Medicines/finished pharmaceutical products

Reference Number: 
HA107 (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: 
Solution, Oral 20mg/mL
Storage condition: 
Do not store above 30°C
Shelf life (months): 
24
Packaging: 
Bottle HDPE: 240mL
Applicant: 
ViiV Healthcare BV, Huis ter Heideweg 62, 3705 LZ Zeist, Netherlands
FPP Manufacturing Site: 

GlaxoSmithKline, 7333 Mississauga North Road, Mississauga, Ontario, Canada

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)) Thermo Fisher Scientific Cork Limited, Currabinny, Carrigaline, County Cork, 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

API WHO Public Inspection Reports: