🇪🇺 IMVAMUNE in European Union

EMA authorised IMVAMUNE on 31 July 2013

Marketing authorisation

EMA — authorised 31 July 2013

  • Application: EMEA/H/C/002596
  • Marketing authorisation holder: Bavarian Nordic A/S
  • Local brand name: Imvanex
  • Indication: Active immunisation against smallpox, monkeypox and disease caused by vaccinia virus in individuals 12 years of age and older (see sections 4.4 and 5.1).The use of this vaccine should be in accordance with official recommendations.
  • Pathway: exceptional circumstances
  • Status: approved

Read official source →

IMVAMUNE in other countries

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

Frequently asked questions

Is IMVAMUNE approved in European Union?

Yes. EMA authorised it on 31 July 2013.

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

Bavarian Nordic A/S holds the EU marketing authorisation.