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HA788

Product Details
WHO Product ID
HA788
Status
Prequalified
INN, dosage form and strength
Cabotegravir (sodium) Tablet, Film-coated 30mg
Date of prequalification
Basis of listing
Prequalification - Abridged
Therapeutic area
HIV/AIDS
Type
Finished Pharmaceutical Product
Dosage form
Tablet, Film-coated
Reference authority
Therapeutic Goods Administration (Australia)
Applicant organization
ViiV Healthcare Pty Ltd
Packaging details and storage conditions
Packaging Type
Bottle, HDPE
Configuration
30x1
Shelf life (months)
36
Storage conditions
Do not store above 30°C
API Manufacturing Site(s)
By Organization
By Active Ingredient
Catalent Micron Technologies Inc.
Crossways Boulevard, Crossways, Dartford
Kent
DA26QY
United Kingdom of Great Britain and Northern Ireland
Cabotegravir (sodium)
Glaxo Operations UK Limited
Priory Street, Hertfordshire
Ware,
SG12 0DJ
United Kingdom of Great Britain and Northern Ireland
Cabotegravir (sodium)
Glaxo Wellcome Manufacturing Pte Ltd
1 Pioneer Sector 1, Jurong
628 413
Singapore
Cabotegravir (sodium)
FPP Manufacturing Site(s)
Glaxo Operations UK Limited
Priory Street, Hertfordshire
Ware,
SG12 0DJ
United Kingdom of Great Britain and Northern Ireland
FPP Packaging Only
Glaxo Wellcome SA
Avenue de Extremadura 3, Aranda de Duero
Burgos,
Spain
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 5 , Part 7

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