Product Details
WHO Product ID
HA768
Status
Prequalified
INN, dosage form and strength
Dolutegravir (sodium) Tablet, Dispersible 5mg
Date of prequalification
Basis of listing
Prequalification - Abridged
Therapeutic area
HIV/AIDS
Type
Finished Pharmaceutical Product
Dosage form
Tablet, Dispersible
Applicant organization
ViiV Healthcare BV
Van Asch van Wijckstraat 55H
Amersfoort,
3811 LP
Netherlands
Packaging details and storage conditions
Packaging Type
Bottle, HDPE
Configuration
60x1, 30mL oral dosing cup and 10mL oral dosing syringe
Shelf life (months)
36
Storage conditions
Do not store above 25°C. Store in the original package to protect from moisture
API Manufacturing Site(s)
By Organization
By Active Ingredient
Glaxo Wellcome Manufacturing Pte Ltd
1 Pioneer Sector 1, Jurong
628 413
Singapore
Dolutegravir (sodium)
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
Glaxo Wellcome SA
Avenue de Extremadura 3, Aranda de Duero
Burgos,
Spain