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HA791

Product Details
WHO Product ID
HA791
Status
Prequalified
INN, dosage form and strength
Abacavir (sulfate)/Dolutegravir (sodium)/Lamivudine Tablet, Dispersible 60mg/5mg/30mg
Date of prequalification
Basis of listing
Prequalification - Abridged
Therapeutic area
HIV/AIDS
Type
Finished Pharmaceutical Product
Dosage form
Tablet, Dispersible
Reference authority
European Medicines Agency
Applicant organization
ViiV Healthcare BV
Van Asch van Wijckstraat 55H
Amersfoort,
3811 LP
Netherlands
Packaging details and storage conditions
Packaging Type
Bottle, HDPE
Configuration
90x1
Shelf life (months)
36
Storage conditions
Do not store above 30°C. Store in the original package in order to protect from
API Manufacturing Site(s)
By Organization
By Active Ingredient
Catalent Micron Technologies Inc.
Crossways Boulevard, Crossways, Dartford
Kent
DA26QY
United Kingdom of Great Britain and Northern Ireland
Dolutegravir (sodium)
Glaxo Operations UK Limited
Cobden Street, Angus
Montrose,
DD10 8EA
United Kingdom of Great Britain and Northern Ireland
Abacavir (sulfate)
Glaxo Operations UK Limited
Priory Street, Hertfordshire
Ware,
SG12 0DJ
United Kingdom of Great Britain and Northern Ireland
Dolutegravir (sodium)
Glaxo Wellcome Manufacturing Pte Ltd
1 Pioneer Sector 1, Jurong
628 413
Singapore
Dolutegravir (sodium), Lamivudine
Mylan Laboratories Limited
Unit 2, Survey 10/42, Gaddapotharam, Sangareddy District
Kazipally Industrial Area,
Telangana
502 319
India
Lamivudine
Piramal Pharma Limited
Sy.Nos. 7-70, 70/1 and 70/2, Digwal (Vil), Kohir Mandal, Sangareddy District
Telangana
502 321
India
Abacavir (sulfate)
S.A. Ajinomoto OmniChem n.v.
OmniChem Division, Cooppallaan 91
Wetteren,
B-9230
Belgium
Dolutegravir (sodium)
Shanghai Desano Chemical Pharmaceutical Co. Ltd.
417 Binhai Road, Laogang Town, Pudong New Area
Shanghai
201302
China
Dolutegravir (sodium)
Shionogi Pharma Co. Ltd.
224-20, Hiraishiebisuno, Kawauchi-cho
Tokushima,
771-0132
Japan
Dolutegravir (sodium)
FPP Manufacturing Site(s)
Glaxo Operations UK Limited
Priory Street, Hertfordshire
Ware,
SG12 0DJ
United Kingdom of Great Britain and Northern Ireland
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 7

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