Product Details
WHO Product ID
RH035
Status
Prequalified
INN, dosage form and strength
Ethinylestradiol/Levonorgestrel Tablet, Sugar coated+Placebo Tablet, Film-coated 30µg/150µg+0mg
Date of prequalification
Basis of listing
Prequalification - Full
Therapeutic area
Reproductive health
Type
Finished Pharmaceutical Product
Dosage form
Tablet, Film-coated + Tablet, Sugar coated
Applicant organization
Mylan Laboratories Limited
Plot No.564/A/22, Road No. 92, Jubilee Hills
Hyderabad,
Telangana
500096
India
Packaging details and storage conditions
Packaging Type
Blister, Alu/PVdC/PVC
Configuration
28x1
Shelf life (months)
36
Storage conditions
Do not store above 30°C, protect from light
API Manufacturing Site(s)
By Organization
By Active Ingredient
Bayer AG
Bergkamen Plant, Ernst Schering Strasse 14
Bergkamen,
59192
Germany
Ethinylestradiol, Levonorgestrel
Bayer AG
Charlottenburg Plant, Max-Dohrn-Strasse 8
Berlin,
10589
Germany
Ethinylestradiol, Levonorgestrel
Industriale Chimica S.R.L
E. H. Grieg 13, Saronno
Varese,
21047
Italy
Levonorgestrel
FPP Manufacturing Site(s)
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
Plot No. 1606-1609, G.I.D.C., Dist. Valsad
Sarigam,
Gujarat
396 155
India