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RH084

Product Details
WHO Product ID
RH084
Status
Prequalified
INN, dosage form and strength
Medroxyprogesterone acetate Suspension for injection 150mg/ml
Date of prequalification
Basis of listing
Prequalification - Full
Therapeutic area
Reproductive health
Type
Finished Pharmaceutical Product
Dosage form
Suspension for injection
Applicant organization
Incepta Pharmaceuticals Ltd.
Unit – 1, Injectable Potent Drug (IPD), Krishnapura, Sahabelishor, Dhaka
Dhamrai,
Bangladesh
Packaging details and storage conditions
Packaging Type
Vial, Type I glass
Configuration
1x1; 1x20
Shelf life (months)
36
Storage conditions
Do not store above 30°C. Do not freeze. Store vials in the cartons to protect fr
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)
Incepta Pharmaceuticals Ltd.
Unit – 1, Injectable Potent Drug (IPD), Krishnapura, Sahabelishor, Dhaka
Dhamrai,
Bangladesh
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 6 , Part 7 , Part 8

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