🇪🇺 HEPATITIS B SURFACE ANTIGEN in European Union

EMA authorised HEPATITIS B SURFACE ANTIGEN on 25 April 2022

Marketing authorisations

EMA — authorised 25 April 2022

  • Application: EMEA/H/C/005466
  • Marketing authorisation holder: VBI Vaccines B.V.
  • Local brand name: PreHevbri
  • Indication: PreHevbri is indicated for active immunisation against infection caused by all known subtypes of the hepatitis B virus in adults. It can be expected that hepatitis D will also be prevented by immunisation with PreHevbri as hepatitis D (caused by the delta agent) does not occur in the absence of hepatitis B infection. The use of PreHevbri should be in accordance with official recommendations.
  • Status: withdrawn

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EMA

  • Application: EMEA/H/C/005063
  • Local brand name: Heplisav B
  • Status: approved

HEPATITIS B SURFACE ANTIGEN in other countries

Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.

Other Immunology / Infectious Disease approved in European Union

Frequently asked questions

Is HEPATITIS B SURFACE ANTIGEN approved in European Union?

Yes. EMA authorised it on 25 April 2022; EMA has authorised it.

Who is the marketing authorisation holder for HEPATITIS B SURFACE ANTIGEN in European Union?

VBI Vaccines B.V. holds the EU marketing authorisation.