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Pharmaceuticals - Community Register


Community register of orphan medicinal products


Product information

Muramyl tripeptide phosphatidyl ethanolamine

EU orphan designation number: EU/3/04/206   
Active ingredient: Muramyl tripeptide phosphatidyl ethanolamine
Indication: Treatment of osteosarcoma
Sponsor: Takeda France SAS
Immeuble Pacific, 11-13 cours Valmy, 92800 Puteaux, France
EU Centralised marketing authorisation: A centralised EU marketing authorisation has been obtained under the name Mepact on 06/03/2009 with the number EU/1/08/502

   Public summary of scientific opinion     EPAR

European Commission proceduresGoto top of the page

Close date procedure Procedure type EMEA number Decision summary publ decision docs annex
23/06/2004 Orphan designation EMEA/OD/013/04 (2004)2313 of 21/06/2004
23/02/2009 Change of name and/or address of sponsor
12/07/2013 Change of name and/or address of sponsor
14/08/2013 Transfer of orphan designation EMEA/OD/013/04/T/01 (2013)5287 of 05/08/2013