Briviact (in Italy: Nubriveo)

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brivaracetam

Authorised
This medicine is authorised for use in the European Union.

Overview

An overview of Briviact and why it is authorised in the EU

Briviact is an epilepsy medicine used as an add-on to other epilepsy medicines to treat partial-onset seizures (epileptic fits starting in one specific part of the brain). It can be used in patients from the age of 4 years with partial-onset seizures with or without secondary generalisation (where the abnormal electrical activity spreads through the brain).

Briviact contains the active substance brivaracetam.

This EPAR was last updated on 26/07/2018

Authorisation details

Product details
Name
Briviact (in Italy: Nubriveo)
Agency product number
EMEA/H/C/003898
Active substance
Brivaracetam
International non-proprietary name (INN) or common name
brivaracetam
Therapeutic area (MeSH)
Epilepsy
Anatomical therapeutic chemical (ATC) code
N03AX23
Additional monitoring

This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring.

Publication details
Marketing-authorisation holder
UCB Pharma SA
Revision
6
Date of issue of marketing authorisation valid throughout the European Union
14/01/2016
Contact address
Allée de la Recherche 60
1070 Bruxelles
Belgium

Product information

11/07/2018 Briviact (in Italy: Nubriveo) - EMEA/H/C/003898 - II/0010/G

Contents

  • Annex I - Summary of product characteristics
  • Annex IIA - Manufacturing-authorisation holder responsible for batch release
  • Annex IIB - Conditions of the marketing authorisation
  • Annex IIIA - Labelling
  • Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.

Pharmacotherapeutic group

ANTIEPILEPTICS

Therapeutic indication

Briviact is indicated as adjunctive therapy in the treatment of partial-onset seizures with or without secondary generalisation in adult and adolescent patients from 16 years of age with epilepsy.

Assessment history

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