WC500165698

15.1.8. Dronedarone – MULTAQ (CAP) ......................................................................... 51
15.1.9. Emtricitabine, rilpivirine, tenofovir disoproxil – EVIPLERA (CAP) ........................... 52
15.1.10. Human coagulation factor IX – NONAFACT (CAP), NAPs .................................... 52
15.1.11. Human protein C – CEPROTIN (CAP), NAP ....................................................... 52
15.1.12. Influenza vaccine (surface antigen, inactivated, prepared in cell cultures) –
OPTAFLU (CAP)......................................................................................................... 52
15.1.13. Loxapine – ADASUVE (CAP) ........................................................................... 52
15.1.14. Moroctocog alfa – REFACTO AF (CAP) ............................................................. 53
15.1.15. Nalmefene – SELINCRO (CAP) ....................................................................... 53
15.1.16. Natalizumab – TYSABRI (CAP) ....................................................................... 53
15.1.17. Nomegestrol, estradiol – IOA (CAP), ZOELY (CAP) ............................................ 53
15.1.18. Nonacog alfa – BENEFIX (CAP) ...................................................................... 53
15.1.19. Orlistat – ALLI (CAP) .................................................................................... 54
15.1.20. Pioglitazone – ACTOS (CAP), GLUSTIN (CAP), NAP Pioglitazone, glimepiride –
TANDEMACT (CAP) Pioglitazone, metformin – COMPETACT (CAP), GLUBRAVA (CAP) ......... 54
15.1.21. Prasugrel – EFIENT (CAP) ............................................................................. 54
15.1.22. Romiplostim – NPLATE (CAP) ......................................................................... 54
15.1.23. Telavancin – VIBATIV (CAP) .......................................................................... 54
15.1.24. Telbivudine – SEBIVO (CAP) .......................................................................... 55
15.1.25. Tocofersolan – VEDROP (CAP) ....................................................................... 55
15.1.26. Ulipristal – ESMYA (CAP) ............................................................................... 55
15.1.27. Vemurafenib – ZELBORAF (CAP) .................................................................... 55
15.1.28. Vismodegib – ERIVEDGE (CAP) ...................................................................... 55
15.2. Follow-up to PSUR procedures ............................................................................ 56
15.2.1. Voriconazole – VFEND (CAP) ........................................................................... 56
16. ANNEX I Post-authorisation Safety Studies (PASS) ............................. 56
16.1. Protocols of PASS imposed in the marketing authorisation(s) ...................... 56
16.1.1. Brentuximab vedotin - ADCETRIS (CAP) ........................................................... 56
16.1.2. Defibrotide - DEFITELIO (CAP) ........................................................................ 56
16.2. Protocols of PASS non-imposed in the marketing authorisation(s) ............... 57
16.2.1. Colistimethate sodium – COLOBREATHE (CAP) .................................................. 57
16.2.2. Elvitegravir, cobicistat, emtricitabine, tenofovir disoproxil – STRIBILD (CAP) ......... 57
16.2.3. Fenofibrate, pravastatin – PRAVAFENIX (CAP) ................................................... 57
16.2.4. Insulin degludec – TRESIBA (CAP) ................................................................... 57
16.3. Results of PASS imposed in the marketing authorisation(s) .................................... 58
16.4. Results of PASS non-imposed in the marketing authorisation(s) ............................. 58
16.4.1. Agomelatine – THYMANAX (CAP), VALDOXAN (CAP) ........................................... 58
16.4.2. Buprenorphine, naloxone – SUBOXONE (CAP) ................................................... 58
16.4.3. Buprenorphine, naloxone – SUBOXONE (CAP) ................................................... 58
16.4.4. Buprenorphine, naloxone – SUBOXONE (CAP) ................................................... 58
16.4.5. Human rotavirus – ROTARIX (CAP) .................................................................. 59
16.5. Interim results of imposed and non-imposed PASS and results of non-imposed PASS
submitted before the entry into force of the revised variations regulation ........................ 59
16.5.1. Apixaban – ELIQUIS (CAP) .............................................................................. 59
Pharmacovigilance Risk Assessment Committee (PRAC)
EMA/PRAC/253432/2014 Page 7/64