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Register of orphan medicinal products


Product information

Cyclopropane-1,1-dicarboxylic acid [4-(6,7-dimethoxy-quinolin-4-yloxy)-phenyl]-amide (4-fluoro-phenyl)-amide, (L)-malate salt

EU orphan designation number: EU/3/08/610   
Active ingredient: Cyclopropane-1,1-dicarboxylic acid [4-(6,7-dimethoxy-quinolin-4-yloxy)-phenyl]-amide (4-fluoro-phenyl)-amide, (L)-malate salt
Indication: Treatment of medullary thyroid carcinoma
Sponsor: Ipsen Pharma
65 quai Georges Gorse, 92100 Boulogne-Billancourt, France
EU Centralised marketing authorisation: A centralised EU marketing authorisation has been obtained under the name Cometriq on 21/03/2014 with the number EU/1/13/890

   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
10/02/2009 Orphan designation EMEA/OD/088/08 (2009)972 of 6/02/2009
1/09/2011 Transfer of orphan designation EMEA/OD/088/08/T/01 (2011)6287 of 30/08/2011
28/09/2016 Transfer of orphan designation EMA/OD/088/08/T/02 (2016) 6312 of 26/09/2016