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MA090

WHO Product ID
MA090
Status
Prequalified
INN, dosage form and strength
Artesunate Powder for solution for injection 120mg/vial
Date of prequalification
Basis of listing
Prequalification - Full
Therapeutic area
Malaria
Type
Finished Pharmaceutical Product
Dosage form
Powder for solution for injection
Applicant organization
Guilin Pharmaceutical Co., Ltd.
INJ-I & INJ-II, No 43 Qilidian Road
Guilin,
Guangxi
541 004
China
Packaging details and storage conditions
Packaging Type
Vial, type I glass+ Ampoule, type I glass + Ampoule, type I glass
Configuration
120mg powder (Artesunate) in 15ml vial + 2ml solution (Sodium bicarbonate) in 2ml ampoule + 10ml solution (sodium chloride) in 10ml ampoule
Shelf life (months)
36
Storage conditions
Do not store above 30°C, protect from light
API Manufacturing Site(s)
By Organization
By Active Ingredient
Guilin Pharmaceutical Co Ltd
API-I No 43 Qilidian Road
Guilin,
Guangxi
541 004
China
Artesunate
FPP Manufacturing Site(s)
Guilin Pharmaceutical Co Ltd
INJ-I & INJ-II, No 43 Qilidian Road
Guilin,
Guangxi
541 004
China
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 3 , Part 4 , Part 5 , Part 6 , Part 7

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