WC500185968

14.1.28. Dolutegravir, abacavir, lamivudine – TRIUMEQ (CAP) ....................................... 67
14.1.29. Eltrombopag – REVOLADE (CAP) .................................................................... 67
14.1.30. Epoetin beta – NEORECORMON (CAP) ............................................................. 68
14.1.31. Golimumab – SIMPONI (CAP) ........................................................................ 68
14.1.32. Insulin degludec, liraglutide – XULTOPHY (CAP) ............................................... 68
14.1.33. Insulin degludec, liraglutide – XULTOPHY (CAP) ............................................... 68
14.1.34. Maraviroc – CELSENTRI (CAP) ....................................................................... 69
14.1.35. Methylnaltrexone bromide – RELISTOR (CAP) .................................................. 69
14.1.36. Perampanel – FYCOMPA (CAP) ....................................................................... 69
14.1.37. Ponatinib – ICLUSIG (CAP) ............................................................................ 69
14.1.38. Regorafenib – STIVARGA (CAP) ..................................................................... 70
14.1.39. Rituximab – MABTHERA (CAP) ....................................................................... 70
14.1.40. Vemurafenib – ZELBORAF (CAP) .................................................................... 70
14.1.41. Vismodegib – ERIVEDGE (CAP) ...................................................................... 70
RMP evaluated in the context of a five-year renewal of the marketing authorisation .......... 71
14.1.42. Filgrastim – NIVESTIM (CAP) ......................................................................... 71
15. ANNEX I - Periodic Safety Update Reports (PSURs) ............................. 71
Evaluation of PSUR procedures ................................................................................... 71
15.1.1. Azilsartan medoxomil – EDARBI (CAP), IPREZIV (CAP) ....................................... 71
15.1.2. Bosutinib – BOSULIF (CAP) ............................................................................. 72
15.1.3. Brentuximab vedotin – ADCETRIS (CAP) ........................................................... 72
15.1.4. Cobicistat – TYBOST (CAP) .............................................................................. 72
15.1.5. Cobicistat, elvitegravir, emtricitabine, tenofovir disoproxil – STRIBILD (CAP) ........ 72
15.1.6. Crizotinib – XALKORI (CAP) ............................................................................. 72
15.1.7. Dabrafenib – TAFINLAR (CAP) ......................................................................... 73
15.1.8. Deferiprone – FERRIPROX (CAP) ...................................................................... 73
15.1.9. Dexmedetomidine – DEXDOR (CAP) ................................................................. 73
15.1.10. Elosulfase alfa – VIMIZIM (CAP) ..................................................................... 73
15.1.11. Elvitegravir – VITEKTA (CAP) ......................................................................... 73
15.1.12. Fenofibrate, simvastatin – CHOLIB (CAP) ........................................................ 74
15.1.13. Florbetaben ( 18 F) – NEURACEQ (CAP) ............................................................. 74
15.1.14. Pioglitazone - ACTOS (CAP), GLUSTIN (CAP), NAP pioglitazone, glimepiride -
TANDEMACT (CAP) pioglitazone, metformin – COMPETACT (CAP), GLUBRAVA (CAP) ......... 74
15.1.15. Human coagulation factor VIII, human von willebrand factor – VONCENTO (CAP) 74
15.1.16. Ibuprofen – PEDEA (CAP) .............................................................................. 74
15.1.17. Influenza vaccine (split virion, inactivated) – IDFLU (CAP), INTANZA (CAP) ......... 75
15.1.18. Influenza vaccine (surface antigen, inactivated, prepared in cell cultures) –
OPTAFLU (CAP)......................................................................................................... 75
15.1.19. Linaclotide – CONSTELLA (CAP) ..................................................................... 75
15.1.20. Loxapine – ADASUVE (CAP) ........................................................................... 75
15.1.21. Midazolam – BUCCOLAM (CAP) ...................................................................... 75
15.1.22. Moroctocog alfa – REFACTO AF (CAP) ............................................................. 76
15.1.23. Nonacog alfa – BENEFIX (CAP) ...................................................................... 76
15.1.24. Pirfenidone – ESBRIET (CAP) ......................................................................... 76
Pharmacovigilance Risk Assessment Committee (PRAC)
EMA/PRAC/257790/2015 Page 8/89