🇪🇺 Hepatitis B Vaccine in European Union

EMA authorised Hepatitis B Vaccine on 27 April 2001

Marketing authorisation

EMA — authorised 27 April 2001

  • Application: EMEA/H/C/000373
  • Marketing authorisation holder: Merck Sharp & Dohme B.V.
  • Local brand name: HBVaxPro
  • Indication: 5 micrograms HBVaxPro is indicated for active immunisation against hepatitis-B-virus infection caused by all known subtypes in individuals from birth through 15 years of age considered at risk of exposure to hepatitis-B virus. The specific at-risk categories to be immunised are to be determined on the basis of the official recommendations. It can be expected that hepatitis D will also be prevented by immunisation with HBVaxPro as hepatitis D (caused by the delta agent) does not occur in the absence of hepatitis-B infection. 10 micrograms HBVaxPro is indicated for active immunisation against he
  • Status: approved

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Other Immunology approved in European Union

Frequently asked questions

Is Hepatitis B Vaccine approved in European Union?

Yes. EMA authorised it on 27 April 2001.

Who is the marketing authorisation holder for Hepatitis B Vaccine in European Union?

Merck Sharp & Dohme B.V. holds the EU marketing authorisation.