Influenza A (H1N1) 2009 monovalent vaccine | WHO - Prequalification of Medical Products (IVDs, Medicines, Vaccines and Immunization Devices, Vector Control)

Vaccine type

Influenza, Pandemic (H1N1)

Commercial Name

Influenza A (H1N1) 2009 monovalent vaccine

Manufacturer

Sanofi Pasteur Inc.

URL

Responsible NRA

CBER/FDA

Country

United States of America

URL

Prequalification Status

Current: No Routine Production

Effective Date

28/01/2010

Pharmaceutical Form

Liquid: ready to use

Presentation

Vial

Number of Doses

1

Diluent

Not Applicable

Route of Administration

Intramuscular

Shelf Life

12 months

Storage Temperature

2-8°C

Vaccine Vial Monitor

none

Secondary Packaging

Carton of 10 vials [Dimensions 8.9 x 4.3 x 4.8 cm]

Tertiary Packaging

Box of 100 cartons (1000 vials/ 1000 doses) [Dimensions 45.9 x 22.9x 21.3 cm]

Multidose Vial Policy

Not Applicable.

Vaccine Preservative

none

Cold Chain Volume

18.36 cm3/dose (in secondary packaging)