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EMA approval · 2024-07-18

EMA Authorised: Agilus (dantrolene sodium, hemiheptahydrate) — Norgine B.V.

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Summary

EMA authorised Agilus for malignant hyperthermia, with active substance dantrolene sodium hemiheptahydrate, manufactured by Norgine B.V.

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Diseases / indications

Drugs mentioned

  • Agilus (dantrolene sodium, hemiheptahydrate)

Snippet

Status: Authorised. Therapeutic area: Malignant Hyperthermia. MAH: Norgine B.V.. Decision date: 29/05/2024