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Register of orphan medicinal products


GRANTED  

Product information

(1'R,6'R)-3-(benzylamine)-6-hydroxy-3'-methyl-4-pentyl-6'-(prop-1-en-2-yl)-[1,1'-bi(cyclohexane)]-2',3,6-triene-2,5-dione

EU orphan designation number: EU/3/17/1933   
Active ingredient: (1'R,6'R)-3-(benzylamine)-6-hydroxy-3'-methyl-4-pentyl-6'-(prop-1-en-2-yl)-[1,1'-bi(cyclohexane)]-2',3,6-triene-2,5-dione
Indication: Treatment of systemic sclerosis
Sponsor: Emerald Health Pharmaceuticals España, S.L.
Parque Científico Tecnológico de Córdoba (Rabanales 21), C/ Astrónoma Cecilia Payne, Edificio Centauro, Planta 1, 14014 Córdoba, España

   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
10/11/2017 Orphan designation EMA/OD/142/17 (2017)7555 of 8/11/2017
2/05/2018 Change of name and/or address of sponsor
22/11/2018 Transfer of orphan designation EMA/OD/0000001966 (2018)7813 of 19/11/2018