🇪🇺 HEPLISAV in European Union

EMA authorised HEPLISAV on 18 February 2021

Marketing authorisation

EMA — authorised 18 February 2021

  • Application: EMEA/H/C/005063
  • Marketing authorisation holder: Dynavax GmbH
  • Local brand name: Heplisav B
  • Indication: Heplisav B is indicated for the active immunisation against hepatitis B virus infection (HBV) caused by all known subtypes of hepatitis B virus in adults 18 years of age and older. The use of Heplisav B should be in accordance with official recommendations. It can be expected that hepatitis D will also be prevented by immunisation with Heplisav B as hepatitis D (caused by the delta agent) does not occur in the absence of hepatitis B infection.
  • Status: approved

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HEPLISAV in other countries

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

Other Immunology approved in European Union

Frequently asked questions

Is HEPLISAV approved in European Union?

Yes. EMA authorised it on 18 February 2021.

Who is the marketing authorisation holder for HEPLISAV in European Union?

Dynavax GmbH holds the EU marketing authorisation.