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.
Treatment of neonatal diabetes
|Orphan designation status||
|EU designation number||
|Date of designation||
Review of designation
Documents related to this orphan designation evaluation
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: