Basic Information
Vaxelis
Regulatory Information
EMEA/H/C/003982
February 15, 2016
December 17, 2015
16
July 23, 2024
Company Information
Netherlands
Robert Boyleweg 4 2333 CG Leiden
MCM Vaccine BV
Active Substances Detail
Diphtheria toxoidtetanus toxoidBordetella pertussis antigens: pertussis toxoid, filamentous haemagglutinin, pertactin, fimbriae Types 2 and 3hepatitis B surface antigen produced in yeast cellspoliovirus (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.
hepatitis B surface antigen produced in yeast cells
EMA Resources
Detailed Information
Therapeutic Indication
### 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.
Overview Summary
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.