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RH074

Product Details
WHO Product ID
RH074
Status
Prequalified
INN, dosage form and strength
Medroxyprogesterone acetate Suspension for injection 150mg
Date of prequalification
Basis of listing
Prequalification - Full
Therapeutic area
Reproductive health
Type
Finished Pharmaceutical Product
Dosage form
Suspension for injection
Applicant organization
Mylan Laboratories Limited
Sarkhej- Bavla NH No- 8A, Plot No 20/21 Pharmaceutical Special Economic Zone, Nr Village Matoda
Ahmedabad,
Gujarat
382213
India
Packaging details and storage conditions
Packaging Type
Vial, USP type I glass
Configuration
1ml vial x25
Shelf life (months)
36
Storage conditions
Do not store above 30°C. Do not freeze
API Manufacturing Site(s)
By Organization
By Active Ingredient
Farmabios S.p.A
Via Pavia 1, Gropello Cairoli
27027
Italy
Medroxyprogesterone acetate
FPP Manufacturing Site(s)
Mylan Laboratories Limited
Sarkhej- Bavla NH No- 8A, Plot No 20/21 Pharmaceutical Special Economic Zone, Nr Village Matoda
Ahmedabad,
Gujarat
382213
India
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 2a , Part 2b , Part 3 , Part 4 , Part 5 , Part 6 , Part 7 , Part 8

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