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Pharmaceuticals - Community Register

  

Community register of orphan medicinal products


GRANTED  

Product information

Aztreonam lysinate (inhalation use)

EU orphan designation number: EU/3/04/204   
Active ingredient: Aztreonam lysinate (inhalation use)
Indication: Treatment of gram negative bacteria lung infections in cystic fibrosis
Sponsor: Gilead Sciences Ireland UC
Carrigtohill, County Cork, T45 DP77, Ireland
EU Centralised marketing authorisation: A centralised EU marketing authorisation has been obtained under the name Cayston on 21/09/2009 with the number EU/1/09/543

   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
28/06/2004 Orphan designation EMEA/OD/006/04 (2004)2312 of 21/06/2004
14/07/2005 Transfer of orphan designation EMEA/OD/006/04/T/01 (2005)2650 of 13/07/2005
4/05/2007 Transfer of orphan designation EMEA/OD/006/04/T/02 (2007)2009 of 2/05/2007
18/05/2018 Transfer of orphan designation EMEA/OD/006/04/T/03 (2018)3131 of 16/05/2018