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Midazolam buccal - Neuraxpharm

Drug Profile

Midazolam buccal - Neuraxpharm

Alternative Names: Buccolam; MHOS; Midazolam hydrochloride oromucosal solution; SHP-615; TAK-815

Latest Information Update: 13 Jan 2025

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At a glance

  • Originator Therakind; ViroPharma
  • Developer Neuraxpharm; Shire; Takeda; Therakind
  • Class 3-ring heterocyclic compounds; Antiepileptic drugs; Benzodiazepines; Chlorinated hydrocarbons; Fluorobenzenes; Hypnosedatives; Imidazoles; Sleep disorder therapies; Small molecules
  • Mechanism of Action GABA A receptor agonists
  • Orphan Drug Status

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

    Yes - Epilepsy
  • New Molecular Entity No

Highest Development Phases

  • Marketed Epilepsy; Status epilepticus

Most Recent Events

  • 01 Sep 2024 CHMP of EMA recommends approval of Midazolam buccal for Epilepsy (In adults) in European Union
  • 30 Jun 2024 Preregistration for Epilepsy in Canada (Buccal)
  • 04 Oct 2022 Launched for Epilepsy (In adolescents, In children, In infants) in Switzerland (Buccal)

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