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Pharmaceuticals - Community Register


Community register of orphan medicinal products


Product information

Mexiletine hydrochloride

EU orphan designation number: EU/3/13/1189   
Active ingredient: Mexiletine hydrochloride
Indication: Treatment of myotonic disorders
Sponsor: Agenzia Industrie Difesa-Stabilimento Chimico Farmaceutico Militare
Via XX Settembre 123/A, 00187, Rome, Italia

   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
9/10/2013 Orphan designation EMA/OD/069/13 (2013)6734 of 7/10/2013