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Ambirix (hepatitis A (inactivated) and hepatitis B (rDNA) (HAB) vaccine (adsorbed))

Region
🇪🇺 EU
Active substance
hepatitis A (inactivated) and hepatitis B (rDNA) (HAB) vaccine (adsorbed)
Company
GlaxoSmithKline Biologicals S.A.
Status
Authorised
Therapeutic area
Hepatitis B; Hepatitis A; Immunization
EU approval
Fri 30 Aug 2002
Application
EMEA/H/C/000426
ATC
J07BC20
Official record
www.ema.europa.eu

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.

Regulatory milestones

No milestones recorded in the last year.

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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.