Médunik Canada once again receives Notice of Compliance from Health Canada for Ruzurgi (amifampridine) following review ordered by court ruling

Médunik Canada

29 June 2021 - Médunik Canada is pleased to announce that Health Canada has reissued the approval (Notice of Compliance) for Ruzurgi (amifampridine), for the symptomatic treatment of Lambert-Eaton myasthenic syndrome in patients six years of age or older and has resumed supply in Canada.

Médunik Canada had suspended supply following a decision of the Federal Court of Canada on 31 May 2021, related to data protection provisions. It was not related to the safety or efficacy of Ruzurgi.

The court decision required Health Canada to reconsider the Notice of Compliance it had issued on 10 August 2020. This reconsideration concluded with the re-issuance of the Notice of Compliance on 24 June 2021. No changes have been made to the Ruzurgi Product Monograph.

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Michael Wonder

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Michael Wonder

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Outcome , Medicine , Canada