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RH061

Product Details
WHO Product ID
RH061
Status
Prequalified
INN, dosage form and strength
Mifepristone Tablet 200mg
Date of prequalification
Basis of listing
Prequalification - Abridged
Therapeutic area
Reproductive health
Type
Finished Pharmaceutical Product
Dosage form
Tablet
Reference authority
Medicines Evaluation Board
Applicant organization
Exelgyn
216 BOULEVARD SAINT GERMAIN
Paris,
75007
France
Packaging details and storage conditions
Packaging Type
Blister, Alu/PVC
Configuration
1x1;3x1;15x1;30x1
Shelf life (months)
48
Storage conditions
Do not store above 25°C
API Manufacturing Site(s)
By Organization
By Active Ingredient
Expansia
Route d'Avignon
Aramon,
F-30390
France
Mifepristone
Indo Phyto Chemicals Pvt Ltd
API Block, Shakhanpur, Ramnagar (M), Nainital District
Kashipur,
Uttarakhand
244 715
India
Mifepristone
VLG CHEM
35, avenue Jean Jaurès
Villeneuve-La-Garenne,
F-92390
France
Mifepristone
FPP Manufacturing Site(s)
Laboratoires MACORS
Rue des Caillottes, Z.I Plaine des Isles
Auxerre,
89000
France
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 7

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