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Register of orphan medicinal products


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Product information

Recombinant human IgG1 kappa light chain monoclonal antibody targeting plasma kallikrein

EU orphan designation number: EU/3/15/1551   
Active ingredient: Recombinant human IgG1 kappa light chain monoclonal antibody targeting plasma kallikrein
Indication: Treatment of hereditary angioedema
Sponsor: Shire Pharmaceuticals Ireland Limited
Block 2-3 Miesian Plaza, 50-58 Baggot Street Lower, Dublin 2, Ireland
EU Centralised marketing authorisation: A centralised EU marketing authorisation has been obtained under the name TAKHZYRO on 22/11/2018 with the number EU/1/18/1340

   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
13/10/2015 Orphan designation EMA/OD/075/15 (2015)7022 of 9/10/2015
16/12/2015 Corrigendum (2015)9522 of 14/12/2015
9/10/2017 Change of name and/or address of sponsor
20/11/2017 Transfer of orphan designation EMA/OD/075/15/T/01 (2017)7800 of 16/11/2017
26/10/2018 Other procedure