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Register of orphan medicinal products


GRANTED  

Product information

(5S,8S,10aR)-N-benzhydryl-5-((S)-2-(methylamino)propanamido)-3-(3-methylbutanoyl)-6-oxodecahydropyrrolo[1,2-a][1,5]diazocine-8-carboxamide

EU orphan designation number: EU/3/15/1576   
Active ingredient: (5S,8S,10aR)-N-benzhydryl-5-((S)-2-(methylamino)propanamido)-3-(3-methylbutanoyl)-6-oxodecahydropyrrolo[1,2-a][1,5]diazocine-8-carboxamide
Indication: Treatment of ovarian cancer
Sponsor: ASPHALION, SL
C/ Tarragona, 151-157, Planta 10, Bloque A, 08014 Barcelona, 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
13/11/2015 Orphan designation EMA/OD/126/15 (2015)8026 of 11/11/2015
1/02/2019 Change of name and/or address of sponsor