Medicines/finished pharmaceutical products

Reference Number: 
HA706 (a)

Date of prequalification: 
19 June 2018
Basis of listing: 
Prequalified by WHO
Status: 
Active
INN: 
Abacavir (sulfate)/Lamivudine
Therapeutic area: 
HIV/AIDS
Dosage form & strength: 
Tablet, Film-coated 600mg/300mg
Storage condition: 
Do not store above 30°C, protect from moisture
Shelf life (months): 
24
Packaging: 
Child resistant blister, PVC/PVdC-Alu/Paper 10x3
Applicant: 
ViiV Healthcare UK Limited, 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom of Great Britain and Northern Ireland
FPP Manufacturing Site: 

Glaxo Operations UK Limited, Priory Street, Ware, Hertfordshire, SG12 0DJ, United Kingdom of Great Britain and Northern Ireland
GlaxoSmithKline Pharmaceuticals S. A. ul., Grunwaldzka 189, 60-332 Poznan, Poland
Glaxo Wellcome SA, Avenue de Extremadura 3, Aranda de Duero, Burgos, Spain

FPP WHO Public Inspection Reports: 
API Manufacturing Site: 

(Abacavir (sulfate)) Glaxo Operations UK Limited, Cobden Street, Montrose, Angus, DD10 8EA, United Kingdom of Great Britain and Northern Ireland
(Abacavir (sulfate)) SmithKline Beecham (Cork) Limited, Currabinny, Carrigaline, County Cork, Ireland
(Abacavir (sulfate)) Piramal Enterprises Limited, Digwal (Vil), Kohir Mandal, Medak District, Telangana, 502 321, India
(Lamivudine) Glaxo Wellcome Manufacturing Pte Ltd, 1 Pioneer Sector 1, Jurong, 628 413, Singapore
(Lamivudine) Mylan Laboratories Limited, Unit 2, Survey No. 10/42, Gaddapotharam, Kazipally Industrial Area, Medak District, Telangana, 502 319, India

API WHO Public Inspection Reports: