WHO Product ID
HA811
Status
Prequalified
INN, dosage form and strength
Lenacapavir Solution for injection 463.5 mg/1.5 mL
Date of prequalification
Basis of listing
Prequalification - Abridged
Therapeutic area
HIV/AIDS
Type
Finished Pharmaceutical Product
Dosage form
Solution for injection
Applicant organization
Gilead Sciences Ireland UC
IDA Business & Technology Park,
Carrigtohill,
T45 DP77
Ireland
Packaging details and storage conditions
Packaging Type
Vial, Glass
Configuration
3ml vial containing 1.5ml solution x 2; 18-gauge Withdrawal needles x 2; disposable syringes x 2; 22-gauge injection safety needles x 2
Shelf life (months)
36
Storage conditions
Do not store above 30°C, protect from light
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)
Hikma Farmaceutica (Portugal) S.A
Fervenca, Estrada do Rio Da Mo, 8 8-A E 8-B, Terrugem SNT
2705-906
Portugal
Patheon Italia S.p.A
Viale Gian Battista Stucchi 110, Monza
20900
Italy
