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RH075

Product Details
WHO Product ID
RH075
Status
Prequalified
INN, dosage form and strength
Medroxyprogesterone acetate Suspension for injection 104mg/0.65ml
Date of prequalification
Basis of listing
Prequalification - Abridged
Therapeutic area
Reproductive health
Type
Finished Pharmaceutical Product
Dosage form
Suspension for injection
Reference authority
Medicines and Healthcare products Regulatory Agency (MHRA)
Applicant organization
Pfizer Limited
Ramsgate Rd., Sandwich
Kent,
CT13 9NJ
United Kingdom of Great Britain and Northern Ireland
Packaging details and storage conditions
Packaging Type
Prefilled single-use injection system, LLDPE
Configuration
Packed in foil laminate pouch, 1x1
Shelf life (months)
36
Storage conditions
Do not store above 30°C. Do not refrigerate or freeze
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 5 , Part 7

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