🇪🇺 ANDEMBRY in European Union

EMA authorised ANDEMBRY on 10 February 2025

Marketing authorisation

EMA — authorised 10 February 2025

  • Application: EMEA/H/C/006116
  • Marketing authorisation holder: CSL Behring GmbH
  • Local brand name: Andembry
  • Indication: Andembry is indicated for routine prevention of recurrent attacks of hereditary angioedema (HAE) in adult and adolescent patients aged 12 years and older.
  • Status: approved

On 10 February 2025, the European Medicines Agency (EMA) granted marketing authorisation for ANDEMBRY, a treatment for preventing recurrent attacks of hereditary angioedema (HAE) in adults and adolescents aged 12 and older. This authorisation was granted to CSL Behring GmbH, the marketing authorisation holder. ANDEMBRY is indicated for routine prevention of HAE attacks in patients aged 12 and older.

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ANDEMBRY in other countries

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

Other Other approved in European Union

Frequently asked questions

Is ANDEMBRY approved in European Union?

Yes. EMA authorised it on 10 February 2025.

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

CSL Behring GmbH holds the EU marketing authorisation.