Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: PHEBURANE   
Auth. number : EU/1/13/822
Active substance : Sodium Phenylbutyrate
ATC: Anatomical main group: A - Alimentary tract and metabolism
Therapeutic subgroup: A16 - Other alimentary tract and metabolism products
Pharmacological subgroup: A16A - Other alimentary tract and metabolism products
Chemical subgroup: A16AX - Various alimentary tract and metabolism products
Chemical substance: A16AX03 - Sodium phenylbutyrate
(See WHO ATC Index)
Indication: 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
Marketing Authorisation Holder: Lucane Pharma
172 rue de Charonne, 75011 Paris, France
EPAR and active package presentations

Package presentations

Information about presentations can be found in the website of the European Medicines Agency under the section "Product Information".
Likewise, presentations on which there has been a Commission decision are referred in the Summary of Product Characteristics (Annex I to the Commission Decision granting the marketing authorisation) which is available in the Community Register.

European Commission proceduresGoto top of the page

Close date procedure Procedure type EMEA number Decision summary publ decision docs annex
05/08/2013 Centralised - Authorisation EMEA/H/C/2500 (2013)5155 of 31/07/2013
11/09/2013 Centralised - Variation EMEA/H/C/2500/IAin/1
Updated with Decision(2014)6277 of 01/09/2014
27/11/2013 Centralised - Notification EMEA/H/C/2500/N/4
Updated with Decision(2014)6277 of 01/09/2014
09/12/2013 Centralised - Variation EMEA/H/C/2500/IB/3
Updated with Decision(2014)6277 of 01/09/2014
03/09/2014 Centralised - Yearly update (2014)6277 of 01/09/2014