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MA057

WHO Product ID
MA057
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
Sanofi
82, avenue Raspail
Gentilly,
94250
France
Packaging details and storage conditions
Packaging Type
Blister, Alu/Alu
Configuration
3x1, 3x25
Shelf life (months)
36
API Manufacturing Site(s)
By Organization
By Active Ingredient
Huvepharma Italia S.r.l
Via R. Lepetit 142
Garessio,
12075
Italy
Artesunate
Ipca Laboratories Ltd
89A-B, 90/91 Industrial Estate, Pologround
Indore,
Madhya Pradesh
452 003
India
Amodiaquine (hydrochloride)
Ipca Laboratories Ltd
Sejavta, Ratlam
Madhya Pradesh
457 001
India
Amodiaquine (hydrochloride)
FPP Manufacturing Site(s)
Maphar Laboratories
Boulevard ALKIMIA N°6, Quartier industriel Sidi Bernoussi
Casablanca,
20250
Morocco
Sanofi-Aventis Maroc
Route de Rabat RP 1 – Aïn Sebaâ, 20250
Casablanca,
Morocco
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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