Pharmaceuticals - Community Register


Community register of orphan medicinal products


Product information


EU orphan designation number: EU/3/06/424   
Active ingredient: Thiotepa
Indication: Conditioning treatment prior to haematopoietic progenitor cell transplantation
Sponsor: ADIENNE S.r.l.
Via Galileo Galilei 19, 20867 Caponago (MB), Italia
EU Centralised marketing authorisation: A centralised EU marketing authorisation has been obtained under the name Tepadina on 15/03/2010 with the number EU/1/10/622

   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
31/01/2007 Orphan designation EMEA/OD/060/06 (2007)352 of 29/01/2007
15/01/2014 Change of name and/or address of sponsor