Medicines/finished pharmaceutical products

Reference Number: 
NT001 (a)

Date of prequalification: 
06 September 2016
Basis of listing: 
Prequalified by WHO
Status: 
Active
INN: 
Diethylcarbamazine (citrate)
Therapeutic area: 
Neglected Tropical Diseases (NTD)
Dosage form & strength: 
Tablet 100mg
Storage condition: 
SRA accepted: No special storage conditions; WHO recommended: Do not store above 30°C. Store in the original package in order to protect from moisture. The shelf life at this storage condition is 36 months
Shelf life (months): 
60
Packaging: 
Blister,Alu/PVC; 10x2
Applicant: 
Sanofi, 82, avenue Raspail, 94250 - Gentilly, France
FPP Manufacturing Site: 

Famar Lyon, 29 Avenue du General de Gaulle, Saint-Genis-Laval, 69230, France
Haupt Pharma Livron SAS, 1 rue Comte de Sinard, Livron sur Drôme, 26250, France

FPP WHO Public Inspection Reports: 
API Manufacturing Site: 

(Diethylcarbamazine (citrate)) SAFC Sigma-Aldrich Ireland Ltd, Arklow, Wicklow, Republic of Ireland

API WHO Public Inspection Reports: