ongoing

6.1.20. Lopinavir, ritonavir – ALUVIA (Art 58 3 ); KALETRA (CAP) -
PSUSA/00001905/201509
Applicant: AbbVie Ltd
PRAC Rapporteur: Isabelle Robine
Scope: Evaluation of a PSUSA procedure
Action: Adoption of recommendation to CHMP
6.1.21. Lurasidone – LATUDA (CAP) - PSUSA/00010114/201510 (with RMP)
Applicant: Sunovion Pharmaceuticals Europe Ltd
PRAC Rapporteur: Qun-Ying Yue
Scope: Evaluation of a PSUSA procedure
Action: Adoption of recommendation to CHMP
6.1.22. Macitentan – OPSUMIT (CAP) - PSUSA/00010115/201510
Applicant: Actelion Registration Ltd.
PRAC Rapporteur: Dolores Montero Corominas
Scope: Evaluation of a PSUSA procedure
Action: Adoption of recommendation to CHMP
6.1.23. Meningococcal group a, c, w135 and y conjugate vaccine – NIMENRIX (CAP) -
PSUSA/00010044/201510
Applicant: Pfizer Limited
PRAC Rapporteur: Rafe Suvarna
Scope: Evaluation of a PSUSA procedure
Action: Adoption of recommendation to CHMP
6.1.24. Micafungin – MYCAMINE (CAP) - PSUSA/00002051/201510
Applicant: Astellas Pharma Europe B.V.
PRAC Rapporteur: Martin Huber
Scope: Evaluation of a PSUSA procedure
Action: Adoption of recommendation to CHMP
6.1.25. Miglustat – ZAVESCA (CAP) - PSUSA/00002062/201510
Applicant: Actelion Registration Ltd.
PRAC Rapporteur: Qun-Ying Yue
Scope: Evaluation of a PSUSA procedure
Action: Adoption of recommendation to CHMP
3 Article 58 of Regulation (EC) No 726/2004 allows the Agency's Committee for Medicinal Products for Human Use (CHMP)
to give opinions, in co-operation with the World Health Organisation (WHO), on medicinal products for human use that are
intended exclusively for markets outside of the European Union (EU)
Pharmacovigilance Risk Assessment Committee (PRAC)
EMA/PRAC/325452/2016 Page 29/52