CHMP supports Maapliv in MSUD
The EMA''s CHMP recommended the granting of a marketing authorisation under exceptional circumstances for Maapliv.
The EMA''s CHMP recommended the granting of a marketing authorisation under exceptional circumstances for Maapliv. The active substance of Maalik is a combination of amino acids free of branched-chain amino acids (BCAA). The medicine will be available as a solution in the form of an infusion for parenteral use (Anatomical Therapeutic Chemical, (ATC) code: B05BA01). Maapliv is indicated for the treatment of maple syrup urine disease (MSUD) presenting with an acute decompensation episode in patients from birth who are not eligible for an oral and enteral branched-chain amino acids free (BCAA- free) formulation. Detailed recommendations for use will be described in the Summary of Product Characteristics (SmPC), which will be published on the EMA website in all official European Union languages after the marketing authorisation has been granted by the European Commission.
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