Medicines/finished pharmaceutical products

Reference Number: 
HA634 (a)

Date of prequalification: 
14 October 2014
Basis of listing: 
Prequalified by WHO
Status: 
Active
INN: 
Dolutegravir (Sodium)
Therapeutic area: 
HIV/AIDS
Dosage form & strength: 
Tablet, Film-coated 50mg
Shelf life (months): 
24
Packaging: 
Bottle HDPE: 30x1
Applicant: 
ViiV Healthcare, 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom of Great Britain and Northern Ireland
FPP Manufacturing Site: 

GlaxoSmithKline LLC, 1011, North Arendall Avenue, Zebulon, North Carolina, 27597, United States of America
Glaxo Wellcome Operations, Priory Street, Ware, Hertfordshire, SG12 0DJ, United Kingdom of Great Britain and Northern Ireland
Glaxo Wellcome SA, Avenue de Extremadura 3, Aranda de Duero, Burgos, Spain

FPP WHO Public Inspection Reports: 
API Manufacturing Site: 

(Dolutegravir (sodium)) Micron Technologies Inc., Crossways Boulevard, Crossways, Dartford, Kent, DA26QY, United Kingdom
(Dolutegravir (sodium)) Fujimoto Chemicals Co Ltd, Senboku Plant, 1-24, Rinkai-cho, Izumiotsu, Osaka, 595-0075, Japan
(Dolutegravir (sodium)) Glaxo Wellcome Manufacturing Pte Ltd, 1 Pioneer Sector 1, Jurong, 628 413, Singapore
(Dolutegravir (sodium)) Shionogi Pharma Chemicals Co Ltd, 224-20, Hiraishiebisuno, Kawauchi-cho, Tokushima, Tokushima, 771-0132, Japan

API WHO Public Inspection Reports: