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6.1.32. Pandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) –<br />
FOCLIVIA (CAP) - Prepandemic influenza vaccine (H5N1) (surface antigen,<br />
inactivated, adjuvanted) - AFLUNOV (CAP) - PSUSA/00010008/201510<br />
Applicant: Novartis Vaccines Influenza Srl<br />
PRAC Rapporteur: Carmela Macchiarulo<br />
Scope: Evaluation of a PSUSA procedure<br />
Action: Adoption of recommendation to CHMP<br />
6.1.33. Para-aminosalicylic acid – GRANUPAS (CAP) - PSUSA/00010171/201510<br />
Applicant: Lucane Pharma<br />
PRAC Rapporteur: Julie Williams<br />
Scope: Evaluation of a PSUSA procedure<br />
Action: Adoption of recommendation to CHMP<br />
6.1.34. Pasireotide – SIGNIFOR (CAP) - PSUSA/00009253/201510<br />
Applicant: Novartis Europharm Ltd<br />
PRAC Rapporteur: Qun-Ying Yue<br />
Scope: Evaluation of a PSUSA procedure<br />
Action: Adoption of recommendation to CHMP<br />
6.1.35. Pazopanib – VOTRIENT (CAP) - PSUSA/00002321/201510<br />
Applicant: Novartis Europharm Ltd<br />
PRAC Rapporteur: Doris Stenver<br />
Scope: Evaluation of a PSUSA procedure<br />
Action: Adoption of recommendation to CHMP<br />
6.1.36. Posaconazole – NOXAFIL (CAP) - PSUSA/00002480/201510<br />
Applicant: Merck Sharp & Dohme Limited<br />
PRAC Rapporteur: Rafe Suvarna<br />
Scope: Evaluation of a PSUSA procedure<br />
Action: Adoption of recommendation to CHMP<br />
6.1.37. Propranolol – HEMANGIOL (CAP) - PSUSA/00010250/201510<br />
Applicant: Pierre Fabre Dermatologie<br />
PRAC Rapporteur: Dolores Montero Corominas<br />
Scope: Evaluation of a PSUSA procedure<br />
Action: Adoption of recommendation to CHMP<br />
Pharmacovigilance Risk Assessment Committee (PRAC)<br />
EMA/PRAC/325452/2016 Page 31/52
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