Product Details
WHO Product ID
HA706
Status
Prequalified
INN, dosage form and strength
Abacavir (sulfate)/Lamivudine Tablet, Film-coated 600mg/300mg
Date of prequalification
Basis of listing
Prequalification - Abridged
Therapeutic area
HIV/AIDS
Type
Finished Pharmaceutical Product
Dosage form
Tablet, Film-coated
Applicant organization
ViiV Healthcare BV
Van Asch van Wijckstraat 55H
Amersfoort,
3811 LP
Netherlands
Packaging details and storage conditions
Packaging Type
blister, Child resistant, PVC/PVdC/Alu/Paper
Configuration
10x3
Shelf life (months)
24
Storage conditions
Do not store above 30°C, protect from moisture
API Manufacturing Site(s)
By Organization
By Active Ingredient
Glaxo Operations UK Limited
Cobden Street, Angus
Montrose,
DD10 8EA
United Kingdom of Great Britain and Northern Ireland
Abacavir (sulfate)
Glaxo Wellcome Manufacturing Pte Ltd
1 Pioneer Sector 1, Jurong
628 413
Singapore
Lamivudine
Mylan Laboratories Limited
Unit 2, Survey 10/42, Gaddapotharam, Sangareddy District
Kazipally Industrial Area,
Telangana
502 319
India
Lamivudine
Piramal Pharma 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
Abacavir (sulfate)
FPP Manufacturing Site(s)
Delpharm Poznań Spółka Akcyjna
ul. Grunwaldzka 189
Poznan,
60-332
Poland
Glaxo Wellcome SA
Avenue de Extremadura 3, Aranda de Duero
Burgos,
Spain