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 15/06/2018

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
Additional monitoring

This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring.

Publication details
Marketing-authorisation holder
MCM Vaccine B.V.
Revision
5
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

06/04/2018 Vaxelis - EMEA/H/C/003982 - N/0029

Contents

  • Annex I - Summary of product characteristics
  • Annex IIA - Manufacturing-authorisation holder responsible for batch release
  • Annex IIB - Conditions of the marketing authorisation
  • Annex IIIA - Labelling
  • Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.

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

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