MedPath
EMA Product

Hexyon

Product approved by European Medicines Agency (EU)

Basic Information

Hexyon

Regulatory Information

EMEA/H/C/002796

Authorised

April 17, 2013

February 21, 2013

33

December 11, 2024

Company Information

France

82 Avenue Raspail 94250 Gentilly

SANOFI WINTHROP INDUSTRIE

Active Substances Detail

filamentous haemagglutininHaemophilus influenzae type B polysaccharide (polyribosylribitol phosphate)hepatitis B surface antigenpertussis toxoidpoliovirus (inactivated) type 1 (Mahoney strain) produced on Vero cellspoliovirus (inactivated) type 2 (MEF-1 strain) produced on Vero cellspoliovirus (inactivated) type 3 (Saukett strain) produced on Vero cellstetanus proteintetanus toxoid adsorbed on aluminium hydroxide, hydratedDiphtheria toxoid

Detailed Information

Therapeutic Indication

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

Overview Summary

This is a summary of the European public assessment report (EPAR) for Hexyon. It explains how the Agency assessed the medicine to recommend its authorisation in the European Union (EU) and its conditions of use. It is not intended to provide practical advice on how to use Hexyon. For practical information about using Hexyon, patients should read the package leaflet or contact their doctor or pharmacist.

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