Medicines/finished pharmaceutical products

Reference Number: 
IN007 (a)

Date of prequalification: 
22 September 2009
Basis of listing: 
Prequalified by WHO
Status: 
Active
INN: 
Zanamivir
Therapeutic area: 
Influenza
Dosage form & strength: 
Powder, for Inhalation 5mg
Storage condition: 
Do not store above 30°C
Shelf life (months): 
120
Packaging: 
Roradisk Blister Alu/Alu: 4 Blisters per disc, a pack contains 1 or 5 Alu foil disks
Applicant: 
Glaxo Wellcome UK Ltd, Stockley Park West, Uxbridge, Middlesex, UB11 1BT, United Kingdom of Great Britain and Northern Ireland
FPP Manufacturing Site: 

GlaxoSmithKline Australia Pty Ltd, 1061 Mountain Highway, Boronia, 3155, Australia
Aspen Bad Oldseloe GmbH, Industriestrasse 32-36, D-23843, Bad Oldesloe, Germany
GlaxoSmithKline LLC, 1011, North Arendall Avenue, Zebulon, North Carolina, 27597, United States of America
SmithKline Beecham Limited, Currabinny, Carrigaline, County Cork, Ireland
Glaxo Wellcome Production, 23 rue Lavoisier, Zone Industrielle No 2, Evreux, 27000, France
Catalent UK Packaging Ltd, Sedge Close, Headway, Great Oakley, Corby, Northamptonshire, NN18 8HS, United Kingdom of Great Britain and Northern Ireland

FPP WHO Public Inspection Reports: 
API Manufacturing Site: 

(Zanamivir) Glaxo Wellcome Manufacturing Pte Ltd, 1 Pioneer Sector 1, Jurong, 628 413, Singapore
(Zanamivir) Glaxo Wellcome Production, 23 rue Lavoisier, Zone Industrielle No 2, Evreux, 27000, France
(Zanamivir) Glaxo Wellcome Operations, Priory Street, Ware, Hertfordshire, SG12 0DJ, United Kingdom of Great Britain and Northern Ireland
(Zanamivir) Glaxo Operations UK Limited, Cobden Street, Montrose, Angus, DD10 8EA, United Kingdom of Great Britain and Northern Ireland

API WHO Public Inspection Reports: