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RH018

Product Details
WHO Product ID
RH018
Status
Prequalified
INN, dosage form and strength
Medroxyprogesterone acetate Powder for suspension for injection 150mg/mL
Date of prequalification
Basis of listing
Prequalification - Abridged
Therapeutic area
Reproductive health
Type
Finished Pharmaceutical Product
Dosage form
Powder for suspension for injection
Reference authority
Swedish Medical Products Agency (MPA)
Applicant organization
Pfizer AB
113 63
Stockholm,
Sweden
Packaging details and storage conditions
Packaging Type
Vial, Glass
Configuration
1ml
Shelf life (months)
60
Storage conditions
Do not store above 25°C
API Manufacturing Site(s)
By Organization
By Active Ingredient
Pharmacia & Upjohn Co
7000 Portage Road
Kalamazoo,
MI 49001
United States of America
Medroxyprogesterone acetate
FPP Manufacturing Site(s)
Pfizer Manufacturing Belgium NV / SA
Rijksweg 12
Puurs Sint-Amands,
2870
Belgium
WHO Public Assessment Reports


Part 1 - Abstract
Part 2 - All accepted presentations (including photo)
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. 

 

Part 1 , Part 2 , Part 3 , Part 4 , Part 5 , Part 7

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