WHO Product ID
RH108
Status
Prequalified
INN, dosage form and strength
Ethinylestradiol/Levonorgestrel Tablet, Sugar coated + Ferrous (Fumarate) Tablet, Film-coated 0.03mg/0.15mg + 75mg
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 PLC
Plot #1, Milk Vita Road
Section-VII
Section-VII
Mirpur,
Dhaka
1216
Bangladesh
Packaging details and storage conditions
Packaging Type
Blister, Alu/PVC/PVDC
Configuration
28 (21 Ethinylestradiol/Levonorgestrel Tablets + 7 Ferrous (Fumarate) Tablets) x1
Shelf life (months)
36
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 PLC
Rajendrapur Potent Product Facility, Noyapara, Bhawal Mirzapur,
Rajendrapur,
Gazipur
1700
Bangladesh