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Pharmaceuticals - Union Register


Register of orphan medicinal products


Product information

Mexiletine hydrochloride

EU orphan designation number: EU/3/14/1353   
Active ingredient: Mexiletine hydrochloride
Indication: Treatment of myotonic disorders
Sponsor: Lupin Europe GmbH
Hanauer Landstraße 139-143, 60314 Frankfurt am Main, Deutschland
EU Centralised marketing authorisation: A centralised EU marketing authorisation has been obtained under the name Namuscla on 18/12/2018 with the number EU/1/18/1325

   Public summary of scientific opinion    

European Commission proceduresGoto top of the page

Close date procedure Procedure type EMEA number Decision summary publ decision docs annex
21/11/2014 Orphan designation EMA/OD/074/14 (2014)8846 of 19/11/2014
13/10/2015 Transfer of orphan designation EMA/OD/074/14/T/01 (2015)7039 of 9/10/2015
22/08/2016 Transfer of orphan designation EMA/OD/074/14/T/02 (2016)5452 of 18/08/2016
4/10/2016 Corrigendum (2016)5452 of 18/08/2016
21/05/2018 Transfer of orphan designation EMA/OD/074/14/T/03 (2018)3134 of 16/05/2018
8/11/2018 Other procedure