Medicines/finished pharmaceutical products

Reference Number: 
RH080 (a)

Date of prequalification: 
12 December 2017
Basis of listing: 
Prequalified by WHO
Status: 
Active
INN: 
Ethinylestradiol/Levonorgestrel
Therapeutic area: 
Reproductive Health
Dosage form & strength: 
Tablet, Sugar coated 30mcg/150mcg
Storage condition: 
Do not store above 30°C
Shelf life (months): 
36
Packaging: 
Blister, Alu/PVC 21x1, 21x3, 21x6
Applicant: 
Temmler Pharma GmbH, Temmlerstraße 2, 35039, Marburg, Germany
FPP Manufacturing Site: 

Haupt Pharma Münster GmbH, Schleebrüggenkamp 15, 48159, Münster, Germany

FPP WHO Public Inspection Reports: 
API Manufacturing Site: 

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

API WHO Public Inspection Reports: