Medicines/finished pharmaceutical products

Reference Number: 
HA641 (a)

Date of prequalification: 
02 February 2015
Basis of listing: 
Prequalified by WHO
Status: 
Active
INN: 
Fluoxetine (hydrochloride)
Therapeutic area: 
HIV/AIDS
Dosage form & strength: 
Tablet, Film-coated 20mg
Storage condition: 
Do not store above 25°C
Shelf life (months): 
48
Packaging: 
Blister Alu/PVC : 10x1, 10x2, 10x3, 10x6, 10x10
Applicant: 
Vitabalans Oy, Varastokatu 8, Hämeenlinna, 13500, Finland
FPP Manufacturing Site: 

Vitabalans Oy, Varastokatu 8, Hämeenlinna, 13500, Finland

FPP WHO Public Inspection Reports: 
API Manufacturing Site: 

(Fluoxetine (hydrochloride)) UNION QUIMICO FARMACEUTICA S.A, Poligon Industrial El Pla, Av. Puigcerdà Nº 9, C-17, Km 17.4, Lliça de Vall, Barcelona, 08185, Spain

API WHO Public Inspection Reports: