1u7kf0g

14.1.23. Apixaban – ELIQUIS (CAP) ............................................................................ 53
14.1.24. Bevacizumab – AVASTIN (CAP) ...................................................................... 53
14.1.25. Cetuximab – ERBITUX (CAP) ......................................................................... 54
14.1.26. Darunavir – PREZISTA (CAP) ......................................................................... 54
14.1.27. Dexamethasone – OZURDEX (CAP) ................................................................ 54
14.1.28. Eslicarbazepine – ZEBINIX (CAP) ................................................................... 54
14.1.29. Etanercept – ENBREL (CAP) ........................................................................... 54
14.1.30. Fidaxomicin – DIFICLIR (CAP) ....................................................................... 55
14.1.31. Ivacaftor – KALYDECO (CAP) ......................................................................... 55
14.1.32. Leflunomide – ARAVA (CAP), LEFLUNOMIDE WINTHROP (CAP) .......................... 55
14.1.33. Lixisenatide – LYXUMIA (CAP) ........................................................................ 55
14.1.34. Ibandronic acid – IBANDRONIC ACID ACCORD (CAP) ....................................... 56
14.1.35. Methylnaltrexone – RELISTOR (CAP) .............................................................. 56
14.1.36. Nilotinib – TASIGNA (CAP) ............................................................................ 56
14.1.37. Palivizumab – SYNAGIS (CAP) ....................................................................... 56
14.1.38. Pandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) –
ADJUPANRIX (CAP) ................................................................................................... 57
14.1.39. Pneumococcal polysaccharide conjugate vaccine (adsorbed) – SYNFLORIX (CAP) . 57
14.1.40. Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) –
PREPANDRIX (CAP) ................................................................................................... 57
14.1.41. Pyronaridine, artesunate – PYRAMAX (Art 58) .................................................. 57
14.1.42. Regorafenib – STIVARGA (CAP) ..................................................................... 58
14.1.43. Saxagliptin – ONGLYZA (CAP) saxagliptin, metformin – KOMBOGLYZE (CAP) ....... 58
14.1.44. Temsirolimus – TORISEL (CAP) ...................................................................... 58
RMP evaluated in the context of a renewal of the marketing authorisation, conditional
renewal or annual reassessment ................................................................................. 58
14.1.45. Lamivudine, abacavir – KIVEXA (CAP) ............................................................ 58
RMP evaluated in the context of a stand-alone RMP procedure ........................................ 59
14.1.46. Atosiban – TRACTOCILE (CAP) ....................................................................... 59
14.1.47. Oseltamivir – TAMIFLU (CAP) ........................................................................ 59
14.1.48. Pandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) –
ADJUPANRIX (CAP), PUMARIX (CAP) ........................................................................... 59
14.1.49. Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) –
PREPANDRIX (CAP) ................................................................................................... 59
15. ANNEX I Periodic Safety Update Reports (PSURs) ............................... 59
Evaluation of PSUR procedures ................................................................................... 60
15.1.1. Alogliptin – VIPIDIA (CAP) .............................................................................. 60
15.1.2. Alogliptin, metformin – VIPDOMET (CAP) .......................................................... 60
15.1.3. Alogliptin, pioglitazone – INCRESYNC (CAP) ...................................................... 60
15.1.4. Apixaban – ELIQUIS (CAP) .............................................................................. 60
15.1.5. Bosentan – STAYVEER (CAP), TRACLEER (CAP) ................................................. 60
15.1.6. Bromfenac – YELLOX (CAP) ............................................................................. 61
15.1.7. Conestat alfa – RUCONEST (CAP) .................................................................... 61
15.1.8. Copper ( 64 Cu) chloride – CUPRYMINA (CAP) ...................................................... 61
15.1.9. Eribulin – HALAVEN (CAP) ............................................................................... 61
15.1.10. Erlotinib – TARCEVA (CAP) ............................................................................ 61
15.1.11. Fidaxomicin – DIFICLIR (CAP) ....................................................................... 62
Pharmacovigilance Risk Assessment Committee (PRAC)
EMA/PRAC/438418/2014 Page 8/75