Amglidia is a medicine used to treat newborns and children with neonatal diabetes, a form of diabetes that occurs in the first 6 months of life and that requires treatment with insulin. Amglidia was shown to be effective in patients with whose disease was caused by certain genetic mutations.
Amglidia contains the active substance glibenclamide.
Neonatal diabetes is rare, and Amglidia was designated an ‘orphan medicine’ (a medicine used in rare diseases) on 15 January 2016.
Amglidia is a ‘hybrid medicine’. This means that it is similar to a ‘reference medicine’ containing the same active substance, but is available in a different formulation. While the reference medicine Daonil is given as tablets, Amglidia is available as a liquid (suspension).
Amglidia : EPAR - Medicine overview (PDF/72.7 KB)
First published: 08/06/2018
Last updated: 08/06/2018
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55 rue de Turbigo
25/02/2021 Amglidia - EMEA/H/C/004379 - IAIN/0010/G
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Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
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Drugs used in diabetes
Amglidia is indicated for the treatment of neonatal diabetes mellitus, for use in newborns, infants and children.
Sulphonylureas like Amglidia have been shown to be effective in patients with mutations in the genes coding for the β-cell ATP-sensitive potassium channel and chromosome 6q24-related transient neonatal diabetes mellitus.