ongoing

5.3.1. Abiraterone – ZYTIGA (CAP) - EMEA/H/C/002321/X/0039............................................. 19
5.3.2. Aflibercept – EYLEA (CAP) - EMEA/H/C/002392/II/0027/G ............................................ 19
5.3.3. Ataluren – TRANSLARNA (CAP) - EMEA/H/C/002720/II/0012 ........................................ 19
5.3.4. Ataluren – TRANSLARNA (CAP) - EMEA/H/C/002720/II/0019 ........................................ 19
5.3.5. Capecitabine – XELODA (CAP) - EMEA/H/C/000316/II/0070 .......................................... 20
5.3.6. Carfilzomib – KYPROLIS (CAP) - EMEA/H/C/003790/II/0001/G ...................................... 20
5.3.7. Ceritinib – ZYKADIA (CAP) - EMEA/H/C/003819/II/0006/G ........................................... 20
5.3.8. Cobimetinib – COTELLIC (CAP) - EMEA/H/C/003960/II/0004/G ..................................... 20
5.3.9. Crizotinib – XALKORI (CAP) - EMEA/H/C/002489/II/0039 ............................................. 21
5.3.10. Dolutegravir – TIVICAY (CAP) - EMEA/H/C/002753/X/0018/G ....................................... 21
5.3.11. Eltrombopag, eltrombopag olamine – REVOLADE (CAP) - EMEA/H/C/001110/II/0029/G ... 21
5.3.12. Empagliflozin, metformin – SYNJARDY (CAP) - EMEA/H/C/003770/II/0015 ..................... 21
5.3.13. Erlotinib – TARCEVA (CAP) - EMEA/H/C/000618/II/0045 .............................................. 22
5.3.14. Evolocumab – REPATHA (CAP) - EMEA/H/C/003766/X/0002 .......................................... 22
5.3.15. Golimumab – SIMPONI (CAP) - EMEA/H/C/000992/II/0063 .......................................... 22
5.3.16. Golimumab – SIMPONI (CAP) - EMEA/H/C/000992/II/0067 .......................................... 22
5.3.17. Imiquimod – ALDARA (CAP) - EMEA/H/C/000179/II/0067 ............................................. 22
5.3.18. Linagliptin – TRAJENTA (CAP) - EMEA/H/C/002110/WS/0915 linagliptin, metformin –
JENTADUETO (CAP) - EMEA/H/C/002279/WS/0915 ...................................................... 23
5.3.19. Lipegfilgrastim – LONQUEX (CAP) - EMEA/H/C/002556/II/0023 ..................................... 23
5.3.20. Meningococcal group a, c, w135 and y conjugate vaccine – MENVEO (CAP) -
EMEA/H/C/001095/II/0056 ....................................................................................... 23
5.3.21. Nintedanib – OFEV (CAP) - EMEA/H/C/003821/II/0006 ................................................ 23
5.3.22. Ocriplasmin – JETREA (CAP) - EMEA/H/C/002381/II/0026 ............................................ 24
5.3.23. Perampanel – FYCOMPA (CAP) - EMEA/H/C/002434/X/0025 .......................................... 24
5.3.24. Ponatinib – ICLUSIG (CAP) - EMEA/H/C/002695/II/0029/G ........................................... 24
5.3.25. Ranibizumab – LUCENTIS (CAP) - EMEA/H/C/000715/II/0061 ....................................... 24
5.3.26. Rivaroxaban – XARELTO (CAP) - EMEA/H/C/000944/II/0042/G ..................................... 24
5.3.27. Simeprevir – OLYSIO (CAP) - EMEA/H/C/002777/II/0015 ............................................. 25
5.3.28. Tedizolid phosphate – SIVEXTRO (CAP) - EMEA/H/C/002846/II/0009 ............................. 25
5.3.29. Teduglutide – REVESTIVE (CAP) - EMEA/H/C/002345/II/0020 ....................................... 25
6. Periodic safety update reports (PSURs) 25
6.1. PSUR procedures including centrally authorised products (CAPs) only ................ 25
6.1.1. Adefovir – HEPSERA (CAP) - PSUSA/00000060/201509 (with RMP)................................ 25
6.1.2. Alipogene tiparvovec – GLYBERA (CAP) - PSUSA/00010056/201510 .............................. 26
6.1.3. Bazedoxifene – CONBRIZA (CAP) - PSUSA/00000302/201510 ....................................... 26
6.1.4. Budesonide, formoterol – BIRESP SPIROMAX (CAP); BUDESONIDE/FORMOTEROL TEVA
(CAP); BUDESONIDE/FORMOTEROL TEVA PHARMA B.V. (CAP); DUORESP SPIROMAX (CAP);
VYLAER SPIROMAX (CAP) - PSUSA/00010202/201510 ................................................. 26
Pharmacovigilance Risk Assessment Committee (PRAC)
EMA/PRAC/325452/2016 Page 4/52