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Overview of WHO Public Assessment Report (WHOPAR)

HA713

WHOPAR
M
Product name
Dolutegravir (Sodium)/Lamivudine/Tenofovir disoproxil fumarate
Dosage
50mg/300mg/300mg - Film-coated Tablet
Laboratory
Macleods Pharmaceuticals Ltd
India

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.