WC500185968
WC500185968
WC500185968
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15.1.22. Moroctocog alfa – REFACTO AF (CAP)<br />
<br />
Evaluation of a PSUSA procedure<br />
Regulatory details:<br />
PRAC Rapporteur: Doris Stenver (DK)<br />
Administrative details:<br />
Procedure number(s): EMEA/H/C/000232/PSUSA/02089/201408<br />
MAH(s): Pfizer Limited<br />
15.1.23. Nonacog alfa – BENEFIX (CAP)<br />
<br />
Evaluation of a PSUSA procedure<br />
Regulatory details:<br />
PRAC Rapporteur: Brigitte Keller-Stanislawski (DE)<br />
Administrative details:<br />
Procedure number(s): EMEA/H/C/000139/PSUSA/02183/201408<br />
MAH(s): Pfizer Limited<br />
15.1.24. Pirfenidone – ESBRIET (CAP)<br />
<br />
Evaluation of a PSUSA procedure<br />
Regulatory details:<br />
PRAC Rapporteur: Julie Williams (UK)<br />
Administrative details:<br />
Procedure number(s): EMEA/H/C/002154/PSUSA/02435/201408<br />
MAH(s): InterMune UK Ltd.<br />
15.1.25. Pandemic influenza vaccine (H5N1, whole virion, vero cell derived, inactivated) –<br />
PANDEMIC INFLUENZA VACCINE H5N1 BAXTER (CAP)<br />
Prepandemic influenza vaccine (H5N1) (whole virion, inactivated, prepared in cell culture) -<br />
VEPACEL (CAP)<br />
<br />
Evaluation of a PSUSA procedure<br />
Regulatory details:<br />
PRAC Rapporteur: Brigitte Keller-Stanislawski (DE)<br />
Administrative details:<br />
Procedure number(s): EMEA/H/C/001200/PSUSA/02282/201408,<br />
EMEA/H/C/002089/PSUSA/02282/201408<br />
MAH(s): Baxter AG<br />
15.1.26. Protein C – CEPROTIN (CAP), NAP<br />
<br />
Evaluation of a PSUSA procedure<br />
Regulatory details:<br />
PRAC Rapporteur: Brigitte Keller-Stanislawski (DE)<br />
Administrative details:<br />
Procedure number(s): EMEA/H/C/000334/PSUSA/02563/201407<br />
MAH(s): Baxter AG<br />
Pharmacovigilance Risk Assessment Committee (PRAC)<br />
EMA/PRAC/257790/2015 Page 76/89