Vaxelis
diphtheria, tetanus, pertussis (acellular, component), hepatitis B (rDNA), poliomyelitis (inactivated) and Haemophilus type b conjugate vaccine (adsorbed)
Table of contents
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.
-
List item
Vaxelis : EPAR - Summary for the public (PDF/83.73 KB)
First published: 26/02/2016
Last updated: 26/02/2016
EMA/859285/2015 -
-
List item
Vaxelis : EPAR - Risk-management-plan summary (PDF/47.23 KB)
First published: 26/02/2016
Last updated: 01/10/2020
Authorisation details
Product details | |
---|---|
Name |
Vaxelis
|
Agency product number |
EMEA/H/C/003982
|
Active substance |
|
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) |
|
Anatomical therapeutic chemical (ATC) code |
J07CA09
|
Publication details | |
---|---|
Marketing-authorisation holder |
MCM Vaccine B.V.
|
Revision |
14
|
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
26/01/2023 Vaxelis - EMEA/H/C/003982 - II/0110
This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
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.