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Pheburane
Authorised
Human
Details
EMA number
EMEA/H/C/002500
ATC code
A16AX03
Authorisation
30 July 2013
Revision
13
EMA page
Therapeutic indication
Treatment of chronic management of urea-cycle disorders.
MeSH:
Carbamoyl-Phosphate Synthase I Deficiency Disease
Group:
Various alimentary tract and metabolism products
Active substances
sodium phenylbutyrate
Marketing Authorisation Holder
Eurocept International B. V.
MAH
Timeline
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EMA
Pheburane authorised
30 Jul 2013
authorised
regulatory
Pheburane | uMedical