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MA126

Product Details
WHO Product ID
MA126
Status
Prequalified
INN, dosage form and strength
Amodiaquine (hydrochloride)/Artesunate Tablet 135mg/50mg
Date of prequalification
Basis of listing
Prequalification - Full
Therapeutic area
Malaria
Type
Finished Pharmaceutical Product
Dosage form
Tablet
Applicant organization
Macleods Pharmaceuticals Ltd
304 Atlanta Arcade, Marol Church Road, Andheri (East)
Mumbai,
400 059
India
Packaging details and storage conditions
Packaging Type
Blister, Alu/Alu
Configuration
10x10; 3x1; 3x25
Shelf life (months)
24
Storage conditions
Do not store above 30°C, store in dry condition, protect from light
API Manufacturing Site(s)
By Organization
By Active Ingredient
Mangalam Drugs & Organics Ltd
Unit 1, Plot No 187, GIDC
Vapi,
Gujarat
396 195
India
Amodiaquine (hydrochloride), Artesunate
FPP Manufacturing Site(s)
Macleods Pharmaceuticals Ltd
Unit 2, Plot No 25-27, Survey No 366, Premier Industrial Estate, Kachigam
Daman,
396 210
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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