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Dantrolene sodium hemiheptahydrate - Norgine

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Drug Profile

Dantrolene sodium hemiheptahydrate - Norgine

Alternative Names: NPJ-5008

Latest Information Update: 09 Apr 2024

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At a glance

  • Originator Norgine
  • Class Antidementias; Antipyretics; Antispastics; Antivirals; Furans; Hydantoins; Imidazolidines; Muscle relaxants; Neuroprotectants; Nitrophenols; Small molecules
  • Mechanism of Action Ryanodine receptor calcium release channel antagonists
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

    No
  • New Molecular Entity No

Highest Development Phases

  • Preregistration Fever

Most Recent Events

  • 26 Mar 2024 Preregistration for Fever in European Union (IV)
  • 26 Mar 2024 Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopts a positive opinion recommending approval of dantrolene sodium hemiheptahydrate for the treatment of malignant hyperthermia
  • 26 Mar 2024 Regulatory submissions to UK MHRA and Swiss Medic are underway by Norgine

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