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EMA Product

Twinrix Paediatric

Product approved by European Medicines Agency (EU)

Basic Information

Twinrix Paediatric

Regulatory Information

EMEA/H/C/000129

Authorised

February 10, 1997

24

February 7, 2024

Company Information

Belgium

Rue de l'Institut, 89 B-1330 Rixensart

GlaxoSmithKline Biologicals SA

Active Substances Detail

hepatitis A virus (inactivated)hepatitis B surface antigen

Detailed Information

Therapeutic Indication

### Therapeutic indication Twinrix Paediatric is indicated for use in non-immune infants, children and adolescents from one year up to and including 15 years who are at risk of both hepatitis-A and hepatitis-B infection.

Overview Summary

This is a summary of the European public assessment report (EPAR). It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the studies performed, to reach their recommendations on how to use the medicine. If you need more information about your medical condition or your treatment, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. If you want more information on the basis of the CHMP recommendations, read the scientific discussion (also part of the EPAR).

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