🇪🇺 DANTROLENE SODIUM in European Union

EMA authorised DANTROLENE SODIUM on 29 May 2024

Marketing authorisation

EMA — authorised 29 May 2024

  • Application: EMEA/H/C/006009
  • Marketing authorisation holder: Norgine B.V.
  • Local brand name: Agilus
  • Indication: In combination with adequate support measures, Agilus is indicated for the treatment of malignant hyperthermia in adults and children of all ages.
  • Status: approved

The European Medicines Agency (EMA) approved Agilus (Dantrolene Sodium) for the treatment of malignant hyperthermia in adults and children of all ages. This approval was granted on 29 May 2024. Agilus is indicated for use in combination with adequate support measures to manage this life-threatening medical condition.

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DANTROLENE SODIUM 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 DANTROLENE SODIUM approved in European Union?

Yes. EMA authorised it on 29 May 2024.

Who is the marketing authorisation holder for DANTROLENE SODIUM in European Union?

Norgine B.V. holds the EU marketing authorisation.