Medicines/finished pharmaceutical products

Reference Number: 
RH075 (a)

Date of prequalification: 
28 November 2017
Basis of listing: 
Prequalified by WHO
Status: 
Active
INN: 
Medroxyprogesterone acetate
Therapeutic area: 
Reproductive Health
Dosage form & strength: 
Suspension for injection 104mg/0.65ml
Storage condition: 
Do not store above 30°C
Shelf life (months): 
36
Packaging: 
Prefilled single-use injection system, LLDPE Packed in foil laminate pouch, 1x1
Applicant: 
Pfizer Limited, Ramsgate Rd., Sandwich, Kent, CT13 9NJ, United Kingdom of Great Britain and Northern Ireland
FPP Manufacturing Site: 

Pfizer Manufacturing Belgium NV / SA, Rijksweg 12, Puurs 2870, Belgium

FPP WHO Public Inspection Reports: 
API Manufacturing Site: 

(Medroxyprogesterone acetate) Pharmacia & Upjohn Co, 7000 Portage Road, Kalamazoo, Michigan, MI 49001, United States of America

API WHO Public Inspection Reports: