Tritanrix HB: Opinion on medicine for use outside EU

diphtheria (D), tetanus (T), pertussis (whole cell) (Pw) and hepatitis B (rDNA) (HBV) vaccine (adsorbed)

Opinion on medicine for use outside the European Union
Withdrawn opinion

Overview

Opinion details

Product details
Name of medicinal product
Tritanrix HB
Agency opinion number
H-W-3838
Opinion status
Withdrawn opinion
Active substance
  • Bordetella pertussis (inactivated)
  • Diphtheria toxoid
  • hepatitis B surface antigen
  • tetanus toxoid
International non-proprietary name (INN) or common name
diphtheria (D), tetanus (T), pertussis (whole cell) (Pw) and hepatitis B (rDNA) (HBV) vaccine (adsorbed)
Therapeutic area (MeSH)
  • Hepatitis
  • Tetanus
  • Immunization
  • Meningitis, Haemophilus
  • Whooping Cough
  • Poliomyelitis
  • Diphtheria
Anatomical therapeutic chemical (ATC) code
J07CA05
Publication details
Opinion holder

GlaxoSmithKline Biologicals S.A.
Rue de l'institut 89
1330 Rixensart
Belgium

Date of opinion
19/12/2013

Product information

19/12/2013 Tritanrix HB H-C-W-3838

Contents

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Pharmacotherapeutic group

Vaccines

Therapeutic indication

Active immunisation against diphtheria, tetanus, pertussis and hepatitis B (HBV) in infants from 6 weeks onwards.

Assessment history

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