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RH052

Product Details
WHO Product ID
RH052
Status
Prequalified
INN, dosage form and strength
Mifepristone Tablet 200mg
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/PVC
Configuration
1x1, 3x1
Shelf life (months)
36
Storage conditions
Do not store above 30°C, protect from light
API Manufacturing Site(s)
By Organization
By Active Ingredient
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
WHO Public Assessment Reports


Part 1 - Abstract
Part 2a - All accepted presentations
Part 2b - Visual appearance of the product
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. 

Samples of the artworks of the SPC/PIL/labelling have not been submitted. Therefore, control of compliance with WHOPAR guidelines (contents and format) has not been possible.

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

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