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Pharmaceuticals - Community Register


Community register of orphan medicinal products


Product information

Omigapil maleate

EU orphan designation number: EU/3/08/540   
Active ingredient: Omigapil maleate
Indication: Treatment of congenital muscular dystrophy with collagen VI deficiency (Ullrich Syndrome and Bethlem Myopathy).
Sponsor: Santhera Pharmaceuticals (Deutschland) GmbH
Marie-Curie Straße 8, 79539 Lörrach, Deutschland

   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
14/05/2008 Orphan designation EMEA/OD/104/07 (2008)1900 of 8/05/2008
28/05/2015 Change of name and/or address of sponsor
13/04/2016 Change of name and/or address of sponsor