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HA110

Product Details
WHO Product ID
HA110
Status
Prequalified
INN, dosage form and strength
Lamivudine/Zidovudine Tablet, Film-coated 150mg/300mg
Date of prequalification
Basis of listing
Prequalification - Abridged
Therapeutic area
HIV/AIDS
Type
Finished Pharmaceutical Product
Dosage form
Tablet, Film-coated
Reference authority
European Medicines Agency
Applicant organization
ViiV Healthcare BV
Van Asch van Wijckstraat 55H
Amersfoort,
3811 LP
Netherlands
Packaging details and storage conditions
Packaging Type
Bottle, HDPE
Configuration
60x1
Shelf life (months)
24
Storage conditions
Do not store above 30°C
Packaging Type
Blister, Alu/PVC
Configuration
10x6
Shelf life (months)
24
Storage conditions
Do not store above 30°C
API Manufacturing Site(s)
By Organization
By Active Ingredient
Aurobindo Pharma Ltd
Unit VIII, Survey No. 10 & 13, Gaddapothoram Village, Jinnaram Mandal, Sangareddy District
I.D.A Kazipally,
Telangana
520319
India
Zidovudine
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
FPP Manufacturing Site(s)
Delpharm Poznań Spółka Akcyjna
ul. Grunwaldzka 189
Poznan,
60-332
Poland
Glaxo Operations UK Limited
Priory Street, Hertfordshire
Ware,
SG12 0DJ
United Kingdom of Great Britain and Northern Ireland

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