Medicines/finished pharmaceutical products

Reference Number: 
RH057

Date of prequalification: 
15 August 2016
Basis of listing: 
Prequalified by WHO
Status: 
Active
INN: 
Levonorgestrel
Therapeutic area: 
Reproductive Health
Dosage form & strength: 
Tablet, Film-coated 0.03mg
Storage condition: 
Do not store above 30°C, protect from light
Shelf life (months): 
36
Packaging: 
Blister, Alu/PVC/PVdC 28x3, 35x3
Applicant: 
Mylan Laboratories Ltd, Plot No.564/A/22, Road No. 92, Jubilee Hills, Hyderabad, Telangana, 500034, India
FPP Manufacturing Site: 

Mylan Laboratories Limited, Sarkhej- Bavla NH No- 8A, Plot No 20/21 Pharmaceutical Special Economic Zone, Nr Village Matoda, Ahmedabad, Gujarat, 382213, India

API Manufacturing Site: 

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

API WHO Public Inspection Reports: