Medicines/finished pharmaceutical products

Reference Number: 
HA704 (a)

Date of prequalification: 
17 July 2018
Basis of listing: 
Prequalified by WHO
Status: 
Active
INN: 
Itraconazole
Therapeutic area: 
HIV/AIDS
Dosage form & strength: 
Capsules, hard 100mg
Storage condition: 
Do not store above 25°C. Avoid excursions above 30°C
Shelf life (months): 
24
Packaging: 
Blister, Alu/Alu 5x3
Applicant: 
Universal Farma S.L., Gran Via Carlos III, 98, 7th floor, Barcelona, 08028, Spain
FPP Manufacturing Site: 

Laboratorios Liconsa SA, Avda. Miralcampo No 7, Polígono Industrial Miralcampo, Azuqueca de Henares, Guadalajara, 19200, Spain

FPP WHO Public Inspection Reports: 
API Manufacturing Site: 

(Itraconazole) Química Sintética SA, C/ Dulcinea, Alcalá de Henares, Madrid, 28805, Spain

API WHO Public Inspection Reports: