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Pharmaceuticals - Community Register


Community list of not active orphan medicinal products


Product information

Amrubicin hydrochloride

EU orphan designation number: EU/3/08/538
Active ingredient: Amrubicin hydrochloride
Indication: Treatment of small cell lung cancer
Sponsor: Celgene Europe Limited
1 Longwalk Road, Stockley Park, Uxbridge, Middlesex UB11 1DB, 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
04/04/2008 Orphan designation EMEA/OD/113/07 (2008)1319 of 02/04/2008
23/10/2008 Transfer of orphan designation EMEA/OD/113/07/T/01 (2008)6246 of 21/10/2008
30/05/2011 Change of name and/or address of sponsor EMEA/OD/113/07
18/05/2016 Removal of orphan designation from Community Register