Product Details
WHO Product ID
EMA Art 58 H-W-002320
Status
Prequalified
INN, dosage form and strength
Fexinidazole Tablet 600mg
Basis of listing
Alternative Listing
Basis of alternative listing
EMA Article 58
Therapeutic area
Neglected tropical diseases
Type
Finished Pharmaceutical Product
Dosage form
Tablet
Applicant organization
Sanofi-aventis groupe
54 rue de la Boétie
Paris,
75008
France
Packaging details and storage conditions
Packaging Type
Blister, Alu/Alu
Configuration
6x1, 8x1, 12x2
Shelf life (months)
36
Storage conditions
Do not store above 30°C
FPP Manufacturing Site(s)
Alcami Carolinas Corporation
1726 North 23rd Street, Wilmington
NC,
28405
United States