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Pharmaceuticals - Community Register

  

Community register of orphan medicinal products


GRANTED  

Product information

Recombinant human tripeptidyl-peptidase 1

EU orphan designation number: EU/3/13/1118   
Active ingredient: Recombinant human tripeptidyl-peptidase 1
Indication: Treatment of neuronal ceroid lipofuscinosis type 2
Sponsor: BioMarin International Limited
Shanbally, Ringaskiddy, County Cork, Ireland
EU Centralised marketing authorisation: A centralised EU marketing authorisation has been obtained under the name Brineura on 30/05/2017 with the number EU/1/17/1192

   Public summary of scientific opinion     EPAR

European Commission proceduresGoto top of the page
Close date procedure Procedure type EMEA number Decision summary publ decision docs annex
14/03/2013 Orphan designation EMA/OD/177/12 (2013)1613 of 12/03/2013
20/10/2015 Transfer of orphan designation EMA/OD/177/12/T/01 (2015)7308 of 16/10/2015