Pharmaceuticals - Union Register


Register of orphan medicinal products


Product information


EU orphan designation number: EU/3/15/1589   
Active ingredient: Glibenclamide
Indication: Treatment of neonatal diabetes
Sponsor: AMMTeK
55 rue de Turbigo, 75003 Paris, France
EU Centralised marketing authorisation: A centralised EU marketing authorisation has been obtained under the name AMGLIDIA on 24/05/2018 with the number EU/1/18/1279

   Public summary of scientific opinion     EPAR

European Commission proceduresGoto top of the page

Close date procedure Procedure type EMEA number Decision summary publ decision docs annex
19/01/2016 Orphan designation EMA/OD/149/15 (2016)251 of 15/01/2016
28/09/2016 Transfer of orphan designation EMA/OD/149/15/T/01 (2016) 6302 of 26/09/2016
10/02/2017 Transfer of orphan designation EMA/OD/149/15 (2017)1050 of 8/02/2017
22/02/2018 Other procedure
14/12/2018 Change of name and/or address of sponsor