Data from EMA (European Medicines Agency) - Curated by EPG Health - Last updated 29 September 2017

Indication(s)

PHEBURANE is indicated as adjunctive therapy in the chronic management of urea cycle disorders, involving deficiencies of carbamylphosphate synthetase, ornithine transcarbamylase or argininosuccinate synthetase.

It is indicated in all patients with neonatal-onset presentation (complete enzyme deficiencies, presenting within the first 28 days of life). It is also indicated in patients with late-onset disease (partial enzyme deficiencies, presenting after the first month of life) who have a history of hyperammonaemic encephalopathy.

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Category Value
Agency product number EMEA/H/C/002500
Orphan designation No
Date First Approved 31-07-2013
Type Medicinal product subject to restricted medical prescription
Marketing authorisation holder Lucane Pharma