Medicines/finished pharmaceutical products

Reference Number: 
RH051 (a)

Date of prequalification: 
06 October 2014
Basis of listing: 
Prequalified by WHO
Status: 
Active
INN: 
Mifepristone
Therapeutic area: 
Reproductive Health
Dosage form & strength: 
Tablet 200mg
Storage condition: 
Do not store above 30°C
Shelf life (months): 
36
Packaging: 
Blister Alu/PVC/PVdC: 1x1, 1x30
Applicant: 
Linepharma International, Regents Place, 338 Euston Road, London, NW1 3BT, United Kingdom of Great Britain and Northern Ireland
FPP Manufacturing Site: 

Laboratorios León Farma SA, C/La Vallina s/n, Polígono Industrial Navatejera, Villaquiilambre, León, 24008, Spain
Delpharma Lille SAS, Rue de Toufflers, ZI de Roubaix-Est, Lys-Lez-Lannoy, 59390, France
Centre Spécialités Pharmaceutiques (CSP), 76-78 avenue du Midi, Cournon d’Auvergne, 63800, France

FPP WHO Public Inspection Reports: 
API Manufacturing Site: 

(Mifepristone) Crystal Pharma SAU, Parque Tecnologico de Boecillo, Parcela 105, Boecillo, Valladolid, 47151, Spain

API WHO Public Inspection Reports: