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

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

10

Diluent

Not Applicable

Route of Administration

Intramuscular

Shelf Life

12 months

Storage Temperature

2-8°C

Vaccine Vial Monitor

none

Secondary Packaging

1 vial carton (10 doses) [Dimensions 3.1 x 3.1 x 6.1 cm]

Tertiary Packaging

Box of 100 cartons of 1 vial (100 vials/ 1000 doses) [Dimensions 32.5 x 17 x 15.6 cm]

Multidose Vial Policy

Not Applicable.

Vaccine Preservative

thiomersal

Cold Chain Volume

6 cm3/dose (in secondary packaging)