EU/3/15/1589: Orphan designation for the treatment of neonatal diabetes



On 15 January 2016, orphan designation (EU/3/15/1589) was granted by the European Commission to AMMTeK, France, for glibenclamide for the treatment of neonatal diabetes.

The sponsorship was transferred to Pharma Services, France, in September 2016 and back to AMMTeK, France, in February 2017.

Glibenclamide has been authorised in the EU as Amglidia since 24 May 2018.

The sponsor’s address was updated in December 2018.

Key facts

Active substance
Intended use
Treatment of neonatal diabetes
Orphan designation status
EU designation number
Date of designation

55 rue de Turbigo
75003 Paris
Tel. +33 1582 81680
Fax +33 1582 81690

Review of designation

The Committee for Orphan Medicinal Products reviewed the orphan designation of Amglidia at the time of marketing authorisation, and confirmed that the orphan designation should be maintained.

More information is available in the PDF icon orphan medicine assessment report .

Documents related to this orphan designation evaluation

Patients' organisations

For contact details of patients’ organisations whose activities are targeted at rare diseases, see:

  • European Organisation for Rare Diseases (EURORDIS), a non-governmental alliance of patient organisations and individuals active in the field of rare diseases.

  • Orphanet, a database containing information on rare diseases, which includes a directory of patients’ organisations registered in Europe.

EU register of orphan medicines

The list of medicines that have received an orphan designation in the EU is available on the European Commission's website:

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