ongoing

Scope: Evaluation of a PSUSA procedure
Action: Adoption of recommendation to CHMP
6.2. PSUR procedures including centrally authorised products (CAPs)
and nationally authorised products (NAPs)
6.2.1. Filgrastim – ACCOFIL (CAP); FILGRASTIM HEXAL (CAP); GRASTOFIL (CAP);
NIVESTIM (CAP); RATIOGRASTIM (CAP) ; TEVAGRASTIM (CAP); ZARZIO (CAP),
NAP - PSUSA/00001391/201509
Applicant: Accord Healthcare Ltd (Accofil), Hexal AG (Filgrastim Hexal), Apotex Europe BV
(Gastrofil), Hospira UK Limited (Nivestim), Ratiopharm GmbH (Ratiograstim), Teva GmbH
(Tevagrastim), Sandoz GmbH (Zarzio), various
PRAC Rapporteur: Kirsti Villikka
Scope: Evaluation of a PSUSA procedure
Action: Adoption of recommendation to CHMP
6.2.2. Influenza vaccine (H1N1)v (whole virion, vero cell derived, inactivated) –
CELVAPAN (CAP), NAP - PSUSA/00002280/201510
Applicant: Nanotherapeutics Bohumil Sro, various
PRAC Rapporteur: Brigitte Keller-Stanislawski
Scope: Evaluation of a PSUSA procedure
Action: Adoption of recommendation to CHMP
6.2.3. Sodium oxybate – XYREM (CAP); NAP - PSUSA/00002757/201510
Applicant: UCB Pharma Ltd., various
PRAC Rapporteur: Leonor Chambel
Scope: Evaluation of a PSUSA procedure
Action: Adoption of recommendation to CHMP
6.2.4. Somatropin – NUTROPINAQ (CAP); OMNITROPE (CAP); SOMATROPIN
BIOPARTNERS (CAP); NAP - PSUSA/00002772/201509
Applicant: Ipsen Pharma (NutropinAq), Sandoz GmbH (Omnitrope), BioPartners GmbH
(Somatropin Biopartners), various
PRAC Rapporteur: Torbjorn Callreus
Scope: Evaluation of a PSUSA procedure
Action: Adoption of recommendation to CHMP
6.2.5. Tadalafil – ADCIRCA (CAP); CIALIS (CAP); NAP - PSUSA/00002841/201510
Applicant: Eli Lilly Nederland B.V.(Adcirca, Cialis), various
PRAC Rapporteur: Miguel-Angel Macia
Scope: Evaluation of a PSUSA procedure
Action: Adoption of recommendation to CHMP
Pharmacovigilance Risk Assessment Committee (PRAC)
EMA/PRAC/325452/2016 Page 33/52