Medicines/finished pharmaceutical products

Reference Number: 
HA597 (a)

Date of prequalification: 
21 October 2013
Basis of listing: 
Prequalified by WHO
Status: 
Active
INN: 
Ondansetron (hydrochloride)
Therapeutic area: 
HIV/AIDS
Dosage form & strength: 
Solution for injection 4mg/2mL
Storage condition: 
Do not store above 25°C
Shelf life (months): 
36
Packaging: 
Ampoule Glass: 2mlx5, 2mlx1; Ampoule Propylene: 2mlx5, 2mlx1
Applicant: 
Demo SA, 21st Km National Road Athens-Lamia, Krioneri, Attiki, 14568, Greece
FPP Manufacturing Site: 

Demo SA, 21st Km National Road Athens-Lamia, Krioneri, Attiki, 14568, Greece

FPP WHO Public Inspection Reports: 
API Manufacturing Site: 

(Ondansetron (hydrochloride)) Dr Reddy's Laboratories Ltd, Unit IV, Plot No 9A, I.D.A, Hyderabad, Andhra Pradesh, 500 055, India

API WHO Public Inspection Reports: