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RH048

Product Details
WHO Product ID
RH048
Status
Prequalified
INN, dosage form and strength
Misoprostol Tablet 200mcg
Date of prequalification
Basis of listing
Prequalification - Full
Therapeutic area
Reproductive health
Type
Finished Pharmaceutical Product
Dosage form
Tablet
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
3x1, 4x1
Shelf life (months)
24
Storage conditions
Do not store above 30°C
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)
FPP Manufacturing Site(s)
China Resources Zizhu Pharmaceutical Co Ltd
No 27 Chaoyang North Road, Chaoyang District
Beijing,
Beijing
100024
China
WHO Public Assessment Reports


Part 1 - Abstract
Part 2 - All accepted presentations (including photo)
Part 3 - WHO-PQ recommended patient information leaflet*
Part 4 - WHO-PQ recommended summary of product characteristics*
Part 5 - Label
Part 6 - Discussion (status at the time of prequalification)
Part 7 - Steps before Prequalification
Part 8 - Steps following Prequalification (from 01 March 2014, only changes to the published information are included)

* This summary of product characteristics/patient information leaflet focus on uses of the medicine covered by WHO Prequalification Team - Medicines. The recommendations for use are based on WHO guidelines and on information from stringent regulatory authorities (term to be revised). The medicine may be authorised for additional or different uses by national medicines regulatory authorities. 

Part 1 , Part 2 , Part 3 , Part 4 , Part 5 , Part 6 , Part 7 , Part 8

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