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Community register of orphan medicinal products


Product information

Amikacin sulfate (liposomal)

EU orphan designation number: EU/3/06/387   
Active ingredient: Amikacin sulfate (liposomal)
Indication: Treatment of Pseudomonas aeruginosa lung infection in cystic fibrosis
Sponsor: Insmed Limited
Overseas House, 66-68 High Road, Bushey Heath, Hertfordshire WD23 1GG, United Kingdom

   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
28/07/2006 Centralised Orphan - Designation EMEA/OD/024/06 (2006)3432 of 25/07/2006
04/06/2008 Centralised Orphan - Change of address EMEA/OD/024/06
08/07/2008 Centralised Orphan - Transfer of orphan designation EMEA/OD/024/06/T/01 (2008)3505 of 04/07/2008
31/10/2011 Orphan - Change name of sponsor EMEA/OD/024/06
04/02/2014 Centralised Orphan - Change of address
20/05/2014 Centralised Orphan - Change of address