Medicines/finished pharmaceutical products

Reference Number: 
HA693 (a)

Date of prequalification: 
14 March 2018
Basis of listing: 
Prequalified by WHO
Status: 
Active
INN: 
Flucytosine
Therapeutic area: 
HIV/AIDS
Dosage form & strength: 
Tablet 500mg
Storage condition: 
Do not store above 25°C, protect from moisture
Shelf life (months): 
24
Packaging: 
Bottle, PP 100x1
Applicant: 
Mylan Laboratories Ltd, Plot No.564/A/22, Road No. 92, Jubilee Hills, Hyderabad, Telangana, 500096, India
FPP Manufacturing Site: 

ICN Polfa Rzeszów S.A., ul. Przemysłowa 2, 35-959 Rzeszów, Poland

FPP WHO Public Inspection Reports: 
API Manufacturing Site: 

(Flucytosine) DSM Nutritional Products Ltd., Zweigniederlassung Werk Sisseln, Hauptstrasse 4, 4334 Sisseln, Switzerland

API WHO Public Inspection Reports: