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MA186

Product Details
WHO Product ID
MA186
Status
Prequalified
INN, dosage form and strength
Artesunate Powder for solution for injection 120 mg
Date of prequalification
Basis of listing
Prequalification - Full
Therapeutic area
Malaria
Type
Finished Pharmaceutical Product
Dosage form
Powder for solution for injection
Applicant organization
Ipca Laboratories Ltd
48 Kandivli Industrial Estate, Kandivli (West)
Mumbai,
Maharashtra
400 067
India
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)
24
Storage conditions
Store below 30°C. Keep the vial and ampoules in the provided carton to protect t
API Manufacturing Site(s)
By Organization
By Active Ingredient
Ipca Laboratories Ltd
Sejavta, Ratlam
Madhya Pradesh
457 002
India
Artesunate (sterile)
FPP Manufacturing Site(s)
Ipca Laboratories Ltd
P.O. Sejavta
Ratlam,
Madhya Pradesh
457 002
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 2 , Part 3 , Part 4 , Part 5 , Part 6 , Part 7 , Part 8

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