1u7kf0g

15.1.12. Human normal immunoglobulin – HYQVIA (CAP) .............................................. 62
15.1.13. Human papillomavirus vaccine [types 16, 18] (recombinant, adjuvanted, adsorbed)
– CERVARIX (CAP) .................................................................................................... 62
15.1.14. Hydroxocobalamin – CYANOKIT (CAP), NAP .................................................... 62
15.1.15. Indacaterol – HIROBRIZ BREEZHALER (CAP), ONBREZ BREEZHALER (CAP), OSLIF
BREEZHALER (CAP) ................................................................................................... 62
15.1.16. Irbesartan, hydrochlorothiazide – COAPROVEL (CAP), KARVEZIDE (CAP),
IRBESARTAN HYDROCHLOROTHIAZIDE ZENTIVA (CAP), NAP ......................................... 63
15.1.17. Linaclotide – CONSTELLA (CAP) ..................................................................... 63
15.1.18. Pandemic influenza vaccine (H1N1) (whole virion, inactivated, prepared in cell
culture) – CELVAPAN (CAP) ........................................................................................ 63
15.1.19. Pegvisomant – SOMAVERT (CAP) ................................................................... 63
15.1.20. Piperaquine, dihydroartemisinin – EURARTESIM (CAP) ...................................... 63
15.1.21. Radium-223 – XOFIGO (CAP) ........................................................................ 64
15.1.22. Rilpivirine – EDURANT (CAP) ......................................................................... 64
15.1.23. Rituximab – MABTHERA (CAP) ....................................................................... 64
15.1.24. Rotavirus vaccine, live, oral – ROTATEQ (CAP) ................................................. 64
15.1.25. Sapropterin – KUVAN (CAP) .......................................................................... 64
15.1.26. Saxagliptin, metformin – KOMBOGLYZE (CAP) ................................................. 64
15.1.27. Stiripentol – DIACOMIT (CAP) ........................................................................ 65
15.1.28. Tafamidis – VYNDAQEL (CAP) ........................................................................ 65
15.2. Follow-up to PSUR procedures ............................................................................ 65
15.2.1. Infliximab – REMICADE (CAP).......................................................................... 65
16. ANNEX I Post-authorisation Safety Studies (PASS) ............................. 65
16.1. Protocols of PASS imposed in the marketing authorisation(s) ................................. 66
16.1.1. Flupirtine (NAP) ............................................................................................. 66
16.2. Protocols of PASS non-imposed in the marketing authorisation(s) ........................... 66
16.2.1. Aliskiren – RASILEZ (CAP) .............................................................................. 66
16.2.2. Catridecacog – NOVOTHIRTEEN (CAP) .............................................................. 66
16.2.3. Darunavir – PREZISTA (CAP) ........................................................................... 66
16.2.4. Eltrombopag – REVOLADE (CAP)...................................................................... 67
16.2.5. Florbetaben ( 18 F) – NEURACEQ (CAP) ............................................................... 67
16.2.6. Human coagulation factor VIII, human von Willibrand factor – VONCENTO (CAP) ... 67
16.2.7. Insulin glargine – LANTUS (CAP) ...................................................................... 67
16.2.8. Insulin glulisine – APIDRA (CAP) ...................................................................... 68
16.2.9. Ranibizumab – LUCENTIS (CAP) ...................................................................... 68
16.2.10. Sodium oxybate – XYREM (CAP) .................................................................... 68
16.2.11. Telavancin – VIBATIV (CAP) .......................................................................... 68
16.2.12. Tenofovir disoproxil – VIREAD (CAP) .............................................................. 68
16.3. Results of PASS imposed in the marketing authorisation(s) .................................... 69
16.4. Results of PASS non-imposed in the marketing authorisation(s) ............................. 69
16.4.1. Ceftaroline fosamil – ZINFORO (CAP) ............................................................... 69
16.4.2. Eltrombopag – REVOLADE (CAP)...................................................................... 69
16.4.3. Etanercept – ENBREL (CAP) ............................................................................ 69
16.4.4. Pandemic influenza vaccine (H1N1) (split virion, inactivated, adjuvanted) –
PANDEMRIX (CAP) .................................................................................................... 70
Pharmacovigilance Risk Assessment Committee (PRAC)
EMA/PRAC/438418/2014 Page 9/75