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.
Glibenclamide for the treatment of neonatal diabetes
|Disease / condition||
Treatment of neonatal diabetes
|Date of decision||
|Orphan decision number||
Review of designation
Sponsor's contact details
For contact details of patients’ organisations whose activities are targeted at rare diseases, see:
- Orphanet, a database containing information on rare diseases, which includes a directory of patients’ organisations registered in Europe;
- European Organisation for Rare Diseases (EURORDIS), a non-governmental alliance of patient organisations and individuals active in the field of rare diseases.