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HA708

Product Details
WHO Product ID
HA708
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
Sun Pharmaceutical Industries Limited
Sun House, 201 B/1, Western Express Highway, Goregaon (East)
Mumbai,
400063
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
2nd Floor, Serene Chambers, Road No. 7, Banjara Hills
Hyderabad,
Telangana
500 034
India
Dolutegravir (sodium)
Sun Pharmaceutical Industries Limited
Plot No. Z-15, Industrial Area, Dahej SEZ, Bharuch
Vagra,
Gujarat
392130
India
Dolutegravir (sodium)
FPP Manufacturing Site(s)
Sun Pharmaceutical Industries Limited
Village Ganguwala, District Sirmour
Paonta Sahib,
Himachal Pradesh
173 025
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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