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EMA Product

Hexacima

Product approved by European Medicines Agency (EU)

Basic Information

Hexacima

Regulatory Information

EMEA/H/C/002702

Authorised

April 17, 2013

February 21, 2013

32

June 11, 2024

Company Information

France

82 Avenue Raspail 94250 Gentilly

SANOFI WINTHROP INDUSTRIE

Active Substances Detail

hepatitis B surface antigenDiphtheria toxoidtetanus toxoidBordetella pertussis antigens Pertussis Toxoid Filamentous Haemagglutininpoliovirus (inactivated) type 1 (Mahoney) type 2 (MEF-1) type 3 (Saukett)Haemophilus influenzae type b polysaccharide (Polyribosylribitol Phosphate) conjugated to Tetanus protein

Detailed Information

Therapeutic Indication

### Therapeutic indication Hexacima (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 Hexacima. 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 Hexacima. For practical information about using Hexacima, patients should read the package leaflet or contact their doctor or pharmacist.

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