🇪🇺 Dawnzera in European Union

EMA authorised Dawnzera on 19 January 2026

Marketing authorisation

EMA — authorised 19 January 2026

  • Application: EMEA/H/C/006554
  • Marketing authorisation holder: Otsuka Pharmaceutical Netherlands B.V.
  • Local brand name: Dawnzera
  • Indication: Dawnzera is indicated for routine prevention of recurrent attacks of hereditary angioedema (HAE) in adults and adolescents aged 12 years and older.
  • Status: approved

The European Medicines Agency (EMA) has granted marketing authorisation for Dawnzera, a medicinal product indicated for the routine prevention of recurrent attacks of hereditary angioedema (HAE) in adults and adolescents aged 12 years and older. This approval was granted on 19 January 2026, following a standard application. Dawnzera is manufactured by Otsuka Pharmaceutical Netherlands B.V.

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Dawnzera in other countries

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

Other Pain approved in European Union

Frequently asked questions

Is Dawnzera approved in European Union?

Yes. EMA authorised it on 19 January 2026.

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

Otsuka Pharmaceutical Netherlands B.V. holds the EU marketing authorisation.