Medicines/finished pharmaceutical products

Reference Number: 
RH082 (a)

Date of prequalification: 
24 October 2017
Basis of listing: 
Prequalified by WHO
Status: 
Active
INN: 
Ethinylestradiol/Levonorgestrel + Placebo
Therapeutic area: 
Reproductive Health
Dosage form & strength: 
Tablet, Sugar coated 30mcg/150mcg + 0mcg
Storage condition: 
SRA accepted: No particular storage conditions are required for this medicinal product; WHO Recommended: Do not store above 30°C. Protect from moisture.The shelf-life at this storage condition is 36 months
Shelf life (months): 
36
Packaging: 
Blister, Alu-PVC/PE.EVOH.PE/PCTFE 28 (21 Active + 7 Placebo) x1, 28x3, 28x6
Applicant: 
Bayer AG, Müllerstraße 178, Berlin, 13353, Germany (MAH: Jenapharm GmbH & Co. KG, Otto-Schott-Str. 15, 07745, Jena, Germany)
FPP Manufacturing Site: 

Bayer Weimar GmbH & Co KG, Doebereinerstrasse 20, Weimar, 99427, Germany
Bayer AG, Müllerstraße 178, Berlin, 13353, Germany

FPP WHO Public Inspection Reports: 
API Manufacturing Site: 

(Ethinylestradiol) Bayer AG, Bergkamen Plant, Ernst Schering Strasse 14, Bergkamen, 59192, Germany
(Levonorgestrel) Bayer AG, Bergkamen Plant, Ernst Schering Strasse 14, Bergkamen, 59192, Germany

API WHO Public Inspection Reports: