🇪🇺 Agamree in European Union

EMA authorised Agamree on 14 December 2023

Marketing authorisation

EMA — authorised 14 December 2023

  • Application: EMEA/H/C/005679
  • Marketing authorisation holder: Santhera Pharmaceuticals (Deutschland) GmbH
  • Local brand name: Agamree
  • Indication: Agamree is indicated for the treatment of Duchenne muscular dystrophy (DMD) in patients aged 4 years and older.
  • Pathway: orphan
  • Status: approved

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Agamree 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 Agamree approved in European Union?

Yes. EMA authorised it on 14 December 2023.

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

Santhera Pharmaceuticals (Deutschland) GmbH holds the EU marketing authorisation.