Product Details
WHO Product ID
RH093
Status
Prequalified
INN, dosage form and strength
Ethinylestradiol/Levonorgestrel Tablet, Sugar coated + Placebo Tablet, Film-coated 30mcg/150mcg + 0mg
Date of prequalification
Basis of listing
Prequalification - Full
Therapeutic area
Reproductive health
Type
Finished Pharmaceutical Product
Dosage form
Tablet, Sugar coated + Tablet, Film-coated
Applicant organization
Renata Ltd
Section 7, Milk Vita Road, Mirpur
Dhaka,
1216
Bangladesh
Packaging details and storage conditions
Packaging Type
Blister, Alu/PVC/PVdC
Configuration
1x (21+7)
Shelf life (months)
24
Storage conditions
Do not store above 30°C. Avoid excursions above 30°C. Protect from moisture
API Manufacturing Site(s)
By Organization
By Active Ingredient
Aspen Oss B.V.
Veersemeer 4, 5347 JN
Oss,
Netherlands
Ethinylestradiol
Aspen Oss B.V.
Kloosterstraat 6, 5349 AB
Oss,
Netherlands
Ethinylestradiol
Industriale Chimica s.r.l.
Via E. H. Grieg 13, 21047
Saronno (Varese),
Italy
Levonorgestrel
Qinhuangdao Zizhu Pharmaceutical Co Ltd
No. 10 Longhai Road, Economic & Technological Development Zone
Qinhuangdao City,
Hebei
066 004
China
Ethinylestradiol
FPP Manufacturing Site(s)
Renata Limited
Rajendrapur Potent Product Facility, Noyapara, Bhawal Mirzapur,
Rajendrapur,
Gazipur
1700
Bangladesh