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Pharmaceuticals - Union Register


Register of orphan medicinal products


Product information

Amikacin sulfate

EU orphan designation number: EU/3/14/1259   
Active ingredient: Amikacin sulfate
Indication: Treatment of nontuberculous mycobacterial lung disease
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
10/04/2014 Orphan designation EMA/OD/191/13 (2014)2518 of 8/04/2014
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/0000003885 (2019)1625 of 21/02/2019