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Pharmaceuticals - Union Register


Register of orphan medicinal products


Product information


EU orphan designation number: EU/3/16/1639   
Active ingredient: (1E,6E)-1,7-bis(3,4-dimethoxyphenyl)-4-cyclobutylmethyl-1,6-heptadiene-3,5-dione
Indication: Treatment of X-linked spinal and bulbar muscular atrophy (Kennedy's disease)
Sponsor: IQVIA RDS Ireland Limited
Estuary House, East Point Business Park, Fairview, Dublin 3, DO3 Y6A2, Ireland

   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
3/05/2016 Orphan designation EMA/OD/252/15 (2016) 2741 of 28/04/2016
21/03/2018 Transfer of orphan designation EMA/OD/252/15/T/01 (2018)1820 of 19/03/2018
2/05/2018 Change of name and/or address of sponsor