WC500169468

MAH(s): Pfizer Limited
2.1.4. Bortezomib – VELCADE (CAP)
Evaluation of a PSUR procedure
Regulatory details:
PRAC Rapporteur: Carmela Macchiarulo (IT)
Administrative details:
Procedure number(s): EMEA/H/C/000539/PSUV/0070 (without RMP)
MAH(s): Janssen-Cilag International N.V.
2.1.5. Ceftaroline fosamil – ZINFORO (CAP)
Evaluation of a PSUR procedure
Regulatory details:
PRAC Rapporteur: Julie Williams (UK)
Administrative details:
Procedure number(s): EMEA/H/C/002252/PSUV/0009 (without RMP)
MAH(s): AstraZeneca AB
2.1.6. Choriogonadotropin alfa – OVITRELLE (CAP)
Evaluation of a PSUR procedure
Regulatory details:
PRAC Rapporteur: Sabine Straus (NL)
Administrative details:
Procedure number(s): EMEA/H/C/000320/PSUV/0059 (without RMP)
MAH(s): Merck Serono Europe Limited
2.1.7. Dapagliflozin – FORXIGA (CAP)
Evaluation of a PSUR procedure
Regulatory details:
PRAC Rapporteur: Qun-Ying Yue (SE)
Administrative details:
Procedure number(s): EMEA/H/C/002322/PSUV/0010 (with RMP version 7.0)
MAH(s): Bristol-Myers Squibb/AstraZeneca EEIG
2.1.8. Doripenem – DORIBAX (CAP)
Evaluation of a PSUR procedure
Regulatory details:
PRAC Rapporteur: Qun-Ying Yue (SE)
Administrative details:
Procedure number(s): EMEA/H/C/000891/PSUV/0025 (with RMP version 7.0)
MAH(s): Janssen-Cilag International N.V.
Pharmacovigilance Risk Assessment Committee (PRAC)
EMA/PRAC/324055/2014 Page 60/73