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Pharmaceuticals - Community Register


Community list of not active orphan medicinal products


Product information

Amiloride hydrochloride dihydrate

EU orphan designation number: EU/3/03/147
Active ingredient: Amiloride hydrochloride dihydrate
Indication: Treatment of cystic fibrosis
Sponsor: Pulmo Tec GmbH
Graf-Arco-Straβe 3, D-89079 Ulm, 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
30/06/2003 Orphan designation EMEA/OD/075/02 (2003)2213 of 30/06/2003
17/11/2008 Change of name and/or address of sponsor
19/12/2008 Removal of orphan designation from Community Register