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Community register of orphan medicinal products


Product information

Tobramycin (inhalation powder)

EU orphan designation number: EU/3/03/140   
Active ingredient: Tobramycin (inhalation powder)
Indication: Treatment of Pseudomonas aeruginosa lung infection in cystic fibrosis
Sponsor: Novartis Europharm Limited
Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland
EU Centralised marketing authorisation: A centralised EU marketing authorisation has been obtained under the name TOBI Podhaler on 20/07/2011 with the number EU/1/10/652

   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
19/03/2003 Orphan designation EMEA/OD/072/02 (2003)846 of 17/03/2003
2/06/2004 Change of name and/or address of sponsor
31/10/2006 Transfer of orphan designation EMEA/OD/072/02/T/01 (2006)5296 of 27/10/2006
5/05/2011 Other procedure
29/08/2014 Change of name and/or address of sponsor
16/05/2018 Transfer of orphan designation EMEA/OD/072/02/T/02 (2018)3031 of 8/05/2018