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MA154

Product Details
WHO Product ID
MA154
Status
Suspended
INN, dosage form and strength
Artemether/Lumefantrine Tablet, Dispersible 40mg/240mg
Date of prequalification
Basis of listing
Prequalification - Full
Therapeutic area
Malaria
Type
Finished Pharmaceutical Product
Dosage form
Tablet, Dispersible
Applicant organization
Guilin Pharmaceutical Co. Ltd
No 43 Qilidian Road
Guilin,
Guangxi
541004
China
Packaging details and storage conditions
Packaging Type
Blister, Alu-PVC/PVDC
Configuration
6x30; 6x1
Shelf life (months)
24
Storage conditions
Do not store above 30°C. Store tablets in the blisters in the provided carton
API Manufacturing Site(s)
By Organization
By Active Ingredient
Ipca Laboratories Ltd
Sejavta, Ratlam
Madhya Pradesh
457 002
India
Artemether, Lumefantrine
Mangalam Drugs & Organics Ltd
Unit 1, Plot No 187, GIDC
Vapi,
Gujarat
396 195
India
Artemether, Lumefantrine
FPP Manufacturing Site(s)
Guilin Pharmaceutical Co., Ltd.
OSD, No 43 Qilidian Road
Guilin,
Guangxi
541 004
China
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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