Product Details
WHO Product ID
RH089
Status
Prequalified
INN, dosage form and strength
Mifepristone Tablet + Misoprostol Tablet, vaginal 200mg + 200mcg
Date of prequalification
Basis of listing
Prequalification - Full
Therapeutic area
Reproductive health
Type
Finished Pharmaceutical Product
Dosage form
Tablet + Tablet, vaginal
Applicant organization
China Resources Zizhu Pharmaceutical Co Ltd
No 27 Chaoyang North Road, Chaoyang District
Beijing,
Beijing
100024
China
Packaging details and storage conditions
Packaging Type
Blister, Alu/Alu
Configuration
1x(1 Mifepristone tablet + 4 Misoprostol vaginal tablets)
Shelf life (months)
24
Storage conditions
Do not store above 30°C, protect from light
API Manufacturing Site(s)
By Organization
By Active Ingredient
Piramal Healthcare UK Ltd
Whalton Road
Morpeth,
NE61 3YA
United Kingdom of Great Britain and Northern Ireland
Misoprostol Dispersion (1:100 in HPMC)
Qinhuangdao Zizhu Pharmaceutical Co Ltd
No. 10 Longhai Road, Economic & Technological Development Zone
Qinhuangdao City,
Hebei
066 004
China
Mifepristone
FPP Manufacturing Site(s)
China Resources Zizhu Pharmaceutical Co Ltd
No 27 Chaoyang North Road, Chaoyang District
Beijing,
Beijing
100024
China