Medicines/finished pharmaceutical products

Reference Number: 
IN003 (a)

Date of prequalification: 
21 September 2009
Basis of listing: 
Prequalified by WHO
Status: 
Active
INN: 
Oseltamivir (phosphate)
Therapeutic area: 
Influenza
Dosage form & strength: 
Powder for Oral suspension 12mg/mL
Storage condition: 
Do not store above 25°C
Shelf life (months): 
24
Packaging: 
Bottle Amber Glass: 30gx100mlx1
Applicant: 
Roche Registration GmbH, Emil-Barell-Strasse, 79639 Grenzach-Wyhlen, Germany
FPP Manufacturing Site: 

F. Hoffmann - La Roche Ltd, Basel, CH-4070, Switzerland
Rottendorf Pharma GmbH, Ostenfelder Strasse 51-61, Ennigerloh, North Rhine-Westphalia, 59320, Germany
F Hoffmann - La Roche Ltd, Wurmisweg, Kaiseraugst, CH-4303, Switzerland

FPP WHO Public Inspection Reports: 
API Manufacturing Site: 

(Oseltamivir (phosphate)) F. Hoffmann - La Roche Ltd, Basel, CH-4070, Switzerland
(Oseltamivir (phosphate)) Patheon API Inc, 6173 E Old Marion Highway, Florence, South Carolina, 29506, United States of America

API WHO Public Inspection Reports: