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Community register of orphan medicinal products


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Product information

Genetically modified Lactococcus lactis bacteria containing the human trefoil factor 1 gene

EU orphan designation number: EU/3/11/903   
Active ingredient: Genetically modified Lactococcus lactis bacteria containing the human trefoil factor 1 gene
Indication: Prevention of oral mucositis in head and neck cancer patients undergoing radiation therapy
Sponsor: Intrexon Actobiotics N.V.
Industriepark Zwijnaarde 7 C, Building D, 9052 Zwijnaarde, Belgïe

   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
29/09/2011 Orphan designation EMA/OD/027/11 (2011)7036 of 27/09/2011
25/11/2015 Change of name and/or address of sponsor
09/10/2017 Change of name and/or address of sponsor