Pharmaceuticals - Community Register

  

Community register of orphan medicinal products


GRANTED  

Product information

Mexiletine hydrochloride

EU orphan designation number: EU/3/14/1353   
Active ingredient: Mexiletine hydrochloride
Indication: Treatment of myotonic disorders
Sponsor: Lupin (Europe) Limited
Suite 1, Victoria Court, Bexton Road, Knutsford, Cheshire WA16 0PF, United Kingdom

   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 09/10/2015
22/08/2016 Transfer of orphan designation EMA/OD/074/14/T/02 (2016)5452 of 18/08/2016
04/10/2016 Corrigendum (2016)5452 of 18/08/2016