Vaxelis

RSS

diphtheria, tetanus, pertussis (acellular, component), hepatitis B (rDNA), poliomyelitis (inactivated) and Haemophilus type b conjugate vaccine (adsorbed)

Authorised
This medicine is authorised for use in the European Union.

Overview

This is a summary of the European public assessment report (EPAR) for Vaxelis. It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is not intended to provide practical advice on how to use Vaxelis.

For practical information about using Vaxelis, patients should read the package leaflet or contact their doctor or pharmacist.

This EPAR was last updated on 06/04/2022

Authorisation details

Product details
Name
Vaxelis
Agency product number
EMEA/H/C/003982
Active substance
  • Diphtheria toxoid
  • tetanus toxoid
  • Bordetella pertussis antigens: pertussis toxoid, filamentous haemagglutinin, pertactin, fimbriae Types 2 and 3
  • hepatitis B surface antigen produced in yeast cells
  • poliovirus (inactivated): type 1 (Mahoney), type 2 (MEF-1), type 3 (Saukett) produced in Vero cells/ Haemophilus influenzae type b polysaccharide (polyribosylribitol phosphate) conjugated to meningococcal protein.
International non-proprietary name (INN) or common name
diphtheria, tetanus, pertussis (acellular, component), hepatitis B (rDNA), poliomyelitis (inactivated) and Haemophilus type b conjugate vaccine (adsorbed)
Therapeutic area (MeSH)
  • Meningitis, Haemophilus
  • Poliomyelitis
  • Tetanus
  • Diphtheria
  • Whooping Cough
  • Hepatitis B
Anatomical therapeutic chemical (ATC) code
J07CA09
Publication details
Marketing-authorisation holder
MCM Vaccine B.V.
Revision
10
Date of issue of marketing authorisation valid throughout the European Union
15/02/2016
Contact address
Robert Boyleweg 4
2333 CG Leiden
Netherlands

Product information

04/04/2022 Vaxelis - EMEA/H/C/003982 - N/0099

Product information documents contain:

You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.

Pharmacotherapeutic group

Vaccines

Therapeutic indication

Vaxelis (DTaP-HB-IPV-Hib) is indicated for primary and booster vaccination in infants and toddlers from the age of 6 weeks, against diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and invasive diseases caused by Haemophilus influenzae type b (Hib). The use of Vaxelis should be in accordance with official recommendations.

Assessment history

How useful was this page?

Add your rating
Average
1 rating
3 ratings