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HA704

Product Details
WHO Product ID
HA704
Status
Prequalified
INN, dosage form and strength
Itraconazole Capsules, hard 100mg
Date of prequalification
Basis of listing
Prequalification - Abridged
Therapeutic area
HIV/AIDS
Type
Finished Pharmaceutical Product
Dosage form
Capsules, hard
Reference authority
Medicines and Healthcare products Regulatory Agency (MHRA)
Applicant organization
Laboratorios Liconsa S.A.
Calle Dulcinea S/N,, Alcalá de Henares,
Madrid,
28805
Spain
Packaging details and storage conditions
Packaging Type
Blister, Alu/Alu
Configuration
5x3
Shelf life (months)
24
Storage conditions
Do not store above 25°C. Avoid excursions above 30°C
API Manufacturing Site(s)
By Organization
By Active Ingredient
Química Sintética SA
C/ Dulcinea, Alcalá de Henares
Madrid,
28805
Spain
Itraconazole
FPP Manufacturing Site(s)
Laboratorios Liconsa S.A.
Avda. Miralcampo No 7, Polígono Industrial Miralcampo, Azuqueca de Henares
Guadalajara,
19200
Spain
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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