Product Details
WHO Product ID
IN007
Status
Prequalified
INN, dosage form and strength
Zanamivir Powder, for Inhalation 5mg
Date of prequalification
Basis of listing
Prequalification - Abridged
Therapeutic area
Influenza
Type
Finished Pharmaceutical Product
Dosage form
Powder, for Inhalation
Applicant organization
Glaxo Wellcome UK Ltd
Stockley Park West
Uxbridge,
UB11 1BT
United Kingdom
Packaging details and storage conditions
Packaging Type
Rotadisk Blister, Alu/Alu
Configuration
4 Blisters per disk a pack contains 1 or 5 Alu foil disks
Shelf life (months)
120
Storage conditions
Do not store above 30°C
API Manufacturing Site(s)
By Organization
By Active Ingredient
Glaxo Operations UK Limited
Cobden Street, Angus
Montrose,
DD10 8EA
United Kingdom of Great Britain and Northern Ireland
Zanamivir
Glaxo Operations UK Limited
Priory Street, Hertfordshire
Ware,
SG12 0DJ
United Kingdom of Great Britain and Northern Ireland
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
FPP Manufacturing Site(s)
Glaxo Wellcome Production
23 rue Lavoisier, Zone Industrielle No 2
Evreux,
27000
France
GlaxoSmithKline Australia Pty Ltd
1061 Mountain Highway
Boronia,
3155
Australia
GlaxoSmithKline LLC
1011, North Arendall Avenue, Zebulon
27597
United States of America
GlaxoSmithKline Trading Services Limited
12 Riverwalk, Citywest Business Campus
Dublin,
24
Ireland