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MA204

WHO Product ID
MA204
Status
Prequalified
INN, dosage form and strength
Tafenoquine Tablet, Dispersible 50mg
Date of prequalification
Basis of listing
Prequalification - Abridged
Therapeutic area
Malaria
Type
Finished Pharmaceutical Product
Dosage form
Tablet, Dispersible
Reference authority
Therapeutic Goods Administration (Australia)
Applicant organization
GlaxoSmithKline Australia Pty Ltd
Level 4/436 Johnston Street Abbotsford
Victoria
3067
Australia
Packaging details and storage conditions
Packaging Type
Blister, Alu/Alu
Configuration
3x10
Shelf life (months)
24
Storage conditions
Do not store above 30°C. Store in the original package in order to protect from
Shelf life (months)
24
API Manufacturing Site(s)
By Organization
By Active Ingredient
Piramal Pharma Limited
Sy.Nos. 7-70, 70/1 and 70/2, Digwal (Vil), Kohir Mandal, Sangareddy District
Telangana
502 321
India
Tafenoquine
FPP Manufacturing Site(s)
Piramal Pharma Limited
Plot No. 67-70, Sector-II Pithampur Dhar District
Madhya Pradesh
454 775
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 5 , Part 7

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