Overview

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 2 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.

Briviact can only be obtained with a prescription. The medicine is available as tablets, an oral solution (a liquid taken by mouth) and a solution for injection or infusion (drip) into a vein, which is used when the medicine cannot be given by mouth.

The recommended starting dose depends on the patient’s body weight. After starting treatment, the dose can be adjusted according to the patient’s needs.

For more information about using Briviact, see the package leaflet or contact a doctor or pharmacist.

Epilepsy is caused by excessive electrical activity in certain areas of the brain. The exact way in which brivaracetam, the active substance in Briviact, works is not clear, but it attaches to a protein called synaptic vesicle protein 2A, which is involved in the release of chemical messengers from nerve cells. This helps Briviact to stabilise electrical activity in the brain and prevent seizures.

Briviact is more effective than placebo (a dummy treatment) at reducing seizures. This was shown in three main studies involving a total of 1,558 patients aged 16 years and above. Either Briviact or placebo was added to patients’ usual epilepsy treatment. Taking the studies together, the frequency of seizures was at least halved in 34 to 38% of those adding Briviact at doses from 25 to 100 mg twice a day. This compares with 20% in those adding placebo.

Supportive studies showed that the doses recommended for children produced similar amounts of the medicine in the body to those seen with recommended doses in adults. Therefore Briviact is expected to work in children in the same way.

The most common side effects with Briviact (which may affect more than 1 in 10 people) are somnolence (sleepiness) and dizziness. For the full list of side effects of Briviact, see the package leaflet.

The European Medicines Agency decided that Briviact’s benefits are greater than its risks and it can be authorised for use in the EU.

Clinical studies have shown add-on treatment with Briviact to be more effective than placebo for controlling partial-onset seizures in adults and children from 2 years of age. Most side effects of Briviact were of mild or moderate severity and were considered manageable.

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Briviact have been included in the summary of product characteristics and the package leaflet.

As for all medicines, data on the use of Briviact are continuously monitored. Side effects reported with Briviact are carefully evaluated and any necessary action taken to protect patients.

Briviact received a marketing authorisation valid throughout the EU on 14 January 2016.

Briviact : EPAR - Medicine overview

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latviešu valoda (LV) (152.19 KB - PDF)
lietuvių kalba (LT) (136.08 KB - PDF)
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Nederlands (NL) (115.2 KB - PDF)
polski (PL) (139.34 KB - PDF)
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română (RO) (134.86 KB - PDF)
slovenčina (SK) (136.95 KB - PDF)
slovenščina (SL) (134.04 KB - PDF)
Suomi (FI) (113.02 KB - PDF)
svenska (SV) (113.66 KB - PDF)

Briviact : EPAR - Risk-management-plan summary

Product information

Briviact : EPAR - Product Information

български (BG) (1.06 MB - PDF)
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dansk (DA) (1.03 MB - PDF)
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lietuvių kalba (LT) (1.45 MB - PDF)
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português (PT) (1.46 MB - PDF)
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slovenščina (SL) (1002.09 KB - PDF)
Suomi (FI) (1.44 MB - PDF)
svenska (SV) (1.14 MB - PDF)

Latest procedure affecting product information: IB/0040

09/01/2024

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This medicine’s product information is available in all official EU languages.
Select 'available languages' to access the language you need.

Product information documents contain:

  • summary of product characteristics (annex I);
  • manufacturing authorisation holder responsible for batch release (annex IIA);
  • conditions of the marketing authorisation (annex IIB);
  • labelling (annex IIIA);
  • package leaflet (annex IIIB).

Briviact : EPAR - All Authorised presentations

български (BG) (138.57 KB - PDF)
español (ES) (128.95 KB - PDF)
čeština (CS) (131.42 KB - PDF)
dansk (DA) (123.88 KB - PDF)
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íslenska (IS) (91.52 KB - PDF)
italiano (IT) (78.44 KB - PDF)
latviešu valoda (LV) (90.17 KB - PDF)
lietuvių kalba (LT) (111.09 KB - PDF)
magyar (HU) (132.73 KB - PDF)
Malti (MT) (133.57 KB - PDF)
Nederlands (NL) (125.33 KB - PDF)
norsk (NO) (89.73 KB - PDF)
polski (PL) (132.97 KB - PDF)
português (PT) (102.23 KB - PDF)
română (RO) (133.25 KB - PDF)
slovenčina (SK) (128.82 KB - PDF)
slovenščina (SL) (90.67 KB - PDF)
Suomi (FI) (122.79 KB - PDF)
svenska (SV) (122.67 KB - PDF)

Product details

Name of medicine
Briviact (in Italy: Nubriveo)
Active substance
Brivaracetam
International non-proprietary name (INN) or common name
brivaracetam
Therapeutic area (MeSH)
Epilepsy
Anatomical therapeutic chemical (ATC) code
N03AX23

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.

Authorisation details

EMA product number
EMEA/H/C/003898
Marketing authorisation holder
UCB Pharma SA

Allée de la Recherche 60
1070 Bruxelles
Belgium

Marketing authorisation issued
13/01/2016
Revision
23

Assessment history

Briviact : EPAR - Procedural steps taken and scientific information after authorisation

Briviact-H-C-3898-P46-012 : EPAR - Assessment Report

Briviact-H-C-3898-P46-011 : EPAR - Assessment Report

Briviact-H-C-3898-P46-010 : EPAR - Assessment Report

Briviact-H-C-3898-P46-009 : EPAR - Assessment Report

Briviact-H-C-3898-II-0032-G : EPAR - Assessment Report - Extension

CHMP post-authorisation summary of opinion for Briviact (II-32-G)

Briviact-H-C-3898-P46-008 : EPAR - Assessment Report

Briviact-H-C-3898-P46-007 : EPAR - Assessment Report

Briviact-H-C-PSUSA-00010447-202001 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation

Briviact-H-C-3898-P46-005 : EPAR - Assessment Report

Briviact-H-C-3898-P46-002 : EPAR - Assessment Report

Briviact-H-C-3898-II-0010-G : EPAR - Assessment Report - Variation

CHMP post-authorisation summary of positive opinion for Briviact

Briviact-H-C-PSUSA-00010447-201607 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation

Briviact : EPAR - Public assessment report

CHMP summary of positive opinion for Briviact

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