Medicines/finished pharmaceutical products

Reference Number: 
HA106 (a)

Date of prequalification: 
20 March 2002
Basis of listing: 
Prequalified by WHO
Status: 
Active
INN: 
Abacavir (sulfate)
Therapeutic area: 
HIV/AIDS
Dosage form & strength: 
Tablet, Film-coated 300mg
Storage condition: 
SRA accepted: Do not store above 30°C; WHO recommended: Do not store above 30°C. The shelf life at this storage condition is 36 months.
Shelf life (months): 
36
Packaging: 
Blister, PVC/Alu/Paper: 10x6
Applicant: 
ViiV Healthcare, 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom of Great Britain and Northern Ireland
FPP Manufacturing Site: 

Glaxo Wellcome Operations, Priory Street, Ware, Hertfordshire, SG12 0DJ, United Kingdom of Great Britain and Northern Ireland
GlaxoSmithKline S. A. ul., Grunwaldzka 189, 60-332 Poznan, Poland

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)) Piramal Enterprises Limited, Digwal (Vil), Kohir, Medak, Andra Pradesh, 502 321, India
(Abacavir (sulfate)) SmithKline Beecham Limited, Currabinny, Carrigaline, County Cork, Ireland

API WHO Public Inspection Reports: