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 BV, Huis ter Heideweg 62, 3705 LZ Zeist, Netherlands
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

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, Sy.Nos. 7-70, 70/1 and 70/2, Digwal (Vil), Kohir Mandal, Sangareddy District, Telangana, 502 321, India
(Abacavir (sulfate)) Thermo Fisher Scientific Cork Limited, Currabinny, Carrigaline, County Cork, Ireland

API WHO Public Inspection Reports: