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Pharmaceuticals - Community Register

  

Community register of orphan medicinal products


GRANTED  

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
Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom
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 Centralised Orphan - Designation EMEA/OD/072/02 (2003)846 of 17/03/2003
02/06/2004 Other procedure
31/10/2006 Centralised Orphan - Transfer of orphan designation EMEA/OD/072/02/T/01 (2006)5296 of 27/10/2006