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Community register of orphan medicinal products


GRANTED  

Product information

(manganese, dichloro [(4aR, 13aR, 17aR, 21aR)-1, 2, 3, 4, 4a, 5, 6, 12, 13, 13a, 14, 15, 16, 17, 17a, 18, 19, 20, 21, 21-eicosahydro-11, 7-nitrilo-7H-dibenzo[ b,h] [1,4,7,10] tetraazacycloheptadecine-?N5, ?N13, ?N18, ?N21, ?N22]-)

EU orphan designation number: EU/3/07/522   
Active ingredient: (manganese, dichloro [(4aR, 13aR, 17aR, 21aR)-1, 2, 3, 4, 4a, 5, 6, 12, 13, 13a, 14, 15, 16, 17, 17a, 18, 19, 20, 21, 21°-eicosahydro-11, 7-nitrilo-7H-dibenzo[ b,h] [1,4,7,10] tetraazacycloheptadecine-κN5, κN13, κN18, κN21, κN22]-)
Indication: Prevention of oral mucositis in head and neck cancer patients undergoing radiation therapy
Sponsor: Celtic Bio-Pharma Services Ltd
Sheridan House, St Ann's Road, Harrow, Middlesex, HA1 1JU, United Kingdom

   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
04/02/2008 Orphan Designation EMEA/OD/089/07 (2008)448 of 31/01/2008