Tritanrix HB - opinion on medicine for use outside EU

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

Overview

The opinion for Tritanrix HB for use outside the European Union has been withdrawn at the request of the opinion holder.

Tritanrix HB : Medicine overview

Reference Number: EMA/809058/2013

Product information

Tritanrix HB : Product information

Latest procedure affecting product information:H-C-W-3838

19/12/2013

Product information documents contain:

• Annex I - Summary of product characteristics
• Annex IIA - Manufacturer responsible for batch release
• Annex IIB - Recommendations to the opinion holder - conditions of use
• Annex IIIA - Labelling
• Annex IIIB - Package leaflet

Tritanrix HB : All presentations

Pharmacotherapeutic group

Vaccines

Therapeutic indication

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

Opinion details

Product details

• Name of medicine:
  Tritanrix HB
• EMA 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  Withdrawn opinion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

• Date of opinion:
  19/12/2013

Assessment history

Tritanrix HB : Withdrawal of the Article 58 scientific opinion - Public statement

Reference Number: EMA/370562/2019

Tritanrix HB : Public Assessment Report

Adopted Reference Number: EMA/CHMP/49887/2014

CHMP summary of positive opinion for Tritanrix HB

Adopted Reference Number: EMA/CHMP/749396/2013