Official address Domenico Scarlattilaan 6 ● 1083 HS Amsterdam ● The Netherlands
An agency of the European Union
Address for visits and deliveries Refer to www.ema.europa.eu/how-to-find-us
Send us a question Go to www.ema.europa.eu/contact Telephone +31 (0)88 781 6000
© European Medicines Agency, 2025. Reproduction is authorised provided the source is acknowledged.
08 June 2026
EMA/PRAC/115322/2026
Human Medicines Division
Pharmacovigilance Risk Assessment Committee (PRAC)
Draft agenda for the meeting on 08-11 June 2026
Chair: Ulla Wändel Liminga – Vice-Chair: Liana Martirosyan
08 June 2026, 09:30 – 19:30, room via teleconference
09 June 2026, 08:30 – 19:30, room via teleconference
10 June 2026, 08:30 – 19:30, room via teleconference
11 June 2026, 08:30 – 16:00, room via teleconference
Organisational, regulatory and methodological matters (ORGAM)
25 June 2026 via teleconference
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).
http://www.ema.europa.eu/how-to-find-us
http://www.ema.europa.eu/contact
http://www.ema.europa.eu/ema/index.jsp?curl=pages/about_us/general/general_content_000508.jsp&mid=WC0b01ac0580028d2a
https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/output-european-medicines-agency-policy-access-documents-related-medicinal-products-human-veterinary_en.pdf
Pharmacovigilance Risk Assessment Committee (PRAC)
EMA/PRAC/115322/2026 Page 2/65
Table of contents
1. Introduction 11
1.1. Welcome and declarations of interest of members, alternates and experts .......... 11
1.2. Agenda of the meeting on 08-11 June 2026 ......................................................... 11
1.3. Minutes of the previous meeting on 04-07 May 2026 ........................................... 11
2. EU referral procedures for safety reasons: urgent EU procedures 11
2.1. Newly triggered procedures ................................................................................. 11
2.2. Ongoing procedures ............................................................................................. 11
2.3. Procedures for finalisation.................................................................................... 11
3. EU referral procedures for safety reasons: other EU referral
procedures 11
3.1. Newly triggered procedure ................................................................................... 11
3.2. Ongoing procedures ............................................................................................. 11
3.3. Procedures for finalisation.................................................................................... 12
3.4. Re-examination procedures .................................................................................. 12
3.5. Others .................................................................................................................. 12
4. Signals assessment and prioritisation 12
4.1. New signals detected from EU spontaneous reporting systems and/or other sources
............................................................................................................................. 12
4.1.1. Abemaciclib – VERZENIOS (CAP); palbociclib – IBRANCE (CAP); ribociclib – KISQALI (CAP)12
4.1.2. Atezolizumab – TECENTRIQ (CAP); avelumab – BAVENCIO (CAP); cemiplimab - LIBTAYO
(CAP); dostarlimab – JEMPERLI (CAP); durvalumab – IMFINZI (CAP); ipilimumab – YERVOY
(CAP); nivolumab – OPDIVO (CAP); nivolumab / relatlimab – OPDUALAG (CAP);
pembrolizumab – KEYTRUDA (CAP); retifanlimab – ZYNYZ (CAP); serplulimab - HETRONIFLY
(CAP); sugemalimab – CEJEMLY (CAP); tislelizumab – TEVIMBRA (CAP); toripalimab –
LOQTORZI (CAP); tremelimumab – IMJUDO (CAP) ....................................................... 12
4.1.3. Belzutifan – WELIREG (CAP) ..................................................................................... 13
4.1.4. Cefpodoxime (NAP) .................................................................................................. 13
4.1.5. Lithium (NAP) ......................................................................................................... 13
4.1.6. Luspatercept - REBLOZYL (CAP) ................................................................................ 13
4.1.7. Osimertinib - TAGRISSO (CAP) .................................................................................. 14
4.2. Signals follow-up and prioritisation ...................................................................... 14
4.2.1. Darolutamide - NUBEQA (CAP) - EMEA/H/C/004790/SDA/005 ....................................... 14
4.2.2. Gemcitabine (NAP) .................................................................................................. 14
4.2.3. Valproate (NAP) and related substances ..................................................................... 14
4.2.4. Vortioxetine - BRINTELLIX (CAP) - EMEA/H/C/002717/SDA/011 .................................... 15
4.2.5. X-ray contrast agents: Iobitridol (NAP); Iodixanol (NAP); Iohexol (NAP); Iomeprol (NAP);
Iopamidol (NAP); Iopromide (NAP); Ioversol (NAP); Ioxitalamic acid (NAP) .................... 15
4.2.6. Zolbetuximab - VYLOY (CAP) - EMEA/H/C/005868/SDA/002 ......................................... 15
Pharmacovigilance Risk Assessment Committee (PRAC)
EMA/PRAC/115322/2026 Page 3/65
4.3. Variation procedure(s) resulting from signal evaluation ...................................... 15
5. Risk management plans (RMPs) 15
5.1. Medicines in the pre-authorisation phase ............................................................. 15
5.1.1. Glepaglutide - (CAP MAA) - EMEA/H/C/005855 ........................................................... 15
5.1.2. Omalizumab - (CAP MAA) - EMEA/H/C/006756 ........................................................... 16
5.1.3. Pegfilgrastim - (CAP MAA) - EMEA/H/C/006085 .......................................................... 16
5.1.4. RABIES VIRUS (INACTIVATED) STRAIN WISTAR (PM/WI 38-1503-3M) - (CAP MAA) -
EMEA/H/C/006602 ................................................................................................... 16
5.2. Medicines in the post-authorisation phase – PRAC-led procedures ....................... 16
5.2.1. Bosentan – STAYVEER (CAP); TRACLEER (CAP) – EMA/VR/0000316336 ......................... 16
5.2.2. Emtricitabine / Tenofovir disoproxil - EMTRICITABINE/TENOFOVIR DISOPROXIL ZENTIVA
(CAP); NAP – EMA/VR/0000335678 ........................................................................... 16
5.2.3. Infliximab – REMICADE (CAP) – EMA/VR/0000338953 .................................................. 17
5.2.4. Lecanemab – LEQEMBI (CAP) – EMA/VR/0000302769 .................................................. 17
5.2.5. Loncastuximab tesirine – ZYNLONTA (CAP) – EMA/VR/0000337919 ............................... 17
5.2.6. Teriflunomide - TERIFLUNOMIDE VIATRIS (CAP), NAP – EMA/VR/0000320266 ................ 17
5.2.7. Tenofovir disoproxil - TENOFOVIR DISOPROXIL ZENTIVA (CAP), NAP – EMA/VR/000034225818
5.3. Medicines in the post-authorisation phase – CHMP-led procedures ...................... 18
5.3.1. Atogepant – AQUIPTA (CAP) – EMA/VR/0000334780 .................................................... 18
5.3.2. Concizumab – ALHEMO (CAP) – EMA/VR/0000335954 .................................................. 18
5.3.3. COVID-19 vaccine (recombinant, adjuvanted) – BIMERVAX (CAP) – EMA/VR/0000316063 19
5.3.4. Daratumumab – DARZALEX (CAP) – EMA/VR/0000334930 ........................................... 19
5.3.5. Dengue tetravalent vaccine (live, attenuated) – DENGUE TETRAVALENT VACCINE (LIVE,
ATTENUATED) TAKEDA (Art 58); QDENGA (CAP) – EMA/VR/0000323434 ....................... 19
5.3.6. Dinutuximab beta – QARZIBA (CAP) – EMA/VR/0000316241 ......................................... 20
5.3.7. Enfortumab vedotin – PADCEV (CAP) – EMA/VR/0000336191........................................ 20
5.3.8. Ertugliflozin – STEGLATRO (CAP) – EMA/VR/0000335920 ............................................. 21
5.3.9. Florbetapir (18F) – AMYVID (CAP) – EMA/VR/0000333287 ............................................. 21
5.3.10. Gemtuzumab ozogamicin – MYLOTARG (CAP) – EMA/VR/0000304835 ............................ 21
5.3.11. Guanfacine – INTUNIV (CAP) – EMA/VR/0000334464 ................................................... 22
5.3.12. Ivacaftor / Tezacaftor / Elexacaftor – KAFTRIO (CAP) – EMA/VR/0000320413 ................. 22
5.3.13. Meningococcal Group A, C, W and Y conjugate vaccine – MENQUADFI (CAP) –
EMA/VR/0000281377 ............................................................................................... 22
5.3.14. Methylphenidate hydrochloride – TUZULBY (CAP) – EMA/X/0000327555......................... 22
5.3.15. Mirabegron – BETMIGA (CAP) – EMA/VR/0000327362 .................................................. 23
5.3.16. Nivolumab / Relatlimab – OPDUALAG (CAP) – EMA/VR/0000339077 .............................. 23
5.3.17. Ocrelizumab – OCREVUS (CAP) – EMA/VR/0000309389................................................ 23
5.3.18. Ocrelizumab – OCREVUS (CAP) – EMA/VR/0000313041................................................ 24
5.3.19. Olezarsen – TRYNGOLZA (CAP) – EMA/VR/0000336189 ................................................ 24
5.3.20. Omaveloxolone – SKYCLARYS (CAP) – EMA/VR/0000296476 ........................................ 24
Pharmacovigilance Risk Assessment Committee (PRAC)
EMA/PRAC/115322/2026 Page 4/65
5.3.21. Palbociclib – IBRANCE (CAP) – EMA/VR/0000316536 ................................................... 25
5.3.22. Pembrolizumab – KEYTRUDA (CAP) – EMA/VR/0000336194 .......................................... 25
5.3.23. Pirtobrutinib – JAYPIRCA (CAP) – EMA/VR/0000316267 ................................................ 25
5.3.24. Respiratory syncytial virus mRNA vaccine (nucleoside modified) – mRESVIA (CAP) –
EMA/VR/0000320244 ............................................................................................... 26
5.3.25. Rimegepant – VYDURA (CAP) – EMA/VR/0000339929 .................................................. 26
5.3.26. Ruxolitinib – OPZELURA (CAP) – EMA/VR/0000313318 ................................................. 26
5.3.27. Sotorasib – LUMYKRAS (CAP) – EMA/VR/0000339051 .................................................. 27
5.3.28. Teclistamab – TECVAYLI (CAP) – EMA/VR/0000336274 ................................................ 27
5.3.29. Tezepelumab – TEZSPIRE (CAP) – EMA/VR/0000321455 .............................................. 27
5.3.30. Tucatinib – TUYSA (CAP) – EMA/VR/0000337235......................................................... 27
6. Periodic safety update reports (PSURs) 28
6.1. PSUR single assessment (PSUSA) procedures including centrally authorised products
(CAPs) only .......................................................................................................... 28
6.1.1. Acalabrutinib – CALQUENCE (CAP) – EMA/PSUR/0000327904 ....................................... 28
6.1.2. Acoramidis – BEYONTTRA (CAP) – EMA/PSUR/0000327953 ........................................... 28
6.1.3. Andexanet alfa – ONDEXXYA (CAP) – EMA/PSUR/0000327908 ...................................... 28
6.1.4. Avacopan – TAVNEOS (CAP) – EMA/PSUR/0000327958 ................................................ 29
6.1.5. Axicabtagene ciloleucel – YESCARTA (CAP) – EMA/PSUR/0000327951 ............................ 29
6.1.6. Aztreonam / Avibactam – EMBLAVEO (CAP) – EMA/PSUR/0000327924........................... 29
6.1.7. Belantamab mafodotin – BLENREP (CAP) – EMA/PSUR/0000327952 .............................. 29
6.1.8. Beremagene geperpavec – VYJUVEK (CAP) – EMA/PSUR/0000327959 ............................ 29
6.1.9. Bevacizumab gamma – LYTENAVA (CAP) – EMA/PSUR/0000327928 .............................. 29
6.1.10. Bezlotoxumab – ZINPLAVA (CAP) – EMA/PSUR/0000327891 ......................................... 30
6.1.11. Bupivacaine – EXPAREL LIPOSOMAL (CAP) – EMA/PSUR/0000327916 ............................ 30
6.1.12. Capivasertib – TRUQAP (CAP) – EMA/PSUR/0000327927 .............................................. 30
6.1.13. Ceritinib – ZYKADIA (CAP) – EMA/PSUR/0000327894 .................................................. 30
6.1.14. Chikungunya vaccine (live) – IXCHIQ (CAP) – EMA/PSUR/0000327923 .......................... 30
6.1.15. Conestat alfa – RUCONEST (CAP) – EMA/PSUR/0000327863 ......................................... 31
6.1.16. COVID-19 mRNA vaccine – KOSTAIVE (CAP) – EMA/PSUR/0000327932 ......................... 31
6.1.17. Delamanid – DELTYBA (CAP) – EMA/PSUR/0000327880 ............................................... 31
6.1.18. Dinutuximab beta – QARZIBA (CAP) – EMA/PSUR/0000327902 ..................................... 31
6.1.19. Dopamine hydrochloride – NEOATRICON (CAP) – EMA/PSUR/0000327930 ...................... 31
6.1.20. Eculizumab – BEKEMV (CAP); EPYSQLI (CAP); SOLIRIS (CAP) – EMA/PSUR/0000327869 . 31
6.1.21. Etranacogene dezaparvovec – HEMGENIX (CAP) – EMA/PSUR/0000327921 .................... 32
6.1.22. Exagamglogene autotemcel – CASGEVY (CAP) – EMA/PSUR/0000327950 ....................... 32
6.1.23. Hydrocortisone – EFMODY (CAP); PLENADREN (CAP) – EMA/PSUR/0000327910 .............. 32
6.1.24. Insulin degludec / Liraglutide – XULTOPHY (CAP) – EMA/PSUR/0000327890 ................... 32
Pharmacovigilance Risk Assessment Committee (PRAC)
EMA/PRAC/115322/2026 Page 5/65
6.1.25. Irinotecan hydrochloride trihydrate – ONIVYDE PEGYLATED LIPOSOMAL (CAP) –
EMA/PSUR/0000327915 ........................................................................................... 32
6.1.26. Ivacaftor / Tezacaftor / Elexacaftor – KAFTRIO (CAP) – EMA/PSUR/0000327903 ............. 33
6.1.27. Larotrectinib – VITRAKVI (CAP) – EMA/PSUR/0000327912 ............................................ 33
6.1.28. Latanoprost – CATIOLANZE (CAP) – EMA/PSUR/0000327866 ........................................ 33
6.1.29. Lazertinib – LAZCLUZE (CAP) – EMA/PSUR/0000327949 ............................................... 33
6.1.30. Linvoseltamab – LYNOZYFIC (CAP) – EMA/PSUR/0000327948 ....................................... 33
6.1.31. Lonafarnib – ZOKINVY (CAP) – EMA/PSUR/0000327913 ............................................... 33
6.1.32. Loncastuximab tesirine – ZYNLONTA (CAP) – EMA/PSUR/0000327917 ........................... 34
6.1.33. Mercaptamine – PROCYSBI (CAP); Mercaptamine bitartrate – CYSTAGON (CAP) –
EMA/PSUR/0000327901 ........................................................................................... 34
6.1.34. Mirvetuximab soravtansine – ELAHERE (CAP) – EMA/PSUR/0000327931 ........................ 34
6.1.35. Nintedanib – OFEV (CAP) – EMA/PSUR/0000327881 .................................................... 34
6.1.36. Nintedanib – VARGATEF (CAP) – EMA/PSUR/0000327882 ............................................. 34
6.1.37. Niraparib / Abiraterone acetate – AKEEGA (CAP) – EMA/PSUR/0000327922 .................... 35
6.1.38. Nirogacestat – OGSIVEO (CAP) – EMA/PSUR/0000327941 ............................................ 35
6.1.39. Obecabtagene autoleucel – AUCATZYL (CAP) – EMA/PSUR/0000327934 ......................... 35
6.1.40. Palopegteriparatide – YORVIPATH (CAP) – EMA/PSUR/0000327865 ............................... 35
6.1.41. Pandemic influenza vaccine (H5N1) (live attenuated, nasal) – PANDEMIC INFLUENZA VACCINE
H5N1 ASTRAZENECA (CAP) – EMA/PSUR/0000327887 ................................................. 35
6.1.42. Panitumumab – VECTIBIX (CAP) – EMA/PSUR/0000327879 .......................................... 35
6.1.43. Parathyroid hormone – NATPAR (CAP) – EMA/PSUR/0000327892 .................................. 36
6.1.44. Pegcetacoplan – ASPAVELI (CAP) – EMA/PSUR/0000327907 ......................................... 36
6.1.45. Piperaquine tetraphosphate / Artenimol – EURARTESIM (CAP) – EMA/PSUR/0000327942 . 36
6.1.46. Prucalopride – RESOLOR (CAP) – EMA/PSUR/0000327877 ............................................ 36
6.1.47. rADAMTS13 – ADZYNMA (CAP) – EMA/PSUR/0000327926 ............................................ 36
6.1.48. Raltegravir – ISENTRESS (CAP) – EMA/PSUR/0000327884 ........................................... 37
6.1.49. Ranibizumab – BYOOVIZ (CAP); EPRUVY (CAP); LUCENTIS (CAP); RANIVISIO (CAP);
RIMMYRAH (CAP); XIMLUCI (CAP) – EMA/PSUR/0000327906 ........................................ 37
6.1.50. RdESAT-6 / rCFP-10 – SIILTIBCY (CAP) – EMA/PSUR/0000327947 ................................ 37
6.1.51. Repotrectinib – AUGTYRO (CAP) – EMA/PSUR/0000327933 ........................................... 37
6.1.52. Selpercatinib – RETSEVMO (CAP) – EMA/PSUR/0000327889 ......................................... 37
6.1.53. Setmelanotide – IMCIVREE (CAP) – EMA/PSUR/0000327886 ......................................... 37
6.1.54. Sirolimus – HYFTOR (CAP) – EMA/PSUR/0000327938 ................................................... 38
6.1.55. Sotorasib – LUMYKRAS (CAP) – EMA/PSUR/0000327925 .............................................. 38
6.1.56. Tofersen – QALSODY (CAP) – EMA/PSUR/0000327929 ................................................. 38
6.1.57. Vamorolone – AGAMREE (CAP) – EMA/PSUR/0000327937 ............................................ 38
6.1.58. Vandetanib – CAPRELSA (CAP) – EMA/PSUR/0000327919 ............................................ 38
6.1.59. Volanesorsen – WAYLIVRA (CAP) – EMA/PSUR/0000327897 ......................................... 39
6.1.60. Zanidatamab – ZIIHERA (CAP) – EMA/PSUR/0000327940 ............................................ 39
Pharmacovigilance Risk Assessment Committee (PRAC)
EMA/PRAC/115322/2026 Page 6/65
6.1.61. Zanubrutinib – BRUKINSA (CAP) – EMA/PSUR/0000327900 .......................................... 39
6.2. PSUR single assessment (PSUSA) procedures including centrally authorised products
(CAPs) and nationally authorised products (NAPs) .............................................. 39
6.2.1. Deferasirox - DEFERASIROX ACCORD (CAP); DEFERASIROX MYLAN (CAP); EXJADE (CAP), NAP
– EMA/PSUR/0000327939 ........................................................................................ 39
6.2.2. Methotrexate - JYLAMVO (CAP); NORDIMET (CAP), NAP – EMA/PSUR/0000327873 .......... 39
6.2.3. Stiripentol - DIACOMIT (CAP), NAP – EMA/PSUR/0000327885 ....................................... 40
6.2.4. Tadalafil - ADCIRCA (CAP); CIALIS (CAP); TADALAFIL LILLY (CAP), NAP –
EMA/PSUR/0000327895 ........................................................................................... 40
6.3. PSUR single assessment (PSUSA) procedures including nationally authorised
products (NAPs) only ........................................................................................... 40
6.3.1. A-tocopheril, a-tocopherol, vitamin E – EMA/PSUR/0000327898 .................................... 40
6.3.2. A-tocopherol / ergocalciferol / phytomenadion / retinol palmitate – EMA/PSUR/000032788340
6.3.3. Acetylsalicylic acid / chlorphenamine / phenylephrine – EMA/PSUR/0000327862 ............. 40
6.3.4. Aluminium chloride hexahydrate – EMA/PSUR/0000327918 .......................................... 41
6.3.5. Aminosalicylic acid – EMA/PSUR/0000327860 ............................................................. 41
6.3.6. Amlodipine / atorvastatin / perindopril, amlodipine / atorvastatin / rampiril –
EMA/PSUR/0000327896 ........................................................................................... 41
6.3.7. Artemether / lumefantrin (apart from the dispersible tablet) – EMA/PSUR/0000327946 .... 41
6.3.8. Ascorbic acid / caffeine / paracetamol / phenylephrine hydrochloride / terpine –
EMA/PSUR/0000327878 ........................................................................................... 41
6.3.9. Bisoprolol – EMA/PSUR/0000327936 .......................................................................... 41
6.3.10. Bisoprolol / perindopril – EMA/PSUR/0000327893 ........................................................ 42
6.3.11. Bromhexine – EMA/PSUR/0000327935 ....................................................................... 42
6.3.12. Carbidopa / levodopa – EMA/PSUR/0000327864 .......................................................... 42
6.3.13. Cinnarizine / dimenhydrinate – EMA/PSUR/0000327867 ............................................... 42
6.3.14. Clenbuterol – EMA/PSUR/0000327861........................................................................ 42
6.3.15. Cyanocobalamin / folic acid, cyanocobalamin / folic acid / potassium iodide –
EMA/PSUR/0000327944 ........................................................................................... 43
6.3.16. Desogestrel / ethinylestradiol – EMA/PSUR/0000327943 .............................................. 43
6.3.17. Dinoprostone – EMA/PSUR/0000327945 ..................................................................... 43
6.3.18. Felbamate – EMA/PSUR/0000327920 ......................................................................... 43
6.3.19. Human coagulation factor VII – EMA/PSUR/0000327871 .............................................. 43
6.3.20. Isoflurane – EMA/PSUR/0000327868 ......................................................................... 43
6.3.21. Minoxidil (non topical formulations) – EMA/PSUR/0000327876 ...................................... 44
6.3.22. Perindopril – EMA/PSUR/0000327874 ......................................................................... 44
6.3.23. Pipamperone – EMA/PSUR/0000327872 ..................................................................... 44
6.3.24. Prothipendyl – EMA/PSUR/0000327875 ...................................................................... 44
6.3.25. Ramipril / bisoprolol – EMA/PSUR/0000327914 ........................................................... 44
6.3.26. Salmeterol – EMA/PSUR/0000327888 ........................................................................ 45
6.3.27. Sulbutiamine – EMA/PSUR/0000327905 ..................................................................... 45
Pharmacovigilance Risk Assessment Committee (PRAC)
EMA/PRAC/115322/2026 Page 7/65
6.3.28. Terbinafine – EMA/PSUR/0000327909 ........................................................................ 45
6.3.29. Valsartan / rosuvastatin – EMA/PSUR/0000327899 ...................................................... 45
6.4. Follow-up to PSUR/PSUSA procedures ................................................................. 45
6.4.1. Semaglutide – RYBELSUS (CAP) – EMA/PAM/0000337900 ............................................ 45
6.4.2. Semaglutide – WEGOVY (CAP); WEGOVY FLEXTOUCH (CAP) – EMA/PAM/0000337800 ..... 46
6.4.3. Semaglutide – OZEMPIC (CAP) – EMA/PAM/0000338018 .............................................. 46
6.4.4. Voretigene neparvovec – LUXTURNA (CAP) – EMA/PAM/0000339319 ............................. 46
6.5. Variation procedure(s) resulting from PSUSA evaluation ..................................... 46
6.5.1. Tacrolimus ADVAGRAF (CAP); MODIGRAF (CAP), NAP – EMA/VR/0000319175 ................ 46
6.6. Expedited summary safety reviews ...................................................................... 47
7. Post-authorisation safety studies (PASS) 47
7.1. Protocols of PASS imposed in the marketing authorisation(s) .............................. 47
7.1.1. Donanemab – KISUNLA (CAP) – EMA/PASS/0000339404 .............................................. 47
7.1.2. Donanemab – KISUNLA (CAP) – EMA/PASS/0000339391 .............................................. 47
7.1.3. Mirdametinib – EZMEKLY (CAP) – EMA/PASS/0000340654 ............................................ 47
7.1.4. Topiramate (NAP) – EMA/PASS/0000340662 ............................................................... 47
7.2. Protocols of PASS non-imposed in the marketing authorisation(s) ...................... 48
7.2.1. Ciltacabtagene autoleucel – CARVYKTI (CAP) – EMA/PAM/0000338559 .......................... 48
7.2.2. COVID-19 mRNA vaccine – MNEXSPIKE (CAP) – EMA/PAM/0000339594 ......................... 48
7.2.3. Donanemab – KISUNLA (CAP) – EMA/PAM/0000338752 ............................................... 48
7.2.4. Efgartigimod alfa – VYVGART (CAP) – EMA/PAM/0000343589 ....................................... 48
7.2.5. Resmetirom – REZDIFFRA (CAP) – EMA/PAM/0000339780 ............................................ 49
7.2.6. Teprotumumab – TEPEZZA (CAP) – EMA/PAM/0000310214 .......................................... 49
7.2.7. Tofacitinib – XELJANZ (CAP) – EMA/PAM/0000316639 .................................................. 49
7.2.8. Upadacitinib – RINVOQ (CAP) – EMA/PAM/0000339078 ................................................ 49
7.2.9. Vonicog alfa – VEYVONDI (CAP) – EMA/PAM/0000337712............................................. 50
7.3. Results of PASS imposed in the marketing authorisation(s) ................................. 50
7.3.1. Belimumab – BENLYSTA (CAP) – EMA/PASS/0000306411 ............................................. 50
7.4. Results of PASS imposed and non-imposed in the marketing authorisation(s) ..... 50
7.4.1. COVID-19 mRNA vaccine – COMIRNATY (CAP); COMIRNATY JN.1 (CAP); COMIRNATY KP.2
(CAP); COMIRNATY LP.8.1 (CAP); COMIRNATY OMICRON XBB.1.5 (CAP); COMIRNATY
ORIGINAL/OMICRON BA.4-5 (CAP) – EMA/VR/0000334558 .......................................... 50
7.4.2. Ivacaftor / Tezacaftor / Elexacaftor – KAFTRIO (CAP) – EMA/VR/0000319887 ................. 51
7.4.3. Laronidase – ALDURAZYME (CAP) – EMA/VR/0000282056 ............................................ 51
7.4.4. Semaglutide – OZEMPIC (CAP); RYBELSUS (CAP) – EMA/VR/0000334523 ...................... 51
7.5. Interim results and other post-authorisation measures for imposed and non-imposed
studies .................................................................................................................. 51
7.5.1. Avacopan – TAVNEOS (CAP) – EMA/PAM/0000336195 ................................................. 51
7.5.2. Cabotegravir – VOCABRIA (CAP) – EMA/PAM/0000339050 ............................................ 52
Pharmacovigilance Risk Assessment Committee (PRAC)
EMA/PRAC/115322/2026 Page 8/65
7.5.3. Cabotegravir – VOCABRIA (CAP) – EMA/PAM/0000339531 ............................................ 52
7.5.4. COVID-19 vaccine (recombinant, adjuvanted) – NUVAXOVID (CAP); NUVAXOVID JN.1 (CAP);
NUVAXOVID XBB.1.5 (CAP) – EMA/PAM/0000317251 ................................................... 52
7.5.5. Damoctocog alfa pegol – JIVI (CAP) – EMA/PAM/0000303584 ....................................... 53
7.5.6. Efgartigimod alfa – VYVGART (CAP) – EMA/PAM/0000339564 ....................................... 53
7.5.7. Fenfluramine – FINTEPLA (CAP) – EMA/PAM/0000339786 ............................................. 53
7.5.8. Lecanemab – LEQEMBI (CAP) – EMA/PAM/0000339581 ................................................ 53
7.5.9. Maribavir – LIVTENCITY (CAP) – EMA/PAM/0000334575 ............................................... 53
7.5.10. Mercaptamine – CYSTADROPS (CAP) – EMA/PAM/0000339522 ...................................... 54
7.5.11. Ofatumumab – KESIMPTA (CAP) – EMA/PAM/0000308145 ............................................ 54
7.5.12. Ofatumumab – KESIMPTA (CAP) – EMA/PAM/0000337728 ............................................ 54
7.5.13. Rilpivirine – REKAMBYS (CAP) – EMA/PAM/0000338758 ............................................... 54
7.5.14. Sarilumab – KEVZARA (CAP) – EMA/PAM/0000339607 ................................................. 55
7.5.15. Tofacitinib – XELJANZ (CAP) – EMA/PAM/0000334570 .................................................. 55
7.5.16. Velaglucerase alfa – VPRIV (CAP) – EMA/PAM/0000339048 .......................................... 55
8. Renewals of the marketing authorisation, conditional renewal and
annual reassessments 56
8.1. Annual reassessments of the marketing authorisation ......................................... 56
8.1.1. Amifampridine – FIRDAPSE (CAP) – EMA/S/0000337252 .............................................. 56
8.1.2. Clofarabine – EVOLTRA (CAP) – EMA/S/0000335797 .................................................... 56
8.1.3. Glucarpidase – VORAXAZE (CAP) – EMA/S/0000322329 ............................................... 56
8.1.4. Maralixibat – LIVMARLI (CAP) – EMA/S/0000317715 .................................................... 56
8.1.5. Velmanase alfa – LAMZEDE (CAP) – EMA/S/0000336192 .............................................. 56
8.2. Conditional renewals of the marketing authorisation ........................................... 57
8.2.1. Epcoritamab – TEPKINLY (CAP) – EMA/R/0000334812 ................................................. 57
8.2.2. Pirtobrutinib – JAYPIRCA (CAP) – EMA/R/0000339971 .................................................. 57
8.3. Renewals of the marketing authorisation ............................................................. 57
8.3.1. Abrocitinib – CIBINQO (CAP) – EMA/R/0000336009 ..................................................... 57
8.3.2. Anifrolumab – SAPHNELO (CAP) – EMA/R/0000335943 ................................................ 57
8.3.3. Artesunate – ARTESUNATE AMIVAS (CAP) – EMA/R/0000333258 .................................. 57
8.3.4. Eptinezumab – VYEPTI (CAP) – EMA/R/0000336059 .................................................... 58
8.3.5. Semaglutide – WEGOVY (CAP); WEGOVY FLEXTOUCH (CAP) – EMA/R/0000336288 ......... 58
8.3.6. Sitagliptin fumarate – SITAGLIPTIN SUN (CAP) – EMA/R/0000335931 ........................... 58
9. Product related pharmacovigilance inspections 58
9.1. List of planned pharmacovigilance inspections ..................................................... 58
9.2. Ongoing or concluded pharmacovigilance inspections .......................................... 58
9.3. Others .................................................................................................................. 58
Pharmacovigilance Risk Assessment Committee (PRAC)
EMA/PRAC/115322/2026 Page 9/65
10. Other safety issues for discussion requested by the Member States,
CHMP or the EMA 59
10.1.1. Levofloxacin (intravenous and oral use) – DE/H/5119/001-003/II/118 ........................... 59
10.1.2. Mycobacterium bovis BCG, Danish strain 1331 – DK/H/3659/001/II/001 ........................ 59
10.1.3. Upadacitinib – RINVOQ (CAP) – EMA/VR/0000312506 .................................................. 59
11. Scientific advice procedures 59
12. Organisational, regulatory and methodological matters 60
12.1. Mandate and organisation of the PRAC ................................................................. 60
12.1.1. PRAC membership ................................................................................................... 60
12.1.2. Nominated proxy ..................................................................................................... 60
12.1.3. Scientific Committee Meetings – alternating face-to-face and virtual meetings schedule for
2027 ...................................................................................................................... 60
12.2. Coordination with EMA Scientific Committees or CMDh-v ..................................... 60
12.3. Coordination with EMA Working Parties/Working Groups/Drafting Groups ......... 60
12.3.1. Healthcare Professionals Working Party (HCPWP) and Patients and Consumers Working Party
(PCWP) – 2025-2028 ............................................................................................... 60
12.3.2. SAWP-PRAC consultation procedure – guidance update ................................................ 60
12.4. Cooperation within the EU regulatory network ..................................................... 60
12.5. Cooperation with International Regulators........................................................... 60
12.5.1. Opening procedures at EMA to non-EU authorities (OPEN) framework – PRAC involvement 60
12.6. Contacts of the PRAC with external parties and interaction with the Interested
Parties to the Committee ...................................................................................... 61
12.7. PRAC work plan .................................................................................................... 61
12.8. Planning and reporting ......................................................................................... 61
12.9. Pharmacovigilance audits and inspections ........................................................... 61
12.9.1. Pharmacovigilance systems and their quality systems .................................................. 61
12.9.2. Pharmacovigilance inspections .................................................................................. 61
12.9.3. Pharmacovigilance audits.......................................................................................... 61
12.10. Periodic safety update reports (PSURs) & Union reference date (EURD) list ........ 61
12.10.1. Periodic safety update reports ................................................................................... 61
12.10.2. PSURs repository ..................................................................................................... 61
12.10.3. Union reference date list – consultation on the draft list ............................................... 61
12.11. Signal management .............................................................................................. 62
12.11.1. Good Pharmacovigilance Practice (GVP) module IX on signal management – revision 2 .... 62
12.12. Adverse drug reactions reporting and additional reporting .................................. 62
12.12.1. Management and reporting of adverse reactions to medicinal products ........................... 62
12.12.2. Additional monitoring ............................................................................................... 62
12.12.3. List of products under additional monitoring – consultation on the draft list .................... 62
12.13. EudraVigilance database ...................................................................................... 62
Pharmacovigilance Risk Assessment Committee (PRAC)
EMA/PRAC/115322/2026 Page 10/65
12.13.1. Activities related to the confirmation of full functionality ............................................... 62
12.14. Risk management plans and effectiveness of risk minimisations ......................... 62
12.14.1. Risk management systems ....................................................................................... 62
12.14.2. Tools, educational materials and effectiveness measurement of risk minimisations .......... 62
12.15. Post-authorisation safety studies (PASS) ............................................................. 62
12.15.1. Post-authorisation Safety Studies – imposed PASS ...................................................... 62
12.15.2. Post-authorisation Safety Studies – non-imposed PASS ................................................ 63
12.16. Community procedures ......................................................................................... 63
12.16.1. Referral procedures for safety reasons ....................................................................... 63
12.17. Renewals, conditional renewals, annual reassessments ....................................... 63
12.18. Risk communication and transparency ................................................................. 63
12.18.1. Public participation in pharmacovigilance .................................................................... 63
12.18.2. Safety communication .............................................................................................. 63
12.19. Continuous pharmacovigilance ............................................................................. 63
12.19.1. Incident management .............................................................................................. 63
12.20. Impact of pharmacovigilance activities ................................................................ 63
12.21. Others .................................................................................................................. 63
12.21.1. Benzyl alcohol and benzoic acid used as excipients in medicinal products - revised labelling
requirements .......................................................................................................... 63
13. Any other business 63
14. Explanatory notes 64
Pharmacovigilance Risk Assessment Committee (PRAC)
EMA/PRAC/115322/2026 Page 11/65
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 08-11 June
2026. See June 2026 PRAC minutes (to be published post July 2026 PRAC meeting).
1.2. Agenda of the meeting on 08-11 June 2026
Action: For adoption
1.3. Minutes of the previous meeting on 04-07 May 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
None
3.2. Ongoing procedures
None
Pharmacovigilance Risk Assessment Committee (PRAC)
EMA/PRAC/115322/2026 Page 12/65
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. Abemaciclib – VERZENIOS (CAP); palbociclib – IBRANCE (CAP); ribociclib – KISQALI
(CAP)
Applicant: Eli Lilly Nederland B.V. (Verzenios), Novartis Europharm Limited (Kisqali), Pfizer
Europe MA EEIG (Ibrance)
PRAC Rapporteur: To be appointed
Scope: Signal of progressive multifocal leukoencephalopathy (PML)
Action: For adoption of PRAC recommendation
EPITT 20271 – New signal
Lead Member State(s): DK, PT
4.1.2. Atezolizumab – TECENTRIQ (CAP); avelumab – BAVENCIO (CAP); cemiplimab -
LIBTAYO (CAP); dostarlimab – JEMPERLI (CAP); durvalumab – IMFINZI (CAP);
ipilimumab – YERVOY (CAP); nivolumab – OPDIVO (CAP); nivolumab / relatlimab –
OPDUALAG (CAP); pembrolizumab – KEYTRUDA (CAP); retifanlimab – ZYNYZ (CAP);
serplulimab - HETRONIFLY (CAP); sugemalimab – CEJEMLY (CAP); tislelizumab –
TEVIMBRA (CAP); toripalimab – LOQTORZI (CAP); tremelimumab – IMJUDO (CAP)
Applicants: Accord Healthcare S.L.U. (Hetronifly), AstraZeneca AB (Imfinzi, Imjudo), Beone
Medicines Ireland Limited (Tevimbra); Bristol-Myers Squibb Pharma (Opdivo), Bristol-Myers
Squibb Pharma EEIG (Opdualag, Yervoy), Cstone Pharmaceuticals Ireland Limited
(Cejemly), Incyte Biosciences Distribution B.V. (Zynyz), Merck Europe B.V. (Bavencio),
Merck Sharp & Dohme B.V. (Keytruda), Glaxosmithkline Trading Services Limited
(Jemperli), Regeneron Ireland U.C. (Libtayo), Roche Registration GmbH (Tecentriq),
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
Pharmacovigilance Risk Assessment Committee (PRAC)
EMA/PRAC/115322/2026 Page 13/65
Topalliance Biosciences Europe Limited (Loqtorzi)
PRAC Rapporteur: To be appointed
Scope: Signal of acquired haemophilia
Action: For adoption of PRAC recommendation
EPITT 20279 – New signal
Lead Member States: DE, DK, HR, NL, NO, PT, AT
4.1.3. Belzutifan – WELIREG (CAP)
Applicant: Merck Sharp & Dohme B.V.
PRAC Rapporteur: Dennis Lex
Scope: Signal of retinal oedema
Action: For adoption of PRAC recommendation
EPITT 20278 – New signal
Lead Member State(s): DE
4.1.4. Cefpodoxime (NAP)
Applicant: various
PRAC Rapporteur: To be appointed
Scope: Signal of drug interaction between cefpodoxime and proton pump inhibitor (PPIs)
resulting in a potentially reduced efficacy of cefpodoxime
Action: For adoption of PRAC recommendation
EPITT 20280
4.1.5. Lithium (NAP)
Applicants: various
PRAC Rapporteur: To be appointed
Scope: Signal of drug interaction between lithium and GLP-1 agonists leading to increased
lithium levels
Action: For adoption of PRAC recommendation
EPITT 20275 – New signal
Lead Member State: DE
4.1.6. Luspatercept - REBLOZYL (CAP)
Applicant: Bristol-Myers Squibb Pharma EEIG
PRAC Rapporteur: Jo Robays
Pharmacovigilance Risk Assessment Committee (PRAC)
EMA/PRAC/115322/2026 Page 14/65
Scope: Signal of ventilation perfusion mismatch
Action: For adoption of PRAC recommendation
EPITT 20281 – New signal
Lead Member State: BE
4.1.7. Osimertinib - TAGRISSO (CAP)
Applicant: AstraZeneca AB
PRAC Rapporteur: Bianca Mulder
Scope: Signal of pulmonary alveolar haemorrhage
Action: For adoption of PRAC recommendation
EPITT 20284 – New signal
Lead Member State: NL
4.2. Signals follow-up and prioritisation
4.2.1. Darolutamide - NUBEQA (CAP) - EMEA/H/C/004790/SDA/005
Applicant: Bayer AG
PRAC Rapporteur: Jan Neuhauser
Scope: Signal of angioedema
Action: For adoption of PRAC recommendation
EPITT 20237 – Follow-up to January 2026
4.2.2. Gemcitabine (NAP)
Applicant(s): various
PRAC Lead: Jenny Jönsson
Scope: Signal of drug reaction with eosinophilia and systemic symptoms (DRESS)
Action: For adoption
EPITT 20256 – New signal
4.2.3. Valproate (NAP) and related substances3
Applicant(s): various
PRAC Lead: Liana Martirosyan
Scope: Signal of neurodevelopmental disorders with paternal exposure
3 Valproic acid, sodium valproate, valproate semisodium, valpromide,
Pharmacovigilance Risk Assessment Committee (PRAC)
EMA/PRAC/115322/2026 Page 15/65
Action: For adoption
EPITT 20191 – Follow-up to December 2025
4.2.4. Vortioxetine - BRINTELLIX (CAP) - EMEA/H/C/002717/SDA/011
Applicant: H. Lundbeck A/S
PRAC Rapporteur: Jo Robays
Scope: Signal of acute pancreatitis
Action: For adoption
EPITT 20234 – Follow-up to January 2026
4.2.5. X-ray contrast agents: Iobitridol (NAP); Iodixanol (NAP); Iohexol (NAP); Iomeprol
(NAP); Iopamidol (NAP); Iopromide (NAP); Ioversol (NAP); Ioxitalamic acid (NAP)
Applicants: various
PRAC Lead: Pernille Harg
Scope: Signal of fixed drug eruption
Action: For adoption
EPITT 20229 - Follow-up to January 2026
4.2.6. Zolbetuximab - VYLOY (CAP) - EMEA/H/C/005868/SDA/002
Applicant: Astellas Pharma Europe B.V.
PRAC Rapporteur: Bianca Mulder
Scope: Signal of protein-losing gastroenteropathy
Action: For adoption
EPITT 20236 – 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. Glepaglutide - (CAP MAA) - EMEA/H/C/005855
Scope (pre D-180 phase): Treatment of adults with short bowel syndrome
Action: For adoption
Pharmacovigilance Risk Assessment Committee (PRAC)
EMA/PRAC/115322/2026 Page 16/65
5.1.2. Omalizumab (CAP MAA) - EMEA/H/C/006756
Scope (pre D-180 phase): Treatment of asthma, chronic rhinosinusitis with nasal polyps
(CRSwNP) and chronic spontaneous urticaria (CSU)
Action: For adoption
5.1.3. Pegfilgrastim (CAP MAA) - EMEA/H/C/006085
Scope (pre D-180 phase): Reduction of neutropoenia in adults
Action: For adoption
5.1.4. RABIES VIRUS (INACTIVATED) STRAIN WISTAR (PM/WI 38-1503-3M) (CAP MAA) -
EMEA/H/C/006602
Scope (pre D-180 phase): Pre-exposure and post-exposure prophylaxis against rabies in all
age groups
Action: For adoption
5.2. Medicines in the post-authorisation phase – PRAC-led procedures
5.2.1. Bosentan – STAYVEER (CAP); TRACLEER (CAP) – EMA/VR/0000316336
Applicant: Janssen Cilag International
PRAC Rapporteur: Zoubida Amimour
Scope: Submission of an updated RMP version 12 for TRACLEER and STAYVEER to remove
the Liver Safety Update Report (LSUR) as a routine pharmacovigilance activity for the
important identified risk of hepatotoxicity. The Annex II is updated accordingly. In addition,
the MAH is updating the list of safety concerns in line with requests from the PRAC in their
assessment report for procedure PSUSA/00000425/202411.
Action: For adoption
5.2.2. Emtricitabine / Tenofovir disoproxil - EMTRICITABINE/TENOFOVIR DISOPROXIL
ZENTIVA (CAP); NAP – EMA/VR/0000335678
Applicants: 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
Pharmacovigilance Risk Assessment Committee (PRAC)
EMA/PRAC/115322/2026 Page 17/65
5.2.3. Infliximab – REMICADE (CAP) – EMA/VR/0000338953
Applicant: Janssen Cilag International
PRAC Rapporteur: Karin Bolin
Scope: Submission of an updated RMP version 23.1 in order to reduce the planned duration
of follow up in the DEVELOP registry from 20 years to 10 years for all patients currently
active in the registry, which is listed as a category 3 study in the RMP, as well as to introduce
additional changes to the RMP.
Action: For adoption
5.2.4. Lecanemab – LEQEMBI (CAP) – EMA/VR/0000302769
Applicant: Eisai GmbH
PRAC Rapporteur: Eva Jirsová
Scope: Submission of an updated RMP version 1.1 in order to propose an update to PASS
study deadlines. In addition, the MAH has taken the opportunity to update Annex II
accordingly.
Action: For adoption
5.2.5. Loncastuximab tesirine – ZYNLONTA (CAP) – EMA/VR/0000337919
Applicant: Swedish Orphan Biovitrum AB (publ)
PRAC Rapporteur: Eva Jirsová
Scope: Submission of an updated RMP version 3.1 in order to remove the Category 3 study
ADCT-402-107 (LOTIS-10). This is a phase 1b, open-label, non-randomized, dose-escalation
hepatic impairment (HI) study to determine the recommended dosing regimen of
loncastuximab tesirine in patients with moderate and severe HI, with assessment of safety
and pharmacokinetics.
Action: For adoption
5.2.6. Teriflunomide - TERIFLUNOMIDE VIATRIS (CAP), NAP – EMA/VR/0000320266
Applicants: Viatris Limited, various
PRAC Rapporteur: Dennis Lex
Scope: C.I.11.z - to propose an updated RMP to align it with the one from reference product
Aubagio® (teriflunomide) RMP version 9.1, dated 28-Mar-2024 (MAH Sanofi), published by
EMA on 12 June 2024.
Action: For adoption
Pharmacovigilance Risk Assessment Committee (PRAC)
EMA/PRAC/115322/2026 Page 18/65
5.2.7. Tenofovir disoproxil - TENOFOVIR DISOPROXIL ZENTIVA (CAP), NAP –
EMA/VR/0000342258
Applicants: Zentiva k.s., various
PRAC Rapporteur: Zoubida Amimour
Scope: Type IB, C.9.b – to provide an updated RMP update following adoption of the same
changes for the reference product VIREAD RMP during procedure EMAVR0000280825.
Important Identified risks: Renal Toxicity; Bone events due to proximal renal tubulopathy /
loss of bone mineral density and Missing Information: Safety in pregnancy and lactation;
Safety in patients with renal impairment were removed. All Specific adverse reaction follow-
up questionnaires were removed.
Action: For adoption
5.3. Medicines in the post-authorisation phase – CHMP-led procedures
5.3.1. Atogepant – AQUIPTA (CAP) – EMA/VR/0000334780
Applicant: Abbvie Deutschland GmbH & Co. KG
PRAC Rapporteur: Rugile Pilviniene
Scope: Update of section 5.1 of the SmPC in order to update long term safety, tolerability
and efficacy information based on final results from study 3101-312-002 listed as a category
3 study in the RMP; this is a phase 3, multicenter, open-label, 156-week extension study to
evaluate the long-term safety and tolerability of oral atogepant for the prevention of
migraine in participants with chronic or episodic migraine. The RMP version 2.3 has also been
submitted.
Action: For adoption
5.3.2. Concizumab – ALHEMO (CAP) – EMA/VR/0000335954
Applicant: Novo Nordisk A/S
PRAC Rapporteur: Marie Louise Schougaard Christiansen
Scope: Extension of indication to include routine prophylaxis of bleeding in paediatric patients
below 12 years of age with haemophilia A or B with or without inhibitors for ALHEMO, based
on the results from the phase 3 study NN7415-4616; this is an open-label study investigating
efficacy, safety and pharmacokinetics of concizumab prophylaxis in children below 12 years
with haemophilia A or B with or without inhibitors. As a consequence, sections 4.1, 4.2, 4.4,
4.5, 4.6, 4.8, 5.1, 5.2, 5.3 and 6.6 of the SmPC are updated. The Package Leaflet is updated
in accordance. Version 3.1 of the RMP has also been submitted. In addition, the MAH took
the opportunity to introduce minor edits to the PI.
Action: For adoption
Pharmacovigilance Risk Assessment Committee (PRAC)
EMA/PRAC/115322/2026 Page 19/65
5.3.3. COVID-19 vaccine (recombinant, adjuvanted) – BIMERVAX (CAP) –
EMA/VR/0000316063
Applicant: Hipra Human Health S.L.
PRAC Rapporteur: Zane Neikena
Scope: Update of section 4.5 of the SmPC in order to add coadministration information with
seasonal influenza vaccines based on final results from study HIPRA-HH-11. HIPRA-HH-11
was a Phase II randomized, double-blind, multi-centre trial to evaluate the safety and
immunogenicity of BIMERVAX when coadministered with seasonal surface antigen,
inactivated adjuvanted influenza vaccine (SIIV) in adults older than 65 years of age fully
vaccinated against COVID-19. The Package Leaflet is updated accordingly. The RMP version
3.0 is also submitted. In addition, the MAH took the opportunity to introduce minor changes
to the PI.
Action: For adoption
5.3.4. Daratumumab – DARZALEX (CAP) – EMA/VR/0000334930
Applicant: Janssen Cilag International
PRAC Rapporteur: Carla Torre
Scope: Update of section 4.8 of the SmPC in order to add ''Hypotension and Weight
decreased'' to the list of adverse drug reactions (ADRs) with frequency ''Common'' and to
update the description of the Summary of the safety profile to remove influenza of the
serious adverse reactions based on final results from study AMY2009 listed as a category 3
study in the RMP; this is phase 2, a multicenter, prospective study of daratumumab-based
therapy in newly diagnosed patients with Amyloid light-chain (AL) amyloidosis and with pre-
existing Mayo Cardiac Stage II and IIIa cardiac involvement, to further characterize cardiac
adverse effects in terms of incidence, severity, clinical presentation, management, and
outcome, and to identify potential mitigation strategies. The package leaflet is updated
accordingly. The RMP version 13.1 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
5.3.5. Dengue tetravalent vaccine (live, attenuated) – DENGUE TETRAVALENT VACCINE
(LIVE, ATTENUATED) TAKEDA (Art 58); QDENGA (CAP) – EMA/VR/0000323434
Applicant: Takeda Pharmaceuticals International AG Ireland Branch
PRAC Rapporteur: Liana Martirosyan
Scope: Update of sections 4.2, 4.8 and 5.1 of the SmPC in order to update safety and
efficacy information regarding the administration of a booster dose based on the final results
of Part 5 from study DEN-301, listed as a category 3 study in the RMP; this is a Phase III,
double-blind, randomized, placebo-controlled trial to investigate the efficacy, safety and
immunogenicity of a Tetravalent Dengue Vaccine (TDV) administered subcutaneously in
healthy children aged 4–16 years old, investigating a TDV booster dose in the booster phase
(Parts 4 and 5) of the trial. The RMP version 3.3 has also been submitted. In addition, the
Pharmacovigilance Risk Assessment Committee (PRAC)
EMA/PRAC/115322/2026 Page 20/65
MAH took the opportunity to introduce minor formatting changes to the PI and to update the
list of local representatives in the Package Leaflet for Qdenga.
Action: For adoption
5.3.6. Dinutuximab beta – QARZIBA (CAP) – EMA/VR/0000316241
Applicant: Recordati Netherlands B.V.
PRAC Rapporteur: Dirk Mentzer
Scope: A grouped application, comprised of the following variations:
C.I.4: Update of sections 4.8 and 5.1 of the SmPC to introduce changes based on the final
results from study APN311-304; this is a Phase II, interventional, single-arm, open-label
study evaluating the anti-tumor activity and safety of dinutuximab beta (ch14.18/CHO)
continuous infusion in pediatric patients with primary refractory or relapsed neuroblastoma.
The Package Leaflet has been updated accordingly.
C.I.4: Update of sections 4.8 and 5.1 of the SmPC to introduce changes based on the final
results from study APN311-202 V1/V2; this is a Phase I/II, interventional, multi-center,
open-label study evaluating the tolerability, immunomodulatory efficacy, and anti-tumor
activity of dinutuximab beta (ch14.18/CHO) administered as prolonged continuous infusion in
combination with subcutaneous aldesleukin (IL-2) in pediatric patients with primary
refractory or relapsed neuroblastoma. The Package Leaflet has been updated accordingly.
C.I.13: Submission of final results from study APN 311-201. This is a Phase II feasibility
study using ch14.18/CHO antibody and subcutaneous interleukin 2 after haploidentical stem
cell transplantation in children with relapsed neuroblastoma.
The RMP version 10.1 has also been submitted. In addition, the MAH took the opportunity to
introduce changes to the PI for completion and to update excipient wording for polysorbates.
Action: For adoption
5.3.7. 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
Pharmacovigilance Risk Assessment Committee (PRAC)
EMA/PRAC/115322/2026 Page 21/65
5.3.8. Ertugliflozin – STEGLATRO (CAP) – EMA/VR/0000335920
Applicant: Merck Sharp & Dohme B.V.
PRAC Rapporteur: Bianca Mulder
Scope: Extension of indication to include treatment of new paediatric population aged 10
years and older for STEGLATRO, based on final results from paediatric study study MK-8835-
P059/B1521066 (P059). This is a randomised, double-blind, placebo-controlled trial to
evaluate the safety and efficacy of two doses of ertugliflozin in paediatric patients from 10
years to less than 18 years of age with type 2 diabetes mellitus and inadequate glycaemic
control on metformin therapy, ± insulin. 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 2.5 of
the RMP has also been submitted. In addition, the Marketing authorisation holder took the
opportunity to implement minor editorial/formatting corrections.
Action: For adoption
5.3.9. 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
5.3.10. Gemtuzumab ozogamicin – MYLOTARG (CAP) – EMA/VR/0000304835
Applicant: Pfizer Europe MA EEIG
PRAC Rapporteur: Carla Torre
Scope: Extension of indication to include, in combination with mitoxantrone and cytarabine
(AraC), the treatment of paediatric patients aged 1 year to less than 18 years with newly
diagnosed CD33-positive acute myeloid leukaemia (AML), except acute promyelocytic
leukaemia (APL) for MYLOTARG, based on results from study MyeChild 01 (WI203680). This
is a Phase 3, randomised, open-label, multicenter study incorporating an embedded dose
finding study in children with newly diagnosed AML/high risk MDS /isolated myeloid sarcoma
(de novo or secondary). 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 2.3 of the RMP has also
been submitted. In addition, the Marketing authorisation holder (MAH) took the opportunity
to introduce minor editorial changes to the PI and to update the list of local representatives
in the Package Leaflet.
Action: For adoption
Pharmacovigilance Risk Assessment Committee (PRAC)
EMA/PRAC/115322/2026 Page 22/65
5.3.11. Guanfacine – INTUNIV (CAP) – EMA/VR/0000334464
Applicant: Takeda Pharmaceuticals International AG Ireland Branch
PRAC Rapporteur: Maria del Pilar Rayon
Scope: Update of section 5.1 of the SmPC in order to update long term efficacy and safety
information based on final results from study SPD503˗401 listed as a specific obligation in
Annex II; this is an interventional, a phase 4, long-term safety and efficacy study comprising
a randomized, double-blind, parallel-group, placebo-controlled, active-comparator phase
followed by an open-label phase conducted in children and adolescents aged 6 to 17 years
with ADHD to assess long term safety of guanfacine; the Package Leaflet and Annex II of
the PI are updated accordingly. The RMP version 5.0 has also been submitted. In addition,
the MAH took the opportunity to introduce editorial changes to the PI.
Action: For adoption
5.3.12. Ivacaftor / Tezacaftor / Elexacaftor – KAFTRIO (CAP) – EMA/VR/0000320413
Applicant: Vertex Pharmaceuticals (Ireland) Limited
PRAC Rapporteur: Dennis Lex
Scope: Submission of Part A (week 96) clinical study report for study VX21-445-125 (study
125). This is a Phase 3, open-label study to evaluate the long-term safety, tolerability,
efficacy, and pharmacodynamics of elexacaftor/tezacaftor/ivacaftor (ELX/TEZ/IVA) in cystic
fibrosis (CF) subjects ≥6 years of age who have qualifying non-F508del ELX/TEZ/IVA-
responsive CFTR mutations. RMP version 10.3 has also been submitted.
Action: For adoption
5.3.13. Meningococcal Group A, C, W and Y conjugate vaccine – MENQUADFI (CAP) –
EMA/VR/0000281377
Applicant: Sanofi Winthrop Industrie
PRAC Rapporteur: Jean-Michel Dogné
Scope: Extension of indication for MENQUADFI to include the active immunisation of patients
from 6 weeks of age based on final results from study MET58 and additional supportive
clinical studies. Study MET58 is a Phase 3, immunogenicity and Safety Study of an
Investigational Quadrivalent Meningococcal Conjugate Vaccine when Administered
Concomitantly with Routine Pediatric Vaccines in Healthy Infants and Toddlers in Europe. As
a consequence, sections 4.1, 4.2, 4.5, 4.8 and 5.1 of the SmPC are updated. The Package
Leaflet is updated in accordance. An updated Risk Management Plan (RMP) version 4.0 is also
included.
Action: For adoption
5.3.14. Methylphenidate hydrochloride – TUZULBY (CAP) – EMA/X/0000327555
Applicant: Neuraxpharm Pharmaceuticals S.L.
PRAC Rapporteur: Dennis Lex
Pharmacovigilance Risk Assessment Committee (PRAC)
EMA/PRAC/115322/2026 Page 23/65
Scope: Extension application to introduce a new pharmaceutical form associated with new
strength (5 mg/ml powder for prolonged-release oral suspension).
The RMP version 1.1 is updated in accordance.
Action: For adoption
5.3.15. Mirabegron – BETMIGA (CAP) – EMA/VR/0000327362
Applicant: Astellas Pharma Europe B.V.
PRAC Rapporteur: Maria del Pilar Rayon
Scope: A grouped application comprised of a Type IB and a Type II variation, as follows:
Type IB (C.7.a): To delete the Betmiga 8 mg/ml granules for prolonged-release oral
suspension from the Betmiga marketing authorisation (EU/1/12/809/019, EU/1/12/809/020)
Type II (C.6.a): To modify the approved therapeutic indication for neurogenic detrusor
overactivity (NDO) to patients less than 18 years of age, weighing 35 kg or more. The
updated indication aligns the weight criteria for children with the remaining tablet posology.
Consequently, sections 4.1, 4.2 and 5.2 of the SmPC are updated. The Package Leaflet is
updated accordingly. The RMP version 9.3 has been submitted. In addition, the MAH took the
opportunity to introduce additional changes to the PI.
Action: For adoption
5.3.16. Nivolumab / Relatlimab – OPDUALAG (CAP) – EMA/VR/0000339077
Applicant: Bristol-Myers Squibb Pharma EEIG
PRAC Rapporteur: Dirk Mentzer
Scope: Update of sections 4.4 and 4.8 of the SmPC in order to revise the wording regarding
Stevens-Johnson Syndrome and Toxic Epidermal Necrolysis; and to add ''Stevens-Johnson
Syndrome and Toxic Epidermal Necrolysis'' to the list of adverse drug reactions (ADRs) with
frequency ''Uncommon'' based on postmarketing data and literature; the Package Leaflet is
updated accordingly. The RMP version 6.0 has also been submitted.
Action: For adoption
5.3.17. Ocrelizumab – OCREVUS (CAP) – EMA/VR/0000309389
Applicant: Roche Registration GmbH
PRAC Rapporteur: Dirk Mentzer
Scope: Extension of indication to include treatment of paediatric patients aged 10 years and
older with relapsing remitting multiple sclerosis (RRMS) for OCREVUS, based on primary
analysis results from the pivotal phase III study (WN42086/Operetta 2) and primary and
updated results from a supportive phase II study (WA39085/Operetta 1). Operetta 1 is an
open-label, parallel-group, dose-finding Phase II study to determine the dosing regimen of
ocrelizumab to be further investigated in Operetta 2, and Operetta 2 is a Phase III,
randomized, double-blind, double-dummy, parallel-group, multicenter, non-inferiority study
Pharmacovigilance Risk Assessment Committee (PRAC)
EMA/PRAC/115322/2026 Page 24/65
to evaluate the efficacy and safety of intravenous ocrelizumab in comparison with fingolimod.
As a consequence, sections 2, 4.1, 4.2, 4.4, 4.5, 4.6, 4.8, 5.1, 5.2 and 6.6 of the SmPC are
updated. The Package Leaflet is updated in accordance. Version 15.0 of the RMP has also
been submitted. In addition, the Marketing authorisation holder (MAH) took the opportunity
to introduce updates to other sections of the SmPC and PL as per previous procedures
linguistic review comments (sodium, pH and osmolality), updates to comply with the
Excipient Guideline (polysorbates), changes to the list of local representatives in the Package
Leaflet, as well as editorial and clarification changes to the PI.
Action: For adoption
5.3.18. 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
5.3.19. Olezarsen – TRYNGOLZA (CAP) – EMA/VR/0000336189
Applicant: Swedish Orphan Biovitrum AB (publ)
PRAC Rapporteur: Kimmo Jaakkola
Scope: Extension of indication to include treatment of adult patients with severe
hypertriglyceridemia for Tryngolza, based on final results from phase 3 studies ISIS 678354-
CS5 (CORE), ISIS 678354-CS6 (CORE2) and ISIS 678354-CS9; and open-label extension
study ISIS 678354-CS15. 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 1.1 of the RMP has
also been submitted. In addition, the MAH took the opportunity to bring the PI in line with
the latest QRD template version 10.4. As part of the application, the MAH is requesting a 1-
year extension of the market protection.
Action: For adoption
5.3.20. Omaveloxolone – SKYCLARYS (CAP) – EMA/VR/0000296476
Applicant: Biogen Netherlands B.V.
PRAC Rapporteur: Amelia Cupelli
Scope: Update of section 5.3 of the SmPC in order to update preclinical information based on
results from study RTA-P-21070: this is a 104-week once daily oral gavage toxicity and
toxicokinetic study with RTA 408 in rats. The RMP version 2.0 has also been submitted.
Action: For adoption
Pharmacovigilance Risk Assessment Committee (PRAC)
EMA/PRAC/115322/2026 Page 25/65
5.3.21. Palbociclib – IBRANCE (CAP) – EMA/VR/0000316536
Applicant: Pfizer Europe MA EEIG
PRAC Rapporteur: Marie Louise Schougaard Christiansen
Scope: Extension of indication to include, in combination with anti-HER2 and endocrine
therapies, the maintenance treatment of adult patients with HR-positive, HER2-positive
locally advanced or metastatic breast cancer (MBC) following induction treatment for
IBRANCE, based on the interim results from the open-label Phase 3 study PATINA (AFT-
38/WI215662). This is a randomized, open-label Phase 3 study evaluating the efficacy and
safety of IBRANCE (palbociclib) in combination with anti-HER2 therapy and endocrine therapy
compared to anti-HER2 therapy and endocrine therapy alone as a first-line maintenance
therapy (following induction chemotherapy treatment) for patients with HR positive, HER2-
positive MBC. As a consequence, sections 4.1, 4.2, 4.4, 4.5, 4.8 and 5.1 of the SmPC are
updated. The Package Leaflet is updated in accordance. RMP version 1.10 has also been
submitted.
Action: For adoption
5.3.22. Pembrolizumab – KEYTRUDA (CAP) – EMA/VR/0000336194
Applicant: Merck Sharp & Dohme B.V.
PRAC Rapporteur: Bianca Mulder
Scope: Extension of indication to include KEYTRUDA, in combination with enfortumab
vedotin, 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 54.1 of the
RMP is submitted, to reflect the updated data.
Action: For adoption
5.3.23. Pirtobrutinib – JAYPIRCA (CAP) – EMA/VR/0000316267
Applicant: Eli Lilly Nederland B.V.
PRAC Rapporteur: Bianca Mulder
Scope: Extension of indication to include treatment of adult patients with chronic lymphocytic
leukaemia (CLL) for JAYPIRCA, based on interim results from studies LOXO-BTK-20023
(BRUIN-CLL-313) and LOXO-BTK-20030 (BRUIN-CLL-314). Study 20023 is a phase 3 open-
label, randomized study of pirtobrutinib (LOXO-305) versus bendamustine plus rituximab in
untreated patients with CLL/SLL. Study 20030 is a phase 3 open-label, randomized study of
pirtobrutinib (LOXO-305) versus ibrutinib in patients with CLL/SLL. As a consequence,
sections 4.1, 4.8, 5.1, and 5.2 of the SmPC are updated. The Package Leaflet is updated in
accordance. Version 4.1 of the RMP has also been submitted.
Pharmacovigilance Risk Assessment Committee (PRAC)
EMA/PRAC/115322/2026 Page 26/65
Action: For adoption
5.3.24. 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
5.3.25. Rimegepant – VYDURA (CAP) – EMA/VR/0000339929
Applicant: Pfizer Europe MA EEIG
PRAC Rapporteur: Karin Erneholm
Scope: Update of sections 4.2, 4.4, 4.8 and 5.1 of the SmPC in order to introduce an every
day (QD) posology regimen for prophylaxis of migraine and to amend an existing warning on
medication overuse headache (MOH), as well as to update clinical safety and efficacy
information based on results from studies C4951010 and C4951011. Study C4951010 is a
phase 4 randomized, double-blind, placebo-controlled study to evaluate the efficacy and
safety of rimegepant in episodic migraine prevention with multiple dosing regimens, while
study C4951011 is a phase 4, open-label study to evaluate the safety and tolerability of daily
dosing of rimegepant in episodic migraine prevention. The Package Leaflet is updated
accordingly. The RMP version 1.1 has also been submitted.
Action: For adoption
5.3.26. Ruxolitinib – OPZELURA (CAP) – EMA/VR/0000313318
Applicant: Incyte Biosciences Distribution B.V.
PRAC Rapporteur: Adam Przybylkowski
Scope: Extension of indication to include treatment of moderate atopic dermatitis in adult
patients who are inadequately controlled with, have a contraindication to, or are intolerant to
topical corticosteroids and topical calcineurin inhibitors for OPZELURA, based on the results of
the pivotal Phase III study INCB 18424-326 and the two supportive Phase III studies INCB
18424-303 and INCB 18424-304. INCB 18424-326 is a Phase 3b, double-blind, multicenter,
randomized, vehicle-controlled, efficacy, and safety study of ruxolitinib cream in adults with
moderate atopic dermatitis. As a consequence, sections 4.1, 4.2, 4.5, 4.8, 5.1, 5.2 and 5.3 of
the SmPC are updated. The Package Leaflet is updated in accordance. Version 1.0 of the RMP
has also been submitted.
Action: For adoption
Pharmacovigilance Risk Assessment Committee (PRAC)
EMA/PRAC/115322/2026 Page 27/65
5.3.27. Sotorasib – LUMYKRAS (CAP) – EMA/VR/0000339051
Applicant: Amgen Europe B.V.
PRAC Rapporteur: Marie Louise Schougaard Christiansen
Scope: To update Annex II and the RMP to request an 18-month extension of the due dates
for the Specific Obligation (SOB) SOB2 related to the Phase 3 Study 20190341.
Action: For adoption
5.3.28. Teclistamab – TECVAYLI (CAP) – EMA/VR/0000336274
Applicant: Janssen Cilag International
PRAC Rapporteur: Veronika Macurova
Scope: Extension of indication to include treatment of adult patients with relapsed or
refractory multiple myeloma who have received at least one prior therapy, for TECVAYLI as
monotherapy, based on interim analysis data from the pivotal study 64007957MMY3006
(MajesTEC-9). This is a Phase 3 randomized study comparing teclistamab monotherapy
versus pomalidomide, bortezomib, dexamethasone (PVd) or carfilzomib, dexamethasone (Kd)
in participants with relapsed or refractory multiple myeloma who have received 1 to 3 prior
lines of therapy, including an anti-CD38 monoclonal antibody and lenalidomide. As a
consequence, sections 4.1, 4.2, 4.4, 4.5, 4.8, 5.1, 5.2 and 6.6 of the SmPC are updated. The
Labelling and Package Leaflet are updated accordingly. The RMP version 6.2 has also been
submitted. In addition, the MAH took the opportunity to introduce editorial changes to the PI
and to update the list of local representatives in the Package Leaflet.
Action: For adoption
5.3.29. Tezepelumab – TEZSPIRE (CAP) – EMA/VR/0000321455
Applicant: AstraZeneca AB
PRAC Rapporteur: Eva Jirsová
Scope: Grouped application comprised of two Type II Variations, as follows:
C.I.13: Submission of the report from study D5180C00024 (SUNRISE) listed as a category 3
study in the RMP. This is a randomised, double-blind, parallel-group, placebo-controlled 28-
week phase 3 efficacy and safety study of tezepelumab in reducing oral corticosteroid use in
adults with oral corticosteroid dependent asthma. The RMP version 7 has also been updated
accordingly.
C.I.11: Submission of an updated RMP version 7 in order to add study D5241C00006
(EMBARK) and study D5241C00007 (JOURNEY) as additional pharmacovigilance activities to
further characterize the important potential risks: “Serious infections” and “Malignancies”.
Action: For adoption
5.3.30. Tucatinib – TUYSA (CAP) – EMA/VR/0000337235
Applicant: Pfizer Europe MA EEIG
Pharmacovigilance Risk Assessment Committee (PRAC)
EMA/PRAC/115322/2026 Page 28/65
PRAC Rapporteur: Jean-Michel Dogné
Scope: Extension of indication to include in combination with trastuzumab and pertuzumab
for the maintenance treatment of adult patients with unresectable locally advanced or
metastatic HER2-positive breast cancer based on final results from Study H2C05. This is a
Phase 3, global,randomized, double-blind, placebo-controlled study of tucatinib vs placebo in
combination with trastuzumab and pertuzumab as maintenance therapy in participants with
advanced HER2+ breast cancer who had last received trastuzumab, pertuzumab, and a
taxane with no evidence of progression. 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 3.0 of the RMP
has also been submitted. As part of the application the MAH is requesting a 1-year extension
of the market protection.
Action: For adoption
6. Periodic safety update reports (PSURs)
6.1. PSUR single assessment (PSUSA) procedures including centrally
authorised products (CAPs) only
6.1.1. Acalabrutinib – CALQUENCE (CAP) – EMA/PSUR/0000327904
Applicant: AstraZeneca AB
PRAC Rapporteur: Barbara Kovacic Bytyqi
Scope: Evaluation of a PSUSA procedure (PSUSA/00010887/202510)
Action: For adoption
6.1.2. Acoramidis – BEYONTTRA (CAP) – EMA/PSUR/0000327953
Applicant: Bayer AG
PRAC Rapporteur: Rhea Fitzgerald
Scope: Evaluation of a PSUSA procedure (PSUSA/00011106/202511)
Action: For adoption
6.1.3. Andexanet alfa – ONDEXXYA (CAP) – EMA/PSUR/0000327908
Applicant: AstraZeneca AB
PRAC Rapporteur: Bianca Mulder
Scope: Evaluation of a PSUSA procedure (PSUSA/00010764/202510)
Action: For adoption
Pharmacovigilance Risk Assessment Committee (PRAC)
EMA/PRAC/115322/2026 Page 29/65
6.1.4. Avacopan – TAVNEOS (CAP) – EMA/PSUR/0000327958
Applicant: Vifor Fresenius Medical Care Renal Pharma France
PRAC Rapporteur: Liana Martirosyan
Scope: Evaluation of a PSUSA procedure (PSUSA/00010967/202509)
Action: For adoption
6.1.5. Axicabtagene ciloleucel – YESCARTA (CAP) – EMA/PSUR/0000327951
Applicant: Kite Pharma EU B.V., ATMP
PRAC Rapporteur: Karin Erneholm
Scope: Evaluation of a PSUSA procedure (PSUSA/00010703/202510)
Action: For adoption
6.1.6. Aztreonam / Avibactam – EMBLAVEO (CAP) – EMA/PSUR/0000327924
Applicant: Pfizer Europe MA EEIG
PRAC Rapporteur: Lina Seibokiene
Scope: Evaluation of a PSUSA procedure (PSUSA/00011055/202510)
Action: For adoption
6.1.7. Belantamab mafodotin – BLENREP (CAP) – EMA/PSUR/0000327952
Applicant: Glaxosmithkline Trading Services Limited
PRAC Rapporteur: Jenny-Maria Jönsson
Scope: Evaluation of a PSUSA procedure (PSUSA/00010869/202510)
Action: For adoption
6.1.8. Beremagene geperpavec – VYJUVEK (CAP) – EMA/PSUR/0000327959
Applicant: Krystal Biotech Netherlands B.V., ATMP
PRAC Rapporteur: Liana Martirosyan
Scope: Evaluation of a PSUSA procedure (PSUSA/00011131/202511)
Action: For adoption
6.1.9. Bevacizumab gamma – LYTENAVA (CAP) – EMA/PSUR/0000327928
Applicant: Outlook Therapeutics NL B.V.
PRAC Rapporteur: Karin Erneholm
Pharmacovigilance Risk Assessment Committee (PRAC)
EMA/PRAC/115322/2026 Page 30/65
Scope: Evaluation of a PSUSA procedure (PSUSA/00011065/202511)
Action: For adoption
6.1.10. Bezlotoxumab – ZINPLAVA (CAP) – EMA/PSUR/0000327891
Applicant: Merck Sharp & Dohme B.V.
PRAC Rapporteur: Adam Przybylkowski
Scope: Evaluation of a PSUSA procedure (PSUSA/00010576/202510)
Action: For adoption
6.1.11. Bupivacaine – EXPAREL LIPOSOMAL (CAP) – EMA/PSUR/0000327916
Applicant: Pacira Ireland Limited
PRAC Rapporteur: Eamon O Murchu
Scope: Evaluation of a PSUSA procedure (PSUSA/00010889/202510)
Action: For adoption
6.1.12. Capivasertib – TRUQAP (CAP) – EMA/PSUR/0000327927
Applicant: AstraZeneca AB
PRAC Rapporteur: Sonja Radowan
Scope: Evaluation of a PSUSA procedure (PSUSA/00011061/202511)
Action: For adoption
6.1.13. Ceritinib – ZYKADIA (CAP) – EMA/PSUR/0000327894
Applicant: Novartis Europharm Limited
PRAC Rapporteur: Jenny-Maria Jönsson
Scope: Evaluation of a PSUSA procedure (PSUSA/00010372/202510)
Action: For adoption
6.1.14. Chikungunya vaccine (live) – IXCHIQ (CAP) – EMA/PSUR/0000327923
Applicant: Valneva Austria GmbH
PRAC Rapporteur: Dirk Mentzer
Scope: Evaluation of a PSUSA procedure (PSUSA/00011058/202511)
Action: For adoption
Pharmacovigilance Risk Assessment Committee (PRAC)
EMA/PRAC/115322/2026 Page 31/65
6.1.15. Conestat alfa – RUCONEST (CAP) – EMA/PSUR/0000327863
Applicant: Pharming Group N.V.
PRAC Rapporteur: Jan Neuhauser
Scope: Evaluation of a PSUSA procedure (PSUSA/00000873/202510)
Action: For adoption
6.1.16. COVID-19 mRNA vaccine – KOSTAIVE (CAP) – EMA/PSUR/0000327932
Applicant: Seqirus Netherlands B.V.
PRAC Rapporteur: Dirk Mentzer
Scope: Evaluation of a PSUSA procedure (PSUSA/00011115/202511)
Action: For adoption
6.1.17. Delamanid – DELTYBA (CAP) – EMA/PSUR/0000327880
Applicant: Otsuka Novel Products GmbH
PRAC Rapporteur: Jo Robays
Scope: Evaluation of a PSUSA procedure (PSUSA/00010213/202510)
Action: For adoption
6.1.18. Dinutuximab beta – QARZIBA (CAP) – EMA/PSUR/0000327902
Applicant: Recordati Netherlands B.V.
PRAC Rapporteur: Dirk Mentzer
Scope: Evaluation of a PSUSA procedure (PSUSA/00010597/202511)
Action: For adoption
6.1.19. Dopamine hydrochloride – NEOATRICON (CAP) – EMA/PSUR/0000327930
Applicant: BrePco Biopharma Limited
PRAC Rapporteur: Maia Uusküla
Scope: Evaluation of a PSUSA procedure (PSUSA/00011066/202511)
Action: For adoption
6.1.20. Eculizumab – BEKEMV (CAP); EPYSQLI (CAP); SOLIRIS (CAP) –
EMA/PSUR/0000327869
Applicant: Alexion Europe
PRAC Rapporteur: Maria Martinez Gonzalez
Pharmacovigilance Risk Assessment Committee (PRAC)
EMA/PRAC/115322/2026 Page 32/65
Scope: Evaluation of a PSUSA procedure (PSUSA/00001198/202510)
Action: For adoption
6.1.21. Etranacogene dezaparvovec – HEMGENIX (CAP) – EMA/PSUR/0000327921
Applicant: CSL Behring GmbH, ATMP
PRAC Rapporteur: Bianca Mulder
Scope: Evaluation of a PSUSA procedure (PSUSA/00011037/202511)
Action: For adoption
6.1.22. Exagamglogene autotemcel – CASGEVY (CAP) – EMA/PSUR/0000327950
Applicant: Vertex Pharmaceuticals (Ireland) Limited, ATMP
PRAC Rapporteur: Bianca Mulder
Scope: Evaluation of a PSUSA procedure (PSUSA/00000244/202511)
Action: For adoption
6.1.23. Hydrocortisone – EFMODY (CAP); PLENADREN (CAP) – EMA/PSUR/0000327910
Applicant: Takeda Pharmaceuticals International AG Ireland Branch
PRAC Rapporteur: Karin Bolin
Scope: Evaluation of a PSUSA procedure (PSUSA/00009176/202511)
Action: For adoption
6.1.24. Insulin degludec / Liraglutide – XULTOPHY (CAP) – EMA/PSUR/0000327890
Applicant: Novo Nordisk A/S
PRAC Rapporteur: Bianca Mulder
Scope: Evaluation of a PSUSA procedure (PSUSA/00010272/202509)
Action: For adoption
6.1.25. Irinotecan hydrochloride trihydrate – ONIVYDE PEGYLATED LIPOSOMAL (CAP) –
EMA/PSUR/0000327915
Applicant: Les Laboratoires Servier
PRAC Rapporteur: David Olsen
Scope: Evaluation of a PSUSA procedure (PSUSA/00010534/202510)
Action: For adoption
Pharmacovigilance Risk Assessment Committee (PRAC)
EMA/PRAC/115322/2026 Page 33/65
6.1.26. Ivacaftor / Tezacaftor / Elexacaftor – KAFTRIO (CAP) – EMA/PSUR/0000327903
Applicant: Vertex Pharmaceuticals (Ireland) Limited
PRAC Rapporteur: Dennis Lex
Scope: Evaluation of a PSUSA procedure (PSUSA/00010868/202510)
Action: For adoption
6.1.27. Larotrectinib – VITRAKVI (CAP) – EMA/PSUR/0000327912
Applicant: Bayer AG
PRAC Rapporteur: Rugile Pilviniene
Scope: Evaluation of a PSUSA procedure (PSUSA/00010799/202511)
Action: For adoption
6.1.28. Latanoprost – CATIOLANZE (CAP) – EMA/PSUR/0000327866
Applicant: Santen Oy
PRAC Rapporteur: Jean-Michel Dogné
Scope: Evaluation of a PSUSA procedure (PSUSA/00000202/202511)
Action: For adoption
6.1.29. Lazertinib – LAZCLUZE (CAP) – EMA/PSUR/0000327949
Applicant: Janssen Cilag International
PRAC Rapporteur: Petar Mas
Scope: Evaluation of a PSUSA procedure (PSUSA/00011110/202511)
Action: For adoption
6.1.30. Linvoseltamab – LYNOZYFIC (CAP) – EMA/PSUR/0000327948
Applicant: Regeneron Ireland Designated Activity Company
PRAC Rapporteur: Veronika Macurova
Scope: Evaluation of a PSUSA procedure (PSUSA/00011130/202510)
Action: For adoption
6.1.31. Lonafarnib – ZOKINVY (CAP) – EMA/PSUR/0000327913
Applicant: TMC Pharma (EU) Limited
PRAC Rapporteur: Adam Przybylkowski
Pharmacovigilance Risk Assessment Committee (PRAC)
EMA/PRAC/115322/2026 Page 34/65
Scope: Evaluation of a PSUSA procedure (PSUSA/00011005/202511)
Action: For adoption
6.1.32. Loncastuximab tesirine – ZYNLONTA (CAP) – EMA/PSUR/0000327917
Applicant: Swedish Orphan Biovitrum AB (publ)
PRAC Rapporteur: Eva Jirsová
Scope: Evaluation of a PSUSA procedure (PSUSA/00011027/202510)
Action: For adoption
6.1.33. Mercaptamine – PROCYSBI (CAP); Mercaptamine bitartrate – CYSTAGON (CAP) –
EMA/PSUR/0000327901
Applicant: Recordati Rare Diseases
PRAC Rapporteur: Maria Martinez Gonzalez
Scope: Evaluation of a PSUSA procedure (PSUSA/00010573/202510)
Action: For adoption
6.1.34. Mirvetuximab soravtansine – ELAHERE (CAP) – EMA/PSUR/0000327931
Applicant: Abbvie Deutschland GmbH & Co. KG
PRAC Rapporteur: Maria del Pilar Rayon
Scope: Evaluation of a PSUSA procedure (PSUSA/00011097/202511)
Action: For adoption
6.1.35. Nintedanib – OFEV (CAP) – EMA/PSUR/0000327881
Applicant: Boehringer Ingelheim International GmbH
PRAC Rapporteur: Barbara Kovacic Bytyqi
Scope: Evaluation of a PSUSA procedure (PSUSA/00010319/202510)
Action: For adoption
6.1.36. Nintedanib – VARGATEF (CAP) – EMA/PSUR/0000327882
Applicant: Boehringer Ingelheim International GmbH
PRAC Rapporteur: Georgia Gkegka
Scope: Evaluation of a PSUSA procedure (PSUSA/00010318/202510)
Action: For adoption
Pharmacovigilance Risk Assessment Committee (PRAC)
EMA/PRAC/115322/2026 Page 35/65
6.1.37. Niraparib / Abiraterone acetate – AKEEGA (CAP) – EMA/PSUR/0000327922
Applicant: Janssen Cilag International
PRAC Rapporteur: Jan Neuhauser
Scope: Evaluation of a PSUSA procedure (PSUSA/00011051/202510)
Action: For adoption
6.1.38. Nirogacestat – OGSIVEO (CAP) – EMA/PSUR/0000327941
Applicant: Merck Europe B.V.
PRAC Rapporteur: Terhi Lehtinen
Scope: Evaluation of a PSUSA procedure (PSUSA/00011163/202511)
Action: For adoption
6.1.39. Obecabtagene autoleucel – AUCATZYL (CAP) – EMA/PSUR/0000327934
Applicant: Autolus GmbH, ATMP
PRAC Rapporteur: Karin Erneholm
Scope: Evaluation of a PSUSA procedure (PSUSA/00011160/202511)
Action: For adoption
6.1.40. Palopegteriparatide – YORVIPATH (CAP) – EMA/PSUR/0000327865
Applicant: Ascendis Pharma Bone Diseases A/S
PRAC Rapporteur: Lina Seibokiene
Scope: Evaluation of a PSUSA procedure (PSUSA/00000173/202511)
Action: For adoption
6.1.41. Pandemic influenza vaccine (H5N1) (live attenuated, nasal) – PANDEMIC
INFLUENZA VACCINE H5N1 ASTRAZENECA (CAP) – EMA/PSUR/0000327887
Applicant: AstraZeneca AB
PRAC Rapporteur: Sonja Radowan
Scope: Evaluation of a PSUSA procedure (PSUSA/00010501/202511)
Action: For adoption
6.1.42. Panitumumab – VECTIBIX (CAP) – EMA/PSUR/0000327879
Applicant: Amgen Europe B.V.
PRAC Rapporteur: David Olsen
Pharmacovigilance Risk Assessment Committee (PRAC)
EMA/PRAC/115322/2026 Page 36/65
Scope: Evaluation of a PSUSA procedure (PSUSA/00002283/202509)
Action: For adoption
6.1.43. Parathyroid hormone – NATPAR (CAP) – EMA/PSUR/0000327892
Applicant: Takeda Pharmaceuticals International AG Ireland Branch
PRAC Rapporteur: Rhea Fitzgerald
Scope: Evaluation of a PSUSA procedure (PSUSA/00010591/202510)
Action: For adoption
6.1.44. Pegcetacoplan – ASPAVELI (CAP) – EMA/PSUR/0000327907
Applicant: Swedish Orphan Biovitrum AB (publ)
PRAC Rapporteur: Kimmo Jaakkola
Scope: Evaluation of a PSUSA procedure (PSUSA/00010974/202511)
Action: For adoption
6.1.45. Piperaquine tetraphosphate / Artenimol – EURARTESIM (CAP) –
EMA/PSUR/0000327942
Applicant: Alfasigma S.p.A.
PRAC Rapporteur: Dennis Lex
Scope: Evaluation of a PSUSA procedure (PSUSA/00001069/202510)
Action: For adoption
6.1.46. Prucalopride – RESOLOR (CAP) – EMA/PSUR/0000327877
Applicant: Takeda Pharmaceuticals International AG Ireland Branch
PRAC Rapporteur: Karin Bolin
Scope: Evaluation of a PSUSA procedure (PSUSA/00002568/202510)
Action: For adoption
6.1.47. rADAMTS13 – ADZYNMA (CAP) – EMA/PSUR/0000327926
Applicant: Takeda Manufacturing Austria AG
PRAC Rapporteur: Maia Uusküla
Scope: Evaluation of a PSUSA procedure (PSUSA/00011077/202511)
Action: For adoption
Pharmacovigilance Risk Assessment Committee (PRAC)
EMA/PRAC/115322/2026 Page 37/65
6.1.48. Raltegravir – ISENTRESS (CAP) – EMA/PSUR/0000327884
Applicant: Merck Sharp & Dohme B.V.
PRAC Rapporteur: Zoubida Amimour
Scope: Evaluation of a PSUSA procedure (PSUSA/00010373/202509)
Action: For adoption
6.1.49. Ranibizumab – BYOOVIZ (CAP); EPRUVY (CAP); LUCENTIS (CAP); RANIVISIO
(CAP); RIMMYRAH (CAP); XIMLUCI (CAP) – EMA/PSUR/0000327906
Applicant: Novartis Europharm Limited
PRAC Rapporteur: Karin Bolin
Scope: Evaluation of a PSUSA procedure (PSUSA/00002609/202510)
Action: For adoption
6.1.50. RdESAT-6 / rCFP-10 – SIILTIBCY (CAP) – EMA/PSUR/0000327947
Applicant: Serum Life Science Europe GmbH
PRAC Rapporteur: Sonja Radowan
Scope: Evaluation of a PSUSA procedure (PSUSA/00011104/202511)
Action: For adoption
6.1.51. Repotrectinib – AUGTYRO (CAP) – EMA/PSUR/0000327933
Applicant: Bristol-Myers Squibb Pharma EEIG
PRAC Rapporteur: Barbara Kovacic Bytyqi
Scope: Evaluation of a PSUSA procedure (PSUSA/00011102/202511)
Action: For adoption
6.1.52. Selpercatinib – RETSEVMO (CAP) – EMA/PSUR/0000327889
Applicant: Eli Lilly Nederland B.V.
PRAC Rapporteur: Bianca Mulder
Scope: Evaluation of a PSUSA procedure (PSUSA/00010917/202511)
Action: For adoption
6.1.53. Setmelanotide – IMCIVREE (CAP) – EMA/PSUR/0000327886
Applicant: Rhythm Pharmaceuticals Netherlands B.V.
PRAC Rapporteur: Miroslava Gocova
Pharmacovigilance Risk Assessment Committee (PRAC)
EMA/PRAC/115322/2026 Page 38/65
Scope: Evaluation of a PSUSA procedure (PSUSA/00010941/202511)
Action: For adoption
6.1.54. Sirolimus – HYFTOR (CAP) – EMA/PSUR/0000327938
Applicant: Plusultra Pharma GmbH
PRAC Rapporteur: Jenny-Maria Jönsson
Scope: Evaluation of a PSUSA procedure (PSUSA/00000025/202511)
Action: For adoption
6.1.55. Sotorasib – LUMYKRAS (CAP) – EMA/PSUR/0000327925
Applicant: Amgen Europe B.V.
PRAC Rapporteur: Marie Louise Schougaard Christiansen
Scope: Evaluation of a PSUSA procedure (PSUSA/00010970/202511)
Action: For adoption
6.1.56. Tofersen – QALSODY (CAP) – EMA/PSUR/0000327929
Applicant: Biogen Netherlands B.V.
PRAC Rapporteur: Kimmo Jaakkola
Scope: Evaluation of a PSUSA procedure (PSUSA/00011064/202510)
Action: For adoption
6.1.57. Vamorolone – AGAMREE (CAP) – EMA/PSUR/0000327937
Applicant: Santhera Pharmaceuticals (Deutschland) GmbH
PRAC Rapporteur: Rhea Fitzgerald
Scope: Evaluation of a PSUSA procedure (PSUSA/00000223/202510)
Action: For adoption
6.1.58. Vandetanib – CAPRELSA (CAP) – EMA/PSUR/0000327919
Applicant: Esteve Pharmaceuticals S.A.
PRAC Rapporteur: Tiphaine Vaillant
Scope: Evaluation of a PSUSA procedure (PSUSA/00009327/202510)
Action: For adoption
Pharmacovigilance Risk Assessment Committee (PRAC)
EMA/PRAC/115322/2026 Page 39/65
6.1.59. Volanesorsen – WAYLIVRA (CAP) – EMA/PSUR/0000327897
Applicant: Akcea Therapeutics Ireland Limited
PRAC Rapporteur: Dennis Lex
Scope: Evaluation of a PSUSA procedure (PSUSA/00010762/202511)
Action: For adoption
6.1.60. Zanidatamab – ZIIHERA (CAP) – EMA/PSUR/0000327940
Applicant: Jazz Pharmaceuticals Ireland Limited
PRAC Rapporteur: Jenny-Maria Jönsson
Scope: Evaluation of a PSUSA procedure (PSUSA/00011147/202511)
Action: For adoption
6.1.61. Zanubrutinib – BRUKINSA (CAP) – EMA/PSUR/0000327900
Applicant: Beone Medicines Ireland Limited
PRAC Rapporteur: Bianca Mulder
Scope: Evaluation of a PSUSA procedure (PSUSA/00010960/202511)
Action: For adoption
6.2. PSUR single assessment (PSUSA) procedures including centrally
authorised products (CAPs) and nationally authorised products
(NAPs)
6.2.1. Deferasirox - DEFERASIROX ACCORD (CAP); DEFERASIROX MYLAN (CAP); EXJADE
(CAP), NAP – EMA/PSUR/0000327939
Applicants: Accord Healthcare S.L.U. (Deferasirox Accord), Mylan Pharmaceuticals Limited
(Deferasirox Mylan), Novartis Europharm Limited (Exjade), various
PRAC Rapporteur: Tiphaine Vaillant
Scope: Evaluation of a PSUSA procedure (PSUSA/00000939/202510)
Action: For adoption
6.2.2. Methotrexate - JYLAMVO (CAP); NORDIMET (CAP), NAP – EMA/PSUR/0000327873
Applicants: Nordic Group B.V. (Nordimet), Oresund Pharma ApS (Jylamvo), various
PRAC Rapporteur: Dennis Lex
Scope: Evaluation of a PSUSA procedure (PSUSA/00002014/202510)
Action: For adoption
Pharmacovigilance Risk Assessment Committee (PRAC)
EMA/PRAC/115322/2026 Page 40/65
6.2.3. Stiripentol - DIACOMIT (CAP), NAP – EMA/PSUR/0000327885
Applicants: Biocodex (Diacomit), various
PRAC Rapporteur: Maia Uusküla
Scope: Evaluation of a PSUSA procedure (PSUSA/00002789/202511)
Action: For adoption
6.2.4. Tadalafil - ADCIRCA (CAP); CIALIS (CAP); TADALAFIL LILLY (CAP), NAP –
EMA/PSUR/0000327895
Applicants: Eli Lilly Nederland B.V. (Adcirca, Cialis, Tadalafil Lilly), various
PRAC Rapporteur: Maria del Pilar Rayon
Scope: Evaluation of a PSUSA procedure (PSUSA/00002841/202510)
Action: For adoption
6.3. PSUR single assessment (PSUSA) procedures including nationally
authorised products (NAPs) only
6.3.1. A-tocopheril, a-tocopherol, vitamin E – EMA/PSUR/0000327898
Applicants: various
PRAC Lead: Roxana Stefania Udrescu
Scope: Evaluation of a PSUSA procedure (PSUSA/00003186/202511)
Action: For adoption
6.3.2. A-tocopherol / ergocalciferol / phytomenadion / retinol palmitate –
EMA/PSUR/0000327883
Applicants: various
PRAC Lead: Miroslava Gocova
Scope: Evaluation of a PSUSA procedure (PSUSA/00002633/202511)
Action: For adoption
6.3.3. Acetylsalicylic acid / chlorphenamine / phenylephrine – EMA/PSUR/0000327862
Applicants: various
PRAC Lead: Adam Przybylkowski
Scope: Evaluation of a PSUSA procedure (PSUSA/00000694/202511)
Action: For adoption
Pharmacovigilance Risk Assessment Committee (PRAC)
EMA/PRAC/115322/2026 Page 41/65
6.3.4. Aluminium chloride hexahydrate – EMA/PSUR/0000327918
Applicants: various
PRAC Lead: Dennis Lex
Scope: Evaluation of a PSUSA procedure (PSUSA/00009050/202511)
Action: For adoption
6.3.5. Aminosalicylic acid – EMA/PSUR/0000327860
Applicants: various
PRAC Lead: Zoubida Amimour
Scope: Evaluation of a PSUSA procedure (PSUSA/00000165/202510)
Action: For adoption
6.3.6. Amlodipine / atorvastatin / perindopril, amlodipine / atorvastatin / rampiril –
EMA/PSUR/0000327896
Applicants: various
PRAC Lead: Veronika Macurova
Scope: Evaluation of a PSUSA procedure (PSUSA/00010431/202510)
Action: For adoption
6.3.7. Artemether / lumefantrin (apart from the dispersible tablet) –
EMA/PSUR/0000327946
Applicants: various
PRAC Lead: Karin Bolin
Scope: Evaluation of a PSUSA procedure (PSUSA/00000236/202510)
Action: For adoption
6.3.8. Ascorbic acid / caffeine / paracetamol / phenylephrine hydrochloride / terpine –
EMA/PSUR/0000327878
Applicants: various
PRAC Lead: Melinda Palfi
Scope: Evaluation of a PSUSA procedure (PSUSA/00002305/202511)
Action: For adoption
6.3.9. Bisoprolol – EMA/PSUR/0000327936
Applicants: various
Pharmacovigilance Risk Assessment Committee (PRAC)
EMA/PRAC/115322/2026 Page 42/65
PRAC Lead: Kimmo Jaakkola
Scope: Evaluation of a PSUSA procedure (PSUSA/00000419/202509)
Action: For adoption
6.3.10. Bisoprolol / perindopril – EMA/PSUR/0000327893
Applicants: various
PRAC Lead: Jana Pecherova
Scope: Evaluation of a PSUSA procedure (PSUSA/00010462/202510)
Action: For adoption
6.3.11. Bromhexine – EMA/PSUR/0000327935
Applicants: various
PRAC Lead: Amelia Cupelli
Scope: Evaluation of a PSUSA procedure (PSUSA/00000437/202509)
Action: For adoption
6.3.12. Carbidopa / levodopa – EMA/PSUR/0000327864
Applicants: various
PRAC Lead: Barbara Kovacic Bytyqi
Scope: Evaluation of a PSUSA procedure (PSUSA/00000548/202510)
Action: For adoption
6.3.13. Cinnarizine / dimenhydrinate – EMA/PSUR/0000327867
Applicants: various
PRAC Lead: Jan Neuhauser
Scope: Evaluation of a PSUSA procedure (PSUSA/00000767/202511)
Action: For adoption
6.3.14. Clenbuterol – EMA/PSUR/0000327861
Applicants: various
PRAC Lead: Amelia Cupelli
Scope: Evaluation of a PSUSA procedure (PSUSA/00000794/202509)
Action: For adoption
Pharmacovigilance Risk Assessment Committee (PRAC)
EMA/PRAC/115322/2026 Page 43/65
6.3.15. Cyanocobalamin / folic acid, cyanocobalamin / folic acid / potassium iodide –
EMA/PSUR/0000327944
Applicants: various
PRAC Lead: Ana Sofia Diniz Martins
Scope: Evaluation of a PSUSA procedure (PSUSA/00000892/202511)
Action: For adoption
6.3.16. Desogestrel / ethinylestradiol – EMA/PSUR/0000327943
Applicants: various
PRAC Lead: Kimmo Jaakkola
Scope: Evaluation of a PSUSA procedure (PSUSA/00000967/202509)
Action: For adoption
6.3.17. Dinoprostone – EMA/PSUR/0000327945
Applicants: various
PRAC Lead: Jenny-Maria Jönsson
Scope: Evaluation of a PSUSA procedure (PSUSA/00001104/202509)
Action: For adoption
6.3.18. Felbamate – EMA/PSUR/0000327920
Applicants: various
PRAC Lead: Tiphaine Vaillant
Scope: Evaluation of a PSUSA procedure (PSUSA/00010155/202509)
Action: For adoption
6.3.19. Human coagulation factor VII – EMA/PSUR/0000327871
Applicants: various
PRAC Lead: Sonja Radowan
Scope: Evaluation of a PSUSA procedure (PSUSA/00001619/202510)
Action: For adoption
6.3.20. Isoflurane – EMA/PSUR/0000327868
Applicants: various
PRAC Lead: Melinda Palfi
Pharmacovigilance Risk Assessment Committee (PRAC)
EMA/PRAC/115322/2026 Page 44/65
Scope: Evaluation of a PSUSA procedure (PSUSA/00001786/202510)
Action: For adoption
6.3.21. Minoxidil (non topical formulations) – EMA/PSUR/0000327876
Applicants: various
PRAC Lead: Eamon O Murchu
Scope: Evaluation of a PSUSA procedure (PSUSA/00002066/202510)
Action: For adoption
6.3.22. Perindopril – EMA/PSUR/0000327874
Applicants: various
PRAC Lead: Karin Erneholm
Scope: Evaluation of a PSUSA procedure (PSUSA/00002354/202510)
Action: For adoption
6.3.23. Pipamperone – EMA/PSUR/0000327872
Applicants: various
PRAC Lead: Dennis Lex
Scope: Evaluation of a PSUSA procedure (PSUSA/00002420/202510)
Action: For adoption
6.3.24. Prothipendyl – EMA/PSUR/0000327875
Applicants: various
PRAC Lead: Jan Neuhauser
Scope: Evaluation of a PSUSA procedure (PSUSA/00002564/202510)
Action: For adoption
6.3.25. Ramipril / bisoprolol – EMA/PSUR/0000327914
Applicants: various
PRAC Lead: Jana Pecherova
Scope: Evaluation of a PSUSA procedure (PSUSA/00011041/202510)
Action: For adoption
Pharmacovigilance Risk Assessment Committee (PRAC)
EMA/PRAC/115322/2026 Page 45/65
6.3.26. Salmeterol – EMA/PSUR/0000327888
Applicants: various
PRAC Lead: Karin Bolin
Scope: Evaluation of a PSUSA procedure (PSUSA/00002681/202510)
Action: For adoption
6.3.27. Sulbutiamine – EMA/PSUR/0000327905
Applicants: various
PRAC Lead: Tiphaine Vaillant
Scope: Evaluation of a PSUSA procedure (PSUSA/00002801/202511)
Action: For adoption
6.3.28. Terbinafine – EMA/PSUR/0000327909
Applicants: various
PRAC Lead: Jana Pecherova
Scope: Evaluation of a PSUSA procedure (PSUSA/00002896/202509)
Action: For adoption
6.3.29. Valsartan / rosuvastatin – EMA/PSUR/0000327899
Applicants: various
PRAC Lead: Polona Golmajer
Scope: Evaluation of a PSUSA procedure (PSUSA/00010735/202510)
Action: For adoption
6.4. Follow-up to PSUR/PSUSA procedures
6.4.1. Semaglutide – RYBELSUS (CAP) – EMA/PAM/0000337900
Applicant: Novo Nordisk A/S
PRAC Rapporteur: Karin Bolin
Scope: Safety review. To assess the potential association between semaglutide exposure and
cardioembolic stroke as part of a post-authorisation measure (LEG). -
EMEA/H/C/PSUSA/00010671/202505. (LEG/01968/1)
Action: For adoption
Pharmacovigilance Risk Assessment Committee (PRAC)
EMA/PRAC/115322/2026 Page 46/65
6.4.2. Semaglutide – WEGOVY (CAP); WEGOVY FLEXTOUCH (CAP) –
EMA/PAM/0000337800
Applicant: Novo Nordisk A/S
PRAC Rapporteur: Karin Bolin
Scope: To assess the potential association between semaglutide exposure and cardioembolic
stroke as part of a post-authorisation measure (LEG). -EMEA/H/C/PSUSA/00010671/202505
Action: For adoption
6.4.3. Semaglutide – OZEMPIC (CAP) – EMA/PAM/0000338018
Applicant: Novo Nordisk A/S
PRAC Rapporteur: Karin Bolin
Scope: Safety review. To assess the potential association between semaglutide exposure and
cardioembolic stroke as part of a post-authorisation measure (LEG). -
EMEA/H/C/PSUSA/00010671/202505. (LEG/01969/1)
Action: For adoption
6.4.4. Voretigene neparvovec – LUXTURNA (CAP) – EMA/PAM/0000339319
Applicant: Novartis Europharm Limited, ATMP
PRAC Rapporteur: Dirk Mentzer
Scope: SPKRPE-PASS final clinical study report requested during PSUSA/00010742/202507
by the PRAC
Action: For adoption
6.5. Variation procedure(s) resulting from PSUSA evaluation
6.5.1. Tacrolimus ADVAGRAF (CAP); MODIGRAF (CAP), NAP – EMA/VR/0000319175
Applicants: Astellas Pharma Europe B.V., various
PRAC Rapporteur: Eamon O Murchu
Scope: Update of section 4.8 of the SmPC in order to include the missing frequency
estimations to the list of adverse drug reactions (ADRs) following PSUSA/00002839/202403
procedure. In addition, the MAH took the opportunity to update the list of local
representatives in the Package Leaflet and to implement editorial changes to the PI.
Action: For adoption
Pharmacovigilance Risk Assessment Committee (PRAC)
EMA/PRAC/115322/2026 Page 47/65
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. Donanemab – KISUNLA (CAP) – EMA/PASS/0000339404
Applicant: Eli Lilly Nederland B.V.
PRAC Rapporteur: Amelia Cupelli
Scope: PASS protocol [107n]: A registry-based observational study to characterise ARIA
within a cohort of donanemab-treated patients in the EU (Protocol I5T-MC-B015)
Action: For adoption
7.1.2. Donanemab – KISUNLA (CAP) – EMA/PASS/0000339391
Applicant: Eli Lilly Nederland B.V.
PRAC Rapporteur: Amelia Cupelli
Scope: PASS protocol [107n]: Secondary database study to characterise safety, drug
utilisation and effectiveness of risk minimisation activities in donanemab treated patients in
the EU (Protocol I5T-MC-B017)
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. Topiramate (NAP) – EMA/PASS/0000340662
Applicants: various
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/115322/2026 Page 48/65
PRAC Rapporteur: Karin Bolin
Scope: PASS amendment [107o]: Post-Authorization Safety Study to assess the
effectiveness of the newly implemented Risk Minimization Measures for Topiramate: HCP and
patient knowledge and behavior survey.
Action: For adoption
7.2. Protocols of PASS non-imposed in the marketing authorisation(s)6
7.2.1. Ciltacabtagene autoleucel – CARVYKTI (CAP) – EMA/PAM/0000338559
Applicant: Janssen Cilag International, ATMP
PRAC Rapporteur: Jo Robays
Scope: Amendment of the protocol for PASS study PCSONCA0014: Post-authorization Safety
Study Survey to Evaluate the Effectiveness of the Ciltacabtagene Autoleucel HCP Educational
Program and the Product Handling Training.
Action: For adoption
7.2.2. COVID-19 mRNA vaccine – MNEXSPIKE (CAP) – EMA/PAM/0000339594
Applicant: Moderna Biotech Spain S.L.
PRAC Rapporteur: Marie Louise Schougaard Christiansen
Scope: Submission of the post-authorisation safety study (PASS) protocol v2.0 for mRNA-
1283-P901; this is a PASS in the United States aimed to estimate the incidence and to
compare the risks of myocarditis and pericarditis among in people who receive mNEXSPIKE
and in those who have not received the prior seasonal formulation of COVID-19 vaccine or
the same seasonal formulation previously.
Action: For adoption
7.2.3. Donanemab – KISUNLA (CAP) – EMA/PAM/0000338752
Applicant: Eli Lilly Nederland B.V.
PRAC Rapporteur: Amelia Cupelli
Scope: Cat. 3 study: Healthcare provider survey to assess the effectiveness of the
donanemab additional risk minimisation activities in the EU
Action: For adoption
7.2.4. Efgartigimod alfa – VYVGART (CAP) – EMA/PAM/0000343589
Applicant: Argenx
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/115322/2026 Page 49/65
PRAC Rapporteur: Rhea Fitzgerald
Scope: Amendment of the protocol (PAS Registration Number EUPAS1000000005) for the
pregnancy registry - A worldwide pregnancy safety study to assess maternal, foetal, and
infant outcomes following exposure to efgartigimod alfa during pregnancy and/or
breastfeeding.
Action: For adoption
7.2.5. Resmetirom – REZDIFFRA (CAP) – EMA/PAM/0000339780
Applicant: Madrigal Pharmaceuticals EU Limited
PRAC Rapporteur: Lina Seibokiene
Scope: Submission of study protocol for a real-world longitudinal data study to address liver
and CV related outcomes in resmetirom treated patients, as compared with a real-world
control arm
Action: For adoption
7.2.6. Teprotumumab – TEPEZZA (CAP) – EMA/PAM/0000310214
Applicant: Amgen Europe B.V.
PRAC Rapporteur: Sonja Radowan
Scope: Draft protocol for PASS (non-imposed) 20250081: Drug utilization study to evaluate
the effectiveness of teprotumumab aRMMs.
Action: For adoption
7.2.7. Tofacitinib – XELJANZ (CAP) – EMA/PAM/0000316639
Applicant: Pfizer Europe MA EEIG
PRAC Rapporteur: Liana Martirosyan
Scope: Submission of amended protocols for the non-imposed (category 3) Post
Authorisation Safety Study (PASS) - version 6.0 (A3921312), and version 6.0 (A3921316) for
Tofacitinib (Xeljanz).
• A3921312: UK, British Society for Rheumatology Biologics Register-Rheumatoid
Arthritis (BSRBR-RA)
• A3921316: Spain (ES), Registry of Adverse Events of Biological Therapies and
Biosimilars in Rheumatoid Diseases (BIOBADASER)
Action: For adoption
7.2.8. Upadacitinib – RINVOQ (CAP) – EMA/PAM/0000339078
Applicant: Abbvie Deutschland GmbH & Co. KG
PRAC Rapporteur: Petar Mas
Pharmacovigilance Risk Assessment Committee (PRAC)
EMA/PRAC/115322/2026 Page 50/65
Scope: Protocol amendment for study P21-825: a drug utilisation study evaluating the
additional risk minimisation measures for upadacitinib in the treatment of atopic dermatitis in
Europe
Action: For adoption
7.2.9. Vonicog alfa – VEYVONDI (CAP) – EMA/PAM/0000337712
Applicant: BAXALTA INNOVATIONS GmbH
PRAC Rapporteur: Karin Bolin
Scope: Protocol for Study TAK-577-4009/EUHASS registry - post-authorisation safety study:
safety surveillance of Veyvondi using secondary data from the EUHASS registry.
Action: For adoption
7.3. Results of PASS imposed in the marketing authorisation(s)7
7.3.1. Belimumab – BENLYSTA (CAP) – EMA/PASS/0000306411
Applicant: Glaxosmithkline (Ireland) Limited
PRAC Rapporteur: Karin Bolin
Scope: PASS results [107q]: A 5-Year prospective observational registry to assess adverse
events of interest and effectiveness in adults with active, autoantibody-positive systemic
Lupus erythematosus treated with or without BENLYSTA (belimumab)
Action: For adoption
7.4. Results of PASS imposed and non-imposed in the marketing
authorisation(s)8
7.4.1. COVID-19 mRNA vaccine – COMIRNATY (CAP); COMIRNATY JN.1 (CAP);
COMIRNATY KP.2 (CAP); COMIRNATY LP.8.1 (CAP); COMIRNATY OMICRON XBB.1.5
(CAP); COMIRNATY ORIGINAL/OMICRON BA.4-5 (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
7 In accordance with Article 107p-q of Directive 2001/83/EC
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/115322/2026 Page 51/65
7.4.2. Ivacaftor / Tezacaftor / Elexacaftor – KAFTRIO (CAP) – EMA/VR/0000319887
Applicant: Vertex Pharmaceuticals (Ireland) Limited
PRAC Rapporteur: Dennis Lex
Scope: Submission of the final report from the 5-year Post Authorisation Safety Study
(PASS) VX20-445-120, listed as a category 3 study in the RMP. This is a longitudinal, registry
based study evaluating the real-world effects and utilisation patterns of elexacaftor,
tezacaftor, and ivacaftor combination therapy (ELX/TEZ/IVA) in patients with cystic fibrosis
(CF). The RMP version 10.2 has also been submitted.
Action: For adoption
7.4.3. Laronidase – ALDURAZYME (CAP) – EMA/VR/0000282056
Applicant: Sanofi B.V.
PRAC Rapporteur: Zoubida Amimour
Scope: Submission of the final report from PASS study ALID01803 listed as a category 3
study in the RMP. This is an observational, open-label study of the effects of Aldurazyme
(laronidase) treatment on lactation in postpartum women with Mucopolysaccharidosis Type I
and their breastfed infants. This study is to determine whether laronidase activity was
present in the breast milk of mothers with MPS I disease and whether Aldurazyme affected
the growth, development, and immunologic response of breastfed infants. The RMP version
2.0 has also been submitted.
Action: For adoption
7.4.4. Semaglutide – OZEMPIC (CAP); RYBELSUS (CAP) – EMA/VR/0000334523
Applicant: Novo Nordisk A/S
PRAC Rapporteur: Karin Bolin
Scope: Submission of the final report from the non-interventional post-authorisation safety
study NN9535-4447, listed as a category 3 study in the RMP for Ozempic and Rybelsus. This
is an epidemiological assessment of the risk for pancreatic cancer associated with the use of
semaglutide in patients with type 2 diabetes: a cohort study based on Nordic registry data.
Action: For adoption
7.5. Interim results and other post-authorisation measures for imposed
and non-imposed studies
7.5.1. Avacopan – TAVNEOS (CAP) – EMA/PAM/0000336195
Applicant: Vifor Fresenius Medical Care Renal Pharma France
PRAC Rapporteur: Liana Martirosyan
Pharmacovigilance Risk Assessment Committee (PRAC)
EMA/PRAC/115322/2026 Page 52/65
Scope: Submission of the first interim report for the required additional pharmacovigilance
activity (Category 3), AVACOSTAR (CS-AVA-2022-0016), which is a post-authorisation safety
study (PASS) to evaluate incidence of safety events of interest in patients treated with
avacopan for ANCA-associated vasculitis (AAV). In the frame of procedure MEA 002
EMEA/H/C/005523, it was agreed in the RMP version 2.1 that interim reports for AVACOSTAR
PASS are submitted every 24 months (after first patient first visit).
Action: For adoption
7.5.2. Cabotegravir – VOCABRIA (CAP) – EMA/PAM/0000339050
Applicant: ViiV Healthcare B.V.
PRAC Rapporteur: Dennis Lex
Scope: Interim study results. 4th interim report. PASS: A real-world five-year Drug
Utilisation Study (DUS). This observational cohort study will aim to better understand the
patient population receiving cabotegravir long acting injection and/or rilpivirine long acting
injection containing regimens in routine clinical practice. The study will assess usage
patterns, adherence, and post marketing clinical effectiveness of these regimens and monitor
for resistance among virologic failures for whom data on resistance testing are available.
(ANX/01282/2)
Action: For adoption
7.5.3. Cabotegravir – VOCABRIA (CAP) – EMA/PAM/0000339531
Applicant: ViiV Healthcare B.V.
PRAC Rapporteur: Dennis Lex
Scope: Interim study results. PASS No. 215162 (EuroSIDA): A prospective observational
cohort study to monitor for hepatotoxicity and regimen discontinuation due to liver related
adverse events among patients initiating CAB containing antiretroviral regimen. Summary
objectives: Monitor for hepatotoxicity; Estimate the number of patients discontinuing CAB
based ARV regimen due to adverse events, and adverse events related to hepatic events.
(MEA/01256/2)
Action: For adoption
7.5.4. COVID-19 vaccine (recombinant, adjuvanted) – NUVAXOVID (CAP); NUVAXOVID
JN.1 (CAP); NUVAXOVID XBB.1.5 (CAP) – EMA/PAM/0000317251
Applicant: Sanofi Winthrop Industrie
PRAC Rapporteur: Dirk Mentzer
Scope: Revised Third Interim Report for PASS 2019nCoV-402: UK A Study Using the Clinical
Practice Research Datalink (CPRD): A surveillance study to characterise the safety profile of
Nuvaxovid in adults aged 18 years and older in the real-world setting using the UK CPRD.
Action: For adoption
Pharmacovigilance Risk Assessment Committee (PRAC)
EMA/PRAC/115322/2026 Page 53/65
7.5.5. Damoctocog alfa pegol – JIVI (CAP) – EMA/PAM/0000303584
Applicant: Bayer AG
PRAC Rapporteur: Bianca Mulder
Scope: Fourth interim report of study number 20904 (HA-SAFE), ‘Observational study
evaluating long-term safety of real-world treatment with damoctocog alfa pegol in previously
treated patients with hemophilia A’. The HA-SAFE study is a post-authorisation measure
defined in Annex II.D of the Jivi EU PI.
Action: For adoption
7.5.6. Efgartigimod alfa – VYVGART (CAP) – EMA/PAM/0000339564
Applicant: Argenx
PRAC Rapporteur: Rhea Fitzgerald
Scope: Third interim report ARGX-113-PAC-2206: A worldwide pregnancy safety study to
assess maternal, fetal, and infant outcomes following exposure to Vyvgart (efgartigimod)
during pregnancy and/or breastfeeding.
Action: For adoption
7.5.7. Fenfluramine – FINTEPLA (CAP) – EMA/PAM/0000339786
Applicant: UCB Pharma
PRAC Rapporteur: Dennis Lex
Scope: Final study result. P46 RWE1624 is a descriptive, retrospective, non-interventional
longitudinal cohort analysis of patients with Cyclin-dependent kinase-like 5 (CDKL5)
deficiency disorder (CDD) in the United States, utilizing data from the Komodo claims
database. (P46/01995/1)
Action: For adoption
7.5.8. Lecanemab – LEQEMBI (CAP) – EMA/PAM/0000339581
Applicant: Eisai GmbH
PRAC Rapporteur: Eva Jirsová
Scope: Cat 3 PASS BAN2401-G000-301 OLE
Evaluate the long-term safety and tolerability of LEC10-BW in subjects with early Alzheimer’s
disease in the Extension Phase. (MEA/01037/1)
Action: For adoption
7.5.9. Maribavir – LIVTENCITY (CAP) – EMA/PAM/0000334575
Applicant: Takeda Pharmaceuticals International AG Ireland Branch
Pharmacovigilance Risk Assessment Committee (PRAC)
EMA/PRAC/115322/2026 Page 54/65
PRAC Rapporteur: Adam Przybylkowski
Scope: Submission of interim results from study TAK-620-4007, an RMP category 3
retrospective chart review of safety outcomes associated with use of maribavir in patients
with post-transplant refractory cytomegalovirus (CMV) infection and comorbid end-stage
renal disease (ESRD) or comorbid severe chronic renal disease requiring peritoneal dialysis or
haemodialysis.
Action: For adoption
7.5.10. Mercaptamine – CYSTADROPS (CAP) – EMA/PAM/0000339522
Applicant: Recordati Rare Diseases
PRAC Rapporteur: Maria del Pilar Rayon
Scope: The fourth interim report for category 3 PASS CYT-DS-001; an open-label,
longitudinal, post authorization safety study to assess the safety of Cystadrops in paediatric
and adult cystinosis patients in long term Use.
Action: For adoption
7.5.11. Ofatumumab – KESIMPTA (CAP) – EMA/PAM/0000308145
Applicant: Novartis Europharm Limited
PRAC Rapporteur: Amelia Cupelli
Scope: First Annual Interim Study Report for long-term PASS, study COMB157G2406 entitled
Kesimpta long-term retrospective safety study utilizing real-world data from existing multiple
sclerosis registries and databases from multiple countries
Action: For adoption
7.5.12. Ofatumumab – KESIMPTA (CAP) – EMA/PAM/0000337728
Applicant: Novartis Europharm Limited
PRAC Rapporteur: Amelia Cupelli
Scope: 5th Interim Report of PASS COMB157G2399 (ALITHIOS): An open-label, single arm,
multi-center extension study evaluating long-term safety, tolerability and effectiveness of
ofatumumab in subjects with relapsing multiple sclerosis.
Action: For adoption
7.5.13. Rilpivirine – REKAMBYS (CAP) – EMA/PAM/0000338758
Applicant: Janssen Cilag International
PRAC Rapporteur: Liana Martirosyan
Scope: Interim study results. 4th interim report. PASS: A real-world five-year Drug
Utilisation Study (DUS). This observational cohort study will aim to better understand the
patient population receiving cabotegravir long acting injection and/or rilpivirine long acting
Pharmacovigilance Risk Assessment Committee (PRAC)
EMA/PRAC/115322/2026 Page 55/65
injection containing regimens in routine clinical practice. The study will assess usage
patterns, adherence, and post marketing clinical effectiveness of these regimens and monitor
for resistance among virologic failures for whom data on resistance testing are available.
(ANX/01281/2)
Action: For adoption
7.5.14. Sarilumab – KEVZARA (CAP) – EMA/PAM/0000339607
Applicant: Sanofi Winthrop Industrie
PRAC Rapporteur: Maria Martinez Gonzalez
Scope: SARILC08312 Interim Report#5: Post-authorization Safety study Surveillance
Program for Sarilumab using Rheumatoid Arthritis Registries in Germany, Spain, Sweden,
and in the United Kingdom (EUPASS35468).
Action: For adoption
7.5.15. Tofacitinib – XELJANZ (CAP) – EMA/PAM/0000334570
Applicant: Pfizer Europe MA EEIG
PRAC Rapporteur: Liana Martirosyan
Scope: Next interim study report for Study A3921352 is an active surveillance, post-
authorization study to characterize the safety of tofacitinib in patients with moderately to
severely active ulcerative colitis in the real-world setting using data from the United
Registries for Clinical Assessment and Research (UR-CARE) in the European Union (EU), as
requested in MEA/01034/1 (EMA/PAM/0000247897).
Action: For adoption
7.5.16. Velaglucerase alfa – VPRIV (CAP) – EMA/PAM/0000339048
Applicant: Takeda Pharmaceuticals International AG Ireland Branch
PRAC Rapporteur: Dennis Lex
Scope: Submission of Feasibility Assessment Report for study TAK-669-4018, a Survey
among Patients, Caregivers and Home Infusion Nurses based in the European Union to
Assess their Awareness and Understanding of the Risk Minimization Measures in the
Educational Materials Supporting VPRIV Infusion at Home
Action: For adoption
Pharmacovigilance Risk Assessment Committee (PRAC)
EMA/PRAC/115322/2026 Page 56/65
8. Renewals of the marketing authorisation, conditional renewal
and annual reassessments
8.1. Annual reassessments of the marketing authorisation
8.1.1. Amifampridine – FIRDAPSE (CAP) – EMA/S/0000337252
Applicant: Serb
PRAC Rapporteur: Karin Bolin
Scope: Annual reassessment of the marketing authorisation
Action: For adoption
8.1.2. Clofarabine – EVOLTRA (CAP) – EMA/S/0000335797
Applicant: Sanofi B.V.
PRAC Rapporteur: Tiphaine Vaillant
Scope: Annual reassessment of the marketing authorisation
Action: For adoption
8.1.3. Glucarpidase – VORAXAZE (CAP) – EMA/S/0000322329
Applicant: Serb
PRAC Rapporteur: Dennis Lex
Scope: Annual reassessment of the marketing authorisation
Action: For adoption
8.1.4. 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
8.1.5. Velmanase alfa – LAMZEDE (CAP) – EMA/S/0000336192
Applicant: Chiesi Farmaceutici S.p.A.
PRAC Rapporteur: Jan Neuhauser
Scope: Annual reassessment of the marketing authorisation
Pharmacovigilance Risk Assessment Committee (PRAC)
EMA/PRAC/115322/2026 Page 57/65
Action: For adoption
8.2. Conditional renewals of the marketing authorisation
8.2.1. Epcoritamab – TEPKINLY (CAP) – EMA/R/0000334812
Applicant: Abbvie Deutschland GmbH & Co. KG
PRAC Rapporteur: Maria Martinez Gonzalez
Scope: Conditional renewal of the marketing authorisation
Action: For adoption
8.2.2. Pirtobrutinib – JAYPIRCA (CAP) – EMA/R/0000339971
Applicant: Eli Lilly Nederland B.V.
PRAC Rapporteur: Bianca Mulder
Scope: Conditional renewal of the marketing authorisation
Action: For adoption
8.3. Renewals of the marketing authorisation
8.3.1. Abrocitinib – CIBINQO (CAP) – EMA/R/0000336009
Applicant: Pfizer Europe MA EEIG
PRAC Rapporteur: Petar Mas
Scope: 5-year renewal of the marketing authorisation
Action: For adoption
8.3.2. Anifrolumab – SAPHNELO (CAP) – EMA/R/0000335943
Applicant: AstraZeneca AB
PRAC Rapporteur: Liana Martirosyan
Scope: 5-year renewal of the marketing authorisation
Action: For adoption
8.3.3. Artesunate – ARTESUNATE AMIVAS (CAP) – EMA/R/0000333258
Applicant: Amivas Ireland Limited
PRAC Rapporteur: Dennis Lex
Scope: 5-year renewal of the marketing authorisation
Pharmacovigilance Risk Assessment Committee (PRAC)
EMA/PRAC/115322/2026 Page 58/65
Action: For adoption
8.3.4. 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
8.3.5. Semaglutide – WEGOVY (CAP); WEGOVY FLEXTOUCH (CAP) – EMA/R/0000336288
Applicant: Novo Nordisk A/S
PRAC Rapporteur: Karin Bolin
Scope: 5-year renewal of the marketing authorisation
Action: For adoption
8.3.6. Sitagliptin fumarate – SITAGLIPTIN SUN (CAP) – EMA/R/0000335931
Applicant: Sun Pharmaceutical Industries (Europe) B.V.
PRAC Rapporteur: Bianca Mulder
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
Pharmacovigilance Risk Assessment Committee (PRAC)
EMA/PRAC/115322/2026 Page 59/65
10. Other safety issues for discussion requested by the Member
States, CHMP or the EMA
10.1.1. Levofloxacin (intravenous and oral use) – DE/H/5119/001-003/II/118
Applicant(s): Sanofi-Aventis Deutschland GmbH (Tavanic)
PRAC Lead: Dennis Lex
Scope: PRAC consultation on a type II national variation to update the product information
regarding the risk of encephalopathy, at request of Germany.
Action: For adoption
10.1.2. Mycobacterium bovis BCG, Danish strain 1331 – DK/H/3659/001/II/001
Applicant(s): AJ Vaccines A/S
PRAC Lead: Karin Erneholm
Scope: PRAC consultation on a type II national variation to update the product information,
to implement additional risk minimisation measures and to disseminate a direct healthcare
professional communication (DHPC) regarding the risk of reactivation of latent BCG
infection , at request of Denmark.
Action: For adoption
10.1.3. Upadacitinib – RINVOQ (CAP) – EMA/VR/0000312506
Applicant: Abbvie Deutschland GmbH & Co. KG
PRAC Rapporteur: Petar Mas
Scope: Extension of indication to include the treatment of severe alopecia areata (AA) in
adult and adolescents 12 years and older for RINVOQ, based on interim results from 2
pivotal, Phase 3 studies (M23-716 Study 1 and Study 2); those are randomized, double
blind, placebo-controlled, multi-center studies of Upadacitinib evaluating the efficacy and
safety of Upadacitinib 15 mg QD and 30 mg QD versus placebo for the treatment of severe
AA in subjects who are at least 12 years of age. As a consequence, sections 4.1, 4.2, 4.4,
4.5, 4.8, 5.1 and 5.2 of the SmPC are updated. The Package Leaflet and Annex II are
updated in accordance. Version 18.0 of the RMP has also been submitted. As part of the
application, the MAH is requesting a 1-year extension of the market protection.
Action: For adoption
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.
Pharmacovigilance Risk Assessment Committee (PRAC)
EMA/PRAC/115322/2026 Page 60/65
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
12.1.3. Scientific Committee Meetings – alternating face-to-face and virtual meetings
schedule for 2027
Action: For adoption
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. Healthcare Professionals Working Party (HCPWP) and Patients and Consumers
Working Party (PCWP) – 2025-2028
Action: For information
12.3.2. SAWP-PRAC consultation procedure – guidance update
Action: For adoption
12.4. Cooperation within the EU regulatory network
None
12.5. Cooperation with International Regulators
12.5.1. Opening procedures at EMA to non-EU authorities (OPEN) framework – PRAC
involvement
Action: For discussion
Pharmacovigilance Risk Assessment Committee (PRAC)
EMA/PRAC/115322/2026 Page 61/65
12.6. Contacts of the PRAC with external parties and interaction with the
Interested Parties to the Committee
None
12.7. PRAC work plan
None
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. PSURs repository
None
12.10.3. Union reference date list – consultation on the draft list
Action: For adoption
Pharmacovigilance Risk Assessment Committee (PRAC)
EMA/PRAC/115322/2026 Page 62/65
12.11. Signal management
12.11.1. Good Pharmacovigilance Practice (GVP) module IX on signal management – revision
2
PRAC lead: Dennis Lex
Action: For adoption
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/115322/2026 Page 63/65
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
None
12.21. Others
12.21.1. Benzyl alcohol and benzoic acid used as excipients in medicinal products - revised
labelling requirements
Action: For discussion
13. Any other business
None
Pharmacovigilance Risk Assessment Committee (PRAC)
EMA/PRAC/115322/2026 Page 64/65
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.
Product related pharmacovigilance inspections
(Item 9 of the PRAC agenda)
Inspections carried out by regulatory agencies to ensure that marketing authorisation holders comply with
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/115322/2026 Page 65/65
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 08-11 June 2026
1.3. Minutes of the previous meeting on 04-07 May 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
3.2. Ongoing procedures
3.3. Procedures for finalisation
3.4. Re-examination procedures
3.5. Others
4. Signals assessment and prioritisation
4.1. New signals detected from EU spontaneous reporting systems and/or other sources
4.1.1. Abemaciclib – VERZENIOS (CAP); palbociclib – IBRANCE (CAP); ribociclib – KISQALI (CAP)
4.1.2. Atezolizumab – TECENTRIQ (CAP); avelumab – BAVENCIO (CAP); cemiplimab - LIBTAYO (CAP); dostarlimab – JEMPERLI (CAP); durvalumab – IMFINZI (CAP); ipilimumab – YERVOY (CAP); nivolumab – OPDIVO (CAP); nivolumab / relatlimab – OPDUALAG (CAP); pemb...
4.1.3. Belzutifan – WELIREG (CAP)
4.1.4. Cefpodoxime (NAP)
4.1.5. Lithium (NAP)
4.1.6. Luspatercept - REBLOZYL (CAP)
4.1.7. Osimertinib - TAGRISSO (CAP)
4.2. Signals follow-up and prioritisation
4.2.1. Darolutamide - NUBEQA (CAP) - EMEA/H/C/004790/SDA/005
4.2.2. Gemcitabine (NAP)
4.2.3. Valproate (NAP) and related substances
4.2.4. Vortioxetine - BRINTELLIX (CAP) - EMEA/H/C/002717/SDA/011
4.2.5. X-ray contrast agents: Iobitridol (NAP); Iodixanol (NAP); Iohexol (NAP); Iomeprol (NAP); Iopamidol (NAP); Iopromide (NAP); Ioversol (NAP); Ioxitalamic acid (NAP)
4.2.6. Zolbetuximab - VYLOY (CAP) - EMEA/H/C/005868/SDA/002
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. Glepaglutide - (CAP MAA) - EMEA/H/C/005855
5.1.2. Omalizumab (CAP MAA) - EMEA/H/C/006756
5.1.3. Pegfilgrastim (CAP MAA) - EMEA/H/C/006085
5.1.4. RABIES VIRUS (INACTIVATED) STRAIN WISTAR (PM/WI 38-1503-3M) (CAP MAA) - EMEA/H/C/006602
5.2. Medicines in the post-authorisation phase – PRAC-led procedures
5.2.1. Bosentan – STAYVEER (CAP); TRACLEER (CAP) – EMA/VR/0000316336
5.2.2. Emtricitabine / Tenofovir disoproxil - EMTRICITABINE/TENOFOVIR DISOPROXIL ZENTIVA (CAP); NAP – EMA/VR/0000335678
5.2.3. Infliximab – REMICADE (CAP) – EMA/VR/0000338953
5.2.4. Lecanemab – LEQEMBI (CAP) – EMA/VR/0000302769
5.2.5. Loncastuximab tesirine – ZYNLONTA (CAP) – EMA/VR/0000337919
5.2.6. Teriflunomide - TERIFLUNOMIDE VIATRIS (CAP), NAP – EMA/VR/0000320266
5.2.7. Tenofovir disoproxil - TENOFOVIR DISOPROXIL ZENTIVA (CAP), NAP – EMA/VR/0000342258
5.3. Medicines in the post-authorisation phase – CHMP-led procedures
5.3.1. Atogepant – AQUIPTA (CAP) – EMA/VR/0000334780
5.3.2. Concizumab – ALHEMO (CAP) – EMA/VR/0000335954
5.3.3. COVID-19 vaccine (recombinant, adjuvanted) – BIMERVAX (CAP) – EMA/VR/0000316063
5.3.4. Daratumumab – DARZALEX (CAP) – EMA/VR/0000334930
5.3.5. Dengue tetravalent vaccine (live, attenuated) – DENGUE TETRAVALENT VACCINE (LIVE, ATTENUATED) TAKEDA (Art 58); QDENGA (CAP) – EMA/VR/0000323434
5.3.6. Dinutuximab beta – QARZIBA (CAP) – EMA/VR/0000316241
5.3.7. Enfortumab vedotin – PADCEV (CAP) – EMA/VR/0000336191
5.3.8. Ertugliflozin – STEGLATRO (CAP) – EMA/VR/0000335920
5.3.9. Florbetapir (18F) – AMYVID (CAP) – EMA/VR/0000333287
5.3.10. Gemtuzumab ozogamicin – MYLOTARG (CAP) – EMA/VR/0000304835
5.3.11. Guanfacine – INTUNIV (CAP) – EMA/VR/0000334464
5.3.12. Ivacaftor / Tezacaftor / Elexacaftor – KAFTRIO (CAP) – EMA/VR/0000320413
5.3.13. Meningococcal Group A, C, W and Y conjugate vaccine – MENQUADFI (CAP) – EMA/VR/0000281377
5.3.14. Methylphenidate hydrochloride – TUZULBY (CAP) – EMA/X/0000327555
5.3.15. Mirabegron – BETMIGA (CAP) – EMA/VR/0000327362
5.3.16. Nivolumab / Relatlimab – OPDUALAG (CAP) – EMA/VR/0000339077
5.3.17. Ocrelizumab – OCREVUS (CAP) – EMA/VR/0000309389
5.3.18. Ocrelizumab – OCREVUS (CAP) – EMA/VR/0000313041
5.3.19. Olezarsen – TRYNGOLZA (CAP) – EMA/VR/0000336189
5.3.20. Omaveloxolone – SKYCLARYS (CAP) – EMA/VR/0000296476
5.3.21. Palbociclib – IBRANCE (CAP) – EMA/VR/0000316536
5.3.22. Pembrolizumab – KEYTRUDA (CAP) – EMA/VR/0000336194
5.3.23. Pirtobrutinib – JAYPIRCA (CAP) – EMA/VR/0000316267
5.3.24. Respiratory syncytial virus mRNA vaccine (nucleoside modified) – mRESVIA (CAP) – EMA/VR/0000320244
5.3.25. Rimegepant – VYDURA (CAP) – EMA/VR/0000339929
5.3.26. Ruxolitinib – OPZELURA (CAP) – EMA/VR/0000313318
5.3.27. Sotorasib – LUMYKRAS (CAP) – EMA/VR/0000339051
5.3.28. Teclistamab – TECVAYLI (CAP) – EMA/VR/0000336274
5.3.29. Tezepelumab – TEZSPIRE (CAP) – EMA/VR/0000321455
5.3.30. Tucatinib – TUYSA (CAP) – EMA/VR/0000337235
6. Periodic safety update reports (PSURs)
6.1. PSUR single assessment (PSUSA) procedures including centrally authorised products (CAPs) only
6.1.1. Acalabrutinib – CALQUENCE (CAP) – EMA/PSUR/0000327904
6.1.2. Acoramidis – BEYONTTRA (CAP) – EMA/PSUR/0000327953
6.1.3. Andexanet alfa – ONDEXXYA (CAP) – EMA/PSUR/0000327908
6.1.4. Avacopan – TAVNEOS (CAP) – EMA/PSUR/0000327958
6.1.5. Axicabtagene ciloleucel – YESCARTA (CAP) – EMA/PSUR/0000327951
6.1.6. Aztreonam / Avibactam – EMBLAVEO (CAP) – EMA/PSUR/0000327924
6.1.7. Belantamab mafodotin – BLENREP (CAP) – EMA/PSUR/0000327952
6.1.8. Beremagene geperpavec – VYJUVEK (CAP) – EMA/PSUR/0000327959
6.1.9. Bevacizumab gamma – LYTENAVA (CAP) – EMA/PSUR/0000327928
6.1.10. Bezlotoxumab – ZINPLAVA (CAP) – EMA/PSUR/0000327891
6.1.11. Bupivacaine – EXPAREL LIPOSOMAL (CAP) – EMA/PSUR/0000327916
6.1.12. Capivasertib – TRUQAP (CAP) – EMA/PSUR/0000327927
6.1.13. Ceritinib – ZYKADIA (CAP) – EMA/PSUR/0000327894
6.1.14. Chikungunya vaccine (live) – IXCHIQ (CAP) – EMA/PSUR/0000327923
6.1.15. Conestat alfa – RUCONEST (CAP) – EMA/PSUR/0000327863
6.1.16. COVID-19 mRNA vaccine – KOSTAIVE (CAP) – EMA/PSUR/0000327932
6.1.17. Delamanid – DELTYBA (CAP) – EMA/PSUR/0000327880
6.1.18. Dinutuximab beta – QARZIBA (CAP) – EMA/PSUR/0000327902
6.1.19. Dopamine hydrochloride – NEOATRICON (CAP) – EMA/PSUR/0000327930
6.1.20. Eculizumab – BEKEMV (CAP); EPYSQLI (CAP); SOLIRIS (CAP) – EMA/PSUR/0000327869
6.1.21. Etranacogene dezaparvovec – HEMGENIX (CAP) – EMA/PSUR/0000327921
6.1.22. Exagamglogene autotemcel – CASGEVY (CAP) – EMA/PSUR/0000327950
6.1.23. Hydrocortisone – EFMODY (CAP); PLENADREN (CAP) – EMA/PSUR/0000327910
6.1.24. Insulin degludec / Liraglutide – XULTOPHY (CAP) – EMA/PSUR/0000327890
6.1.25. Irinotecan hydrochloride trihydrate – ONIVYDE PEGYLATED LIPOSOMAL (CAP) – EMA/PSUR/0000327915
6.1.26. Ivacaftor / Tezacaftor / Elexacaftor – KAFTRIO (CAP) – EMA/PSUR/0000327903
6.1.27. Larotrectinib – VITRAKVI (CAP) – EMA/PSUR/0000327912
6.1.28. Latanoprost – CATIOLANZE (CAP) – EMA/PSUR/0000327866
6.1.29. Lazertinib – LAZCLUZE (CAP) – EMA/PSUR/0000327949
6.1.30. Linvoseltamab – LYNOZYFIC (CAP) – EMA/PSUR/0000327948
6.1.31. Lonafarnib – ZOKINVY (CAP) – EMA/PSUR/0000327913
6.1.32. Loncastuximab tesirine – ZYNLONTA (CAP) – EMA/PSUR/0000327917
6.1.33. Mercaptamine – PROCYSBI (CAP); Mercaptamine bitartrate – CYSTAGON (CAP) – EMA/PSUR/0000327901
6.1.34. Mirvetuximab soravtansine – ELAHERE (CAP) – EMA/PSUR/0000327931
6.1.35. Nintedanib – OFEV (CAP) – EMA/PSUR/0000327881
6.1.36. Nintedanib – VARGATEF (CAP) – EMA/PSUR/0000327882
6.1.37. Niraparib / Abiraterone acetate – AKEEGA (CAP) – EMA/PSUR/0000327922
6.1.38. Nirogacestat – OGSIVEO (CAP) – EMA/PSUR/0000327941
6.1.39. Obecabtagene autoleucel – AUCATZYL (CAP) – EMA/PSUR/0000327934
6.1.40. Palopegteriparatide – YORVIPATH (CAP) – EMA/PSUR/0000327865
6.1.41. Pandemic influenza vaccine (H5N1) (live attenuated, nasal) – PANDEMIC INFLUENZA VACCINE H5N1 ASTRAZENECA (CAP) – EMA/PSUR/0000327887
6.1.42. Panitumumab – VECTIBIX (CAP) – EMA/PSUR/0000327879
6.1.43. Parathyroid hormone – NATPAR (CAP) – EMA/PSUR/0000327892
6.1.44. Pegcetacoplan – ASPAVELI (CAP) – EMA/PSUR/0000327907
6.1.45. Piperaquine tetraphosphate / Artenimol – EURARTESIM (CAP) – EMA/PSUR/0000327942
6.1.46. Prucalopride – RESOLOR (CAP) – EMA/PSUR/0000327877
6.1.47. rADAMTS13 – ADZYNMA (CAP) – EMA/PSUR/0000327926
6.1.48. Raltegravir – ISENTRESS (CAP) – EMA/PSUR/0000327884
6.1.49. Ranibizumab – BYOOVIZ (CAP); EPRUVY (CAP); LUCENTIS (CAP); RANIVISIO (CAP); RIMMYRAH (CAP); XIMLUCI (CAP) – EMA/PSUR/0000327906
6.1.50. RdESAT-6 / rCFP-10 – SIILTIBCY (CAP) – EMA/PSUR/0000327947
6.1.51. Repotrectinib – AUGTYRO (CAP) – EMA/PSUR/0000327933
6.1.52. Selpercatinib – RETSEVMO (CAP) – EMA/PSUR/0000327889
6.1.53. Setmelanotide – IMCIVREE (CAP) – EMA/PSUR/0000327886
6.1.54. Sirolimus – HYFTOR (CAP) – EMA/PSUR/0000327938
6.1.55. Sotorasib – LUMYKRAS (CAP) – EMA/PSUR/0000327925
6.1.56. Tofersen – QALSODY (CAP) – EMA/PSUR/0000327929
6.1.57. Vamorolone – AGAMREE (CAP) – EMA/PSUR/0000327937
6.1.58. Vandetanib – CAPRELSA (CAP) – EMA/PSUR/0000327919
6.1.59. Volanesorsen – WAYLIVRA (CAP) – EMA/PSUR/0000327897
6.1.60. Zanidatamab – ZIIHERA (CAP) – EMA/PSUR/0000327940
6.1.61. Zanubrutinib – BRUKINSA (CAP) – EMA/PSUR/0000327900
6.2. PSUR single assessment (PSUSA) procedures including centrally authorised products (CAPs) and nationally authorised products (NAPs)
6.2.1. Deferasirox - DEFERASIROX ACCORD (CAP); DEFERASIROX MYLAN (CAP); EXJADE (CAP), NAP – EMA/PSUR/0000327939
6.2.2. Methotrexate - JYLAMVO (CAP); NORDIMET (CAP), NAP – EMA/PSUR/0000327873
6.2.3. Stiripentol - DIACOMIT (CAP), NAP – EMA/PSUR/0000327885
6.2.4. Tadalafil - ADCIRCA (CAP); CIALIS (CAP); TADALAFIL LILLY (CAP), NAP – EMA/PSUR/0000327895
6.3. PSUR single assessment (PSUSA) procedures including nationally authorised products (NAPs) only
6.3.1. A-tocopheril, a-tocopherol, vitamin E – EMA/PSUR/0000327898
6.3.2. A-tocopherol / ergocalciferol / phytomenadion / retinol palmitate – EMA/PSUR/0000327883
6.3.3. Acetylsalicylic acid / chlorphenamine / phenylephrine – EMA/PSUR/0000327862
6.3.4. Aluminium chloride hexahydrate – EMA/PSUR/0000327918
6.3.5. Aminosalicylic acid – EMA/PSUR/0000327860
6.3.6. Amlodipine / atorvastatin / perindopril, amlodipine / atorvastatin / rampiril – EMA/PSUR/0000327896
6.3.7. Artemether / lumefantrin (apart from the dispersible tablet) – EMA/PSUR/0000327946
6.3.8. Ascorbic acid / caffeine / paracetamol / phenylephrine hydrochloride / terpine – EMA/PSUR/0000327878
6.3.9. Bisoprolol – EMA/PSUR/0000327936
6.3.10. Bisoprolol / perindopril – EMA/PSUR/0000327893
6.3.11. Bromhexine – EMA/PSUR/0000327935
6.3.12. Carbidopa / levodopa – EMA/PSUR/0000327864
6.3.13. Cinnarizine / dimenhydrinate – EMA/PSUR/0000327867
6.3.14. Clenbuterol – EMA/PSUR/0000327861
6.3.15. Cyanocobalamin / folic acid, cyanocobalamin / folic acid / potassium iodide – EMA/PSUR/0000327944
6.3.16. Desogestrel / ethinylestradiol – EMA/PSUR/0000327943
6.3.17. Dinoprostone – EMA/PSUR/0000327945
6.3.18. Felbamate – EMA/PSUR/0000327920
6.3.19. Human coagulation factor VII – EMA/PSUR/0000327871
6.3.20. Isoflurane – EMA/PSUR/0000327868
6.3.21. Minoxidil (non topical formulations) – EMA/PSUR/0000327876
6.3.22. Perindopril – EMA/PSUR/0000327874
6.3.23. Pipamperone – EMA/PSUR/0000327872
6.3.24. Prothipendyl – EMA/PSUR/0000327875
6.3.25. Ramipril / bisoprolol – EMA/PSUR/0000327914
6.3.26. Salmeterol – EMA/PSUR/0000327888
6.3.27. Sulbutiamine – EMA/PSUR/0000327905
6.3.28. Terbinafine – EMA/PSUR/0000327909
6.3.29. Valsartan / rosuvastatin – EMA/PSUR/0000327899
6.4. Follow-up to PSUR/PSUSA procedures
6.4.1. Semaglutide – RYBELSUS (CAP) – EMA/PAM/0000337900
6.4.2. Semaglutide – WEGOVY (CAP); WEGOVY FLEXTOUCH (CAP) – EMA/PAM/0000337800
6.4.3. Semaglutide – OZEMPIC (CAP) – EMA/PAM/0000338018
6.4.4. Voretigene neparvovec – LUXTURNA (CAP) – EMA/PAM/0000339319
6.5. Variation procedure(s) resulting from PSUSA evaluation
6.5.1. Tacrolimus ADVAGRAF (CAP); MODIGRAF (CAP), NAP – EMA/VR/0000319175
6.6. Expedited summary safety reviews
7. Post-authorisation safety studies (PASS)
7.1. Protocols of PASS imposed in the marketing authorisation(s)
7.1.1. Donanemab – KISUNLA (CAP) – EMA/PASS/0000339404
7.1.2. Donanemab – KISUNLA (CAP) – EMA/PASS/0000339391
7.1.3. Mirdametinib – EZMEKLY (CAP) – EMA/PASS/0000340654
7.1.4. Topiramate (NAP) – EMA/PASS/0000340662
7.2. Protocols of PASS non-imposed in the marketing authorisation(s)
7.2.1. Ciltacabtagene autoleucel – CARVYKTI (CAP) – EMA/PAM/0000338559
7.2.2. COVID-19 mRNA vaccine – MNEXSPIKE (CAP) – EMA/PAM/0000339594
7.2.3. Donanemab – KISUNLA (CAP) – EMA/PAM/0000338752
7.2.4. Efgartigimod alfa – VYVGART (CAP) – EMA/PAM/0000343589
7.2.5. Resmetirom – REZDIFFRA (CAP) – EMA/PAM/0000339780
7.2.6. Teprotumumab – TEPEZZA (CAP) – EMA/PAM/0000310214
7.2.7. Tofacitinib – XELJANZ (CAP) – EMA/PAM/0000316639
7.2.8. Upadacitinib – RINVOQ (CAP) – EMA/PAM/0000339078
7.2.9. Vonicog alfa – VEYVONDI (CAP) – EMA/PAM/0000337712
7.3. Results of PASS imposed in the marketing authorisation(s)
7.3.1. Belimumab – BENLYSTA (CAP) – EMA/PASS/0000306411
7.4. Results of PASS imposed and non-imposed in the marketing authorisation(s)
7.4.1. COVID-19 mRNA vaccine – COMIRNATY (CAP); COMIRNATY JN.1 (CAP); COMIRNATY KP.2 (CAP); COMIRNATY LP.8.1 (CAP); COMIRNATY OMICRON XBB.1.5 (CAP); COMIRNATY ORIGINAL/OMICRON BA.4-5 (CAP) – EMA/VR/0000334558
7.4.2. Ivacaftor / Tezacaftor / Elexacaftor – KAFTRIO (CAP) – EMA/VR/0000319887
7.4.3. Laronidase – ALDURAZYME (CAP) – EMA/VR/0000282056
7.4.4. Semaglutide – OZEMPIC (CAP); RYBELSUS (CAP) – EMA/VR/0000334523
7.5. Interim results and other post-authorisation measures for imposed and non-imposed studies
7.5.1. Avacopan – TAVNEOS (CAP) – EMA/PAM/0000336195
7.5.2. Cabotegravir – VOCABRIA (CAP) – EMA/PAM/0000339050
7.5.3. Cabotegravir – VOCABRIA (CAP) – EMA/PAM/0000339531
7.5.4. COVID-19 vaccine (recombinant, adjuvanted) – NUVAXOVID (CAP); NUVAXOVID JN.1 (CAP); NUVAXOVID XBB.1.5 (CAP) – EMA/PAM/0000317251
7.5.5. Damoctocog alfa pegol – JIVI (CAP) – EMA/PAM/0000303584
7.5.6. Efgartigimod alfa – VYVGART (CAP) – EMA/PAM/0000339564
7.5.7. Fenfluramine – FINTEPLA (CAP) – EMA/PAM/0000339786
7.5.8. Lecanemab – LEQEMBI (CAP) – EMA/PAM/0000339581
7.5.9. Maribavir – LIVTENCITY (CAP) – EMA/PAM/0000334575
7.5.10. Mercaptamine – CYSTADROPS (CAP) – EMA/PAM/0000339522
7.5.11. Ofatumumab – KESIMPTA (CAP) – EMA/PAM/0000308145
7.5.12. Ofatumumab – KESIMPTA (CAP) – EMA/PAM/0000337728
7.5.13. Rilpivirine – REKAMBYS (CAP) – EMA/PAM/0000338758
7.5.14. Sarilumab – KEVZARA (CAP) – EMA/PAM/0000339607
7.5.15. Tofacitinib – XELJANZ (CAP) – EMA/PAM/0000334570
7.5.16. Velaglucerase alfa – VPRIV (CAP) – EMA/PAM/0000339048
8. Renewals of the marketing authorisation, conditional renewal and annual reassessments
8.1. Annual reassessments of the marketing authorisation
8.1.1. Amifampridine – FIRDAPSE (CAP) – EMA/S/0000337252
8.1.2. Clofarabine – EVOLTRA (CAP) – EMA/S/0000335797
8.1.3. Glucarpidase – VORAXAZE (CAP) – EMA/S/0000322329
8.1.4. Maralixibat – LIVMARLI (CAP) – EMA/S/0000317715
8.1.5. Velmanase alfa – LAMZEDE (CAP) – EMA/S/0000336192
8.2. Conditional renewals of the marketing authorisation
8.2.1. Epcoritamab – TEPKINLY (CAP) – EMA/R/0000334812
8.2.2. Pirtobrutinib – JAYPIRCA (CAP) – EMA/R/0000339971
8.3. Renewals of the marketing authorisation
8.3.1. Abrocitinib – CIBINQO (CAP) – EMA/R/0000336009
8.3.2. Anifrolumab – SAPHNELO (CAP) – EMA/R/0000335943
8.3.3. Artesunate – ARTESUNATE AMIVAS (CAP) – EMA/R/0000333258
8.3.4. Eptinezumab – VYEPTI (CAP) – EMA/R/0000336059
8.3.5. Semaglutide – WEGOVY (CAP); WEGOVY FLEXTOUCH (CAP) – EMA/R/0000336288
8.3.6. Sitagliptin fumarate – SITAGLIPTIN SUN (CAP) – EMA/R/0000335931
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
10.1.1. Levofloxacin (intravenous and oral use) – DE/H/5119/001-003/II/118
10.1.2. Mycobacterium bovis BCG, Danish strain 1331 – DK/H/3659/001/II/001
10.1.3. Upadacitinib – RINVOQ (CAP) – EMA/VR/0000312506
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
12.1.3. Scientific Committee Meetings – alternating face-to-face and virtual meetings schedule for 2027
12.2. Coordination with EMA Scientific Committees or CMDh-v
12.3. Coordination with EMA Working Parties/Working Groups/Drafting Groups
12.3.1. Healthcare Professionals Working Party (HCPWP) and Patients and Consumers Working Party (PCWP) – 2025-2028
12.3.2. SAWP-PRAC consultation procedure – guidance update
12.4. Cooperation within the EU regulatory network
12.5. Cooperation with International Regulators
12.5.1. Opening procedures at EMA to non-EU authorities (OPEN) framework – PRAC involvement
12.6. Contacts of the PRAC with external parties and interaction with the Interested Parties to the Committee
12.7. PRAC work plan
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. PSURs repository
12.10.3. Union reference date list – consultation on the draft list
12.11. Signal management
12.11.1. Good Pharmacovigilance Practice (GVP) module IX on signal management – revision 2
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
12.21. Others
12.21.1. Benzyl alcohol and benzoic acid used as excipients in medicinal products - revised labelling requirements
13. Any other business
14. Explanatory notes
09.06.2026
Datei
PD
