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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, F-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