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Pharmaceuticals - Community Register


Community register of orphan medicinal products


Product information

Histamine dihydrochloride

EU orphan designation number: EU/3/05/272   
Active ingredient: Histamine dihydrochloride
Indication: Treatment of acute myeloid leukaemia
Sponsor: Noventia Pharma Srl
Via Carlo Pisacane 31, 47121 Forli, Italia
EU Centralised marketing authorisation: A centralised EU marketing authorisation has been obtained under the name Ceplene on 7/10/2008 with the number EU/1/08/477

   Public summary of scientific opinion     EPAR

European Commission proceduresGoto top of the page

Close date procedure Procedure type EMEA number Decision summary publ decision docs annex
20/04/2005 Orphan designation EMEA/OD/094/04 (2005)1202 of 11/04/2005
22/09/2006 Transfer of orphan designation EMEA/OD/094/04/T/01 (2006)3831 of 21/08/2006
12/10/2012 Transfer of orphan designation EMEA/OD/094/04/T/02 (2012)7218 of 10/10/2012
12/12/2017 Transfer of orphan designation EMEA/OD/094/04/T/03 (2017)8597 of 8/12/2017