ongoing

8.3.9. Levetiracetam – LEVETIRACETAM TEVA (CAP) - EMEA/H/C/002316/R/0021
(without RMP)
Applicant: Teva B.V.
PRAC Rapporteur: Veerle Verlinden
Scope: 5-year renewal of the marketing authorisation
Action: For adoption of advice to CHMP
8.3.10. Perflutren – LUMINITY (CAP) - EMEA/H/C/000654/R/0021 (without RMP)
Applicant: Lantheus MI UK Ltd
PRAC Rapporteur: Almath Spooner
Scope: 5-year renewal of the marketing authorisation
Action: For adoption of advice to CHMP
8.3.11. Piperaquine tetraphosphate, artenimol – EURARTESIM (CAP) -
EMEA/H/C/001199/R/0023 (without RMP)
Applicant: Sigma-Tau Industrie Farmaceutiche Riunite S.p.A.
PRAC Rapporteur: Julie Williams
Scope: 5-year renewal of the marketing authorisation
Action: For adoption of advice to CHMP
8.3.12. Pramipexole – PRAMIPEXOLE ACCORD (CAP) - EMEA/H/C/002291/R/0010 (without
RMP)
Applicant: Accord Healthcare Ltd
PRAC Rapporteur: Doris Stenver
Scope: 5-year renewal of the marketing authorisation
Action: For adoption of advice to CHMP
8.3.13. Rilpivirine – EDURANT (CAP) - EMEA/H/C/002264/R/0022 (with RMP)
Applicant: Janssen-Cilag International N.V.
PRAC Rapporteur: Sabine Straus
Scope: 5-year renewal of the marketing authorisation
Action: For adoption of advice to CHMP
8.3.14. Saxagliptin, metformin hydrochloride – KOMBOGLYZE (CAP) -
EMEA/H/C/002059/R/0032 (without RMP)
Applicant: AstraZeneca AB
PRAC Rapporteur: Menno van der Elst
Scope: 5-year renewal of the marketing authorisation
Action: For adoption of advice to CHMP
Pharmacovigilance Risk Assessment Committee (PRAC)
EMA/PRAC/325452/2016 Page 46/52