (CAP) -
EMA/PAM/0000350566 ............................................................................................. 59
7.5.3. Beclometasone / Formoterol / Glycopyrronium bromide – TRYDONIS (CAP) -
EMA/PAM/0000350569 ............................................................................................. 59
7.5.4. Cabotegravir – APRETUDE (CAP) – EMA/PAM/0000348786............................................ 60
7.5.5. Cabotegravir – VOCABRIA (CAP) – EMA/PAM/0000348704 ............................................ 60
7.5.6. Clascoterone – WINLEVI (CAP) – EMA/PAM/0000325634 .............................................. 60
7.5.7. Danicopan – VOYDEYA (CAP) – EMA/PAM/0000357946 ................................................ 60
7.5.8. Dimethyl fumarate – SKILARENCE (CAP) – EMA/PAM/0000357021 ................................ 61
7.5.9. Efgartigimod alfa – VYVGART (CAP) – EMA/PAM/0000358689 ....................................... 61
7.5.10. Estetrol – FYLREVY (CAP) – EMA/PAM/0000357663...................................................... 61
7.5.11. Etuvetidigene autotemcel – WASKYRA (CAP) – EMA/PAM/0000357590 ........................... 61
7.5.12. Fingolimod – GILENYA (CAP) – EMA/PAM/0000320326 ................................................. 61
7.5.13. Hydroxycarbamide – XROMI (CAP) – EMA/PAM/0000350555 ......................................... 62
7.5.14. Inebilizumab – UPLIZNA (CAP) – EMA/PAM/0000357900 .............................................. 62
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7.5.15. Interferon beta-1A – AVONEX (CAP) – EMA/PAM/0000315762 ...................................... 62
7.5.16. Interferon beta-1A – REBIF (CAP) – EMA/PAM/0000315764 .......................................... 62
7.5.17. Interferon beta-1B – BETAFERON (CAP) – EMA/PAM/0000309054 ................................. 63
7.5.18. Octocog alfa – KOVALTRY (CAP) – EMA/PAM/0000343782 ............................................ 63
7.5.19. Peginterferon beta-1A – PLEGRIDY (CAP) – EMA/PAM/0000315767 ............................... 63
7.5.20. Ravulizumab – ULTOMIRIS (CAP) – EMA/PAM/0000358006........................................... 63
7.5.21. Respiratory syncytial virus vaccine (bivalent, recombinant) – ABRYSVO (CAP) –
EMA/PAM/0000350900 ............................................................................................. 64
7.5.22. Risankizumab – SKYRIZI (CAP) – EMA/PAM/0000348711 ............................................. 64
7.5.23. Selexipag – UPTRAVI (CAP) – EMA/PAM/0000357993 ................................................... 64
7.5.24. Siponimod – MAYZENT (CAP) – EMA/PAM/0000357691 ................................................ 64
7.5.25. Sutimlimab – ENJAYMO (CAP) – EMA/PAM/0000347729 ............................................... 64
8. Renewals of the marketing authorisation, conditional renewal and
annual reassessments 65
8.1. Annual reassessments of the marketing authorisation ......................................... 65
8.1.1. Maralixibat – LIVMARLI (CAP) – EMA/S/0000317715 .................................................... 65
8.1.2. Tofersen – QALSODY (CAP) – EMA/S/0000349866 ....................................................... 65
8.2. Conditional renewals of the marketing authorisation ........................................... 65
8.2.1. Adagrasib – KRAZATI (CAP) – EMA/R/0000350422 ...................................................... 65
8.2.2. Brexucabtagene autoleucel – TECARTUS (CAP) – EMA/R/0000355892 ............................ 65
8.2.3. Spesolimab – SPEVIGO (CAP) – EMA/R/0000348377 .................................................... 66
8.2.4. Loncastuximab tesirine – ZYNLONTA (CAP) – EMA/R/0000358132 ................................. 66
8.2.5. Repotrectinib – AUGTYRO (CAP) – EMA/R/0000357913 ................................................ 66
8.2.6. Sotorasib – LUMYKRAS (CAP) – EMA/R/0000360417 .................................................... 66
8.2.7. Trastuzumab deruxtecan – ENHERTU (CAP) – EMA/R/0000360418 ................................ 66
8.3. Renewals of the marketing authorisation ............................................................. 67
8.3.1. Enfortumab vedotin – PADCEV (CAP) – EMA/R/0000351076 ......................................... 67
8.3.2. Eptinezumab – VYEPTI (CAP) – EMA/R/0000336059 .................................................... 67
8.3.3. Finerenone – KERENDIA (CAP) – EMA/R/0000340433 .................................................. 67
8.3.4. Lisocabtagene maraleucel / Lisocabtagene maraleucel – BREYANZI (CAP) –
EMA/R/0000355073 ................................................................................................. 67
8.3.5. Pegfilgrastim – STIMUFEND (CAP) – EMA/R/0000351198 ............................................. 67
8.3.6. Pneumococcal polysaccharide conjugate vaccine (20-valent, adsorbed) – PREVENAR 20 (CAP)
– EMA/R/0000340648 .............................................................................................. 68
8.3.7. Risperidone – OKEDI (CAP) – EMA/R/0000343015 ....................................................... 68
8.3.8. Sapropterin – SAPROPTERIN DIPHARMA (CAP) – EMA/R/0000348315 ............................ 68
8.3.9. Sitagliptin / Metformin hydrochloride – SITAGLIPTIN METFORMIN HYDROCHLORIDE MYLAN
(CAP) – EMA/R/0000349188 ..................................................................................... 68
8.3.10. Somatrogon – NGENLA (CAP) – EMA/R/0000340629 .................................................... 68
8.3.11. Tebentafusp – KIMMTRAK (CAP) – EMA/R/0000355059 ................................................ 68
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8.3.12. Tecovirimat - TECOVIRIMAT SIGA (CAP) - EMA/R/0000340615 ..................................... 69
8.3.13. Tofacitinib – XELJANZ (CAP) – EMA/R/0000350878 ...................................................... 69
9. Product related pharmacovigilance inspections 69
9.1. List of planned pharmacovigilance inspections ..................................................... 69
9.2. Ongoing or concluded pharmacovigilance inspections .......................................... 69
9.3. Others .................................................................................................................. 69
10. Other safety issues for discussion requested by the Member States,
CHMP or the EMA 69
11. Scientific advice procedures 70
12. Organisational, regulatory and methodological matters 70
12.1. Mandate and organisation of the PRAC ................................................................. 70
12.1.1. PRAC membership ................................................................................................... 70
12.1.2. Nominated proxy ..................................................................................................... 70
12.2. Coordination with EMA Scientific Committees or CMDh-v ..................................... 70
12.3. Coordination with EMA Working Parties/Working Groups/Drafting Groups ......... 70
12.3.1. Areas of collaboration between PRAC and Methodology Working Party (MWP) ................. 70
12.4. Cooperation within the EU regulatory network ..................................................... 70
12.5. Cooperation with International Regulators........................................................... 70
12.6. Contacts of the PRAC with external parties and interaction with the Interested
Parties to the Committee ...................................................................................... 70
12.7. PRAC work plan .................................................................................................... 71
12.7.1. PRAC work plan 2026 - update .................................................................................. 71
12.8. Planning and reporting ......................................................................................... 71
12.9. Pharmacovigilance audits and inspections ........................................................... 71
12.9.1. Pharmacovigilance systems and their quality systems .................................................. 71
12.9.2. Pharmacovigilance inspections .................................................................................. 71
12.9.3. Pharmacovigilance audits.......................................................................................... 71
12.10. Periodic safety update reports (PSURs) & Union reference date (EURD) list ........ 71
12.10.1. Periodic safety update reports ................................................................................... 71
12.10.2. Granularity and Periodicity Advisory Group (GPAG) ...................................................... 71
12.10.3. PSURs repository ..................................................................................................... 71
12.10.4. Union reference date list – consultation on the draft list ............................................... 71
12.11. Signal management .............................................................................................. 72
12.11.1. Signal management – feedback from Signal Management Review Technical (SMART) Working
Group .................................................................................................................... 72
12.12. Adverse drug reactions reporting and additional reporting .................................. 72
12.12.1. Management and reporting of adverse reactions to medicinal products ........................... 72
12.12.2. Additional monitoring ............................................................................................... 72
12.12.3. List of products under additional monitoring – consultation on the draft list .................... 72
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12.13. EudraVigilance database ...................................................................................... 72
12.13.1. Activities related to the confirmation of full functionality ............................................... 72
12.14. Risk management plans and effectiveness of risk minimisations ......................... 72
12.14.1. Risk management systems ....................................................................................... 72
12.14.2. Tools, educational materials and effectiveness measurement of risk minimisations .......... 72
12.15. Post-authorisation safety studies (PASS) ............................................................. 72
12.15.1. Post-authorisation Safety Studies – imposed PASS ...................................................... 72
12.15.2. Post-authorisation Safety Studies – non-imposed PASS ................................................ 73
12.16. Community procedures ......................................................................................... 73
12.16.1. Referral procedures for safety reasons ....................................................................... 73
12.17. Renewals, conditional renewals, annual reassessments ....................................... 73
12.18. Risk communication and transparency ................................................................. 73
12.18.1. Public participation in pharmacovigilance .................................................................... 73
12.18.2. Safety communication .............................................................................................. 73
12.19. Continuous pharmacovigilance ............................................................................. 73
12.19.1. Incident management .............................................................................................. 73
12.20. Impact of pharmacovigilance activities ................................................................ 73
12.20.1. Strategy on measuring the impact of pharmacovigilance: draft technical specifications for a
qualitative impact study on healthcare professionals’ preferences for additional risk
minimisation measures (under EMA/2024/OP/0016) .................................................... 73
12.21. Others .................................................................................................................. 73
12.21.1. Extension application timetable alignment with MAA timetable ...................................... 73
13. Any other business 74
14. Explanatory notes 74
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1. Introduction
1.1. Welcome and declarations of interest of members, alternates and
experts
Pre-meeting list of participants and restrictions in relation to declarations of interests
applicable to the items of the agenda for the PRAC plenary session to be held 31 August-03
September 2026. See September 2026 PRAC minutes (to be published post October 2026
PRAC meeting).
1.2. Agenda of the meeting on 31 August-03 September 2026
Action: For adoption
1.3. Minutes of the previous meeting on 06-09 July 2026
Action: For adoption
2. EU referral procedures for safety reasons: urgent EU
procedures
2.1. Newly triggered procedures
None
2.2. Ongoing procedures
None
2.3. Procedures for finalisation
None
3. EU referral procedures for safety reasons: other EU referral
procedures
3.1. Newly triggered procedure
3.1.1. Ferric carboxymaltose, ferric derisomaltose, ferric gluconate, iron sucrose, iron
dextran (NAP) - EMA/REF/0000369747
Applicant(s): various
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PRAC Rapporteur: To be appointed; PRAC Co-rapporteur: To be appointed
Scope: Review of the benefit-risk balance following notification by Austria of a referral under
Article 31 of Directive 2001/83/EC, based on pharmacovigilance data
Action: For adoption (Appointment of Rapporteurs; Adoption of the timetable (TT); List of
questions)
3.2. Ongoing procedures
None
3.3. Procedures for finalisation
None
3.4. Re-examination procedures1
None
3.5. Others
None
4. Signals assessment and prioritisation2
4.1. New signals detected from EU spontaneous reporting systems
and/or other sources
4.1.1. Acitretin (NAP)
Applicant: various
PRAC Lead: To be appointed
Scope: Signal of erectile dysfunction
Action: For adoption
EPITT 20310 – New signal
Lead Member State(s): DK
1 Re-examination of PRAC recommendation under Article 32 of Directive 2001/83/EC
2 Each signal refers to a substance or therapeutic class. The route of marketing authorisation is indicated in brackets (CAP for
Centrally Authorised Products; NAP for Nationally Authorised Products including products authorised via Mutual Recognition
Procedures and Decentralised Procedure). Product names are listed for reference Centrally Authorised Products (CAP) only.
PRAC recommendations will specify the products concerned in case of any regulatory action required
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4.1.2. Anakinra - KINERET (CAP)
Applicant: Swedish Orphan Biovitrum AB (publ)
PRAC Rapporteur: Karin Erneholm
Scope: Signal of fulminant hepatitis
Action: For adoption
EPITT 20308 – New signal
Lead Member State(s): DK
4.1.3. Deucravacitinib – SOTYKTU (CAP)
Applicant: Bristol-Myers Squibb Pharma EEIG
PRAC Rapporteur: Liana Martirosyan
Scope: Signal of pemphigoid
Action: For adoption
EPITT 20304 – New signal
Lead Member State(s): NL
4.1.4. Fentanyl (transdermal patches) (NAP)
Applicant: various
PRAC Lead: To be appointed
Scope: Signal of accidental exposure
Action: For adoption
EPITT 17778 – New signal
Lead Member State(s): NL
4.1.5. Gefitinib - IRESSA (CAP)
Applicant: Bristol-Myers Squibb Pharma EEIG
PRAC Rapporteur: Jenny-Maria Jönsson
Scope: Signal of pulmonary alveolar haemorrhage
Action: For adoption
EPITT 20307 – New signal
Lead Member State(s): SE
4.1.6. Idarucizumab - PRAXBIND (CAP)
Applicant: Boehringer Ingelheim International GmbH
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PRAC Rapporteur: Bianca Mulder
Scope: Signal of disseminated intravascular coagulation
Action: For adoption
EPITT 20297 – New signal
Lead Member State(s): NL
4.1.7. Infliximab - FLIXABI (CAP), REMICADE (CAP), REMSIMA (CAP), ZESSLY (CAP)
Applicants: Celltrion Healthcare Hungary Kft. (REMSIMA), Janssen Cilag International
(REMICADE), Samsung Bioepis NL B.V. (FLIXABI), Sandoz GmbH (ZESSLY)
PRAC Rapporteur: Karin Bolin
Scope: Signal of IgA nephropathy
Action: For adoption
EPITT 18649 – New signal
Lead Member State(s): SE
4.1.8. Lazertinib - LAZCLUZE (CAP)
Applicant: Janssen Cilag International
PRAC Lead: Petar Mas
Scope: Signal of colitis
Action: For adoption of PRAC recommendation
EPITT 20296 – New signal
Lead Member State(s): HR
4.1.9. Progestogens3 (NAP)
Applicant: various
PRAC Lead: To be appointed
Scope: Signal of meningioma
Action: For adoption
EPITT 20300 – New signal
Lead Member State(s): NL, DE, DK, SE, FI, FR, IT, PL, HR, IE
3 chlormadinone/ethinylestradiol, cyproterone acetate/estradiol valerate, cyproterone/ethinylestradiol, dienogest,
dienogest/estradiol, dienogest/ethinylestradiol, drospirenone, drospirenone/estetrol, drospirenone/estradiol,
drospirenone/ethinylestradiol, estradiol/levonorgestrel, estradiol/norethisterone, estradiol/progesterone, estradiol
valerate/norgestrel, ethinylestradiol/gestodene, ethinylestradiol/levonorgestrel, ethinylestradiol/norelgestromin,
ethinylestradiol/norethisterone, ethinylestradiol/norgestimate, levonorgestrel, lynestrenol, medroxyprogesterone <100 mg oral
formulations, medroxyprogesterone acetate/estradiol, megestrol, nomegestrol acetate/estradiol, norethisterone, progesterone
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4.2. Signals follow-up and prioritisation
4.2.1. Oxacillin (NAP)
Applicant(s): various
PRAC Lead: Eva Jirsová
Scope: Signal of drug reaction with eosinophilia and systemic symptoms (DRESS)
Action: For adoption
EPITT 20223 - Follow-up to January 2026
4.3. Variation procedure(s) resulting from signal evaluation
None
5. Risk management plans (RMPs)
5.1. Medicines in the pre-authorisation phase
5.1.1. Anselamimab (CAP MAA) - EMEA/H/C/006422, Orphan
Scope (pre D-180 phase): Treatment of adult patients with kappa light chain amyloidosis
Action: For adoption
5.1.2. Apixaban (CAP MAA) - EMEA/H/C/006752
Scope (pre D-180 phase): Prevention of venous thromboembolic events (VTE), stroke and
systemic embolism; treatment of deep vein thrombosis (DVT) and pulmonary embolism
(PE) in adults. Treatment of VTE in children from 28 days to < 18 years of age.
Action: For adoption
5.1.3. Baxdrostat (CAP MAA) - EMEA/H/C/006597
Scope (pre D-180 phase): Treatment of hypertension in adults
Action: For adoption
5.1.4. Bevacizumab (CAP MAA) - EMEA/H/C/005995
Scope (pre D-180 phase): Treatment of adult patients with advanced or metastatic cancers
Action: For adoption
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5.1.5. Ensartinib (CAP MAA) - EMEA/H/C/006757
Scope (pre D-180 phase): The treatment of adult patients with anaplastic lymphoma kinase
(ALK)-positive advanced non-small cell lung cancer (NSCLC).
Action: For adoption
5.1.6. Filgrastim (CAP MAA) - EMEA/H/C/007009
Scope (pre D-60 phase): Reduction in the duration of neutropenia and the incidence of
febrile neutropenia; mobilisation of peripheral blood progenitor cells (PBPCs); increase in
the neutrophil counts and reduction in the incidence and duration of infection-related
events; treatment of persistent neutropenia
Action: For adoption
5.1.7. Fondaparinux sodium (CAP MAA) - EMEA/H/C/006824
Scope (pre D-180 phase): Prevention of venous thromboembolic events (VTE), treatment of
deep vein thrombosis (DVT), treatment of pulmonary embolism, treatment of unstable
angina and myocardial infarction in adults
Action: For adoption
5.1.8. Gadoquatrane (CAP MAA) - EMEA/H/C/006443
Scope (pre D-180 phase): For contrast enhancement in magnetic resonance imaging (MRI)
used for adults and paediatric patients of all ages.
Action: For adoption
5.1.9. Insulin aspart (CAP MAA) - EMEA/H/C/006677
Scope (pre D-180 phase): Treatment of diabetes mellitus from 1 year of age
Action: For adoption
5.1.10. Insulin aspart (CAP MAA) - EMEA/H/C/006864
Scope (pre D-180 phase): Treatment of diabetes mellitus from 1 year of age
Action: For adoption
5.1.11. Lunsotogene parvec (CAP MAA) - EMEA/H/C/006802, Orphan
ATMP
Scope (pre D-120 phase, accelerated assessment): Treatment of biallelic OTOF variant-
associated hearing loss in adults and children
Action: For adoption
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5.1.12. Orforglipron (CAP MAA) - EMEA/H/C/006632
Scope (pre D-180 phase): Treatment of obesity and type 2 diabetes mellitus in adults
Action: For adoption
5.1.13. Pimicotinib (CAP MAA) - EMEA/H/C/006383, PRIME, Orphan
Scope (pre D-180 phase): Treatment of tenosynovial giant cell tumour in adults and
adolescents from 12 years of age
Action: For adoption
5.1.14. Ruxolitinib (CAP MAA) - EMEA/H/C/006793
Scope (pre D-180 phase): Treatment of myelofibrosis (MF) and polycythaemia vera (PV) in
adults, and treatment of Graft versus host disease (GvHD) in adults and children
Action: For adoption
5.1.15. Sintilimab (CAP MAA) - EMEA/H/C/006743
Scope (pre D-180 phase): Treatment of non-squamous non-small cell lung cancer in adults
Action: For adoption
5.1.16. Zopapogene imadenovec (CAP MAA) - EMEA/H/C/006508, Orphan
ATMP
Scope (pre D-180 phase): Treatment of respiratory papillomatosis in adults
Action: For adoption
5.2. Medicines in the post-authorisation phase – PRAC-led procedures
5.2.1. Dimethyl fumarate – DIMETHYL FUMARATE MYLAN (CAP); NAP –
EMA/VR/0000344712
Applicants: Mylan Pharmaceuticals Limited, various
PRAC Rapporteur: Dennis Lex
Scope: Type IB, C.9.b - the MAH updated the proposed RMP in line with the reference
product Tecfidera RMP version 17.0, dated 2024, published by EMA on 11 July 2024.
The following significant changes were made in the current RMP:
- List of important risks and missing information were deleted
- Important identified risk- Decreased in leukocyte and lymphocyte counts and drug induced
liver injury has been deleted
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- Important potential risk-Serious and opportunistic infections (other than PML and herpes
zoster) and Interaction with nephrotoxic medications leading to renal toxicity has been
deleted.
- Missing information- Safety profile in patients over the age of 55 years, Safety profile in
patients with hepatic impairment, Safety profile in patients with severe active GI disease and
Increased risk of infection in patients concomitantly taking anti-neoplastic or
immunosuppressive therapies has been deleted.
Part II (SVII and SVIII), Part III and Part VI were updated accordingly.
Action: For adoption
5.2.2. Emtricitabine / Tenofovir disoproxil - EMTRICITABINE/TENOFOVIR DISOPROXIL
ZENTIVA (CAP); NAP – EMA/VR/0000335678
Applicant(s): Zentiva k.s., various
PRAC Rapporteur: Ana Sofia Diniz Martins
Scope: To update the RMP in line with the reference medicinal product:
To remove missing Information Safety in pregnancy and lactation. To add Annex 4: Specific
Adverse Reaction Follow-up Questionnaire for Lack of efficacy in pre-exposure prophylaxis.
And to remove Follow-up form for renal toxicity, Follow-up form for renal tubulopathy,
Follow-up form for bone events, Pregnancy report form (to report pregnancy before outcome
is known) and Pregnancy outcome report (to be used when pregnancy outcome is known).
Action: For adoption
5.2.3. Fosdenopterin – NULIBRY (CAP) – EMA/VR/0000347997
Applicant: TMC Pharma (EU) Limited
PRAC Rapporteur: Dennis Lex
Scope: Submission of an updated RMP version 3.0 following PSUSA procedure
EMEA/H/C/PSUSA/00011017/202508. The Annex II is updated accordingly.
Action: For adoption
5.2.4. Sonidegib – ODOMZO (CAP) – EMA/VR/0000357142
Applicant: Sun Pharmaceutical Industries (Europe) B.V.
PRAC Rapporteur: Petar Mas
Scope: Submission of the final report from study NISSO (CLDE225A2404) listed as a
category 3 study in the RMP. This is a non-imposed, non-interventional, multi-national, multi-
center post-authorization safety study) to assess the long-term safety and tolerability of
Odomzo (sonidegib) administered in patients with locally advanced basal cell carcinoma
(laBCC). The RMP version 9.2 has also been submitted.
Action: For adoption
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5.2.5. Pomalidomide - POMALIDOMIDE KRKA (CAP); NAP - EMA/VR/0000361252
Applicant(s): KRKA tovarna zdravil d.d. Novo mesto, various
PRAC Rapporteur: Maria Martinez Gonzalez
Scope: Type IB, C.9.b -to align the RMP with the RMP version 18.0 of reference product
Imnovid published on 20 January 2026. To remove the reference to the questionnaire for
male patients of pregnant partners from the follow-up questionnaire.
Action: For adoption
5.3. Medicines in the post-authorisation phase – CHMP-led procedures
5.3.1. Abiraterone acetate – ABIRATERONE MYLAN (CAP); NAP – EMA/VR/0000291298
Applicants: Mylan Pharmaceuticals Limited, various
PRAC Rapporteur: Maria del Pilar Rayon
Scope: Grouped application comprising of 3 Extension of indication variations for
ABIRATERONE MYLAN, as follows:
C.I.6: to update the currently approved indication for metastatic hormone sensitive prostate
cancer (mHSPC) patients to also include non-high risk mHSPC
C.I.6: to include the treatment of newly diagnosed mHSPC in adult men in combination with
androgen deprivation therapy (ADT) and docetaxel in patients who are fit for chemotherapy
C.I.6: to include the treatment of newly diagnosed high risk non-metastatic hormone
sensitive prostate cancer (HSPC) in adult men in combination with ADT and radiotherapy
The variations are based on literature data. As a consequence, sections 4.1, 4.2 and 5.1 of
the SmPC are updated. The Package Leaflet is updated in accordance. Version 1.2 of the RMP
has also been submitted.
Action: For adoption
5.3.2. Abrocitinib – CIBINQO (CAP) – EMA/VR/0000350662
Applicant: Pfizer Europe MA EEIG
PRAC Rapporteur: Petar Mas
Scope: Update of section 4.4 and 4.8 of the SmPC in order to update long-term safety
information based on results from study B7451015, listed as a category 3 study in the RMP.
This is a Phase 3 Multicenter, Long-Term Extension Study Investigating the Efficacy and
Safety of Abrocitinib, With or Without Topical Medications Administered to Subjects Aged 12
Years and Older With Moderate to Severe Atopic Dermatitis. The RMP version 5.1 has also
been submitted.
Action: For adoption
Pharmacovigilance Risk Assessment Committee (PRAC)
EMA/PRAC/164465/2026 Page 21/75
5.3.3. Afamelanotide – SCENESSE (CAP) – EMA/VR/0000325360
Applicant: Clinuvel Europe Limited
PRAC Rapporteur: Dennis Lex
Scope: Submission of the final report from study CUV052 listed as a category 3 study in the
RMP. This is a phase II study to evaluate the pharmacokinetics of afamelanotide in patients
with erythropoietic protoporphyria. The RMP version 11 has also been submitted.
Action: For adoption
5.3.4. Aflibercept – OPUVIZ (CAP) – EMA/VR/0000357444
Applicant: Samsung Bioepis NL B.V.
PRAC Rapporteur: Zoubida Amimour
Scope: Quality
Action: For adoption
5.3.5. Apixaban – ELIQUIS (CAP) – EMA/VR/0000327005
Applicant: Bristol-Myers Squibb Pfizer EEIG
PRAC Rapporteur: Bianca Mulder
Scope: Extension of indication to include neonates in the currently approved indication
treatment of venous thromboembolism (VTE) and prevention of recurrent VTE in paediatric
patients from birth to less than 18 years of age for ELIQUIS, based on final results from
pivotal study CV185325. This is an open-label, multi-centre, randomized, active controlled
trial to provide PK data and data on anti-Xa activity to support the extrapolation of efficacy to
children, to evaluate safety and efficacy of apixaban in children (full term neonates to less
than 18 years of age) who require anticoagulation for venous thromboembolism, and Study
2, modelling and simulation study to derive dosing of apixaban for use in neonates for
treatment of venous thromboembolism; As a consequence, section 4.1, 4.2, 4.8, and 5.1 of
the SmPC are updated. The Package Leaflet and Labelling are updated in accordance. Version
24.0 of the RMP has also been submitted. In addition, the Marketing authorisation holder
(MAH) took the opportunity to update the Patient Card to mention Eliquis only once on the
title page and refer to apixaban throughout the rest of the card.
Action: For adoption
5.3.6. Asciminib – SCEMBLIX (CAP) – EMA/VR/0000342126
Applicant: Novartis Europharm Limited
PRAC Rapporteur: Eva Jirsová
Scope: Update of section 4.4 of the SmPC in order to add a new warning on arterial occlusive
events, based on a safety review. The Package Leaflet is updated accordingly. The RMP
version 8.0 has also been submitted.
Action: For adoption
Pharmacovigilance Risk Assessment Committee (PRAC)
EMA/PRAC/164465/2026 Page 22/75
5.3.7. Atidarsagene autotemcel – LIBMELDY (CAP) – EMA/VR/0000334917
Applicant: Orchard Therapeutics (Netherlands) B.V.
PRAC Rapporteur: Dirk Mentzer
Scope: A grouped application consisting of:
C.12: Submission of the final report from study 201222 listed as a category 3 study in the
RMP. This is a Phase I/II clinical trial of haematopoietic stem cell gene therapy for the
treatment of metachromatic leukodystrophy (MLD).
C.12: Submission of the final report from study CUP 207394 listed as a category 3 study in
the RMP. This is a gene therapy protocol using autologous haematopoietic stem cells for a
patient with metachromatic leukodystrophy (MLD).
C.12: Submission of the final report from studies CUP 206258 and HE 205029 listed as
category 3 studies in the RMP. These are Expanded Access Programs (EAP) for hematopoietic
stem cell gene therapy OTL-200 in subjects with early-onset metachromatic leukodystrophy
(MLD).
The RMP version 4.1 has also been submitted.
Action: For adoption
5.3.8. Atropine sulfate – RYJUNEA (CAP) – EMA/VR/0000357137
Applicant: Santen Oy
PRAC Rapporteur: Dennis Lex
Scope: Update of section 5.1 of the SmPC in order to update efficacy information based on
results from study SYD-101-001. This is a Phase 3, Randomized, Double Masked, Vehicle
Controlled Study to Assess the Safety and Efficacy of SYD-101 Ophthalmic Solution for the
Treatment of Myopia in Children. The RMP version 2 has also been submitted.
Action: For adoption
5.3.9. Cabotegravir – APRETUDE (CAP) – EMA/VR/0000331993
Applicant: ViiV Healthcare B.V.
PRAC Rapporteur: Dennis Lex
Scope: Update of sections 4.6 and 5.2 of the SmPC in order to update information and
recommendations on pregnancy, based on interim results from the open label extension
(OLE) phase of the Phase 3 study HPTN 084 (study 201739) on the use of cabotegravir (CAB)
for HIV-1 pre-exposure prophylaxis (PrEP) during pregnancy. The Package Leaflet is updated
accordingly. The RMP version 2.0 has also been submitted. In addition, the MAH took the
opportunity to introduce updates to the information on excipients in alignment with the
excipient guideline and to introduce minor editorial and formatting changes to the PI.
Action: For adoption
Pharmacovigilance Risk Assessment Committee (PRAC)
EMA/PRAC/164465/2026 Page 23/75
5.3.10. Cabotegravir – VOCABRIA (CAP) – EMA/VR/0000332087
Applicant: ViiV Healthcare B.V.
PRAC Rapporteur: Dennis Lex
Scope: Update of sections 4.4, 4.6 and 5.2 of the SmPC in order to update information on
pregnancy based on interim results from study HPTN 084/084-01; this is phase 3 double
blind safety and efficacy study of long-acting injectable cabotegravir compared to daily oral
TDF/FTC for pre-exposure prophylaxis in HIV-uninfected women – Pregnancy Safety and PK
Interim Analysis; the Package Leaflet is updated accordingly. The RMP version 6.0 has also
been submitted. In addition, the MAH took the opportunity to bring the PI in line with the
latest QRD template and to make typographical edits.
Action: For adoption
5.3.11. Capivasertib – TRUQAP (CAP) – EMA/VR/0000293735
Applicant: AstraZeneca AB
PRAC Rapporteur: Sonja Radowan
Scope: Extension of indication to include Truqap in combination with abiraterone for the
treatment of metastatic castration-sensitive prostate cancer characterized by PTEN deficient
tumours based on non-clinical and clinical dataset, including interim results from the pivotal
study D361BC00001 (CAPItello-281); this is a Phase III double-blind, randomised, placebo-
controlled study assessing the efficacy and safety of capivasertib + abiraterone versus
placebo + abiraterone as treatment for patients with de novo metastatic hormone-sensitive
prostate cancer (mHSPC) characterised by PTEN deficiency; As a consequence, sections 4.1,
4.2, 4.4, 4.8, 5.1, 5.2 and 5.3 of the SmPC are updated. The Package Leaflet is updated in
accordance. Version 3.1 of the RMP has also been submitted. As part of the application, the
MAH is requesting a 1-year extension of the market protection.
Action: For adoption
5.3.12. Dabigatran etexilate – PRADAXA (CAP) – EMA/VR/0000347421
Applicant: Boehringer Ingelheim International GmbH
PRAC Rapporteur: Marie Louise Schougaard Christiansen
Scope: A grouped application consisting of:
Type II (C.4): Update sections 4.1 and 4.2 of the SmPC following the deletion of
pharmaceutical form “coated granules”; the Package Leaflet, Annex II, and Labelling are
updated accordingly. An updated RMP version 43.0 has also been submitted. In addition, the
Applicant took the opportunity to bring the PI in line with the latest QRD template (version
10.4), and to introduce editorial and linguistic changes to the translated PI for Sweden,
Spain, Denmark, Norway, Netherland and France.
Type IB (C.7.a): Delete the pharmaceutical form “coated granules” from the Pradaxa
marketing authorisation (EU/1/08/442/025-030).
Action: For adoption
Pharmacovigilance Risk Assessment Committee (PRAC)
EMA/PRAC/164465/2026 Page 24/75
5.3.13. Dapivirine – DAPIVIRINE VAGINAL RING 25 MG (CAP) – EMA/X/0000314697
Applicant: International Partnership For Microbicides
PRAC Rapporteur: Jan Neuhauser
Scope: Extension application to add a new strength of 100 mg for dapivirine vaginal delivery
system, for vaginal use grouped with a type IA variation (A.2.a) to change the (invented)
name of the medicinal product from ‘Dapivirine Vaginal Ring 25 mg’ to ‘Dapivirine Vaginal
Ring’. The RMP (version 2.1) is updated in accordance.
Action: For adoption
5.3.14. Dasatinib – SPRYCEL (CAP) – EMA/VR/0000356665
Applicant: Bristol-Myers Squibb Pharma EEIG
PRAC Rapporteur: Marie Louise Schougaard Christiansen
Scope: Update of section 4.8 of the SmPC in order to remove the wording referring to the
absence of pleural effusion and pulmonary arterial hypertension in paediatric patients
following the update in Company Core Data Sheet and based on results from study
CA180226; this is an open label, multi-center, Phase 2 study of dasatinib therapy in children
and adolescents with newly diagnosed CP-CML or with Ph+ leukaemias resistant or intolerant
to imatinib. The RMP version 19.0 has also been submitted.
Action: For adoption
5.3.15. Deferasirox – EXJADE (CAP) – EMA/VR/0000333352
Applicant: Novartis Europharm Limited
PRAC Rapporteur: Tiphaine Vaillant
Scope: Update of sections 4.3 and 4.5 of the SmPC in order to remove the existing
contraindication for the combination of deferasirox with other iron chelator therapies, based
on a cumulative review of the available data. The Package Leaflet is updated accordingly. The
RMP version 24.0 has also been submitted.
Action: For adoption
5.3.16. Delgocitinib – ANZUPGO (CAP) – EMA/VR/0000315280
Applicant: LEO PHARMA A/S
PRAC Rapporteur: Liana Martirosyan
Scope: Extension of indication to include treatment of adolescents 12 years and older with
moderate to severe chronic hand eczema (CHE) for whom topical corticosteroids are
inadequate or inappropriate for ANZUPGO, based on final results from study LP0133-1426
(DELTA TEEN); this is a phase 3 pivotal clinical trial to evaluate efficacy and safety of twice-
daily applications of delgocitinib cream compared with cream vehicle for a 16-week treatment
period in adolescents 12-17 years of age with moderate to severe chronic hand eczema. The
trial is a randomized, double-blind, vehicle-controlled study. As a consequence, sections 4.1,
Pharmacovigilance Risk Assessment Committee (PRAC)
EMA/PRAC/164465/2026 Page 25/75
4.2, 4.8, 5.1, 5.2 and 5.3 of the SmPC are updated. The Package Leaflet is updated
accordingly. Version 1.1 of the RMP has also been submitted. In addition, the MAH took the
opportunity to update the list of local representatives in the Package Leaflet.
Action: For adoption
5.3.17. Dolutegravir – TIVICAY (CAP) – EMA/VR/0000351003
Applicant: ViiV Healthcare B.V.
PRAC Rapporteur: Dennis Lex
Scope: Extension of indication to include, in combination with other anti-retroviral medicinal
products, the treatment of Human Immunodeficiency Virus (HIV) infected neonates from
birth to less than 4 weeks and weighing at least 2 kg for TIVICAY, based on safety,
tolerability, and PK data from the study 212161 (IMPAACT 2023) conducted in term
(gestational age >=37 weeks) neonates exposed to HIV-1 weighing at least 2 kg and
enrolled within 5 days of birth who received dolutegravir (DTG) in addition to standard of
care prophylaxis. As a consequence, sections 4.1, 4.2, 4.5, 4.8, 5.1 and 5.2 of the SmPC are
updated. The Package Leaflet is updated accordingly. Version 23.0 of the RMP has also been
submitted. In addition, the MAH is taking the opportunity to introduce minor amendments to
the PI.
Action: For adoption
5.3.18. Enfortumab vedotin – PADCEV (CAP) – EMA/VR/0000336191
Applicant: Astellas Pharma Europe B.V.
PRAC Rapporteur: Eva Jirsová
Scope: Extension of indication to include Padcev, in combination with pembrolizumab, as
neoadjuvant treatment and then continued after radical cystectomy as adjuvant treatment, is
indicated for the treatment of adults with muscle invasive bladder cancer (MIBC) who are
eligible for cisplatin-containing chemotherapy, based on the results from Interim Analysis 1
of the pivotal Study KN-B15 (EV-304); this is a phase 3, randomized, open-label study to
evaluate perioperative enfortumab vedotin plus pembrolizumab (MK-3475) versus
neoadjuvant gemcitabine and cisplatin in cisplatin-eligible participants with Muscle-Invasive
Bladder Cancer. As consequence, sections 4.1, 4.2, 4.8, and 5.1 of the SmPC have been
updated; the Package Leaflet is updated accordingly. Version 6.1 of the RMP is submitted, to
reflect the updated data. In addition, the MAH took the opportunity to update the list of local
representatives in the Package Leaflet.
Action: For adoption
5.3.19. Epcoritamab – TEPKINLY (CAP) – EMA/VR/0000358245
Applicant: Abbvie Deutschland GmbH & Co. KG
PRAC Rapporteur: Maria Martinez Gonzalez
Scope: Update of sections 4.8, 5.1, and 5.2 of the SmPC in order to update the efficacy and
safety information based on results from study GCT3013-05 listed as a specific obligation
Pharmacovigilance Risk Assessment Committee (PRAC)
EMA/PRAC/164465/2026 Page 26/75
(category 2) in the Annex II; this is a randomized, open-label, phase 3 trial of epcoritamab
vs investigator’s choice chemotherapy in relapsed/refractory diffuse large B-cell lymphoma.
The Package Leaflet and Annex II are updated accordingly. The RMP version 4.1.0 has also
been submitted.
Action: For adoption
5.3.20. Exagamglogene autotemcel – CASGEVY (CAP) – EMA/VR/0000356719
Applicant: Vertex Pharmaceuticals (Ireland) Limited
PRAC Rapporteur: Bianca Mulder
Scope: Update of sections 4.8 and 5.1 of the SmPC in order to update clinical safety and
efficacy information based on final results from study CTX001-111 (in subjects with
transfusion-dependent β‑thalassemia (TDT)) and study CTX001-121 (in subjects with severe
sickle cell disease (SCD)) as well as interim results from study CTX001-131 (long-term
follow-up in subjects with either TDT or severe SCD), listed as specific obligations in the
Annex II. The Package Leaflet is updated accordingly. The RMP version 2.0 has also been
submitted. In addition, the MAH took the opportunity to introduce additional changes to the
PI.
Action: For adoption
5.3.21. Fenfluramine – FINTEPLA (CAP) – EMA/VR/0000350597
Applicant: UCB Pharma
PRAC Rapporteur: Dennis Lex
Scope: Extension of indication to include treatment of seizures associated with cyclin-
dependant kinase-like 5 (CDKL5) deficiency disorder (CDD) for patients aged 1 year and
older as adjunctive therapy in patients inadequately controlled with anti-seizure medicines,
for FINTEPLA, based on results from study ZX008-2103 (EP0216). This is a Phase 3,
randomized, double-blind, placebo-controlled, fixed-dose, multicenter study to assess the
efficacy and safety of fenfluramine HCl when used as adjunctive therapy for seizures in
participants with CDD. As a consequence, sections 4.1, 4.2, 4.4, 4.8, 5.1 and 5.2 of the
SmPC are updated. The Package Leaflet is updated in accordance. Version 5.4 of the RMP has
also been submitted.
Action: For adoption
5.3.22. Fenfluramine – FINTEPLA (CAP) – EMA/VR/0000350494
Applicant: UCB Pharma
PRAC Rapporteur: Dennis Lex
Scope: Extension of indication to include treatment of seizures associated with Dravet
syndrome in patients aged 1 to <2 years for FINTEPLA based on results from EP0213 study.
EP0213 is an open- label, single-arm, phase 3 study to evaluate safety, tolerability, and
pharmacokinetics of fenfluramine HCl (Hydrochloride) in infants 1 year to less than 2 years of
age with Dravet syndrome. As consequence, sections 4.1, 4.2, 4.4, 4.8, 5.1 and 5.2 of the
Pharmacovigilance Risk Assessment Committee (PRAC)
EMA/PRAC/164465/2026 Page 27/75
SmPC are updated. The Package Leaflet is updated in accordance. Version 5.3 of the RMP has
also been submitted. The PI is brought in line with the latest QRD template version 10.4. In
addition, the MAH took the opportunity to implement editorial changes to the PI.
Action: For adoption
5.3.23. Filgotinib – JYSELECA (CAP) – EMA/VR/0000350853
Applicant: Alfasigma S.p.A.
PRAC Rapporteur: Petar Mas
Scope: Update of sections 4.4, 4.8 and 5.1 of the SmPC in order to update long term efficacy
and safety information following final results from study GS-US-417-0304 (FINCH 4), listed
as a category 3 study in the RMP, and based on the pooled safety data from the Phase 2 and
Phase 3 clinical studies conducted with figotinib in rheumatoid arthritis patients. FINCH 4 is a
Phase 3 multicenter, open-label, long-term extension (LTE) study to assess the safety and
efficacy of filgotinib in subjects with rheumatoid arthritis. The RMP version 7.2 and Annex II
have also been updated.
Action: For adoption
5.3.24. Florbetapir (18F) – AMYVID (CAP) – EMA/VR/0000333287
Applicant: Eli Lilly Nederland B.V.
PRAC Rapporteur: Dennis Lex
Scope: Update of section 4.8 of the SmPC in order to revise the frequency category of ADRs
and include additional adverse reaction terms related to injection site reactions based on a
pooled safety analysis incorporating cumulative florbetapir (18F) exposure data from 26 979
subjects from 48 clinical trials; the Package Leaflet is updated accordingly. The RMP version
6.1 has also been submitted. In addition, the MAH took the opportunity update Annex II.D of
the SmPC to align with proposed RMP changes.
Action: For adoption
5.3.25. Givinostat – DUVYZAT (CAP) – EMA/VR/0000343703
Applicant: Italfarmaco S.p.A.
PRAC Rapporteur: Liana Martirosyan
Scope: Update of section 5.3 of the SmPC based on results from carcinogenicity studies in
mice and rat. The RMP version 1.1 has also been submitted.
Action: For adoption
5.3.26. Givinostat – DUVYZAT (CAP) – EMA/VR/0000343737
Applicant: Italfarmaco S.p.A.
PRAC Rapporteur: Liana Martirosyan
Pharmacovigilance Risk Assessment Committee (PRAC)
EMA/PRAC/164465/2026 Page 28/75
Scope: Update of sections 4.2 and 5.2 of the SmPC based on final results from study
ITF/2357/60. This is a Phase I, open-label, non-randomized study to evaluate the
pharmacokinetic, safety and tolerability of ITF2357 given as an oral single 50 mg dose in
participants with chronic hepatic impairment relative to matched participants with normal
hepatic function. The RMP version 1.1 has also been submitted.
Action: For adoption
5.3.27. Glofitamab – COLUMVI (CAP) – EMA/VR/0000327100
Applicant: Roche Registration GmbH
PRAC Rapporteur: Veronika Macurova
Scope: Update of sections 4.2, 4.4 and 4.8 of the SmPC in order to add a new warning on
‘haemophagocytic lymphohistiocytosis’ and to add it to the list of adverse drug reactions
(ADRs) with frequency not known, based on a drug safety report. The Package Leaflet is
updated accordingly. The RMP version 6.0 has also been submitted. In addition, the MAH
took the opportunity to introduce minor editorial and administrative changes to the PI.
Action: For adoption
5.3.28. Glofitamab – COLUMVI (CAP) – EMA/VR/0000348695
Applicant: Roche Registration GmbH
PRAC Rapporteur: Veronika Macurova
Scope: Update of sections 4.4 and 4.8 of the SmPC in order to add ‘Progressive multifocal
leukoencephalopathy (PML)’ to the list of adverse drug reactions (ADRs) with frequency 'not
known’ based on post-marketing data and literature. The Package Leaflet is updated
accordingly. The RMP version 7 has also been submitted.
Action: For adoption
5.3.29. Ivacaftor – KALYDECO (CAP) – EMA/VR/0000343903
Applicant: Vertex Pharmaceuticals (Ireland) Limited
PRAC Rapporteur: Maria Martinez Gonzalez
Scope: A grouped application consisting of:
Type II variation (C.6.a) Extension of indication in combination with
ivacaftor/tezacaftor/elexacaftor for existing treatment of cystic fibrosis (CF) to paediatric
patients aged 1 to less than 6 years who have at least one non Class I mutation in the CFTR
gene, for KALYDECO granules, based on interim results from study VX22-445-122; this is a
phase 3, open-label study evaluating the pharmacokinetics, safety, and tolerability of
elexacaftor/tezacaftor/ivacaftor in cystic fibrosis subjects 12 to less than 24 months of age;
As a consequence, sections 4.1, 4.2, 4.8, and 5.1 of the SmPC are updated. The Package
Leaflet and Labelling are updated in accordance. Version 16.1 of the RMP has also been
submitted.
Action: For adoption
Pharmacovigilance Risk Assessment Committee (PRAC)
EMA/PRAC/164465/2026 Page 29/75
5.3.30. Ivacaftor / Tezacaftor / Elexacaftor – KAFTRIO (CAP) – EMA/X/0000343848
Applicant: Vertex Pharmaceuticals (Ireland) Limited
PRAC Rapporteur: Dennis Lex
Scope: Extension application to add a new strength, 45 mg/30 mg/60 mg granules, grouped
with a type II variation (C.6.a) to extend the existing indication of cystic fibrosis (CF) to
paediatric patients aged 1 to less than 6 years who have at least one non-Class I mutation in
the cystic fibrosis transmembrane conductance regulator (CFTR) gene, for the granules
strengths (60mg/40mg/80mg and 75mg/50mg/100mg). The RMP (version 10.4) is updated
in accordance.
Action: For adoption
5.3.31. Levacetylleucine – AQNEURSA (CAP) – EMA/VR/0000354947
Applicant: Intrabio Ireland Limited
PRAC Rapporteur: Dennis Lex
Scope: A grouped application consisting of:
C.6: Extension of indication to include treatment of Ataxia-telangiectasia for AQNEURSA
based on results from study IB1001-303. This is a Phase 3 study to investigate the effects of
N-Acetyl-L-Leucine on Ataxia-Telangiectasia (A-T). As a consequence, sections 4.1, 4.2, 4.8
and 5.1 of the SmPC are updated. The Package Leaflet is updated in accordance. Version 2.0
of the RMP has also been submitted. As part of the application, the MAH is requesting a 1-
year extension of the market protection.
C.6: Modification of the approved indication for Niemann-Pick type C disease to include
treatment of the neurological manifestations in patients aged 4 years and older and weighing
at least 15 kg based on results from study IB1001-301. This is a Phase III study to assess
the safety and efficacy of N-Acetyl-L-Leucine versus Placebo for the treatment of Niemann-
Pick type C disease (NPC). As a consequence, sections 4.1, 4.2, 4.8, 5.1 and 5.2 of the SmPC
are updated. The Package Leaflet is updated in accordance. Version 2.0 of the RMP has also
been submitted.
C.4: Update of sections 4.2 and 6.6 of the SmPC in order to add the use of smaller feeding
tubes for enteral administration and to add yoghurt as an alternative administration method
for young children based on results from studies IB1001-201, IB1001-202, IB1001 203, and
IB1001-301. The Package Leaflet is updated accordingly.
Action: For adoption
5.3.32. Maralixibat – LIVMARLI (CAP) – EMA/VR/0000320544
Applicant: Mirum Pharmaceuticals International B.V.
PRAC Rapporteur: Adam Przybylkowski
Scope: A grouped application consisting of:
C.I.13: Submission of the final report from study MRX- 503 listed as category 3 study in the
RMP. This is a phase 3 study to Evaluate the Long-Term Safety and Efficacy of Maralixibat in
Pharmacovigilance Risk Assessment Committee (PRAC)
EMA/PRAC/164465/2026 Page 30/75
the Treatment of Subjects with Progressive Familial Intrahepatic Cholestasis (PFIC). The RMP
version 7.2 has also been submitted.
C.I.13: Submission of the final report for a retrospective study titled ''Analysis of Clinical
Outcomes in PFIC: Comparison of Maralixibat from Studies MRX-502/503 and MRX-801
versus Natural History (NAtural course and Prognosis of PFIC and Effect of biliary Diversion
[NAPPED])''.
Action: For adoption
5.3.33. Melphalan flufenamide – PEPAXTI (CAP) – EMA/VR/0000350278
Applicant: Oncopeptides AB
PRAC Rapporteur: Dennis Lex
Scope: Extension of indication to include, in combination with dexamethasone, the treatment
of adult patients with multiple myeloma who have received at least two prior lines of
therapies, whose disease is refractory to lenalidomide and the last line of therapy, for
PEPAXTI, based on final results from study OP-103 (OCEAN); this is a randomized, open-
label phase 3 study in patients with relapsed or refractory multiple myeloma following 2 to 4
lines of prior therapies and who were refractory to lenalidomide and the last line of therapy.
As a consequence, sections 4.1, 4.4, 4.8 and 5.1 of the SmPC are updated. The Package
Leaflet is updated in accordance. Version 1.4 of the RMP has also been submitted.
Action: For adoption
5.3.34. Metreleptin – MYALEPTA (CAP) – EMA/VR/0000356904
Applicant: Chiesi Farmaceutici S.p.A.
PRAC Rapporteur: Adam Przybylkowski
Scope: Update of sections 4.4, and 4.8 of the SmPC in order to amend existing safety
information on T cell lymphoma based on cumulative safety evidence from the clinical
studies, post-marketing data, and literature; the Annex II and the Package Leaflet are
updated accordingly. The RMP version 2.4 to remove Lymphoma from the list of Important
Potential Risks has also been submitted. In addition, the MAH took the opportunity to update
the information on polysorbates.
Action: For adoption
5.3.35. Mirabegron – BETMIGA (CAP) – EMA/VR/0000349861
Applicant: Astellas Pharma Europe B.V.
PRAC Rapporteur: Maria del Pilar Rayon
Scope: Update of section 4.4 of the SmPC in order to add a new warning on ANCA Associated
Vasculitis based on clinical, post-marketing, literature, and nonclinical evidence. The RMP
version 10.0 has also been submitted. In addition, the MAH took the opportunity to update
the list of local representatives in the Package Leaflet.
Action: For adoption
Pharmacovigilance Risk Assessment Committee (PRAC)
EMA/PRAC/164465/2026 Page 31/75
5.3.36. Naloxone – NYXOID (CAP) – EMA/VR/0000325329
Applicant: Mundipharma Corporation (Ireland) Limited
PRAC Rapporteur: Liana Martirosyan
Scope: Change in the legal status of Nyxoid from ‘medicinal product subject to medical
prescription’ to ‘medicinal products not subject to medical prescription’.
Action: For adoption
5.3.37. Obinutuzumab – GAZYVARO (CAP) – EMA/VR/0000350995
Applicant: Roche Registration GmbH
PRAC Rapporteur: Jenny-Maria Jönsson
Scope: Extension of indication to include treatment of adult patients with primary
membranous nephropathy (pMN) for GAZYVARO, based on the results from study WA41937
(MAJESTY); this is a Phase III, randomized, open-label active comparator-controlled
multicenter study to evaluate efficacy and safety of obinutuzumab in patients with pMN. As a
consequence, sections 4.1, 4.2, 4.4, 4.8, 5.1, 5.2 and 6.6 of the SmPC are updated. The
Package Leaflet is updated in accordance. Version 14 of the RMP has also been submitted. In
addition, the MAH took the opportunity to introduce minor edits to the PI.
Action: For adoption
5.3.38. Obinutuzumab – GAZYVARO (CAP) – EMA/VR/0000327013
Applicant: Roche Registration GmbH
PRAC Rapporteur: Jenny-Maria Jönsson
Scope: A grouped application comprised of two Type II Variations, as follows:
C.6.a: Extension of indication to include treatment of adult patients with active systemic
lupus erythematosus (SLE) who are receiving standard therapy, for GAZYVARO, based on the
results from study CA42750 (ALLEGORY); this is a Phase III, randomized, double-blind,
placebo-controlled, multicenter study evaluating the efficacy and safety of obinutuzumab in
patients with SLE treated with standard-of-care therapy. As a consequence, sections 4.1,
4.2, 4.4, 4.8, 5.1, 5.2 and 6.6 of the SmPC are updated. The Package Leaflet is updated in
accordance. In addition, the Marketing authorisation holder (MAH) took the opportunity to
update the SmPC with minor edits. Version 12 of the RMP has also been submitted.
C.4: Update of section 4.2 of the SmPC to introduce short duration infusion (SDI) as method
of administration for SLE patients, supported by previously submitted data in patients with
Follicular Lymphoma and by simulations conducted using an integrated population PK model
to estimate exposures following administration as an SDI to SLE patients.
Action: For adoption
5.3.39. Obinutuzumab – GAZYVARO (CAP) – EMA/VR/0000349826
Applicant: Roche Registration GmbH
Pharmacovigilance Risk Assessment Committee (PRAC)
EMA/PRAC/164465/2026 Page 32/75
PRAC Rapporteur: Jenny-Maria Jönsson
Scope: Extension of indication to include treatment of patients 2 years of age and older with
idiopathic nephrotic syndrome (INS) for GAZYVARO, based on final results from Phase 3
INShore (WA43380) study; this is a Phase 3, international, multicenter, randomised open
label study to evaluate the efficacy and safety of Gazyvaro versus mycophenolate mofetil
(MMF) in patients with childhood onset idiopathic nephrotic syndrome. As a consequence,
sections 4.1, 4.2, 4.4, 4.8, 5.1, 5.2 and 6.6 of the SmPC are updated. The Package Leaflet is
updated in accordance. Version 13 of the RMP has also been submitted. In addition, the MAH
took the opportunity to implement editorial changes to the PI.
Action: For adoption
5.3.40. Ocrelizumab – OCREVUS (CAP) – EMA/VR/0000313041
Applicant: Roche Registration GmbH
PRAC Rapporteur: Dirk Mentzer
Scope: Update of sections 4.4 and 4.8 of the SmPC in order to add a new warning on ‘Liver
Injury’ and to add it to the list of adverse drug reactions (ADRs) with frequency ‘rare’, based
on a cumulative safety review. The Package Leaflet is updated accordingly. In addition, the
MAH took the opportunity to submit a DHPC Letter and to introduce minor changes to the PI,
including the Labelling section.
Action: For adoption
5.3.41. Ocrelizumab – OCREVUS (CAP) – EMA/VR/0000357152
Applicant: Roche Registration GmbH
PRAC Rapporteur: Dirk Mentzer
Scope: Update of sections 4.4 and 4.6 of the SmPC in order to update information on the use
of ocrelizumab therapy pre-conception and up to the first trimester of pregnancy, and on
infants potentially exposed to ocrelizumab during pregnancy or via breastfeeding, based on
the final analyses of 2 clinical studies - MN42988 (MINORE) and MN42989 (SOPRANINO) and
other supportive data (the final CSR from an observational pregnancy registry (WA40063)
and a cumulative review of pregnancy, lactation and infant data from women with multiple
sclerosis (MS) treated with ocrelizumab from the Company Global Safety Database). The
Package Leaflet is updated accordingly. The RMP version 17.0 has also been submitted. In
addition, the MAH took the opportunity to introduce minor editorial updates and clarifications
to the PI.
Action: For adoption
5.3.42. Pneumococcal polysaccharide conjugate vaccine (15 valent, adsorbed) –
VAXNEUVANCE (CAP) – EMA/VR/0000356991
Applicant: Merck Sharp & Dohme B.V.
PRAC Rapporteur: Dirk Mentzer
Pharmacovigilance Risk Assessment Committee (PRAC)
EMA/PRAC/164465/2026 Page 33/75
Scope: Update of section 5.1 of the SmPC in order to introduce efficacy information against
acute otitis media in infants and children based on final results from post authorisation
efficacy study V114-032 listed as obligation in the Annex II; this is a phase 3, randomized,
double-blind, parallel-group, multicenter, efficacy study to evaluate V114 in the prevention of
VT-AOM in healthy infants enrolled at approximately 2 months of age. The RMP version 3.1
has also been submitted. In addition, the MAH took the opportunity to introduce editorial
changes to the PI.
Action: For adoption
5.3.43. Radium-223 – XOFIGO (CAP) – EMA/VR/0000350998
Applicant: Bayer AG
PRAC Rapporteur: Rugile Pilviniene
Scope: Submission of the final report from study 20510 RADIANT listed as an obligation in
the Annex II of the Product Information. The Annex II and the RMP (version 9.1) are updated
accordingly.
Action: For adoption
5.3.44. Radium-223 – XOFIGO (CAP) – EMA/VR/0000351078
Applicant: Bayer AG
PRAC Rapporteur: Rugile Pilviniene
Scope: Extension of indication to include the combination treatment with enzalutamide for
mCRPC with bone metastases for XOFIGO and modifications of existing indication, based on
final results from study PEACE-3; this is a randomized multicenter phase III trial comparing
enzalutamide vs. a combination of Ra223 and enzalutamide in asymptomatic or mildly
symptomatic castration resistant prostate cancer patients metastatic to bone; As a
consequence, sections 4.1, 4.2, 4.4, 4.8 and 5.1 of the SmPC are updated. The Package
Leaflet is updated in accordance. Version 8.2 of the RMP has also been submitted.
Action: For adoption
5.3.45. Respiratory syncytial virus mRNA vaccine (nucleoside modified) – MRESVIA (CAP) –
EMA/VR/0000320244
Applicant: Moderna Biotech Spain S.L.
PRAC Rapporteur: Jean-Michel Dogné
Scope: Update of sections 4.4, 4.8 and 5.1 of the SmPC in order to update clinical efficacy
and safety information on the use of mRESVIA in immunocompromised individuals 18 years
of age and older, based on interim results from study mRNA-1345-P303 Part B; this is a
Phase 3 study to evaluate the immunogenicity and safety of mRNA-1345, an mRNA vaccine
targeting respiratory syncytial virus, in high-risk adults. The updated RMP version 6.0 has
also been submitted.
Action: For adoption
Pharmacovigilance Risk Assessment Committee (PRAC)
EMA/PRAC/164465/2026 Page 34/75
5.3.46. Rilzabrutinib – WAYRILZ (CAP) – EMA/VR/0000357430
Applicant: Sanofi B.V.
PRAC Rapporteur: Dennis Lex
Scope: A grouped application consisting of:
C.12: Submission of the final report from study LUNA-2 (PRN1008 010), listed as a category
3 study in the RMP. This is a Phase 1/2 Study Investigating the Safety, Pharmacokinetics,
and Clinical Activity of Rilzabrutinib, an Oral Bruton tyrosine kinase (BTK) Inhibitor, in
Patients with Relapsed Immune Thrombocytopenia. The RMP version 2 has also been
submitted.
C.12: Submission of the final report from study LUNA-3 (PRN1008 018), listed as a category
3 study in the RMP. This is a Phase 3, Multicenter, Randomized, Double-Blind, Placebo
Controlled, Parallel-Group Study with an Open-Label Extension to Evaluate the Efficacy and
Safety of Oral Rilzabrutinib in Adults and Adolescents with Persistent or Chronic Immune
Thrombocytopenia. The RMP version 2 has also been submitted.
Action: For adoption
5.3.47. Selumetinib – KOSELUGO (CAP) – EMA/VR/0000347385
Applicant: AstraZeneca AB
PRAC Rapporteur: Jenny-Maria Jönsson
Scope: A grouped application consisting of:
C.4: Update of sections 4.4, and 4.8 of the SmPC in order to include revised information on
the retinal disorders based on review of all available safety data. The RMP version 5.2 has
also been submitted.
C.4: Update of sections 4.4, and 4.8 of the SmPC in order to revise time‑to‑onset data
following correction of programming error in the KOMET study, describing the median time to
onset at maximum Common Terminology Criteria for Adverse Event (CTCAE) grade.
Action: For adoption
5.3.48. Somapacitan – SOGROYA (CAP) – EMA/VR/0000350795
Applicant: Novo Nordisk A/S
PRAC Rapporteur: Dennis Lex
Scope: Extension of indication for SOGROYA to include treatment of growth failure in children
and adolescents with Turner Syndrome (TS) based on final results from three clinical studies,
two phase 3 studies (4467 and 4469) and a phase 2 study (4245). As a consequence,
sections 4.1, 4.2, 4.8, 5.1 and 5.2 of the SmPC are updated. The Package Leaflet is updated
in accordance. Version 5.1 of the RMP has also been submitted. Furthermore, the PI is
brought in line with the QRD template version 10.4.
Action: For adoption
Pharmacovigilance Risk Assessment Committee (PRAC)
EMA/PRAC/164465/2026 Page 35/75
5.3.49. Sulfur hexafluoride – SONOVUE (CAP) – EMA/VR/0000355106
Applicant: Bracco International B.V.
PRAC Rapporteur: Tiphaine Vaillant
Scope: Update of section 4.3 of the SmPC in order to remove an existing contraindication
based on post-marketing data and literature. The Package Leaflet is updated accordingly. The
RMP version 11.0 has also been submitted.
Action: For adoption
5.3.50. Talazoparib – TALZENNA (CAP) – EMA/VR/0000350865
Applicant: Pfizer Europe MA EEIG
PRAC Rapporteur: Carla Torre
Scope: Extension of indication to include TALZENNA in combination with enzalutamide for the
treatment of homologous recombination repair (HRR) gene-mutated metastatic hormone-
sensitive prostate cancer (mHSPC), based on interim results from study C3441052
(TALAPRO-3); this is a pivotal multinational, randomised, double-blind Phase 3 study of
talazoparib + enzalutamide versus placebo + enzalutamide in men with HRRm mHSPC. As a
consequence, sections 4.1, 4.2, 4.8, 5.1 and 5.2 of the SmPC are updated. The Package
Leaflet is updated in accordance. Version 3.0 of the RMP has also been submitted.
Furthermore, the PI is brought in line with the latest QRD template version 10.4.
Action: For adoption
5.3.51. Trastuzumab – HERZUMA (CAP) – EMA/X/0000343856
Applicant: Celltrion Healthcare Hungary Kft.
PRAC Rapporteur: Dirk Mentzer
Scope: Extension application to introduce addition of a new pharmaceutical form, new
strength and new route of admin (600 mg solution for injection, subcutaneous use). Due to
the introduction of the subcutaneous formulation, the Product Information of the IV
formulations (150mg + 420mg powder for concentrate for solution for infusion) were also
updated in addition to editorial changes according to the last version of the QRD guidance.
Action: For adoption
5.3.52. Ustekinumab – IMULDOSA (CAP) – EMA/VR/0000347840
Applicant: Accord Healthcare S.L.U.
PRAC Rapporteur: Rhea Fitzgerald
Scope: Quality
Action: For adoption
Pharmacovigilance Risk Assessment Committee (PRAC)
EMA/PRAC/164465/2026 Page 36/75
6. Periodic safety update reports (PSURs)
6.1. PSUR single assessment (PSUSA) procedures including centrally
authorised products (CAPs) only
6.1.1. Abacavir – ZIAGEN (CAP) – EMA/PSUR/0000344374
Applicant: ViiV Healthcare B.V.
PRAC Rapporteur: Zoubida Amimour
Scope: Evaluation of a PSUSA procedure (PSUSA/00000010/202512)
Action: For adoption
6.1.2. Abatacept – ORENCIA (CAP) – EMA/PSUR/0000344377
Applicant: Bristol-Myers Squibb Pharma EEIG
PRAC Rapporteur: Kimmo Jaakkola
Scope: Evaluation of a PSUSA procedure (PSUSA/00000013/202512)
Action: For adoption
6.1.3. Adalimumab – AMGEVITA (CAP); AMSPARITY (CAP); HEFIYA (CAP); HUKYNDRA
(CAP); HULIO (CAP); HUMIRA (CAP); HYRIMOZ (CAP); IDACIO (CAP); IMRALDI
(CAP); LIBMYRIS (CAP); YUFLYMA (CAP) – EMA/PSUR/0000344425
Applicants: Abbvie Deutschland GmbH & Co. KG, Amgen Europe B.V., Biosimilar
Collaborations Ireland Limited, Celltrion Healthcare Hungary Kft, Fresenius Kabi Deutschland
GmbH, Pfizer Europe MA EEIG, Samsung Bioepis NL B.V., Sandoz GmbH, STADA Arzneimittel
AG
PRAC Rapporteur: Karin Bolin
Scope: Evaluation of a PSUSA procedure (PSUSA/00010783/202512)
Action: For adoption
6.1.4. Amino acids – MAAPLIV (CAP) – EMA/PSUR/0000344441
Applicant: Recordati Rare Diseases
PRAC Rapporteur: Amelia Cupelli
Scope: Evaluation of a PSUSA procedure (PSUSA/00011149/202601)
Action: For adoption
Pharmacovigilance Risk Assessment Committee (PRAC)
EMA/PRAC/164465/2026 Page 37/75
6.1.5. Angiotensin II – GIAPREZA (CAP) – EMA/PSUR/0000344429
Applicants: Paion Pharma GmbH, Paion Deutschland GmbH
PRAC Rapporteur: Bianca Mulder
Scope: Evaluation of a PSUSA procedure (PSUSA/00010785/202512)
Action: For adoption
6.1.6. Avapritinib – AYVAKYT (CAP) – EMA/PSUR/0000344431
Applicant: Blueprint Medicines (Netherlands) B.V.
PRAC Rapporteur: Bianca Mulder
Scope: Evaluation of a PSUSA procedure (PSUSA/00010878/202601)
Action: For adoption
6.1.7. Belzutifan – WELIREG (CAP) – EMA/PSUR/0000344453
Applicant: Merck Sharp & Dohme B.V.
PRAC Rapporteur: Dennis Lex
Scope: Evaluation of a PSUSA procedure (PSUSA/00011107/202602)
Action: For adoption
6.1.8. Birch bark extract – FILSUVEZ (CAP) – EMA/PSUR/0000344404
Applicant: Chiesi Farmaceutici S.p.A.
PRAC Rapporteur: Zane Neikena
Scope: Evaluation of a PSUSA procedure (PSUSA/00010446/202601)
Action: For adoption
6.1.9. Brensocatib – BRINSUPRI (CAP) – EMA/PSUR/0000344438
Applicant: Insmed Netherlands B.V.
PRAC Rapporteur: Zane Neikena
Scope: Evaluation of a PSUSA procedure (PSUSA/00011170/202602)
Action: For adoption
6.1.10. Brexucabtagene autoleucel – TECARTUS (CAP) – EMA/PSUR/0000344416
Applicant: Kite Pharma EU B.V.
PRAC Rapporteur: Bianca Mulder
Pharmacovigilance Risk Assessment Committee (PRAC)
EMA/PRAC/164465/2026 Page 38/75
Scope: Evaluation of a PSUSA procedure (PSUSA/00010903/202601)
Action: For adoption
6.1.11. Catumaxomab – KORJUNY (CAP) – EMA/PSUR/0000344454
Applicant: Atnahs Pharma Netherlands B.V.
PRAC Rapporteur: Bianca Mulder
Scope: Evaluation of a PSUSA procedure (PSUSA/00011108/202602)
Action: For adoption
6.1.12. Crovalimab – PIASKY (CAP) – EMA/PSUR/0000344450
Applicant: Roche Registration GmbH
PRAC Rapporteur: Bianca Mulder
Scope: Evaluation of a PSUSA procedure (PSUSA/00011071/202602)
Action: For adoption
6.1.13. Danicopan – VOYDEYA (CAP) – EMA/PSUR/0000344446
Applicant: Alexion Europe
PRAC Rapporteur: Dennis Lex
Scope: Evaluation of a PSUSA procedure (PSUSA/00011056/202601)
Action: For adoption
6.1.14. Dapivirine – DAPIVIRINE VAGINAL RING 25 MG (Art 58) – EMA/PSUR/0000339021
Applicant: International Partnership For Microbicides
PRAC Rapporteur: Jan Neuhauser
Scope: Evaluation of a PSUSA procedure (PSUV Dapivirine)
Action: For adoption
6.1.15. Daridorexant – QUVIVIQ (CAP) – EMA/PSUR/0000344443
Applicant: Idorsia Pharmaceuticals Deutschland GmbH
PRAC Rapporteur: Ana Sofia Diniz Martins
Scope: Evaluation of a PSUSA procedure (PSUSA/00010993/202601)
Action: For adoption
Pharmacovigilance Risk Assessment Committee (PRAC)
EMA/PRAC/164465/2026 Page 39/75
6.1.16. Delgocitinib – ANZUPGO (CAP) – EMA/PSUR/0000344461
Applicant: LEO PHARMA A/S
PRAC Rapporteur: Liana Martirosyan
Scope: Evaluation of a PSUSA procedure (PSUSA/00011091/202601)
Action: For adoption
6.1.17. Donanemab – KISUNLA (CAP) – EMA/PSUR/0000344439
Applicant: Eli Lilly Nederland B.V.
PRAC Rapporteur: Amelia Cupelli
Scope: Evaluation of a PSUSA procedure (PSUSA/00011165/202601)
Action: For adoption
6.1.18. Elinzanetant – LYNKUET (CAP) – EMA/PSUR/0000344463
Applicant: Bayer AG
PRAC Rapporteur: Guðrún Stefánsdóttir
Scope: Evaluation of a PSUSA procedure (PSUSA/00011171/202601)
Action: For adoption
6.1.19. Epinephrine – EURNEFFY (CAP) – EMA/PSUR/0000344451
Applicant: Alk-Abello A/S
PRAC Rapporteur: Terhi Lehtinen
Scope: Evaluation of a PSUSA procedure (PSUSA/00011081/202602)
Action: For adoption
6.1.20. Eptacog alfa (activated) – NOVOSEVEN (CAP) – EMA/PSUR/0000344447
Applicant: Novo Nordisk A/S
PRAC Rapporteur: Bianca Mulder
Scope: Evaluation of a PSUSA procedure (PSUSA/00001245/202512)
Action: For adoption
6.1.21. Ertugliflozin – STEGLATRO (CAP); Ertugliflozin / Metformin hydrochloride –
SEGLUROMET (CAP); Ertugliflozin / Sitagliptin – STEGLUJAN (CAP) –
EMA/PSUR/0000344430
Applicant: Merck Sharp & Dohme B.V.
Pharmacovigilance Risk Assessment Committee (PRAC)
EMA/PRAC/164465/2026 Page 40/75
PRAC Rapporteur: Bianca Mulder
Scope: Evaluation of a PSUSA procedure (PSUSA/00010784/202512)
Action: For adoption
6.1.22. Evinacumab – EVKEEZA (CAP) – EMA/PSUR/0000344420
Applicant: Ultragenyx Germany GmbH
PRAC Rapporteur: Karin Bolin
Scope: Evaluation of a PSUSA procedure (PSUSA/00010945/202602)
Action: For adoption
6.1.23. Faricimab – VABYSMO (CAP) – EMA/PSUR/0000344426
Applicant: Roche Registration GmbH
PRAC Rapporteur: Carla Torre
Scope: Evaluation of a PSUSA procedure (PSUSA/00011016/202601)
Action: For adoption
6.1.24. Garadacimab – ANDEMBRY (CAP) – EMA/PSUR/0000344455
Applicant: CSL Behring GmbH
PRAC Rapporteur: Marie Louise Schougaard Christiansen
Scope: Evaluation of a PSUSA procedure (PSUSA/00011109/202601)
Action: For adoption
6.1.25. Gefapixant – LYFNUA (CAP) – EMA/PSUR/0000344383
Applicant: Merck Sharp & Dohme B.V.
PRAC Rapporteur: Jan Neuhauser
Scope: Evaluation of a PSUSA procedure (PSUSA/00000132/202601)
Action: For adoption
6.1.26. Ivacaftor – KALYDECO (CAP) – EMA/PSUR/0000344411
Applicant: Vertex Pharmaceuticals (Ireland) Limited
PRAC Rapporteur: Maria Martinez Gonzalez
Scope: Evaluation of a PSUSA procedure (PSUSA/00009204/202601)
Action: For adoption
Pharmacovigilance Risk Assessment Committee (PRAC)
EMA/PRAC/164465/2026 Page 41/75
6.1.27. Lamivudine / Abacavir – KIVEXA (CAP) – EMA/PSUR/0000344375
Applicant: ViiV Healthcare B.V.
PRAC Rapporteur: Zoubida Amimour
Scope: Evaluation of a PSUSA procedure (PSUSA/00000011/202512)
Action: For adoption
6.1.28. Lecanemab – LEQEMBI (CAP) – EMA/PSUR/0000344458
Applicant: Eisai GmbH
PRAC Rapporteur: Eva Jirsová
Scope: Evaluation of a PSUSA procedure (PSUSA/00011132/202601)
Action: For adoption
6.1.29. Lisocabtagene maraleucel / Lisocabtagene maraleucel – BREYANZI (CAP) –
EMA/PSUR/0000344421
Applicant: Bristol-Myers Squibb Pharma EEIG
PRAC Rapporteur: Dirk Mentzer
Scope: Evaluation of a PSUSA procedure (PSUSA/00010990/202602)
Action: For adoption
6.1.30. Lonoctocog alfa – AFSTYLA (CAP) – EMA/PSUR/0000344406
Applicant: CSL Behring GmbH
PRAC Rapporteur: Sonja Radowan
Scope: Evaluation of a PSUSA procedure (PSUSA/00010559/202601)
Action: For adoption
6.1.31. Lutetium (177Lu) oxodotreotide – LUTATHERA (CAP) – EMA/PSUR/0000344414
Applicant: Advanced Accelerator Applications
PRAC Rapporteur: Adam Przybylkowski
Scope: Evaluation of a PSUSA procedure (PSUSA/00010643/202512)
Action: For adoption
6.1.32. Metreleptin – MYALEPTA (CAP) – EMA/PSUR/0000344434
Applicant: Chiesi Farmaceutici S.p.A.
PRAC Rapporteur: Adam Przybylkowski
Pharmacovigilance Risk Assessment Committee (PRAC)
EMA/PRAC/164465/2026 Page 42/75
Scope: Evaluation of a PSUSA procedure (PSUSA/00010700/202601)
Action: For adoption
6.1.33. Mexiletine – NAMUSCLA (CAP) – EMA/PSUR/0000344427
Applicant: Lupin Europe GmbH
PRAC Rapporteur: Eva Jirsová
Scope: Evaluation of a PSUSA procedure (PSUSA/00010738/202512)
Action: For adoption
6.1.34. Mirdametinib – EZMEKLY (CAP) – EMA/PSUR/0000344444
Applicants: Springworks Therapeutics Ireland Limited, Merck Europe B.V.
PRAC Rapporteur: Bianca Mulder
Scope: Evaluation of a PSUSA procedure (PSUSA/00011161/202602)
Action: For adoption
6.1.35. Omalizumab – OMLYCLO (CAP); XOLAIR (CAP) – EMA/PSUR/0000344391
Applicants: Celltrion Healthcare Hungary Kft., Novartis Europharm Limited
PRAC Rapporteur: Karin Bolin
Scope: Evaluation of a PSUSA procedure (PSUSA/00002214/202512)
Action: For adoption
6.1.36. Pandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted,
prepared in cell cultures) – INCELLIPAN (CAP); Zoonotic influenza vaccine (H5N1)
(surface antigen, inactivated, adjuvanted, prepared in cell cultures) – CELLDEMIC
(CAP) – EMA/PSUR/0000344449
Applicant: Seqirus Netherlands B.V.
PRAC Rapporteur: Jenny-Maria Jönsson
Scope: Evaluation of a PSUSA procedure (PSUSA/00011057/202601)
Action: For adoption
6.1.37. Pirtobrutinib – JAYPIRCA (CAP) – EMA/PSUR/0000344380
Applicant: Eli Lilly Nederland B.V.
PRAC Rapporteur: Bianca Mulder
Scope: Evaluation of a PSUSA procedure (PSUSA/00000155/202601)
Action: For adoption
Pharmacovigilance Risk Assessment Committee (PRAC)
EMA/PRAC/164465/2026 Page 43/75
6.1.38. Plerixafor – MOZOBIL (CAP) – EMA/PSUR/0000344390
Applicant: Sanofi B.V.
PRAC Rapporteur: Bianca Mulder
Scope: Evaluation of a PSUSA procedure (PSUSA/00002451/202512)
Action: For adoption
6.1.39. Pneumococcal polysaccharide conjugate vaccine (15 valent, adsorbed) –
VAXNEUVANCE (CAP) – EMA/PSUR/0000344419
Applicant: Merck Sharp & Dohme B.V.
PRAC Rapporteur: Dirk Mentzer
Scope: Evaluation of a PSUSA procedure (PSUSA/00010975/202601)
Action: For adoption
6.1.40. Quadrivalent influenza vaccine (recombinant, prepared in cell culture) – SUPEMTEK
TETRA (CAP) – EMA/PSUR/0000344432
Applicant: Sanofi Winthrop Industrie
PRAC Rapporteur: Zoubida Amimour
Scope: Evaluation of a PSUSA procedure (PSUSA/00010886/202601)
Action: For adoption
6.1.41. Relugolix – ORGOVYX (CAP) – EMA/PSUR/0000344433
Applicant: Accord Healthcare S.L.U.
PRAC Rapporteur: Karin Erneholm
Scope: Evaluation of a PSUSA procedure (PSUSA/00010994/202601)
Action: For adoption
6.1.42. Romosozumab – EVENITY (CAP) – EMA/PSUR/0000344428
Applicant: UCB Pharma
PRAC Rapporteur: Tiphaine Vaillant
Scope: Evaluation of a PSUSA procedure (PSUSA/00010824/202601)
Action: For adoption
6.1.43. Rucaparib – RUBRACA (CAP) – EMA/PSUR/0000344413
Applicant: pharmaand GmbH
Pharmacovigilance Risk Assessment Committee (PRAC)
EMA/PRAC/164465/2026 Page 44/75
PRAC Rapporteur: Jenny-Maria Jönsson
Scope: Evaluation of a PSUSA procedure (PSUSA/00010694/202512)
Action: For adoption
6.1.44. Sarilumab – KEVZARA (CAP) – EMA/PSUR/0000344412
Applicant: Sanofi Winthrop Industrie
PRAC Rapporteur: Maria Martinez Gonzalez
Scope: Evaluation of a PSUSA procedure (PSUSA/00010609/202601)
Action: For adoption
6.1.45. Sebetralstat – EKTERLY (CAP) – EMA/PSUR/0000344437
Applicant: Kalvista Pharmaceuticals (Ireland) Limited
PRAC Rapporteur: Zane Neikena
Scope: Evaluation of a PSUSA procedure (PSUSA/00011154/202601)
Action: For adoption
6.1.46. Sutimlimab – ENJAYMO (CAP) – EMA/PSUR/0000344445
Applicant: Recordati Rare Diseases
PRAC Rapporteur: Jan Neuhauser
Scope: Evaluation of a PSUSA procedure (PSUSA/00011023/202602)
Action: For adoption
6.1.47. Tafasitamab – MINJUVI (CAP) – EMA/PSUR/0000344435
Applicant: Incyte Biosciences Distribution B.V.
PRAC Rapporteur: Jenny-Maria Jönsson
Scope: Evaluation of a PSUSA procedure (PSUSA/00010951/202601)
Action: For adoption
6.1.48. Tagraxofusp – ELZONRIS (CAP) – EMA/PSUR/0000344436
Applicant: Stemline Therapeutics B.V.
PRAC Rapporteur: Bianca Mulder
Scope: Evaluation of a PSUSA procedure (PSUSA/00010896/202512)
Action: For adoption
Pharmacovigilance Risk Assessment Committee (PRAC)
EMA/PRAC/164465/2026 Page 45/75
6.1.49. Talquetamab – TALVEY (CAP) – EMA/PSUR/0000344393
Applicant: Janssen Cilag International
PRAC Rapporteur: Barbara Kovacic Bytyqi
Scope: Evaluation of a PSUSA procedure (PSUSA/00000099/202602)
Action: For adoption
6.1.50. Tebentafusp – KIMMTRAK (CAP) – EMA/PSUR/0000344442
Applicant: Immunocore Ireland Limited
PRAC Rapporteur: Bianca Mulder
Scope: Evaluation of a PSUSA procedure (PSUSA/00010991/202601)
Action: For adoption
6.1.51. Tecovirimat – TECOVIRIMAT SIGA (CAP) – EMA/PSUR/0000344448
Applicant: Siga Technologies Netherlands B.V.
PRAC Rapporteur: Dennis Lex
Scope: Evaluation of a PSUSA procedure (PSUSA/00010971/202601)
Action: For adoption
6.1.52. Teprotumumab – TEPEZZA (CAP) – EMA/PSUR/0000344456
Applicant: Amgen Europe B.V.
PRAC Rapporteur: Sonja Radowan
Scope: Evaluation of a PSUSA procedure (PSUSA/00011148/202601)
Action: For adoption
6.1.53. Tezacaftor / Ivacaftor – SYMKEVI (CAP) – EMA/PSUR/0000344423
Applicant: Vertex Pharmaceuticals (Ireland) Limited
PRAC Rapporteur: Eamon O Murchu
Scope: Evaluation of a PSUSA procedure (PSUSA/00010730/202602)
Action: For adoption
6.1.54. Tiratricol – EMCITATE (CAP) – EMA/PSUR/0000344457
Applicant: Rare Thyroid Therapeutics International AB
PRAC Rapporteur: Zoubida Amimour
Pharmacovigilance Risk Assessment Committee (PRAC)
EMA/PRAC/164465/2026 Page 46/75
Scope: Evaluation of a PSUSA procedure (PSUSA/00011114/202602)
Action: For adoption
6.1.55. Ustekinumab – FYMSKINA (CAP); IMULDOSA (CAP); OTULFI (CAP); PYZCHIVA
(CAP); QOYVOLMA (CAP); STELARA (CAP); STEQEYMA (CAP); USGENA (CAP);
USRENTY (CAP); USYMRO (CAP); UZPRUVO (CAP); WEZENLA (CAP); YESINTEK
(CAP) – EMA/PSUR/0000344407
Applicants: Formycon AG, Accord Healthcare S.L.U., Fresenius Kabi Deutschland GmbH,
Samsung Bioepis NL B.V., Celltrion Healthcare Hungary Kft., Janssen Cilag International,
STADA Arzneimittel AG, Biosimilar Collaborations Ireland Limited, Elc Group s.r.o., Gedeon
Richter Plc., Amgen Technology (Ireland) Unlimited Company
PRAC Rapporteur: Rhea Fitzgerald
Scope: Evaluation of a PSUSA procedure (PSUSA/00003085/202512)
Action: For adoption
6.1.56. Vericiguat – VERQUVO (CAP) – EMA/PSUR/0000344417
Applicant: Bayer AG
PRAC Rapporteur: Kimmo Jaakkola
Scope: Evaluation of a PSUSA procedure (PSUSA/00010950/202601)
Action: For adoption
6.1.57. Voclosporin – LUPKYNIS (CAP) – EMA/PSUR/0000344422
Applicant: Otsuka Pharmaceutical Netherlands B.V.
PRAC Rapporteur: Adam Przybylkowski
Scope: Evaluation of a PSUSA procedure (PSUSA/00011020/202601)
Action: For adoption
6.1.58. Vorasidenib – VORANIGO (CAP) – EMA/PSUR/0000344440
Applicant: Les Laboratoires Servier
PRAC Rapporteur: Jo Robays
Scope: Evaluation of a PSUSA procedure (PSUSA/00011157/202602)
Action: For adoption
6.1.59. Zuranolone – ZURZUVAE (CAP) – EMA/PSUR/0000344462
Applicant: Biogen Netherlands B.V.
PRAC Rapporteur: Guðrún Stefánsdóttir
Pharmacovigilance Risk Assessment Committee (PRAC)
EMA/PRAC/164465/2026 Page 47/75
Scope: Evaluation of a PSUSA procedure (PSUSA/00011158/202602)
Action: For adoption
6.2. PSUR single assessment (PSUSA) procedures including centrally
authorised products (CAPs) and nationally authorised products
(NAPs)
6.2.1. Alendronic acid / Colecalciferol – ADROVANCE (CAP); FOSAVANCE (CAP); VANTAVO
(CAP), NAP; alendronic acid / calcium / colecalciferol (NAP) –
EMA/PSUR/0000344382
Applicant(s): Organon N.V., various
PRAC Rapporteur: Jan Neuhauser
Scope: Evaluation of a PSUSA procedure (PSUSA/00000079/202601)
Action: For adoption
6.2.2. Lamivudine / Abacavir / Zidovudine - TRIZIVIR (CAP), NAP –
EMA/PSUR/0000344408
Applicant(s): ViiV Healthcare B.V., various
PRAC Rapporteur: Zoubida Amimour
Scope: Evaluation of a PSUSA procedure (PSUSA/00003144/202512)
Action: For adoption
6.2.3. Lenalidomide - LENALIDOMIDE ACCORD (CAP); LENALIDOMIDE KRKA (CAP);
LENALIDOMIDE MYLAN (CAP); REVLIMID (CAP), NAP – EMA/PSUR/0000344392
Applicants: Accord Healthcare S.L.U., Bristol-Myers Squibb Pharma EEIG, KRKA tovarna
zdravil d.d. Novo mesto, Mylan Pharmaceuticals Limited, various
PRAC Rapporteur: Tiphaine Vaillant
Scope: Evaluation of a PSUSA procedure (PSUSA/00001838/202512)
Action: For adoption
6.2.4. Repaglinide - NOVONORM (CAP); PRANDIN (CAP); NAP – EMA/PSUR/0000344399
Applicant(s): Novo Nordisk A/S, various
PRAC Rapporteur: Bianca Mulder
Scope: Evaluation of a PSUSA procedure (PSUSA/00002618/202512)
Action: For adoption
Pharmacovigilance Risk Assessment Committee (PRAC)
EMA/PRAC/164465/2026 Page 48/75
6.3. PSUR single assessment (PSUSA) procedures including nationally
authorised products (NAPs) only
6.3.1. 5 fluorouracil (topical application) – EMA/PSUR/0000344410
Applicants: various
PRAC Lead: Dennis Lex
Scope: Evaluation of a PSUSA procedure (PSUSA/00010000/202601)
Action: For adoption
6.3.2. Alendronate – EMA/PSUR/0000344376
Applicants: various
PRAC Lead: Karin Erneholm
Scope: Evaluation of a PSUSA procedure (PSUSA/00000078/202601)
Action: For adoption
6.3.3. Alitretinoin (oral use) – EMA/PSUR/0000344424
Applicants: various
PRAC Lead: Jan Neuhauser
Scope: Evaluation of a PSUSA procedure (PSUSA/00010710/202601)
Action: For adoption
6.3.4. Alizapride – EMA/PSUR/0000344378
Applicants: various
PRAC Lead: Jo Robays
Scope: Evaluation of a PSUSA procedure (PSUSA/00000091/202601)
Action: For adoption
6.3.5. Allergen for therapy: Dactylis Glomerata L., Phleum Pratense L., Anthoxanthum
Odoratum L., Lolium Perenne L., Poa Pratensis L. (sublingual tablet) –
EMA/PSUR/0000344403
Applicants: various
PRAC Lead: Dirk Mentzer
Scope: Evaluation of a PSUSA procedure (PSUSA/00010465/202512)
Action: For adoption
Pharmacovigilance Risk Assessment Committee (PRAC)
EMA/PRAC/164465/2026 Page 49/75
6.3.6. Amino acid combinations (only combinations of pure amino acids or combination of
amino acids with mineral compounds/electrolytes, i.v. application) –
EMA/PSUR/0000344409
Applicants: various
PRAC Lead: Dennis Lex
Scope: Evaluation of a PSUSA procedure (PSUSA/00010187/202601)
Action: For adoption
6.3.7. Aminophylline – EMA/PSUR/0000344384
Applicants: various
PRAC Lead: Ana Sofia Diniz Martins
Scope: Evaluation of a PSUSA procedure (PSUSA/00000164/202601)
Action: For adoption
6.3.8. Amisulpride – EMA/PSUR/0000344386
Applicants: various
PRAC Lead: Eamon O Murchu
Scope: Evaluation of a PSUSA procedure (PSUSA/00000167/202601)
Action: For adoption
6.3.9. Antithrombin III – EMA/PSUR/0000344418
Applicants: various
PRAC Lead: Amelia Cupelli
Scope: Evaluation of a PSUSA procedure (PSUSA/00003159/202512)
Action: For adoption
6.3.10. Atropine / diphenoxylate – EMA/PSUR/0000344381
Applicants: various
PRAC Lead: Jana Pecherova
Scope: Evaluation of a PSUSA procedure (PSUSA/00000269/202601)
Action: For adoption
6.3.11. Benzydamine / cetylpyridine – EMA/PSUR/0000344385
Applicants: various
Pharmacovigilance Risk Assessment Committee (PRAC)
EMA/PRAC/164465/2026 Page 50/75
PRAC Lead: Amelia Cupelli
Scope: Evaluation of a PSUSA procedure (PSUSA/00000378/202601)
Action: For adoption
6.3.12. Beta-alanine – EMA/PSUR/0000344401
Applicants: various
PRAC Lead: Barbara Kovacic Bytyqi
Scope: Evaluation of a PSUSA procedure (PSUSA/00010510/202601)
Action: For adoption
6.3.13. Bezafibrate – EMA/PSUR/0000344389
Applicants: various
PRAC Lead: Carla Torre
Scope: Evaluation of a PSUSA procedure (PSUSA/00000405/202601)
Action: For adoption
6.3.14. Biotin – EMA/PSUR/0000344397
Applicants: various
PRAC Lead: Jan Neuhauser
Scope: Evaluation of a PSUSA procedure (PSUSA/00000414/202601)
Action: For adoption
6.3.15. Calcitriol – EMA/PSUR/0000344379
Applicants: various
PRAC Lead: Amelia Cupelli
Scope: Evaluation of a PSUSA procedure (PSUSA/00000495/202601)
Action: For adoption
6.3.16. Carboprost – EMA/PSUR/0000344396
Applicants: various
PRAC Lead: Eva Jirsová
Scope: Evaluation of a PSUSA procedure (PSUSA/00000560/202601)
Action: For adoption
Pharmacovigilance Risk Assessment Committee (PRAC)
EMA/PRAC/164465/2026 Page 51/75
6.3.17. Cilostazol – EMA/PSUR/0000344415
Applicants: various
PRAC Lead: Adam Przybylkowski
Scope: Evaluation of a PSUSA procedure (PSUSA/00010209/202601)
Action: For adoption
6.3.18. Diacerein – EMA/PSUR/0000344398
Applicants: various
PRAC Lead: Tiphaine Vaillant
Scope: Evaluation of a PSUSA procedure (PSUSA/00001026/202512)
Action: For adoption
6.3.19. Estriol – EMA/PSUR/0000344405
Applicants: various
PRAC Lead: Terhi Lehtinen
Scope: Evaluation of a PSUSA procedure (PSUSA/00001282/202512)
Action: For adoption
6.3.20. Exemestane – EMA/PSUR/0000344395
Applicants: various
PRAC Lead: Barbara Kovacic Bytyqi
Scope: Evaluation of a PSUSA procedure (PSUSA/00001345/202512)
Action: For adoption
6.3.21. Famciclovir – EMA/PSUR/0000344387
Applicants: various
PRAC Lead: Veronika Macurova
Scope: Evaluation of a PSUSA procedure (PSUSA/00001349/202512)
Action: For adoption
6.3.22. Nifurtimox – EMA/PSUR/0000344452
Applicants: various
PRAC Lead: Maria del Pilar Rayon
Pharmacovigilance Risk Assessment Committee (PRAC)
EMA/PRAC/164465/2026 Page 52/75
Scope: Evaluation of a PSUSA procedure (PSUSA/00011088/202601)
Action: For adoption
6.3.23. Sertindole – EMA/PSUR/0000344394
Applicants: various
PRAC Lead: Melinda Palfi
Scope: Evaluation of a PSUSA procedure (PSUSA/00002695/202601)
Action: For adoption
6.4. Follow-up to PSUR/PSUSA procedures
None
6.5. Variation procedure(s) resulting from PSUSA evaluation
None
6.6. Expedited summary safety reviews4
None
7. Post-authorisation safety studies (PASS)
7.1. Protocols of PASS imposed in the marketing authorisation(s)5
7.1.1. Cabotegravir – VOCABRIA (CAP); Rilpivirine – REKAMBYS (CAP) –
EMA/PASS/0000358848
Applicants: Janssen Cilag International, ViiV Healthcare B.V.
PRAC Rapporteur: Liana Martirosyan
Scope: PASS 107o [PASS protocol amendment]: Drug Utilization, Adherence, Effectiveness
and Resistance: A Prospective Observational Cohort Study in People living with HIV (PLWH)
initiating ARV regimen of CAB+RPV LA in Collaboration with EuroSIDA
Action: For adoption
4 Submission of expedited summary safety reports for review in addition to the requirements for submission of PSUR(s) falling
within the pandemic period and requirements set out in the list of Union reference dates (EURD list) provided for under Article
107c(7) of Directive 2001/83/EC
5 In accordance with Article 107n of Directive 2001/83/EC
Pharmacovigilance Risk Assessment Committee (PRAC)
EMA/PRAC/164465/2026 Page 53/75
7.1.2. Lonafarnib – ZOKINVY (CAP) – EMA/PASS/0000357585
Applicant: TMC Pharma (EU) Limited
PRAC Rapporteur: Adam Przybylkowski
Scope: PASS amendment [107o]: Prospective Non-Interventional observational study to
evaluate the long-term safety and effectiveness of lonafarnib treatment among patients with
Hutchinson-Gilford Progeria Syndrome (HGPS) or a processing deficient progeroid
laminopathy (PDPL) in real-world clinical care settings (STI-LNF-400).
Action: For adoption
7.1.3. Mirdametinib - Ezmekly (CAP) - EMA/PASS/0000340654
Applicant: Merck Europe B.V.
PRAC Rapporteur: Bianca Mulder
Scope: PASS protocol [107n]: Non-interventional PASS to confirm the long-term safety of
mirdametnib, in the treatment of symptomatic, inoperable plexiform neurofibromas (PN) in
paediatric and adult patients with neurofibromatosis type 1 (NF1) aged 2 years and above.
Action: For adoption
7.1.4. Sodium valproate (NAP) – EMA/PASS/0000328174
Applicants: various
PRAC Rapporteur: Liana Martirosyan
Scope: PASS interim report: valproate [study protocol evaluated within procedure
EMEA/H/N/PSP/J/0094]; AVALON: Assessment of VALproate in utero exposure On
Neurodevelopment
Action: For adoption
7.2. Protocols of PASS non-imposed in the marketing authorisation(s)6
7.2.1. Aficamten – MYQORZO (CAP) – EMA/PAM/0000347918
Applicant: Cytokinetics (Ireland) Limited
PRAC Rapporteur: Eva Jirsová
Scope: Protocol for cat 3 study in the RMP CY 6044: Meta-analysis of two Phase 3 studies
(CY 6031 and CY 6032) and one Phase 2 study (CY 6021, Cohorts 1 and 2) to evaluate the
cardiovascular safety profile of aficamten (MYQORZO) in patients with symptomatic
obstructive hypertrophic cardiomyopathy (oHCM), focusing on time to first occurrence of
major adverse cardiovascular events (MACE). This study constitutes an additional
pharmacovigilance activity as described in the EU Risk Management Plan (RMP). To assess
6 In accordance with Article 107m of Directive 2001/83/EC, supervised by PRAC in accordance with Article 61a (6) of
Regulation (EC) No 726/2004
Pharmacovigilance Risk Assessment Committee (PRAC)
EMA/PRAC/164465/2026 Page 54/75
aficamten cardiovascular safety based on endpoints of time to first occurrence of MACE
(cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, and cardiovascular
hospitalization) from randomization up to the end of study follow-up visit.
Action: For adoption
7.2.2. Cladribine – MAVENCLAD (CAP) – EMA/PAM/0000357455
Applicant: Merck Europe B.V.
PRAC Rapporteur: Carla Torre
Scope: Revised protocol version 3.0 for the non-imposed non-interventional PASS cat.3
Pregnancy outcomes in women exposed to oral cladribine: a multi-country cohort database
study – CLEAR Study.
Action: For adoption
7.2.3. Delgocitinib – ANZUPGO (CAP) – EMA/PAM/0000291999
Applicant: LEO PHARMA A/S
PRAC Rapporteur: Liana Martirosyan
Scope: Submission of a revised protocol for the non-imposed non-interventional PASS
"Delgocitinib cream 20 mg/g in moderate to severe chronic hand eczema and risk of non-
melanoma skin cancer: a nationwide registry based long-term post-authorisation safety
study", as requested as part of MEA 003.
Action: For adoption
7.2.4. Deucravacitinib – SOTYKTU (CAP) – EMA/PAM/0000357688
Applicant: Bristol-Myers Squibb Pharma EEIG
PRAC Rapporteur: Liana Martirosyan
Scope: Revised protocol for PASS IM011194: Long-term, observational cohort study of adults
with plaque psoriasis, who are new users of deucravacitinib, non-TNFi (tumor necrosis factor
inhibitor) biologics, TNFi biologics, or non-biologic systemic therapy in the real-world clinical
setting (IM011194). To evaluate the long-term safety of deucravacitinib in patients with
psoriasis in the real-world setting.
Action: For adoption
7.2.5. Efgartigimod alfa – VYVGART (CAP) – EMA/PAM/0000358653
Applicant: Argenx
PRAC Rapporteur: Rhea Fitzgerald
Scope: Amendment of the protocol for RMP category 3 study ARGX-113-PASS-2208: A non-
interventional, post-authorisation safety study of patients treated with efgartigimod alfa
(MEA/01444/2)
Pharmacovigilance Risk Assessment Committee (PRAC)
EMA/PRAC/164465/2026 Page 55/75
Action: For adoption
7.2.6. Efgartigimod alfa – VYVGART (CAP) – EMA/PAM/0000358063
Applicant: Argenx
PRAC Rapporteur: Rhea Fitzgerald
Scope: Protocol Amendment for the RMP category 3 study ARGX-113-2316: Post-
Authorisation Safety Study (PASS) to Evaluate the Risk of Malignancies in Patients with
Myasthenia Gravis (MG) Treated with Efgartigimod
Action: For adoption
7.2.7. Etrasimod – VELSIPITY (CAP) – EMA/PAM/0000357465
Applicant: Pfizer Europe MA EEIG
PRAC Rapporteur: Karin Bolin
Scope: Post-Authorisation Measure (PAM) [MEA] – Submission of Substantial Amendment 3
(version 4) to Protocol C5041046: “An Active Surveillance, Post-Authorization Safety Study
to Characterize the Safety of Etrasimod in Patients with Ulcerative Colitis Using Real-World
Data in the European Union” (as listed in PART III of RMP)
Action: For adoption
7.2.8. Inebilizumab – UPLIZNA (CAP) – EMA/PAM/0000357017
Applicant: Amgen Europe B.V.
PRAC Rapporteur: Amelia Cupelli
Scope: Protocol amendment submission of PASS Cat.3 Study A real-world observational
study of treatment patterns and outcomes for patients with neuromyelitis optica spectrum
disorders (NMOSDs), immunoglobulin G4-related disease (IgG4-RD) and generalized
Myasthenia Gravis (gMG) treated with inebilizumab (UPLIZNA) in Europe
Action: For adoption
7.2.9. Inebilizumab – UPLIZNA (CAP) – EMA/PAM/0000357209
Applicant: Amgen Europe B.V.
PRAC Rapporteur: Amelia Cupelli
Scope: Protocol amendment for PASS “An Observational Pregnancy Safety Study in Women
with Neuromyelitis Optica Spectrum Disorder (NMOSD) or Generalized Myasthenia Gravis
(gMG) Exposed to UPLIZNA® (inebilizumab-cdon) During Pregnancy
Action: For adoption
Pharmacovigilance Risk Assessment Committee (PRAC)
EMA/PRAC/164465/2026 Page 56/75
7.2.10. Mavacamten – CAMZYOS (CAP) - EMA/PAM/0000343701
Applicant: Bristol-Myers Squibb Pharma EEIG
PRAC Rapporteur: Kimmo Jaakkola
Scope: Protocol amendment of CV027013: a post-authorisation, multi-national, long-term,
observational study in patients with obstructive Hypertrophic Cardiomyopathy in the real-
world setting in Europe
Action: For adoption
7.2.11. Naltrexone hydrochloride / Bupropion hydrochloride – MYSIMBA (CAP) –
EMA/PAM/0000349763
Applicant: Orexigen Therapeutics Ireland Limited
PRAC Rapporteur: Dennis Lex
Scope: Protocol of study (PASS) NB-454 - A Cross-Sectional Survey to Evaluate the
Effectiveness of the Revised Mysimba Physician Prescribing Checklist (PPC) in Europe
(MEA/02056/1)
Action: For adoption
7.2.12. Nipocalimab – IMAAVY (CAP) – EMA/PAM/0000357528
Applicant: Janssen Cilag International
PRAC Rapporteur: Dirk Mentzer
Scope: Protocol for RMP category 3 study PCSNSPA0211: A Post-authorization Safety Study
Using US Administrative Health Insurance Claims Databases to Assess Pregnancy, Maternal,
and Infant Outcomes in Women with Generalized Myasthenia Gravis Who Were Exposed to
Nipocalimab During Pregnancy
Action: For adoption
7.2.13. Nipocalimab – IMAAVY (CAP) – EMA/PAM/0000358639
Applicant: Janssen Cilag International
PRAC Rapporteur: Dirk Mentzer
Scope: Protocol for RMP category 3 study PCSNSPA0210: A Non-Interventional, Post-
Authorization Safety Study (PASS) of Patients Treated with Nipocalimab for Generalized
Myasthenia Gravis (gMG) in Routine Clinical Practice in the United States (MEA/01868/1)
Action: For adoption
7.3. Results of PASS imposed in the marketing authorisation(s)7
None
7 In accordance with Article 107p-q of Directive 2001/83/EC
Pharmacovigilance Risk Assessment Committee (PRAC)
EMA/PRAC/164465/2026 Page 57/75
7.4. Results of PASS imposed and non-imposed in the marketing
authorisation(s)8
7.4.1. Baricitinib – OLUMIANT (CAP) – EMA/VR/0000345885
Applicant: Eli Lilly Nederland B.V.
PRAC Rapporteur: Adam Przybylkowski
Scope: Submission of the final report of the Category 3 European Union Post-Authorisation
Safety Study (EU PASS) I4V-MC-B011, Objective 4, atopic dermatitis (AD) cohort (Study
B011). This is an Observational Cohort Study to Assess the Safety of Baricitinib Compared
with Other Therapies used in the Treatment of Atopic Dermatitis in Nordic Countries –
Objective 4: Assessment of Risk Minimisation Measures. The RMP version 30.1 has also been
submitted.
Action: For adoption
7.4.2. COVID-19 mRNA vaccine – COMIRNATY (CAP) – EMA/VR/0000343925
Applicant: BioNTech Manufacturing GmbH
PRAC Rapporteur: Liana Martirosyan
Scope: A grouped application consisting of:
Type II (C.12): Submission of final report from study C4591052 listed as a category 3 study
in the RMP. This is a non-interventional Post-Authorization Safety Study of Comirnaty
Original/Omicron BA.1 and Comirnaty Original/Omicron BA.4-5 in Europe. The RMP version
17.1 has also been submitted.
Type IB (C.9.b): Submission of an updated RMP version 17.1 in order to propose to change
the final results due date and a consequential change of 12-month progress reports for study
C4591036, listed as a category 3 study in the RMP.
Action: For adoption
7.4.3. COVID-19 mRNA vaccine – COMIRNATY (CAP) – EMA/VR/0000334558
Applicant: BioNTech Manufacturing GmbH
PRAC Rapporteur: Liana Martirosyan
Scope: Submission of the final clinical study report for the non-interventional study
C4591022, listed as a category 3 study in the RMP. This is a non-interventional post-approval
safety study of pregnancy and infant outcomes in the Organization of Teratology Information
Specialists (OTIS)/MotherToBaby Pregnancy Registry.
Action: For adoption
8 In accordance with Article 61a (6) of Regulation (EC) No 726/2004, in line with the revised variations regulation for any
submission as of 4 August 2013
Pharmacovigilance Risk Assessment Committee (PRAC)
EMA/PRAC/164465/2026 Page 58/75
7.4.4. Elosulfase alfa – VIMIZIM (CAP) – EMA/VR/0000268096
Applicant: Biomarin International Limited
PRAC Rapporteur: Rhea Fitzgerald
Scope: Update of sections 4.6, 4.8 and 5.1 of the SmPC based on final results from Morquio
A Registry Study (MARS, Study 110-504) listed as a category 1 study in the RMP; this is an
observational registry study to evaluate long-term safety and effectiveness of elosulfase alfa.
The RMP version 7.0 has also been submitted. In addition, the MAH took the opportunity to
update Annex II and to update the PI in accordance with the latest EMA excipients guideline.
Action: For adoption
7.4.5. Fexinidazole – FEXINIDAZOLE WINTHROP (CAP) – EMA/VR/0000356314
Applicant: Sanofi Winthrop Industrie
PRAC Rapporteur: Liana Martirosyan
Scope: Submission of the final report for study FEXINC09395: a Post Authorization Safety
Study (PASS) of Fexinidazole for Human African Trypanosomiasis: Analysis of Real-Life
Safety and Effectiveness Data on Fexinidazole, listed as a category 3 study in the RMP. The
RMP version 4.0 has also been submitted.
Action: For adoption
7.4.6. Ponesimod – PONVORY (CAP) – EMA/VR/0000320506
Applicant: Laboratoires Juvise Pharmaceuticals
PRAC Rapporteur: Karin Erneholm
Scope: Submission of the final report from non-interventional post authorisation safety study
PCSNSP003693 listed as a category 3 study in the RMP. This is a Survey to Assess the
Effectiveness of Ponvory Educational Materials for Additional Risk Minimization Measures in
the European Union.
Action: For adoption
7.4.7. Tacrolimus - ADVAGRAF (CAP); MODIGRAF (CAP); NAP – EMA/VR/0000315125
Applicants: Astellas Pharma Europe B.V., various
PRAC Rapporteur: Eamon O Murchu
Scope: Submission of the final report from noninterventional post-authorization safety study
(NIPASS) listed as a category 3 study in the RMP. This is a feasibility assessment of
conducting a NIPASS of outcomes associated with the use of tacrolimus around conception,
or during pregnancy or lactation using data from available secondary use data sources to
replicate the Transplant Pregnancy Registry International (TPRI) study. The RMP version 6.0
has also been submitted.
Action: For adoption
Pharmacovigilance Risk Assessment Committee (PRAC)
EMA/PRAC/164465/2026 Page 59/75
7.4.8. Voretigene neparvovec – LUXTURNA (CAP) – EMA/VR/0000357435
Applicant: Novartis Europharm Limited
PRAC Rapporteur: Dirk Mentzer
Scope: Submission of the final report from study SPKRPE-PASS, following the request from
PRAC in PSUSA/00010742/202507. This is a post-authorization, multicenter, longitudinal,
observational safety registry study for patients treated with voretigene neparvovec in US.
Action: For adoption
7.5. Interim results and other post-authorisation measures for imposed
and non-imposed studies
7.5.1. Abaloparatide – ELADYNOS (CAP) – EMA/PAM/0000357990
Applicant: Theramex Ireland Limited
PRAC Rapporteur: Karin Erneholm
Scope: 1st interim report for European and US non-interventional PASS to evaluate
cardiovascular events in patients newly exposed to abaloparatide or teriparatide.
Action: For adoption
7.5.2. Beclometasone / Formoterol / Glycopyrronium bromide - TRIMBOW (CAP) -
EMA/PAM/0000350566
Applicant: Chiesi Farmaceutici S.p.A.
PRAC Rapporteur: Jan Neuhauser
Scope: Interim study results. 3rd interim report. PASS CLI-05993BA1-05 (TRIBE):
Multinational database cohort study to assess adverse cardiovascular and cerebrovascular
outcomes in patients with chronic obstructive pulmonary disease initiating a fixed triple
therapy containing beclometasone dipropionate, formoterol fumarate and glycopyrronium
administered via dry powder inhaler (DPI) compared to pressurized metered dose inhaler
(pMDI) (MEA/01097/3)
Action: For adoption
7.5.3. Beclometasone / Formoterol / Glycopyrronium bromide – TRYDONIS (CAP) -
EMA/PAM/0000350569
Applicant: Chiesi Farmaceutici S.p.A.
PRAC Rapporteur: Jan Neuhauser
Scope: Interim study results. 3rd interim report. PASS CLI-05993BA1-05 (TRIBE):
Multinational database cohort study to assess adverse cardiovascular and cerebrovascular
outcomes in patients with chronic obstructive pulmonary disease initiating a fixed triple
Pharmacovigilance Risk Assessment Committee (PRAC)
EMA/PRAC/164465/2026 Page 60/75
therapy containing beclometasone dipropionate, formoterol fumarate and glycopyrronium
administered via dry powder inhaler (DPI) compared to pressurized metered dose inhaler
(pMDI) (MEA/01098/3)
Action: For adoption
7.5.4. Cabotegravir – APRETUDE (CAP) – EMA/PAM/0000348786
Applicant: ViiV Healthcare B.V.
PRAC Rapporteur: Dennis Lex
Scope: The interim report for Category 3 MEA Antiretroviral Pregnancy Registry, as a
standalone post-approval measure, for cabotegravir sodium 30mg film-coated tablets and
cabotegravir prolonged- release suspension for injection (600mg/3ml) (Apretude) to monitor
prenatal exposures to ARV drugs to detect a potential increase in the risk of birth defects
through a prospective exposure-registration cohort and to assess maternal and foetal
outcomes following cabotegravir use during pregnancy.
Action: For adoption
7.5.5. Cabotegravir – VOCABRIA (CAP) – EMA/PAM/0000348704
Applicant: ViiV Healthcare B.V.
PRAC Rapporteur: Dennis Lex
Scope: Interim study results. Pregnancy and Neonatal Outcomes Following Prenatal Exposure
to Cabotegravir: Data from the Antiretroviral Pregnancy Registry (APR) (MEA/02050/1)
Action: For adoption
7.5.6. Clascoterone – WINLEVI (CAP) – EMA/PAM/0000325634
Applicant: Cassiopea S.p.A.
PRAC Rapporteur: Zane Neikena
Scope: Feasibility assessment for a post- authorisation safety study (PASS) to characterise
the potential risk of HPA axis suppression with long-term use of Winlevi in adolescents,
Action: For adoption
7.5.7. Danicopan – VOYDEYA (CAP) – EMA/PAM/0000357946
Applicant: Alexion Europe
PRAC Rapporteur: Dennis Lex
Scope: PAM [MEA]: Category 3 Study - Additional Pharmacovigilance Activity in the Risk
Management Plan Submission of Paroxysmal Nocturnal Hemoglobinuria (PNH) IPIG-Registry
Biennial Interim Report, Protocol ALX-PNH-502. This is the first biennial interim report for
Voydeya (danicopan).
Action: For adoption
Pharmacovigilance Risk Assessment Committee (PRAC)
EMA/PRAC/164465/2026 Page 61/75
7.5.8. Dimethyl fumarate – SKILARENCE (CAP) – EMA/PAM/0000357021
Applicant: Almirall S.A.
PRAC Rapporteur: Karin Bolin
Scope: 8th Study Progress Report (2026 Annual Progress Report): "An observational Post-
Authorisation Safety Study of Skilarence in European Psoriasis Registers" M-41008-40; follow
on from EMA/PAM/0000280759
Action: For adoption
7.5.9. Efgartigimod alfa – VYVGART (CAP) – EMA/PAM/0000358689
Applicant: Argenx
PRAC Rapporteur: Rhea Fitzgerald
Scope: Second interim report for the RMP category 3 study ARGX-113-PASS-2208: A
Noninterventional Post-Authorisation Safety Study of Patients Treated with Efgartigimod Alfa
Action: For adoption
7.5.10. Estetrol – FYLREVY (CAP) – EMA/PAM/0000357663
Applicant: Gedeon Richter Plc.
PRAC Rapporteur: Sonja Radowan
Scope: Submission of feasibility report on potential real-world data study as additional
pharmacovigilance activity in the RMP (MEA/02085/1)
Action: For adoption
7.5.11. Etuvetidigene autotemcel – WASKYRA (CAP) – EMA/PAM/0000357590
Applicant: Fondazione Telethon Ets
PRAC Rapporteur: Jo Robays
Scope: Updated PASS protocol (version 4.0) for the imposed interventional Post-Approval
Safety Study (PASS) WAS-TLT003-01, a Category 1- Required additional pharmacovigilance
activity, a Phase III/IV low-interventional study, with primary objective being the assessment
of long-term safety across multiple endpoints.
The updated protocol includes the changes recommended by CAT and PRAC in their
assessment of v3.0 (EMA/PAM/0000334844), as well as other changes required by the FDA
and other changes introduced by the Applicant, with the aim of maintaining a globally aligned
protocol.
Action: For adoption
7.5.12. Fingolimod – GILENYA (CAP) – EMA/PAM/0000320326
Applicant: Novartis Europharm Limited
Pharmacovigilance Risk Assessment Committee (PRAC)
EMA/PRAC/164465/2026 Page 62/75
PRAC Rapporteur: Tiphaine Vaillant
Scope: 6th Annual Interim Report of Study CFTY720D2311: A two-year, double-blind,
randomized, multicenter, active-controlled Core Phase study to evaluate the safety and
efficacy of fingolimod administered orally once daily versus interferon β-1a i.m. once weekly
in pediatric patients with multiple sclerosis with five-year fingolimod Extension Phase.
Action: For adoption
7.5.13. Hydroxycarbamide – XROMI (CAP) – EMA/PAM/0000350555
Applicant: Lipomed GmbH
PRAC Rapporteur: Jo Robays
Scope: Submission of the interim progress report related to the protocol NOVDD-001 related
to the Category 3 MEA – Required additional pharmacovigilance activities (Planned Additional
Pharmacovigilance Studies) in the approved Risk Management Plan: ‘A comparative
observational study to evaluate the safety and effectiveness of Xromi (hydroxycarbamide oral
solution 100mg/ml) for the prevention of vasoocclusive complications of sickle cell disease in
children under 2 years of age’.
Action: For adoption
7.5.14. Inebilizumab – UPLIZNA (CAP) – EMA/PAM/0000357900
Applicant: Amgen Europe B.V.
PRAC Rapporteur: Amelia Cupelli
Scope: Ad hoc interim report submission of PASS Cat.3 Study CorEvitas SPHERES (Synergy
of Prospective Health & Experimental Research for Emerging Solutions) Registry for
Neuromyelitis Optica Spectrum Disorder (NMOSD)
Action: For adoption
7.5.15. Interferon beta-1A – AVONEX (CAP) – EMA/PAM/0000315762
Applicant: Biogen Netherlands B.V.
PRAC Rapporteur: Maria del Pilar Rayon
Scope: Submission of the Study Report for joint PASS INFORM - Interferon-Beta Exposure in
the 2nd and 3rd Trimester of Pregnancy - a Register-Based Drug Utilisation Study in Finland
and Sweden Study (MEA/01269/2)
Action: For adoption
7.5.16. Interferon beta-1A – REBIF (CAP) – EMA/PAM/0000315764
Applicant: Merck Europe B.V.
PRAC Rapporteur: Maria del Pilar Rayon
Pharmacovigilance Risk Assessment Committee (PRAC)
EMA/PRAC/164465/2026 Page 63/75
Scope: Submission of the Study Report for joint PASS INFORM - Interferon-Beta Exposure in
the 2nd and 3rd Trimester of Pregnancy - a Register-Based Drug Utilisation Study in Finland
and Sweden Study.
Action: For adoption
7.5.17. Interferon beta-1B – BETAFERON (CAP) – EMA/PAM/0000309054
Applicant: Bayer AG
PRAC Rapporteur: Maria del Pilar Rayon
Scope: Submission of the Study Report for joint PASS INFORM - Interferon-Beta Exposure in
the 2nd and 3rd Trimester of Pregnancy - a Register-Based Drug Utilisation Study in Finland
and Sweden Study (MEA/01260/2)
Action: For adoption
7.5.18. Octocog alfa – KOVALTRY (CAP) – EMA/PAM/0000343782
Applicant: Bayer AG
PRAC Rapporteur: Dirk Mentzer
Scope: Submission of annual PedNet (European Paediatric Network for Haemophilia
Management) report of 2025 containing data for Kovaltry as interim results for
epidemiological Study 15689
Procedure No.: EMEA/H/C/003825/MEA/005
Action: For adoption
7.5.19. Peginterferon beta-1A – PLEGRIDY (CAP) – EMA/PAM/0000315767
Applicant: Biogen Netherlands B.V.
PRAC Rapporteur: Maria del Pilar Rayon
Scope: Submission of the Study Report for joint PASS INFORM - Interferon-Beta Exposure in
the 2nd and 3rd Trimester of Pregnancy - a Register-Based Drug Utilisation Study in Finland
and Sweden Study.
Action: For adoption
7.5.20. Ravulizumab – ULTOMIRIS (CAP) – EMA/PAM/0000358006
Applicant: Alexion Europe
PRAC Rapporteur: Kimmo Jaakkola
Scope: PAM [MEA]: Category 3 Study - Additional Pharmacovigilance Activity in the Risk
Management Plan Submission of atypical haemolytic uraemic syndrome (aHUS) Registry
Biennial Interim Report, Protocol M11-001, dated 18 Jun 2026. This is the third biennial
interim report for Ultomiris (ravulizumab).
Pharmacovigilance Risk Assessment Committee (PRAC)
EMA/PRAC/164465/2026 Page 64/75
Action: For adoption
7.5.21. Respiratory syncytial virus vaccine (bivalent, recombinant) – ABRYSVO (CAP) –
EMA/PAM/0000350900
Applicant: Pfizer Europe MA EEIG
PRAC Rapporteur: Liana Martirosyan
Scope: Progress Report 2 for the PASS C3671026 for Abrysvo, a post-authorisation safety
study of Abrysvo in pregnant women and their offspring in a real world setting in Europe and
UK (following EMA/PAM/0000321444 CHMP AR dated 26/03/2026)
Action: For adoption
7.5.22. Risankizumab – SKYRIZI (CAP) – EMA/PAM/0000348711
Applicant: Abbvie Deutschland GmbH & Co. KG
PRAC Rapporteur: Liana Martirosyan
Scope: Progress report for PASS study P23-654: Comparative Cohort Study of Long-term
Safety Outcomes of Risankizumab Compared to Biologic Treatments for Ulcerative Colitis and
Crohn’s Disease in a Real-world Setting in Sweden and Denmark.
Action: For adoption
7.5.23. Selexipag – UPTRAVI (CAP) – EMA/PAM/0000357993
Applicant: Janssen Cilag International
PRAC Rapporteur: Zoubida Amimour
Scope: 9th interim report of study AC-065A401, EXPlortory Observational Study of Uptravi in
Real-LifE (EXPOSURE)
Action: For adoption
7.5.24. Siponimod – MAYZENT (CAP) – EMA/PAM/0000357691
Applicant: Novartis Europharm Limited
PRAC Rapporteur: Maria del Pilar Rayon
Scope: Fifth interim study report of Study CBAF312A2411: Evaluation of pregnancy and
infant outcomes in Mayzent patients using PRegnancy outcomes Intensive Monitoring (PRIM)
data.
Action: For adoption
7.5.25. Sutimlimab – ENJAYMO (CAP) – EMA/PAM/0000347729
Applicant: Recordati Rare Diseases
Pharmacovigilance Risk Assessment Committee (PRAC)
EMA/PRAC/164465/2026 Page 65/75
PRAC Rapporteur: Jan Neuhauser
Scope: Third annual interim report for PASS OBS16454 - Sutimlimab Cold Agglutinin Disease
Real World Evidence Registry (CADENCE).
Action: For adoption
8. Renewals of the marketing authorisation, conditional renewal
and annual reassessments
8.1. Annual reassessments of the marketing authorisation
8.1.1. Maralixibat – LIVMARLI (CAP) – EMA/S/0000317715
Applicant: Mirum Pharmaceuticals International B.V.
PRAC Rapporteur: Adam Przybylkowski
Scope: Annual reassessment of the marketing authorisation
Action: For adoption
8.1.2. Tofersen – QALSODY (CAP) – EMA/S/0000349866
Applicant: Biogen Netherlands B.V.
PRAC Rapporteur: Kimmo Jaakkola
Scope: Annual reassessment of the marketing authorisation
Action: For adoption
8.2. Conditional renewals of the marketing authorisation
8.2.1. Adagrasib – KRAZATI (CAP) – EMA/R/0000350422
Applicant: Bristol-Myers Squibb Pharma EEIG
PRAC Rapporteur: Kimmo Jaakkola
Scope: Conditional renewal of the marketing authorisation
Action: For adoption
8.2.2. Brexucabtagene autoleucel – TECARTUS (CAP) – EMA/R/0000355892
Applicant: Kite Pharma EU B.V., ATMP
PRAC Rapporteur: Bianca Mulder
Scope: Conditional renewal of the marketing authorisation
Pharmacovigilance Risk Assessment Committee (PRAC)
EMA/PRAC/164465/2026 Page 66/75
Action: For adoption
8.2.3. Spesolimab – SPEVIGO (CAP) – EMA/R/0000348377
Applicant: LEO PHARMA A/S
PRAC Rapporteur: Zoubida Amimour
Scope: Conditional renewal of the marketing authorisation
Action: For adoption
8.2.4. Loncastuximab tesirine – ZYNLONTA (CAP) – EMA/R/0000358132
Applicant: Swedish Orphan Biovitrum AB (publ)
PRAC Rapporteur: Eva Jirsová
Scope: Conditional renewal of the marketing authorisation
Action: For adoption
8.2.5. Repotrectinib – AUGTYRO (CAP) – EMA/R/0000357913
Applicant: Bristol-Myers Squibb Pharma EEIG
PRAC Rapporteur: Barbara Kovacic Bytyqi
Scope: Conditional renewal of the marketing authorisation
Action: For adoption
8.2.6. Sotorasib – LUMYKRAS (CAP) – EMA/R/0000360417
Applicant: Amgen Europe B.V.
PRAC Rapporteur: Marie Louise Schougaard Christiansen
Scope: Conditional renewal of the marketing authorisation
Action: For adoption
8.2.7. Trastuzumab deruxtecan – ENHERTU (CAP) – EMA/R/0000360418
Applicant: Daiichi Sankyo Europe GmbH
PRAC Rapporteur: Carla Torre
Scope: Conditional renewal of the marketing authorisation
Action: For adoption
Pharmacovigilance Risk Assessment Committee (PRAC)
EMA/PRAC/164465/2026 Page 67/75
8.3. Renewals of the marketing authorisation
8.3.1. Enfortumab vedotin – PADCEV (CAP) – EMA/R/0000351076
Applicant: Astellas Pharma Europe B.V.
PRAC Rapporteur: Eva Jirsová
Scope: 5-year renewal of the marketing authorisation
Action: For adoption
8.3.2. Eptinezumab – VYEPTI (CAP) – EMA/R/0000336059
Applicant: H. Lundbeck A/S
PRAC Rapporteur: Liana Martirosyan
Scope: 5-year renewal of the marketing authorisation
Action: For adoption
8.3.3. Finerenone – KERENDIA (CAP) – EMA/R/0000340433
Applicant: Bayer AG
PRAC Rapporteur: Bianca Mulder
Scope: 5-year renewal of the marketing authorisation
Action: For adoption
8.3.4. Lisocabtagene maraleucel / Lisocabtagene maraleucel – BREYANZI (CAP) –
EMA/R/0000355073
Applicant: Bristol-Myers Squibb Pharma EEIG
PRAC Rapporteur: Dirk Mentzer
Scope: 5-year renewal of the marketing authorisation
Action: For adoption
8.3.5. Pegfilgrastim – STIMUFEND (CAP) – EMA/R/0000351198
Applicant: Fresenius Kabi Deutschland GmbH
PRAC Rapporteur: Bianca Mulder
Scope: 5-year renewal of the marketing authorisation
Action: For adoption
Pharmacovigilance Risk Assessment Committee (PRAC)
EMA/PRAC/164465/2026 Page 68/75
8.3.6. Pneumococcal polysaccharide conjugate vaccine (20-valent, adsorbed) – PREVENAR
20 (CAP) – EMA/R/0000340648
Applicant: Pfizer Europe MA EEIG
PRAC Rapporteur: Jean-Michel Dogné
Scope: 5-year renewal of the marketing authorisation
Action: For adoption
8.3.7. Risperidone – OKEDI (CAP) – EMA/R/0000343015
Applicant: Laboratorios Farmaceuticos Rovi S.A.
PRAC Rapporteur: Dennis Lex
Scope: 5-year renewal of the marketing authorisation
Action: For adoption
8.3.8. Sapropterin – SAPROPTERIN DIPHARMA (CAP) – EMA/R/0000348315
Applicant: DIPHARMA Arzneimittel GmbH
PRAC Rapporteur: Eamon O Murchu
Scope: 5-year renewal of the marketing authorisation
Action: For adoption
8.3.9. Sitagliptin / Metformin hydrochloride – SITAGLIPTIN METFORMIN HYDROCHLORIDE
MYLAN (CAP) – EMA/R/0000349188
Applicants: Mylan Pharmaceuticals Limited, Mylan Ireland Limited
PRAC Rapporteur: Bianca Mulder
Scope: 5-year renewal of the marketing authorisation
Action: For adoption
8.3.10. Somatrogon – NGENLA (CAP) – EMA/R/0000340629
Applicant: Pfizer Europe MA EEIG
PRAC Rapporteur: Liana Martirosyan
Scope: 5-year renewal of the marketing authorisation
Action: For adoption
8.3.11. Tebentafusp – KIMMTRAK (CAP) – EMA/R/0000355059
Applicant: Immunocore Ireland Limited
Pharmacovigilance Risk Assessment Committee (PRAC)
EMA/PRAC/164465/2026 Page 69/75
PRAC Rapporteur: Bianca Mulder
Scope: 5-year renewal of the marketing authorisation
Action: For adoption
8.3.12. Tecovirimat - TECOVIRIMAT SIGA (CAP) - EMA/R/0000340615
Applicant: Siga Technologies Netherlands B.V.
PRAC Rapporteur: Dennis Lex
Scope: 5-year renewal of the marketing authorisation
Action: For adoption
8.3.13. Tofacitinib – XELJANZ (CAP) – EMA/R/0000350878
Applicant: Pfizer Europe MA EEIG
PRAC Rapporteur: Liana Martirosyan
Scope: 5-year renewal of the marketing authorisation
Action: For adoption
9. Product related pharmacovigilance inspections
9.1. List of planned pharmacovigilance inspections
None
9.2. Ongoing or concluded pharmacovigilance inspections
Disclosure of information on results of pharmacovigilance inspections could undermine the
protection of the purpose of these inspections, investigations and audits. Therefore such
information is not reported in the agenda.
9.3. Others
None
10. Other safety issues for discussion requested by the Member
States, CHMP or the EMA
None
Pharmacovigilance Risk Assessment Committee (PRAC)
EMA/PRAC/164465/2026 Page 70/75
11. Scientific advice procedures
Information related to this section cannot be released at the present time as it is deemed to
contain commercially confidential information.
12. Organisational, regulatory and methodological matters
12.1. Mandate and organisation of the PRAC
12.1.1. PRAC membership
Action: For information
12.1.2. Nominated proxy
Action: For information
12.2. Coordination with EMA Scientific Committees or CMDh-v
None
12.3. Coordination with EMA Working Parties/Working Groups/Drafting
Groups
12.3.1. Areas of collaboration between PRAC and Methodology Working Party (MWP)
PRAC lead: Ulla Wändel Liminga, Liana Martirosyan, Carla Torre
Action: For discussion
12.4. Cooperation within the EU regulatory network
None
12.5. Cooperation with International Regulators
None
12.6. Contacts of the PRAC with external parties and interaction with the
Interested Parties to the Committee
None
Pharmacovigilance Risk Assessment Committee (PRAC)
EMA/PRAC/164465/2026 Page 71/75
12.7. PRAC work plan
12.7.1. PRAC work plan 2026 - update
PRAC lead: Ulla Wändel Liminga, Liana Martirosyan
Action: For discussion
12.8. Planning and reporting
None
12.9. Pharmacovigilance audits and inspections
12.9.1. Pharmacovigilance systems and their quality systems
None
12.9.2. Pharmacovigilance inspections
None
12.9.3. Pharmacovigilance audits
None
12.10. Periodic safety update reports (PSURs) & Union reference date
(EURD) list
12.10.1. Periodic safety update reports
None
12.10.2. Granularity and Periodicity Advisory Group (GPAG)
None
12.10.3. PSURs repository
None
12.10.4. Union reference date list – consultation on the draft list
Action: For adoption
Pharmacovigilance Risk Assessment Committee (PRAC)
EMA/PRAC/164465/2026 Page 72/75
12.11. Signal management
12.11.1. Signal management – feedback from Signal Management Review Technical (SMART)
Working Group
PRAC lead: Dennis Lex
Action: For discussion
12.12. Adverse drug reactions reporting and additional reporting
12.12.1. Management and reporting of adverse reactions to medicinal products
None
12.12.2. Additional monitoring
None
12.12.3. List of products under additional monitoring – consultation on the draft list
Action: For adoption
12.13. EudraVigilance database
12.13.1. Activities related to the confirmation of full functionality
None
12.14. Risk management plans and effectiveness of risk minimisations
12.14.1. Risk management systems
None
12.14.2. Tools, educational materials and effectiveness measurement of risk minimisations
None
12.15. Post-authorisation safety studies (PASS)
12.15.1. Post-authorisation Safety Studies – imposed PASS
None
Pharmacovigilance Risk Assessment Committee (PRAC)
EMA/PRAC/164465/2026 Page 73/75
12.15.2. Post-authorisation Safety Studies – non-imposed PASS
None
12.16. Community procedures
12.16.1. Referral procedures for safety reasons
None
12.17. Renewals, conditional renewals, annual reassessments
None
12.18. Risk communication and transparency
12.18.1. Public participation in pharmacovigilance
None
12.18.2. Safety communication
None
12.19. Continuous pharmacovigilance
12.19.1. Incident management
None
12.20. Impact of pharmacovigilance activities
12.20.1. Strategy on measuring the impact of pharmacovigilance: draft technical
specifications for a qualitative impact study on healthcare professionals’ preferences
for additional risk minimisation measures (under EMA/2024/OP/0016)
PRAC leads: Dennis Lex, Liana Martisoryan
Action: For discussion
12.21. Others
12.21.1. Extension application timetable alignment with MAA timetable
Action: For discussion
Pharmacovigilance Risk Assessment Committee (PRAC)
EMA/PRAC/164465/2026 Page 74/75
13. Any other business
None
14. Explanatory notes
The Notes give a brief explanation of relevant agenda items and should be read in conjunction with the
agenda.
List of acronyms and abbreviations
For a list of acronyms and abbreviations used in the PRAC agenda, see:
List of abbreviations used in EMA human medicines scientific committees and CMDh documents, and in
relation to EMA’s regulatory activities
EU Referral procedures for safety reasons: Urgent EU procedures and Other EU referral
procedures
(Items 2 and 3 of the PRAC agenda)
A referral is a procedure used to resolve issues such as concerns over the safety or benefit-risk balance of a
medicine or a class of medicines. In a referral, the EMA is requested to conduct a scientific assessment of a
particular medicine or class of medicines on behalf of the European Union (EU). For further detailed
information on safety related referrals please see: Referral procedures: human medicines | European
Medicines Agency (europa.eu)
Signals assessment and prioritisation
(Item 4 of the PRAC agenda)
A safety signal is information on a new or incompletely documented adverse event that is potentially caused
by a medicine and that warrants further investigation. Signals are generated from several sources such as
spontaneous reports, clinical studies and the scientific literature. The evaluation of safety signals is a routine
part of pharmacovigilance and is essential to ensuring that regulatory authorities have a comprehensive
knowledge of a medicine’s benefits and risks.
The presence of a safety signal does not mean that a medicine has caused the reported adverse event. The
adverse event could be a symptom of another illness or caused by another medicine taken by the patient.
The evaluation of safety signals is required to establish whether or not there is a causal relationship between
the medicine and the reported adverse event.
The evaluation of safety signals may not necessarily conclude that the medicine caused the adverse event in
question. In cases where a causal relationship is confirmed or considered likely, regulatory action may be
necessary and this usually takes the form of an update of the summary of product characteristics and the
package leaflet.
Risk Management Plans (RMPs)
(Item 5 of the PRAC agenda)
The RMP describes what is known and not known about the side effects of a medicine and states how these
risks will be prevented or minimised in patients. It also includes plans for studies and other activities to gain
more knowledge about the safety of the medicine and risk factors for developing side effects.
RMPs are continually modified and updated throughout the lifetime of the medicine as new information
becomes available.
Assessment of Periodic Safety Update Reports (PSURs)
(Item 6 of the PRAC agenda)
A PSUR is a report providing an evaluation of the benefit-risk balance of a medicine, which is submitted by
marketing authorisation holders at defined time points following a medicine’s authorisation.
PSURs summarises data on the benefits and risks of a medicine and includes the results of all studies carried
out with this medicine (in the authorised and unauthorised indications).
Post-authorisation Safety Studies (PASS)
(Item 7 of the PRAC agenda)
A PASS is a study of an authorised medicinal product carried out to obtain further information on its safety,
or to measure the effectiveness of risk management measures. The results of a PASS help regulatory
agencies to evaluate the safety and benefit-risk profile of a medicine.
https://www.ema.europa.eu/en/documents/other/abbreviations-used-ema-scientific-committees-and-cmd-documents-and-relation-emas-regulatory-activities_en.pdf
https://www.ema.europa.eu/en/documents/other/abbreviations-used-ema-scientific-committees-and-cmd-documents-and-relation-emas-regulatory-activities_en.pdf
https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/pharmacovigilance-post-authorisation/referral-procedures-human-medicines
https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/pharmacovigilance-post-authorisation/referral-procedures-human-medicines
Pharmacovigilance Risk Assessment Committee (PRAC)
EMA/PRAC/164465/2026 Page 75/75
Product related pharmacovigilance inspections
(Item 9 of the PRAC agenda)
Inspections carried out by regulatory agencies to ensure that marketing authorisation holders comply with
their pharmacovigilance obligations.
More detailed information on the above terms can be found on the EMA website: www.ema.europa.eu/
Article 58 procedures (Art 58)
Article 58 of Regulation (EC) No 726/2004 allows the Committee for Medicinal Products for Human Use
(CHMP) to give opinions, in co-operation with the World Health Organisation (WHO) on medicinal products
for human use that are intended exclusively for markets outside of the European Union (EU)
http://www.ema.europa.eu/
1. Introduction
1.1. Welcome and declarations of interest of members, alternates and experts
1.2. Agenda of the meeting on 31 August-03 September 2026
1.3. Minutes of the previous meeting on 06-09 July 2026
2. EU referral procedures for safety reasons: urgent EU procedures
2.1. Newly triggered procedures
2.2. Ongoing procedures
2.3. Procedures for finalisation
3. EU referral procedures for safety reasons: other EU referral procedures
3.1. Newly triggered procedure
3.1.1. Ferric carboxymaltose, ferric derisomaltose, ferric gluconate, iron sucrose, iron dextran (NAP) - EMA/REF/0000369747
3.2. Ongoing procedures
3.3. Procedures for finalisation
3.4. Re-examination procedures0F0F
3.5. Others
4. Signals assessment and prioritisation1F1F
4.1. New signals detected from EU spontaneous reporting systems and/or other sources
4.1.1. Acitretin (NAP)
4.1.2. Anakinra - KINERET (CAP)
4.1.3. Deucravacitinib – SOTYKTU (CAP)
4.1.4. Fentanyl (transdermal patches) (NAP)
4.1.5. Gefitinib - IRESSA (CAP)
4.1.6. Idarucizumab - PRAXBIND (CAP)
4.1.7. Infliximab - FLIXABI (CAP), REMICADE (CAP), REMSIMA (CAP), ZESSLY (CAP)
4.1.8. Lazertinib - LAZCLUZE (CAP)
4.1.9. Progestogens2F2F (NAP)
4.2. Signals follow-up and prioritisation
4.2.1. Oxacillin (NAP)
4.3. Variation procedure(s) resulting from signal evaluation
5. Risk management plans (RMPs)
5.1. Medicines in the pre-authorisation phase
5.1.1. Anselamimab (CAP MAA) - EMEA/H/C/006422, Orphan
5.1.2. Apixaban (CAP MAA) - EMEA/H/C/006752
5.1.3. Baxdrostat (CAP MAA) - EMEA/H/C/006597
5.1.4. Bevacizumab (CAP MAA) - EMEA/H/C/005995
5.1.5. Ensartinib (CAP MAA) - EMEA/H/C/006757
5.1.6. Filgrastim (CAP MAA) - EMEA/H/C/007009
5.1.7. Fondaparinux sodium (CAP MAA) - EMEA/H/C/006824
5.1.8. Gadoquatrane (CAP MAA) - EMEA/H/C/006443
5.1.9. Insulin aspart (CAP MAA) - EMEA/H/C/006677
5.1.10. Insulin aspart (CAP MAA) - EMEA/H/C/006864
5.1.11. Lunsotogene parvec (CAP MAA) - EMEA/H/C/006802, Orphan
5.1.12. Orforglipron (CAP MAA) - EMEA/H/C/006632
5.1.13. Pimicotinib (CAP MAA) - EMEA/H/C/006383, PRIME, Orphan
5.1.14. Ruxolitinib (CAP MAA) - EMEA/H/C/006793
5.1.15. Sintilimab (CAP MAA) - EMEA/H/C/006743
5.1.16. Zopapogene imadenovec (CAP MAA) - EMEA/H/C/006508, Orphan
5.2. Medicines in the post-authorisation phase – PRAC-led procedures
5.2.1. Dimethyl fumarate – DIMETHYL FUMARATE MYLAN (CAP); NAP – EMA/VR/0000344712
5.2.2. Emtricitabine / Tenofovir disoproxil - EMTRICITABINE/TENOFOVIR DISOPROXIL ZENTIVA (CAP); NAP – EMA/VR/0000335678
5.2.3. Fosdenopterin – NULIBRY (CAP) – EMA/VR/0000347997
5.2.4. Sonidegib – ODOMZO (CAP) – EMA/VR/0000357142
5.2.5. Pomalidomide - POMALIDOMIDE KRKA (CAP); NAP - EMA/VR/0000361252
5.3. Medicines in the post-authorisation phase – CHMP-led procedures
5.3.1. Abiraterone acetate – ABIRATERONE MYLAN (CAP); NAP – EMA/VR/0000291298
5.3.2. Abrocitinib – CIBINQO (CAP) – EMA/VR/0000350662
5.3.3. Afamelanotide – SCENESSE (CAP) – EMA/VR/0000325360
5.3.4. Aflibercept – OPUVIZ (CAP) – EMA/VR/0000357444
5.3.5. Apixaban – ELIQUIS (CAP) – EMA/VR/0000327005
5.3.6. Asciminib – SCEMBLIX (CAP) – EMA/VR/0000342126
5.3.7. Atidarsagene autotemcel – LIBMELDY (CAP) – EMA/VR/0000334917
5.3.8. Atropine sulfate – RYJUNEA (CAP) – EMA/VR/0000357137
5.3.9. Cabotegravir – APRETUDE (CAP) – EMA/VR/0000331993
5.3.10. Cabotegravir – VOCABRIA (CAP) – EMA/VR/0000332087
5.3.11. Capivasertib – TRUQAP (CAP) – EMA/VR/0000293735
5.3.12. Dabigatran etexilate – PRADAXA (CAP) – EMA/VR/0000347421
5.3.13. Dapivirine – DAPIVIRINE VAGINAL RING 25 MG (CAP) – EMA/X/0000314697
5.3.14. Dasatinib – SPRYCEL (CAP) – EMA/VR/0000356665
5.3.15. Deferasirox – EXJADE (CAP) – EMA/VR/0000333352
5.3.16. Delgocitinib – ANZUPGO (CAP) – EMA/VR/0000315280
5.3.17. Dolutegravir – TIVICAY (CAP) – EMA/VR/0000351003
5.3.18. Enfortumab vedotin – PADCEV (CAP) – EMA/VR/0000336191
5.3.19. Epcoritamab – TEPKINLY (CAP) – EMA/VR/0000358245
5.3.20. Exagamglogene autotemcel – CASGEVY (CAP) – EMA/VR/0000356719
5.3.21. Fenfluramine – FINTEPLA (CAP) – EMA/VR/0000350597
5.3.22. Fenfluramine – FINTEPLA (CAP) – EMA/VR/0000350494
5.3.23. Filgotinib – JYSELECA (CAP) – EMA/VR/0000350853
5.3.24. Florbetapir (18F) – AMYVID (CAP) – EMA/VR/0000333287
5.3.25. Givinostat – DUVYZAT (CAP) – EMA/VR/0000343703
5.3.26. Givinostat – DUVYZAT (CAP) – EMA/VR/0000343737
5.3.27. Glofitamab – COLUMVI (CAP) – EMA/VR/0000327100
5.3.28. Glofitamab – COLUMVI (CAP) – EMA/VR/0000348695
5.3.29. Ivacaftor – KALYDECO (CAP) – EMA/VR/0000343903
5.3.30. Ivacaftor / Tezacaftor / Elexacaftor – KAFTRIO (CAP) – EMA/X/0000343848
5.3.31. Levacetylleucine – AQNEURSA (CAP) – EMA/VR/0000354947
5.3.32. Maralixibat – LIVMARLI (CAP) – EMA/VR/0000320544
5.3.33. Melphalan flufenamide – PEPAXTI (CAP) – EMA/VR/0000350278
5.3.34. Metreleptin – MYALEPTA (CAP) – EMA/VR/0000356904
5.3.35. Mirabegron – BETMIGA (CAP) – EMA/VR/0000349861
5.3.36. Naloxone – NYXOID (CAP) – EMA/VR/0000325329
5.3.37. Obinutuzumab – GAZYVARO (CAP) – EMA/VR/0000350995
5.3.38. Obinutuzumab – GAZYVARO (CAP) – EMA/VR/0000327013
5.3.39. Obinutuzumab – GAZYVARO (CAP) – EMA/VR/0000349826
5.3.40. Ocrelizumab – OCREVUS (CAP) – EMA/VR/0000313041
5.3.41. Ocrelizumab – OCREVUS (CAP) – EMA/VR/0000357152
5.3.42. Pneumococcal polysaccharide conjugate vaccine (15 valent, adsorbed) – VAXNEUVANCE (CAP) – EMA/VR/0000356991
5.3.43. Radium-223 – XOFIGO (CAP) – EMA/VR/0000350998
5.3.44. Radium-223 – XOFIGO (CAP) – EMA/VR/0000351078
5.3.45. Respiratory syncytial virus mRNA vaccine (nucleoside modified) – MRESVIA (CAP) – EMA/VR/0000320244
5.3.46. Rilzabrutinib – WAYRILZ (CAP) – EMA/VR/0000357430
5.3.47. Selumetinib – KOSELUGO (CAP) – EMA/VR/0000347385
5.3.48. Somapacitan – SOGROYA (CAP) – EMA/VR/0000350795
5.3.49. Sulfur hexafluoride – SONOVUE (CAP) – EMA/VR/0000355106
5.3.50. Talazoparib – TALZENNA (CAP) – EMA/VR/0000350865
5.3.51. Trastuzumab – HERZUMA (CAP) – EMA/X/0000343856
5.3.52. Ustekinumab – IMULDOSA (CAP) – EMA/VR/0000347840
6. Periodic safety update reports (PSURs)
6.1. PSUR single assessment (PSUSA) procedures including centrally authorised products (CAPs) only
6.1.1. Abacavir – ZIAGEN (CAP) – EMA/PSUR/0000344374
6.1.2. Abatacept – ORENCIA (CAP) – EMA/PSUR/0000344377
6.1.3. Adalimumab – AMGEVITA (CAP); AMSPARITY (CAP); HEFIYA (CAP); HUKYNDRA (CAP); HULIO (CAP); HUMIRA (CAP); HYRIMOZ (CAP); IDACIO (CAP); IMRALDI (CAP); LIBMYRIS (CAP); YUFLYMA (CAP) – EMA/PSUR/0000344425
6.1.4. Amino acids – MAAPLIV (CAP) – EMA/PSUR/0000344441
6.1.5. Angiotensin II – GIAPREZA (CAP) – EMA/PSUR/0000344429
6.1.6. Avapritinib – AYVAKYT (CAP) – EMA/PSUR/0000344431
6.1.7. Belzutifan – WELIREG (CAP) – EMA/PSUR/0000344453
6.1.8. Birch bark extract – FILSUVEZ (CAP) – EMA/PSUR/0000344404
6.1.9. Brensocatib – BRINSUPRI (CAP) – EMA/PSUR/0000344438
6.1.10. Brexucabtagene autoleucel – TECARTUS (CAP) – EMA/PSUR/0000344416
6.1.11. Catumaxomab – KORJUNY (CAP) – EMA/PSUR/0000344454
6.1.12. Crovalimab – PIASKY (CAP) – EMA/PSUR/0000344450
6.1.13. Danicopan – VOYDEYA (CAP) – EMA/PSUR/0000344446
6.1.14. Dapivirine – DAPIVIRINE VAGINAL RING 25 MG (Art 58) – EMA/PSUR/0000339021
6.1.15. Daridorexant – QUVIVIQ (CAP) – EMA/PSUR/0000344443
6.1.16. Delgocitinib – ANZUPGO (CAP) – EMA/PSUR/0000344461
6.1.17. Donanemab – KISUNLA (CAP) – EMA/PSUR/0000344439
6.1.18. Elinzanetant – LYNKUET (CAP) – EMA/PSUR/0000344463
6.1.19. Epinephrine – EURNEFFY (CAP) – EMA/PSUR/0000344451
6.1.20. Eptacog alfa (activated) – NOVOSEVEN (CAP) – EMA/PSUR/0000344447
6.1.21. Ertugliflozin – STEGLATRO (CAP); Ertugliflozin / Metformin hydrochloride – SEGLUROMET (CAP); Ertugliflozin / Sitagliptin – STEGLUJAN (CAP) – EMA/PSUR/0000344430
6.1.22. Evinacumab – EVKEEZA (CAP) – EMA/PSUR/0000344420
6.1.23. Faricimab – VABYSMO (CAP) – EMA/PSUR/0000344426
6.1.24. Garadacimab – ANDEMBRY (CAP) – EMA/PSUR/0000344455
6.1.25. Gefapixant – LYFNUA (CAP) – EMA/PSUR/0000344383
6.1.26. Ivacaftor – KALYDECO (CAP) – EMA/PSUR/0000344411
6.1.27. Lamivudine / Abacavir – KIVEXA (CAP) – EMA/PSUR/0000344375
6.1.28. Lecanemab – LEQEMBI (CAP) – EMA/PSUR/0000344458
6.1.29. Lisocabtagene maraleucel / Lisocabtagene maraleucel – BREYANZI (CAP) – EMA/PSUR/0000344421
6.1.30. Lonoctocog alfa – AFSTYLA (CAP) – EMA/PSUR/0000344406
6.1.31. Lutetium (177Lu) oxodotreotide – LUTATHERA (CAP) – EMA/PSUR/0000344414
6.1.32. Metreleptin – MYALEPTA (CAP) – EMA/PSUR/0000344434
6.1.33. Mexiletine – NAMUSCLA (CAP) – EMA/PSUR/0000344427
6.1.34. Mirdametinib – EZMEKLY (CAP) – EMA/PSUR/0000344444
6.1.35. Omalizumab – OMLYCLO (CAP); XOLAIR (CAP) – EMA/PSUR/0000344391
6.1.36. Pandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted, prepared in cell cultures) – INCELLIPAN (CAP); Zoonotic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted, prepared in cell cultures) – CELLDEMIC (C...
6.1.37. Pirtobrutinib – JAYPIRCA (CAP) – EMA/PSUR/0000344380
6.1.38. Plerixafor – MOZOBIL (CAP) – EMA/PSUR/0000344390
6.1.39. Pneumococcal polysaccharide conjugate vaccine (15 valent, adsorbed) – VAXNEUVANCE (CAP) – EMA/PSUR/0000344419
6.1.40. Quadrivalent influenza vaccine (recombinant, prepared in cell culture) – SUPEMTEK TETRA (CAP) – EMA/PSUR/0000344432
6.1.41. Relugolix – ORGOVYX (CAP) – EMA/PSUR/0000344433
6.1.42. Romosozumab – EVENITY (CAP) – EMA/PSUR/0000344428
6.1.43. Rucaparib – RUBRACA (CAP) – EMA/PSUR/0000344413
6.1.44. Sarilumab – KEVZARA (CAP) – EMA/PSUR/0000344412
6.1.45. Sebetralstat – EKTERLY (CAP) – EMA/PSUR/0000344437
6.1.46. Sutimlimab – ENJAYMO (CAP) – EMA/PSUR/0000344445
6.1.47. Tafasitamab – MINJUVI (CAP) – EMA/PSUR/0000344435
6.1.48. Tagraxofusp – ELZONRIS (CAP) – EMA/PSUR/0000344436
6.1.49. Talquetamab – TALVEY (CAP) – EMA/PSUR/0000344393
6.1.50. Tebentafusp – KIMMTRAK (CAP) – EMA/PSUR/0000344442
6.1.51. Tecovirimat – TECOVIRIMAT SIGA (CAP) – EMA/PSUR/0000344448
6.1.52. Teprotumumab – TEPEZZA (CAP) – EMA/PSUR/0000344456
6.1.53. Tezacaftor / Ivacaftor – SYMKEVI (CAP) – EMA/PSUR/0000344423
6.1.54. Tiratricol – EMCITATE (CAP) – EMA/PSUR/0000344457
6.1.55. Ustekinumab – FYMSKINA (CAP); IMULDOSA (CAP); OTULFI (CAP); PYZCHIVA (CAP); QOYVOLMA (CAP); STELARA (CAP); STEQEYMA (CAP); USGENA (CAP); USRENTY (CAP); USYMRO (CAP); UZPRUVO (CAP); WEZENLA (CAP); YESINTEK (CAP) – EMA/PSUR/0000344407
6.1.56. Vericiguat – VERQUVO (CAP) – EMA/PSUR/0000344417
6.1.57. Voclosporin – LUPKYNIS (CAP) – EMA/PSUR/0000344422
6.1.58. Vorasidenib – VORANIGO (CAP) – EMA/PSUR/0000344440
6.1.59. Zuranolone – ZURZUVAE (CAP) – EMA/PSUR/0000344462
6.2. PSUR single assessment (PSUSA) procedures including centrally authorised products (CAPs) and nationally authorised products (NAPs)
6.2.1. Alendronic acid / Colecalciferol – ADROVANCE (CAP); FOSAVANCE (CAP); VANTAVO (CAP), NAP; alendronic acid / calcium / colecalciferol (NAP) – EMA/PSUR/0000344382
6.2.2. Lamivudine / Abacavir / Zidovudine - TRIZIVIR (CAP), NAP – EMA/PSUR/0000344408
6.2.3. Lenalidomide - LENALIDOMIDE ACCORD (CAP); LENALIDOMIDE KRKA (CAP); LENALIDOMIDE MYLAN (CAP); REVLIMID (CAP), NAP – EMA/PSUR/0000344392
6.2.4. Repaglinide - NOVONORM (CAP); PRANDIN (CAP); NAP – EMA/PSUR/0000344399
6.3. PSUR single assessment (PSUSA) procedures including nationally authorised products (NAPs) only
6.3.1. 5 fluorouracil (topical application) – EMA/PSUR/0000344410
6.3.2. Alendronate – EMA/PSUR/0000344376
6.3.3. Alitretinoin (oral use) – EMA/PSUR/0000344424
6.3.4. Alizapride – EMA/PSUR/0000344378
6.3.5. Allergen for therapy: Dactylis Glomerata L., Phleum Pratense L., Anthoxanthum Odoratum L., Lolium Perenne L., Poa Pratensis L. (sublingual tablet) – EMA/PSUR/0000344403
6.3.6. Amino acid combinations (only combinations of pure amino acids or combination of amino acids with mineral compounds/electrolytes, i.v. application) – EMA/PSUR/0000344409
6.3.7. Aminophylline – EMA/PSUR/0000344384
6.3.8. Amisulpride – EMA/PSUR/0000344386
6.3.9. Antithrombin III – EMA/PSUR/0000344418
6.3.10. Atropine / diphenoxylate – EMA/PSUR/0000344381
6.3.11. Benzydamine / cetylpyridine – EMA/PSUR/0000344385
6.3.12. Beta-alanine – EMA/PSUR/0000344401
6.3.13. Bezafibrate – EMA/PSUR/0000344389
6.3.14. Biotin – EMA/PSUR/0000344397
6.3.15. Calcitriol – EMA/PSUR/0000344379
6.3.16. Carboprost – EMA/PSUR/0000344396
6.3.17. Cilostazol – EMA/PSUR/0000344415
6.3.18. Diacerein – EMA/PSUR/0000344398
6.3.19. Estriol – EMA/PSUR/0000344405
6.3.20. Exemestane – EMA/PSUR/0000344395
6.3.21. Famciclovir – EMA/PSUR/0000344387
6.3.22. Nifurtimox – EMA/PSUR/0000344452
6.3.23. Sertindole – EMA/PSUR/0000344394
6.4. Follow-up to PSUR/PSUSA procedures
6.5. Variation procedure(s) resulting from PSUSA evaluation
6.6. Expedited summary safety reviews3F3F
7. Post-authorisation safety studies (PASS)
7.1. Protocols of PASS imposed in the marketing authorisation(s)4F4F
7.1.1. Cabotegravir – VOCABRIA (CAP); Rilpivirine – REKAMBYS (CAP) – EMA/PASS/0000358848
7.1.2. Lonafarnib – ZOKINVY (CAP) – EMA/PASS/0000357585
7.1.3. Mirdametinib - Ezmekly (CAP) - EMA/PASS/0000340654
7.1.4. Sodium valproate (NAP) – EMA/PASS/0000328174
7.2. Protocols of PASS non-imposed in the marketing authorisation(s)5F5F
7.2.1. Aficamten – MYQORZO (CAP) – EMA/PAM/0000347918
7.2.2. Cladribine – MAVENCLAD (CAP) – EMA/PAM/0000357455
7.2.3. Delgocitinib – ANZUPGO (CAP) – EMA/PAM/0000291999
7.2.4. Deucravacitinib – SOTYKTU (CAP) – EMA/PAM/0000357688
7.2.5. Efgartigimod alfa – VYVGART (CAP) – EMA/PAM/0000358653
7.2.6. Efgartigimod alfa – VYVGART (CAP) – EMA/PAM/0000358063
7.2.7. Etrasimod – VELSIPITY (CAP) – EMA/PAM/0000357465
7.2.8. Inebilizumab – UPLIZNA (CAP) – EMA/PAM/0000357017
7.2.9. Inebilizumab – UPLIZNA (CAP) – EMA/PAM/0000357209
7.2.10. Mavacamten – CAMZYOS (CAP) - EMA/PAM/0000343701
7.2.11. Naltrexone hydrochloride / Bupropion hydrochloride – MYSIMBA (CAP) – EMA/PAM/0000349763
7.2.12. Nipocalimab – IMAAVY (CAP) – EMA/PAM/0000357528
7.2.13. Nipocalimab – IMAAVY (CAP) – EMA/PAM/0000358639
7.3. Results of PASS imposed in the marketing authorisation(s)6F6F
7.4. Results of PASS imposed and non-imposed in the marketing authorisation(s)7F7F
7.4.1. Baricitinib – OLUMIANT (CAP) – EMA/VR/0000345885
7.4.2. COVID-19 mRNA vaccine – COMIRNATY (CAP) – EMA/VR/0000343925
7.4.3. COVID-19 mRNA vaccine – COMIRNATY (CAP) – EMA/VR/0000334558
7.4.4. Elosulfase alfa – VIMIZIM (CAP) – EMA/VR/0000268096
7.4.5. Fexinidazole – FEXINIDAZOLE WINTHROP (CAP) – EMA/VR/0000356314
7.4.6. Ponesimod – PONVORY (CAP) – EMA/VR/0000320506
7.4.7. Tacrolimus - ADVAGRAF (CAP); MODIGRAF (CAP); NAP – EMA/VR/0000315125
7.4.8. Voretigene neparvovec – LUXTURNA (CAP) – EMA/VR/0000357435
7.5. Interim results and other post-authorisation measures for imposed and non-imposed studies
7.5.1. Abaloparatide – ELADYNOS (CAP) – EMA/PAM/0000357990
7.5.2. Beclometasone / Formoterol / Glycopyrronium bromide - TRIMBOW (CAP) - EMA/PAM/0000350566
7.5.3. Beclometasone / Formoterol / Glycopyrronium bromide – TRYDONIS (CAP) - EMA/PAM/0000350569
7.5.4. Cabotegravir – APRETUDE (CAP) – EMA/PAM/0000348786
7.5.5. Cabotegravir – VOCABRIA (CAP) – EMA/PAM/0000348704
7.5.6. Clascoterone – WINLEVI (CAP) – EMA/PAM/0000325634
7.5.7. Danicopan – VOYDEYA (CAP) – EMA/PAM/0000357946
7.5.8. Dimethyl fumarate – SKILARENCE (CAP) – EMA/PAM/0000357021
7.5.9. Efgartigimod alfa – VYVGART (CAP) – EMA/PAM/0000358689
7.5.10. Estetrol – FYLREVY (CAP) – EMA/PAM/0000357663
7.5.11. Etuvetidigene autotemcel – WASKYRA (CAP) – EMA/PAM/0000357590
7.5.12. Fingolimod – GILENYA (CAP) – EMA/PAM/0000320326
7.5.13. Hydroxycarbamide – XROMI (CAP) – EMA/PAM/0000350555
7.5.14. Inebilizumab – UPLIZNA (CAP) – EMA/PAM/0000357900
7.5.15. Interferon beta-1A – AVONEX (CAP) – EMA/PAM/0000315762
7.5.16. Interferon beta-1A – REBIF (CAP) – EMA/PAM/0000315764
7.5.17. Interferon beta-1B – BETAFERON (CAP) – EMA/PAM/0000309054
7.5.18. Octocog alfa – KOVALTRY (CAP) – EMA/PAM/0000343782
7.5.19. Peginterferon beta-1A – PLEGRIDY (CAP) – EMA/PAM/0000315767
7.5.20. Ravulizumab – ULTOMIRIS (CAP) – EMA/PAM/0000358006
7.5.21. Respiratory syncytial virus vaccine (bivalent, recombinant) – ABRYSVO (CAP) – EMA/PAM/0000350900
7.5.22. Risankizumab – SKYRIZI (CAP) – EMA/PAM/0000348711
7.5.23. Selexipag – UPTRAVI (CAP) – EMA/PAM/0000357993
7.5.24. Siponimod – MAYZENT (CAP) – EMA/PAM/0000357691
7.5.25. Sutimlimab – ENJAYMO (CAP) – EMA/PAM/0000347729
8. Renewals of the marketing authorisation, conditional renewal and annual reassessments
8.1. Annual reassessments of the marketing authorisation
8.1.1. Maralixibat – LIVMARLI (CAP) – EMA/S/0000317715
8.1.2. Tofersen – QALSODY (CAP) – EMA/S/0000349866
8.2. Conditional renewals of the marketing authorisation
8.2.1. Adagrasib – KRAZATI (CAP) – EMA/R/0000350422
8.2.2. Brexucabtagene autoleucel – TECARTUS (CAP) – EMA/R/0000355892
8.2.3. Spesolimab – SPEVIGO (CAP) – EMA/R/0000348377
8.2.4. Loncastuximab tesirine – ZYNLONTA (CAP) – EMA/R/0000358132
8.2.5. Repotrectinib – AUGTYRO (CAP) – EMA/R/0000357913
8.2.6. Sotorasib – LUMYKRAS (CAP) – EMA/R/0000360417
8.2.7. Trastuzumab deruxtecan – ENHERTU (CAP) – EMA/R/0000360418
8.3. Renewals of the marketing authorisation
8.3.1. Enfortumab vedotin – PADCEV (CAP) – EMA/R/0000351076
8.3.2. Eptinezumab – VYEPTI (CAP) – EMA/R/0000336059
8.3.3. Finerenone – KERENDIA (CAP) – EMA/R/0000340433
8.3.4. Lisocabtagene maraleucel / Lisocabtagene maraleucel – BREYANZI (CAP) – EMA/R/0000355073
8.3.5. Pegfilgrastim – STIMUFEND (CAP) – EMA/R/0000351198
8.3.6. Pneumococcal polysaccharide conjugate vaccine (20-valent, adsorbed) – PREVENAR 20 (CAP) – EMA/R/0000340648
8.3.7. Risperidone – OKEDI (CAP) – EMA/R/0000343015
8.3.8. Sapropterin – SAPROPTERIN DIPHARMA (CAP) – EMA/R/0000348315
8.3.9. Sitagliptin / Metformin hydrochloride – SITAGLIPTIN METFORMIN HYDROCHLORIDE MYLAN (CAP) – EMA/R/0000349188
8.3.10. Somatrogon – NGENLA (CAP) – EMA/R/0000340629
8.3.11. Tebentafusp – KIMMTRAK (CAP) – EMA/R/0000355059
8.3.12. Tecovirimat - TECOVIRIMAT SIGA (CAP) - EMA/R/0000340615
8.3.13. Tofacitinib – XELJANZ (CAP) – EMA/R/0000350878
9. Product related pharmacovigilance inspections
9.1. List of planned pharmacovigilance inspections
9.2. Ongoing or concluded pharmacovigilance inspections
9.3. Others
10. Other safety issues for discussion requested by the Member States, CHMP or the EMA
11. Scientific advice procedures
12. Organisational, regulatory and methodological matters
12.1. Mandate and organisation of the PRAC
12.1.1. PRAC membership
12.1.2. Nominated proxy
12.2. Coordination with EMA Scientific Committees or CMDh-v
12.3. Coordination with EMA Working Parties/Working Groups/Drafting Groups
12.3.1. Areas of collaboration between PRAC and Methodology Working Party (MWP)
12.4. Cooperation within the EU regulatory network
12.5. Cooperation with International Regulators
12.6. Contacts of the PRAC with external parties and interaction with the Interested Parties to the Committee
12.7. PRAC work plan
12.7.1. PRAC work plan 2026 - update
12.8. Planning and reporting
12.9. Pharmacovigilance audits and inspections
12.9.1. Pharmacovigilance systems and their quality systems
12.9.2. Pharmacovigilance inspections
12.9.3. Pharmacovigilance audits
12.10. Periodic safety update reports (PSURs) & Union reference date (EURD) list
12.10.1. Periodic safety update reports
12.10.2. Granularity and Periodicity Advisory Group (GPAG)
12.10.3. PSURs repository
12.10.4. Union reference date list – consultation on the draft list
12.11. Signal management
12.11.1. Signal management – feedback from Signal Management Review Technical (SMART) Working Group
12.12. Adverse drug reactions reporting and additional reporting
12.12.1. Management and reporting of adverse reactions to medicinal products
12.12.2. Additional monitoring
12.12.3. List of products under additional monitoring – consultation on the draft list
12.13. EudraVigilance database
12.13.1. Activities related to the confirmation of full functionality
12.14. Risk management plans and effectiveness of risk minimisations
12.14.1. Risk management systems
12.14.2. Tools, educational materials and effectiveness measurement of risk minimisations
12.15. Post-authorisation safety studies (PASS)
12.15.1. Post-authorisation Safety Studies – imposed PASS
12.15.2. Post-authorisation Safety Studies – non-imposed PASS
12.16. Community procedures
12.16.1. Referral procedures for safety reasons
12.17. Renewals, conditional renewals, annual reassessments
12.18. Risk communication and transparency
12.18.1. Public participation in pharmacovigilance
12.18.2. Safety communication
12.19. Continuous pharmacovigilance
12.19.1. Incident management
12.20. Impact of pharmacovigilance activities
12.20.1. Strategy on measuring the impact of pharmacovigilance: draft technical specifications for a qualitative impact study on healthcare professionals’ preferences for additional risk minimisation measures (under EMA/2024/OP/0016)
12.21. Others
12.21.1. Extension application timetable alignment with MAA timetable
13. Any other business
14. Explanatory notes
01.09.2026
Datei
PD
