Data from EMA (European Medicines Agency) - Curated by EPG Health - Last updated 15 May 2018

Indication(s)

Treatment of adult and paediatric (in any age range) patients with confirmed diagnosis of hereditary tyrosinemia type 1 (HT-1) in combination with dietary restriction of tyrosine and phenylalanine.

Full Prescribing information

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More information

Category Value
Agency product number EMEA/H/C/004281
Orphan designation No
Date First Approved 24-08-2017
Type Medicinal product subject to restricted medical prescription
Marketing authorisation holder MendeliKABS Europe Ltd