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RH051

Product Details
WHO Product ID
RH051
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
Swedish Medical Products Agency (MPA)
Applicant organization
Linepharma International Ltd
Regents Place, 338 Euston Road
London,
NW1 3BT
United Kingdom
Packaging details and storage conditions
Packaging Type
Blister, Alu/PVC/PVdC
Configuration
1x1, 1x30
Shelf life (months)
36
Storage conditions
Do not store above 25°C, protect from light
API Manufacturing Site(s)
By Organization
By Active Ingredient
Crystal Pharma SAU
Parque Tecnologico de Boecillo, Parcela 105
Boecillo,
47151
Spain
Mifepristone
FPP Manufacturing Site(s)
Centre Spécialités Pharmaceutiques (CSP)
76-78 avenue du Midi
Cournon d’Auvergne,
63800
France
Delpharma Lille SAS
Rue de Toufflers, ZI de Roubaix-Est
Lys-Lez-Lannoy,
59390
France
Laboratorios León Farma SA
C/La Vallina s/n, Polígono Industrial Navatejera, Villaquilambre
León,
24008
Spain
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 5 , Part 7

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