Medicines/finished pharmaceutical products

Reference Number: 
RH038

Date of prequalification: 
11 March 2014
Basis of listing: 
Prequalified by WHO
Status: 
Active
INN: 
Ethinylestradiol/Levonorgestrel + Ferrous Fumarate
Therapeutic area: 
Reproductive Health
Dosage form & strength: 
Ethinylestradiol/Levonorgestrel Tablet + Placebo (Ferrous Fumarate Tablet) 30mcg/150mcg + 75mg
Storage condition: 
Do not store above 30°C, protect from light
Shelf life (months): 
36
Packaging: 
Blister Alu/PVC/PvDC: (21+7)x1
Applicant: 
Mylan Laboratories Ltd, Plot No.564/A/22, Road No. 92, Jubilee Hills, Hyderabad, Telangana, 500096, 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
Mylan Laboratories Limited, Unit 2, 1608/1609 GIDC, Sarigam, Valsad District, Gujarat, 396 155, India

API Manufacturing Site: 

(Levonorgestrel) Bayer AG, Bergkamen Plant, Ernst Schering Strasse 14, Bergkamen, 59192, Germany
(Levonorgestrel) Bayer AG, Charlottenburg Plant, Max-Dohrn-Strasse 8, Berlin, 10589, Germany
(Ethinylestradiol) Bayer AG, Bergkamen Plant, Ernst Schering Strasse 14, Bergkamen, 59192, Germany
(Ethinylestradiol) Bayer AG, Charlottenburg Plant, Max-Dohrn-Strasse 8, Berlin, 10589, Germany

API WHO Public Inspection Reports: