WC500165698

14.1.4. Idelalisib ....................................................................................................... 43
14.1.5. Ibrutinib ....................................................................................................... 43
14.1.6. Mifepristone .................................................................................................. 44
14.1.7. Nonacog gamma ............................................................................................ 44
14.1.8. Perflubutane ................................................................................................. 44
14.1.9. Secukinumab ................................................................................................ 44
14.1.10. Simeprevir .................................................................................................. 44
14.1.11. Simoctocog alfa ........................................................................................... 44
14.1.12. Tacrolimus .................................................................................................. 44
14.1.13. Tobramycin ................................................................................................. 45
14.1.14. Trametinib .................................................................................................. 45
14.2. Medicines already authorised ............................................................................. 45
RMP in the context of a variation – PRAC led procedure ................................................. 45
14.2.1. Dabigatran – PRADAXA (CAP) .......................................................................... 45
14.2.2. Human fibrinogen, human thrombin – EVICEL (CAP) .......................................... 45
14.2.3. Insulin glulisine – APIDRA (CAP) ...................................................................... 45
14.2.4. Prucalopride – RESOLOR (CAP) ........................................................................ 46
14.2.5. Tegafur, gimeracil, oteracil – TEYSUNO (CAP) ................................................... 46
RMP in the context of a variation – CHMP led procedure................................................. 46
14.2.6. Abiraterone – ZYTIGA (CAP) ............................................................................ 46
14.2.7. Adefovir dipivoxil – HEPSERA (CAP) ................................................................. 46
14.2.8. Amifampridine – FIRDAPSE (CAP) .................................................................... 47
14.2.9. Anidulafungin – ECALTA (CAP) ......................................................................... 47
14.2.10. Ceftaroline fosamil – ZINFORO (CAP) ............................................................. 47
14.2.11. Eslicarbazepine – ZEBINIX (CAP) ................................................................... 47
14.2.12. Exenatide – BYDUREON (CAP) ....................................................................... 48
14.2.13. Golimumab – SIMPONI (CAP) ........................................................................ 48
14.2.14. Human fibrogen, human thrombin – EVARREST (CAP) ...................................... 48
14.2.15. Iloprost – VENTAVIS (CAP)............................................................................ 48
14.2.16. Pandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) –
FOCLIVIA (CAP) ........................................................................................................ 48
14.2.17. Pasireotide – SIGNIFOR (CAP) ....................................................................... 49
14.2.18. Ponatinib – ICLUSIG (CAP) ............................................................................ 49
RMP in the context of a PSUR procedure ...................................................................... 49
RMP evaluated in the context of PASS results ............................................................... 49
RMP in the context of a renewal of the marketing authorisation, conditional renewal or
annual reassessment ................................................................................................. 50
15. ANNEX I Assessment of Periodic Safety Update Reports (PSURs) ....... 50
15.1. Evaluation of PSUR procedures ..................................................................... 50
15.1.1. Aflibercept – ZALTRAP (CAP) ........................................................................... 50
15.1.2. Agalsidase beta – FABRAZYME (CAP) ................................................................ 50
15.1.3. Asenapine – SYCREST (CAP) ........................................................................... 50
15.1.4. Axitinib – INLYTA (CAP) .................................................................................. 51
15.1.5. Azilsartan medoxomil – EDARBI (CAP), IPREZIV (CAP) ....................................... 51
15.1.6. Brentuximab vedotin – ADCETRIS (CAP) ........................................................... 51
15.1.7. Catridecacog – NOVOTHIRTEEN (CAP) .............................................................. 51
Pharmacovigilance Risk Assessment Committee (PRAC)
EMA/PRAC/253432/2014 Page 6/64