Medicines/finished pharmaceutical products

Reference Number: 
HP003

Date of prequalification: 
18 December 2018
Basis of listing: 
Prequalified by WHO
Status: 
Active
INN: 
Sofosbuvir
Therapeutic area: 
Hepatitis
Dosage form & strength: 
Tablet, Film-coated 400mg
Storage condition: 
Do not store above 30°C, store in dry condition
Shelf life (months): 
24
Packaging: 
Bottle,HDPE 28x1
Applicant: 
European Egyptian Pharmaceuticals Industries Co, PO Box 111, El Manshia Alex, Cairo Desert Road KM 25, Amriya, Alexandria, Egypt
FPP Manufacturing Site: 

European Egyptian Pharmaceuticals Industries Co, PO Box 111, El Manshia Alex, Cairo Desert Road KM 25, Amriya, Alexandria, Egypt

API Manufacturing Site: 

(Sofosbuvir) CAD Middle East Pharmaceutical Industries LLC., King Khalid, International Airport, Industrial District, P.O. Box: 26721, Riyadh, 11496, Saudi Arabia