WC500185968

12.15. Contacts of the PRAC with external parties and interaction of the EMA with interested
parties ..................................................................................................................... 60
12.15.1. Guidelines of the International Conference on Harmonisation of Technical
Requirements for Registration of Pharmaceuticals for Human Use (ICH) .......................... 60
12.15.2. Others ........................................................................................................ 60
12.16. Others ........................................................................................................... 60
13. Any other business .............................................................................. 60
13.1. Medication errors .............................................................................................. 60
13.2. Pharmacovigilance programme and revised implementation governance .................. 61
13.3. Product Information: revision of the review process for initial marketing authorisation
.............................................................................................................................. 61
13.4. Type II variations: revised procedural timetables .................................................. 61
14. ANNEX I - Risk Management Plans ...................................................... 62
Medicines in the pre-authorisation phase ..................................................................... 62
14.1.1. Allogenic human heterologous liver cells ........................................................... 62
14.1.2. Aripiprazole ................................................................................................... 62
14.1.3. Atazanavir, cobicistat ..................................................................................... 62
14.1.4. Dasiprotimut ................................................................................................. 62
14.1.5. Docetaxel ..................................................................................................... 62
14.1.6. Ferric citrate coordination complex ................................................................... 63
14.1.7. Guanfacine.................................................................................................... 63
14.1.8. Human alfa1-proteinase inhibitor ..................................................................... 63
14.1.9. Lumacaftor, ivacaftor ..................................................................................... 63
14.1.10. Mercaptamine .............................................................................................. 63
14.1.11. Netupitant, palonosetron ............................................................................... 63
14.1.12. Parathyroid hormone .................................................................................... 63
14.1.13. Pemetrexed ................................................................................................. 64
14.1.14. Pregabalin ................................................................................................... 64
14.1.15. Pregabalin ................................................................................................... 64
14.1.16. Voriconazole ................................................................................................ 64
Medicines already authorised ...................................................................................... 64
RMP in the context of a variation – PRAC-led procedure ................................................. 64
14.1.17. Desloratadine – AERIUS (CAP), AZOMYR (CAP), NEOCLARITYN (CAP) ................. 64
14.1.18. Ibritumomab tiuxetan – ZEVALIN (CAP) .......................................................... 65
14.1.19. Pioglitazone – ACTOS (CAP), GLUSTIN (CAP) pioglitazone, metformin – COMPETACT
(CAP), GLUBRAVA (CAP) pioglitazone, glimepiride – TANDEMACT (CAP)........................... 65
14.1.20. Pregabalin – LYRICA (CAP) ............................................................................ 65
14.1.21. Teduglutide – REVESTIVE (CAP) .................................................................... 65
RMP in the context of a variation – CHMP-led procedure ................................................ 66
14.1.22. Abatacept – ORENCIA (CAP) .......................................................................... 66
14.1.23. Aflibercept – EYLEA (CAP) ............................................................................. 66
14.1.24. Ambrisentan – VOLIBRIS (CAP) ..................................................................... 66
14.1.25. Capsaicin – QUTENZA (CAP) .......................................................................... 66
14.1.26. Dolutegravir, abacavir, lamivudine – TRIUMEQ (CAP) ....................................... 67
14.1.27. Dolutegravir, abacavir, lamivudine – TRIUMEQ (CAP) ....................................... 67
Pharmacovigilance Risk Assessment Committee (PRAC)
EMA/PRAC/257790/2015 Page 7/89