None used on labelling for supply through UN agencies. Also marketed with labelled commercial name ComBE Five (Reconstituted). | WHO - Prequalification of Medical Products (IVDs, Medicines, Vaccines and Immunization Devices, Vector Control)

Vaccine type

Diphtheria-Tetanus-Pertussis (whole cell)-Hepatitis B-Haemophilus influenzae type b

Commercial Name

None used on labelling for supply through UN agencies. Also marketed with labelled commercial name ComBE Five (Reconstituted).

Manufacturer

Biological E. Limited

URL

Responsible NRA

Central Drugs Standard Control Organization

Country

India

URL

Prequalification Status

Current

Effective Date

01/09/2011

Pharmaceutical Form

Lyophilised active component to be reconstituted with liquid active component before use

Presentation

Two vial set (active + active)

Number of Doses

Diluent

Liquid active component

Route of Administration

Intramuscular

Shelf Life

24 months

Storage Temperature

2-8°C

Vaccine Vial Monitor

Type 14

Secondary Packaging

carton of 216 vials of Hib and 216 vials of DTP-HepB

Multidose Vial Policy

Not Applicable.

Vaccine Preservative

thiomersal

Cold Chain Volume

58.7 cm3/dose (in secondary packaging)

Container Photo

Container Photo (Bigger\ Higher Resolution)

Package Insert