Medicines/finished pharmaceutical products

Reference Number: 
HP007 (a)

Date of prequalification: 
14 October 2016
Basis of listing: 
Prequalified by WHO
Status: 
Active
INN: 
Daclatasvir (dihydrochloride)
Therapeutic area: 
Hepatitis
Dosage form & strength: 
Tablet, Film-coated 30mg
Storage condition: 
SRA accepted: This medicinal product does not require any special storage conditions; WHO recommended: Do not store above 30°C. The shelf life at this storage condition is 30 months.
Shelf life (months): 
30
Packaging: 
Blister, Alu/PVC-ACLAR 14x2
Applicant: 
Bristol-Myers Squibb Company, P.O. Box 5400, New Jersey, United States of America
FPP Manufacturing Site: 

Astra Zeneca Pharmaceuticals LP, 4601 Highway 62 East, Mount Vernon, Indiana, 47620, United States of America
Bristol-Myers Squibb (BMS), Contrada Fontana del Ceraso, Anagni-Frosinone, 3012, Italy
Bristol-Myers Squibb Manufacturing Company, State Road #3, Km 77.5, Humacao, 00791, Puerto Rico

FPP WHO Public Inspection Reports: 
API Manufacturing Site: 

(Daclatasvir dihydrochloride) Swords Laboratories , Water Lane, Dublin, Swords County, Ireland

API WHO Public Inspection Reports: