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EMA Product

Infanrix Hexa

Product approved by European Medicines Agency (EU)

Basic Information

Infanrix Hexa

Regulatory Information

EMEA/H/C/000296

Authorised

October 23, 2000

June 29, 2000

48

September 4, 2024

Company Information

Belgium

Rue de l'Institut, 89 B-1330 Rixensart

GlaxoSmithKline Biologicals SA

Active Substances Detail

Diphtheria toxoidtetanus toxoidBordetella pertussis antigens (pertussis toxoid, filamentous haemagglutinin, pertactin)hepatitis B surface antigenpoliovirus (inactivated) (type-1 (Mahoney strain), type-2 (MEF-1 strain), type-3 (Saukett strain))Haemophilus influenzae type b polysaccharide

Detailed Information

Therapeutic Indication

### Therapeutic indication Infanrix hexa is indicated for primary and booster vaccination of infants from the age of 6 weeks and toddlers against diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and disease caused by Haemophilus influenzae type b. The use of Infanrix hexa should be in accordance with official recommendations.

Overview Summary

Infanrix hexa is a vaccine used to protect infants from six weeks of age and toddlers against diphtheria, tetanus, pertussis (whooping cough), hepatitis B, poliomyelitis (polio) and diseases such as bacterial meningitis caused by the bacterium Haemophilus influenzae type b (Hib). Infanrix hexa contains the following active substances: - toxoids (chemically weakened toxins) from diphtheria and tetanus; - parts of Bordetella pertussis (pertussis, a bacterium that causes whooping cough); - parts of the hepatitis B virus; - inactivated polioviruses; - polysaccharides (sugars) from Hib.

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