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HA701

Product Details
WHO Product ID
HA701
Status
Prequalified
INN, dosage form and strength
Dolutegravir (sodium) Tablet, Film-coated 50mg
Date of prequalification
Basis of listing
Prequalification - Full
Therapeutic area
HIV/AIDS
Type
Finished Pharmaceutical Product
Dosage form
Tablet, Film-coated
Applicant organization
Emcure Pharmaceuticals Ltd
Plot No. P-1 & P-2, I.T.B.T. Park, Phase II, MIDC, Hinjawadi
Pune,
Maharashtra
411057
India
Packaging details and storage conditions
Packaging Type
Bottle, HDPE
Configuration
30x1; 90x1
Shelf life (months)
36
Storage conditions
Do not store above 30°C
API Manufacturing Site(s)
By Organization
By Active Ingredient
Laurus Labs Limited
Unit 1, Plot No 21, Jawaharlal Nehru Pharma City, Anakapalli District
Parawada,
Andhra Pradesh
531 021
India
Dolutegravir (sodium)
FPP Manufacturing Site(s)
Emcure Pharmaceuticals Ltd
Plot No. P-1 & P-2, I.T.B.T. Park, Phase II, MIDC, Hinjawadi
Pune,
Maharashtra
411057
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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