药品/药物成品

Reference Number: 
HA110 (a)

Date of prequalification: 
20 March 2002
Basis of listing: 
Prequalified by WHO
Status: 
Active
INN: 
Lamivudine/Zidovudine
Therapeutic area: 
HIV/AIDS
Dosage form & strength: 
Tablet, Film-coated 150mg/300mg
Storage condition: 
Do not store above 30°C
Shelf life (months): 
24
Packaging: 
Bottle HDPE: 60x1; Blister Alu/PVC: 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: 

(Lamivudine) Mylan Laboratories Ltd, Unit 1, Survey 10/42, Gaddapotharam, Kazipally Industrial Area, Sangareddy, Telangana, 502 319, India
(Lamivudine) Glaxo Wellcome Manufacturing Pte Ltd, 1 Pioneer Sector 1, Jurong, 628 413, Singapore
(Zidovudine) Aurobindo Pharma Ltd, Unit VIII, Survey No. 10 & 13, Gaddapothoram Village, I.D.A Kazipally, Jinnaram Mandal, Sanga Reddy District, Telangana, 520319, India