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HA789

Product Details
WHO Product ID
HA789
Status
Prequalified
INN, dosage form and strength
Cabotegravir Suspension for injection 600mg/3mL
Date of prequalification
Basis of listing
Prequalification - Abridged
Therapeutic area
HIV/AIDS
Type
Finished Pharmaceutical Product
Dosage form
Suspension for injection
Reference authority
Therapeutic Goods Administration (Australia)
Applicant organization
ViiV Healthcare Pty Ltd
Packaging details and storage conditions
Packaging Type
Vial, Glass
Configuration
1x3mL, 25x3mL
Shelf life (months)
36
Storage conditions
Do not store above 30°C. Do not freeze
API Manufacturing Site(s)
By Organization
By Active Ingredient
Glaxo Wellcome Manufacturing Pte Ltd
1 Pioneer Sector 1, Jurong
628 413
Singapore
Cabotegravir
FPP Manufacturing Site(s)
Glaxo Operations UK Limited (trading as Glaxo Wellcome Operations)
Harmire Road, Barnard Castle
County Durham,
DL12 8DT
United Kingdom of Great Britain and Northern Ireland
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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