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HA128

Product Details
WHO Product ID
HA128
Status
Prequalified
INN, dosage form and strength
Lamivudine Solution, Oral 10mg/mL
Date of prequalification
Basis of listing
Prequalification - Abridged
Therapeutic area
HIV/AIDS
Type
Finished Pharmaceutical Product
Dosage form
Solution, Oral
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
240ml
Shelf life (months)
24
Storage conditions
Do not store above 25°C
API Manufacturing Site(s)
By Organization
By Active Ingredient
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)
Bora Pharmaceutical Services Inc.
7333 Mississauga North
Mississauga,
Ontario
L5N 6L4
Canada
WHO Public Assessment Reports


Part 1 - Abstract
Part 2 - All accepted presentations (including photo)
Part 3 - WHO-PQ recommended patient information leaflet*
Part 4 - WHO-PQ recommended summary of product characteristics*
Part 5 - Label
Part 6 - Discussion (status at the time of prequalification)
Part 7 - Steps before Prequalification
Part 8 - Steps following Prequalification (from 01 March 2014, only changes to the published information are included)

* This summary of product characteristics/patient information leaflet focus on uses of the medicine covered by WHO Prequalification Team - Medicines. The recommendations for use are based on WHO guidelines and on information from stringent regulatory authorities (term to be revised). The medicine may be authorised for additional or different uses by national medicines regulatory authorities. 

Part 1 , Part 2 , Part 7

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