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15.1.11. Fidaxomicin – DIFICLIR (CAP)<br />
<br />
Evaluation of a PSUR procedure<br />
Regulatory details:<br />
PRAC Rapporteur: Qun-Ying Yue (SE)<br />
Administrative details:<br />
Procedure number(s): EMEA/H/C/002087/PSUV/0017<br />
MAH(s): Astellas Pharma Europe B.V.<br />
15.1.12. Human normal immunoglobulin – HYQVIA (CAP)<br />
<br />
Evaluation of a PSUR procedure<br />
Regulatory details:<br />
PRAC Rapporteur: Brigitte Keller-Stanislawski (DE)<br />
Administrative details:<br />
Procedure number(s): EMEA/H/C/002491/PSUV/0004<br />
MAH(s): Baxter Innovations GmbH<br />
15.1.13. Human papillomavirus vaccine [types 16, 18] (recombinant, adjuvanted, adsorbed)<br />
– CERVARIX (CAP)<br />
<br />
Evaluation of a PSUR procedure<br />
Regulatory details:<br />
PRAC Rapporteur: Jean-Michel Dogné (BE)<br />
Administrative details:<br />
Procedure number(s): EMEA/H/C/000721/PSUV/0055<br />
MAH(s): GlaxoSmithKline Biologicals S.A.<br />
15.1.14. Hydroxocobalamin – CYANOKIT (CAP), NAP<br />
<br />
Evaluation of a PSUSA 37 procedure<br />
Regulatory details:<br />
PRAC Rapporteur: Isabelle Robine (FR)<br />
Administrative details:<br />
Procedure number(s): EMEA/H/C/PSUSA/00001690/201311<br />
MAH(s): Merck Santé S.A.S.<br />
15.1.15. Indacaterol – HIROBRIZ BREEZHALER (CAP), ONBREZ BREEZHALER (CAP), OSLIF<br />
BREEZHALER (CAP)<br />
<br />
Evaluation of a PSUR procedure<br />
Regulatory details:<br />
PRAC Rapporteur: Torbjörn Callréus (DK)<br />
Administrative details:<br />
Procedure number(s): EMEA/H/C/001211/PSUV/0031, EMEA/H/C/001114/PSUV/0030,<br />
EMEA/H/C/001210/PSUV/0030<br />
MAH(s): Novartis Europharm Ltd<br />
37 PSUR single assessment, referring to CAP, NAP<br />
Pharmacovigilance Risk Assessment Committee (PRAC)<br />
EMA/PRAC/438418/2014 Page 62/75
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