Prognia
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🇪🇺EU · EMAAuthorisedATC: J07BC20

Ambirix(hepatitis A virus (inactivated);hepatitis B surface antigen)

Hepatitis B;Hepatitis A;Immunization

Marketing Authorisation Holder: GlaxoSmithKline Biologicals S.A.

EMA Authorisation: 30/08/2002

INN: hepatitis A (inactivated) and hepatitis B (rDNA) (HAB) vaccine (adsorbed)

Indication

Ambirix is for use in non-immune persons from one year up to and including 15 years of age for protection against hepatitis-A and hepatitis-B infection. Protection against hepatitis-B infections may not be obtained until after the second dose. Therefore: Ambirix should be used only when there is a relatively low risk of hepatitis-B infection during the vaccination course; it is recommended that Ambirix should be administered in settings where completion of the two-dose vaccination course can be assured.

Official EMA Resources

View on EMA (ema.europa.eu)

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Medical disclaimer: This information is intended for qualified healthcare professionals. Always verify with the official EMA Summary of Product Characteristics (SmPC) before clinical use.