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Community register of orphan medicinal products


Product information

Amphotericin B (for inhalation use)

EU orphan designation number: EU/3/06/391   
Active ingredient: Amphotericin B (for inhalation use)
Indication: Prevention of pulmonary fungal infection in patients deemed at risk
Sponsor: Novartis Europharm Limited
Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland

   Public summary of scientific opinion    

European Commission proceduresGoto top of the page

Close date procedure Procedure type EMEA number Decision summary publ decision docs annex
31/08/2006 Orphan designation EMEA/OD/027/06 (2006)3961 of 28/08/2006
15/07/2009 Corrigendum (2009)5674 of 09/07/2009
31/08/2010 Transfer of orphan designation EMEA/OD/027/06/T/01 (2010)5969 of 25/08/2010
23/03/2011 Change of name and/or address of sponsor EMEA/OD/027/06
14/03/2014 Transfer of orphan designation EMEA/OD/027/06/T/02 (2014)1741 of 12/03/2014
29/08/2014 Change of name and/or address of sponsor
16/05/2018 Transfer of orphan designation EMA/OD/027/06/T/03 (2018)3034 of 08/05/2018