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HA810

WHO Product ID
HA810
Status
Prequalified
INN, dosage form and strength
Lenacapavir Tablet, Film-coated 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
Gilead Sciences Ireland UC
IDA Business & Technology Park,
Carrigtohill,
T45 DP77
Ireland
Packaging details and storage conditions
Packaging Type
Bottle, HDPE
Configuration
4x1
Shelf life (months)
36
Storage conditions
Do not store above 30°C. Store in the original package in order to protect from moisture
API Manufacturing Site(s)
By Organization
By Active Ingredient
Gilead Alberta, ULC
1021 Hayter Road, Alberta
Edmonton,
T6S 1A1
Canada
Lenacapavir
Yuhan Chemical, Inc
162 Cheongwonsandan 8-gil, Hwaseong-si
Mado-myeon,
18543
Republic of Korea
Lenacapavir
FPP Manufacturing Site(s)
Esteve Química S.A. (Intermediate manufacturer)
Calle Ter-Poligono Industrial 94, Celra
Girona
17460
Spain
Gilead Sciences Ireland UC
IDA Business & Technology Park,
Carrigtohill,
T45 DP77
Ireland
Rottendorf Pharma GmbH
Ostenfelder Strasse 51-61
Ennigerloh,
Nordrhein-Westfalen
59320
Germany
FPP Packaging Only
Rottendorf Pharma GmbH
Am Fleigendahl 3
Ennigerloh,
Nordrhein-Westfalen
59320
Germany
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 authorized for additional or different uses by national medicines regulatory authorities. 

Part 1 , Part 2 , Part 7

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