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Community register of orphan medicinal products


GRANTED  

Product information

Methyl O-4-O-[2-[2-[2-[2-[[N-[(1R)-1-[[4-(aminoiminomethyl)phenyl]methyl]-2-oxo-2-(1-piperidinyl)ethyl]-N2-[(4-methoxy-2,3,6-trimethylphenyl)sulfonyl]-L-α-asparaginyl-4-aminobutanoyl-N6-[5-[(3aS,4S,6aR)-hexahydro-2-oxo-1H-thieno[3,4-d]imidazol-4-yl]-1-oxopentyl]-L-lysyl]amino]ethoxy]ethoxy]ethoxy]ethyl]-2,3-di-O-methyl-6-O-sulfo-α-D-glucopyranosyl-(1->4)-O-2,3-di-O-methyl-β-D-glucopyranuronosyl-(1->4)-O-2,3,6-tri-O-sulfo-α-D-glucopyranosyl-(1->4)-O-2,3-di-O-methyl-α-L-idopyranuronosyl-(1->4)-3-O-methyl-α-D-glucopyranoside 2,6-bis(hydrogen sulfate) octasodium salt

EU orphan designation number: EU/3/11/884   
Active ingredient: Methyl O-4-O-[2-[2-[2-[2-[[N-[(1R)-1-[[4-(aminoiminomethyl)phenyl]methyl]-2-oxo-2-(1-piperidinyl)ethyl]-N2-[(4-methoxy-2,3,6-trimethylphenyl)sulfonyl]-L-α-asparaginyl-4-aminobutanoyl-N6-[5-[(3aS,4S,6aR)-hexahydro-2-oxo-1H-thieno[3,4-d]imidazol-4-yl]-1-oxopentyl]-L-lysyl]amino]ethoxy]ethoxy]ethoxy]ethyl]-2,3-di-O-methyl-6-O-sulfo-α-D-glucopyranosyl-(1->4)-O-2,3-di-O-methyl-β-D-glucopyranuronosyl-(1->4)-O-2,3,6-tri-O-sulfo-α-D-glucopyranosyl-(1->4)-O-2,3-di-O-methyl-α-L-idopyranuronosyl-(1->4)-3-O-methyl-α-D-glucopyranoside 2,6-bis(hydrogen sulfate) octasodium salt
Indication: Prevention of ischaemia/reperfusion injury associated with solid organ transplantation
Sponsor: Endotis Pharma
102 avenue Gaston Roussel, 93230 Romainville, France

   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
09/08/2011 Orphan designation EMA/OD/014/11 (2011)5809 of 05/08/2011