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MA160

Product Details
WHO Product ID
MA160
Status
Prequalified
INN, dosage form and strength
Artemether/Lumefantrine Tablet 80mg/480mg
Date of prequalification
Basis of listing
Prequalification - Full
Therapeutic area
Malaria
Type
Finished Pharmaceutical Product
Dosage form
Tablet
Applicant organization
Ipca Laboratories Ltd
48 Kandivli Industrial Estate, Kandivli (West)
Mumbai,
Maharashtra
400 067
India
Packaging details and storage conditions
Packaging Type
Blister, Alu-Alu
Configuration
6x1; 6x30; 6x1x30
Shelf life (months)
36
Storage conditions
Do not store above 30°C, store in the original container, protect from light
API Manufacturing Site(s)
By Organization
By Active Ingredient
Ipca Laboratories Ltd
Sejavta, Ratlam
Madhya Pradesh
457 002
India
Artemether, Lumefantrine
FPP Manufacturing Site(s)
Ipca Laboratories Ltd
Plot No 255/1, Village Athal
Silvassa,
Dadra and Nagar Haveli
Daman and Diu 396230
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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