Medicines/finished pharmaceutical products

Reference Number: 
HA618 (a)

Date of prequalification: 
13 August 2014
Basis of listing: 
Prequalified by WHO
Status: 
Active
INN: 
Dexamethasone phosphate
Therapeutic area: 
HIV/AIDS
Dosage form & strength: 
Solution for injection 4mg
Shelf life (months): 
36
Packaging: 
Ampoule Glass Type 1: 1mlx3, 1mlx100
Applicant: 
Kern Pharma SL, Venus 72, Poligono Industrial Colón II, Terrassa, Barcelona, 08228, Spain
FPP Manufacturing Site: 

Kern Pharma SL, Venus 72, Poligono Industrial Colón II, Terrassa, Barcelona, 08228, Spain

FPP WHO Public Inspection Reports: 
API Manufacturing Site: 

(Dexamethasone (sodium phosphate)) Aventis Pharma SA, Planta 2, Vertolaye, 63480, France

API WHO Public Inspection Reports: