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HA693

Product Details
WHO Product ID
HA693
Status
Prequalified
INN, dosage form and strength
Flucytosine Tablet 500mg
Date of prequalification
Basis of listing
Prequalification - Abridged
Therapeutic area
HIV/AIDS
Type
Finished Pharmaceutical Product
Dosage form
Tablet
Reference authority
Agence nationale de sécurité du médicament et des produits de santé (ANSM)
Applicant organization
Mylan Laboratories Limited
Plot No.564/A/22, Road No. 92, Jubilee Hills
Hyderabad,
Telangana
500096
India
Packaging details and storage conditions
Packaging Type
Bottle, PP
Configuration
100x1
Shelf life (months)
24
Storage conditions
Do not store above 25°C, protect from moisture
API Manufacturing Site(s)
By Organization
By Active Ingredient
Nantong Jinghua Pharmaceutical Co. Ltd.,
No. 20, 3 Haibin Road, Yanhai Economic Development Zone, Rudong
Nantong,
Jiangsu
226 407
China
Flucytosine
FPP Manufacturing Site(s)
ICN Polfa Rzeszów S.A.
ul. Przemysłowa 2
Rzeszów,
35-959
Poland
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 3 , Part 4 , Part 5 , Part 7

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