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Pharmaceuticals - Community Register

  

Community register of orphan medicinal products


GRANTED  

Product information

Ornithine phenylacetate

EU orphan designation number: EU/3/11/945   
Active ingredient: Ornithine phenylacetate
Indication: Treatment of acute liver failure
Sponsor: Mallinckrodt Pharmaceuticals Ireland Limited
College Business & Technology Park Cruiserath, Blanchardstown, Dublin 15, 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
13/01/2012 Orphan designation EMA/OD/105/11 (2012)131 of 11/01/2012
26/09/2014 Transfer of orphan designation EMA/OD/105/11/T/01 (2014)7017 of 24/09/2014
30/01/2017 Transfer of orphan designation EMA/OD/105/11 (2017)532 of 26/01/2017
17/04/2018 Transfer of orphan designation EMA/OD/105/11/T/03 (2018)2355 of 13/04/2018