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Pharmaceuticals - Union Register

  

Register of orphan medicinal products


GRANTED  

Product information

Amikacin sulfate (liposomal)

EU orphan designation number: EU/3/06/387   
Active ingredient: Amikacin sulfate (liposomal)
Indication: Τreatment of Pseudomonas aeruginosa lung infection in cystic fibrosis
Sponsor: Insmed Netherlands B.V.
Building D Floor 4th, Graadt Van Roggenweg 328-344, Utrecht, 3531 AH, Nederland

   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 Orphan designation EMEA/OD/024/06 (2006)3432 of 25/07/2006
4/06/2008 Change of name and/or address of sponsor EMEA/OD/024/06
8/07/2008 Transfer of orphan designation EMEA/OD/024/06/T/01 (2008)3505 of 4/07/2008
31/10/2011 Change of name and/or address of sponsor EMEA/OD/024/06
4/02/2014 Change of name and/or address of sponsor
20/05/2014 Change of name and/or address of sponsor
4/02/2019 Change of name and/or address of sponsor
25/02/2019 Transfer of orphan designation EMA/OD/0000003770 (2019)1624 of 21/02/2019