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MA093

Product Details
WHO Product ID
MA093
Status
Prequalified
INN, dosage form and strength
Dihydroartemisinin/Piperaquine phosphate Tablet, Film-coated 20mg/160mg
Date of prequalification
Basis of listing
Prequalification - Abridged
Therapeutic area
Malaria
Type
Finished Pharmaceutical Product
Dosage form
Tablet, Film-coated
Reference authority
European Medicines Agency
Applicant organization
Alfasigma S.p.A
Via Ragazzi del ’99, 5 I-40133
Bologna,
Italy
Packaging details and storage conditions
Packaging Type
Blister, Alu/PVC/PVdC
Configuration
3x1,6x1,9x1,12x1
Shelf life (months)
24
Storage conditions
Do not store above 30°C. Store in the original package in order to protect from
API Manufacturing Site(s)
By Organization
By Active Ingredient
Mangalam Drugs & Organics Ltd
Unit 1, Plot No 187, GIDC
Vapi,
Gujarat
396 195
India
Dihydroartemisinin, Piperaquine phosphate
FPP Manufacturing Site(s)
Alfasigma S.p.A
Via Ragazzi del ’99, 5 I-40133
Bologna,
Italy
WHO Public Assessment Reports


Part 1 - Abstract
Part 2a - All accepted presentations
Part 2b - Visual appearance of the product
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. 

Samples of the artworks of the SPC/PIL/labelling have not been submitted. Therefore, control of compliance with WHOPAR guidelines (contents and format) has not been possible.

Part 1 , Part 2a , Part 2b , Part 7

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