Briviact

brivaracetam

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This is a summary of the European public assessment report (EPAR) for Briviact. It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is not intended to provide practical advice on how to use Briviact.

For practical information about using Briviact, patients should read the package leaflet or contact their doctor or pharmacist.

What is Briviact and what is it used for?

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 adults and adolescents from the age of 16 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.

How is Briviact used?

Briviact is available as tablets (10, 25, 50, 75 and 100 mg), an oral solution (10 mg/ml) and a solution for injection or infusion (drip) into a vein (10 mg/ml). The recommended starting dose is either 25 mg twice a day or 50 mg twice a day, depending on the patient’s condition. The dose can then be adjusted according to the patient’s needs up to a maximum of 100 mg twice a day.

Briviact can be given by injection or by infusion (drip) into a vein if it cannot be given by mouth.

For further information, see the package leaflet.

The medicine can only be obtained with a prescription.

How does Briviact work?

The active substance in Briviact, brivaracetam, is an epilepsy medicine. Epilepsy is caused by excessive electrical activity in certain areas of the brain. The exact way in which brivaracetam 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.

What benefits of Briviact have been shown in studies?

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.

What are the risks associated with Briviact?

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 all side effects reported with Briviact, see the package leaflet.

Briviact must not be used in patients who are hypersensitive (allergic) to brivaracetam, to other pyrrolidone derivatives (substances that are chemically similar to brivaracetam), or to any of the other ingredients.

Why is Briviact approved?

The Agency’s Committee for Medicinal Products for Human Use (CHMP) decided that Briviact’s benefits are greater than its risks and recommended that it be approved 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 adolescents from 16 years of age. Most side effects of Briviact were of mild or moderate severity and were considered manageable.

What measures are being taken to ensure the safe and effective use of Briviact?

A risk management plan has been developed to ensure that Briviact is used as safely as possible. Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Briviact, including the appropriate precautions to be followed by healthcare professionals and patients.

Further information can be found in the summary of the risk management plan.

Other information about Briviact

The European Commission granted a marketing authorisation valid throughout the European Union for Briviact on 14 January 2016.

For more information about treatment with Briviact, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

Name Language First published Last updated
Briviact : EPAR - Summary for the public BG = bălgarski 25/01/2016  
Briviact : EPAR - Summary for the public ES = español 25/01/2016  
Briviact : EPAR - Summary for the public CS = čeština 25/01/2016  
Briviact : EPAR - Summary for the public DA = dansk 25/01/2016  
Briviact : EPAR - Summary for the public DE = Deutsch 25/01/2016  
Briviact : EPAR - Summary for the public ET = eesti keel 25/01/2016  
Briviact : EPAR - Summary for the public EL = elliniká 25/01/2016  
Briviact : EPAR - Summary for the public EN = English 25/01/2016  
Briviact : EPAR - Summary for the public FR = français 25/01/2016  
Briviact : EPAR - Summary for the public IT = italiano 25/01/2016  
Briviact : EPAR - Summary for the public LV = latviešu valoda 25/01/2016  
Briviact : EPAR - Summary for the public LT = lietuvių kalba 25/01/2016  
Briviact : EPAR - Summary for the public HU = magyar 25/01/2016  
Briviact : EPAR - Summary for the public MT = Malti 25/01/2016  
Briviact : EPAR - Summary for the public NL = Nederlands 25/01/2016  
Briviact : EPAR - Summary for the public PL = polski 25/01/2016  
Briviact : EPAR - Summary for the public PT = português 25/01/2016  
Briviact : EPAR - Summary for the public RO = română 25/01/2016  
Briviact : EPAR - Summary for the public SK = slovenčina 25/01/2016  
Briviact : EPAR - Summary for the public SL = slovenščina 25/01/2016  
Briviact : EPAR - Summary for the public FI = suomi 25/01/2016  
Briviact : EPAR - Summary for the public SV = svenska 25/01/2016  
Briviact : EPAR - Summary for the public HR = Hrvatski 25/01/2016  
Name Language First published Last updated
Briviact : EPAR - Risk-management-plan summary (English only) 25/01/2016  

This EPAR was last updated on 19/05/2016 .

Authorisation details

Product details

Product details for Briviact
NameBriviact
Agency product numberEMEA/H/C/003898
Active substance

brivaracetam

International non-proprietary name (INN) or common name

brivaracetam

Therapeutic area Epilepsy
Anatomical therapeutic chemical (ATC) code N03AX23
Additional monitoring

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

Publication details

Publication details for Briviact
Marketing-authorisation holder

UCB Pharma SA

Revision1
Date of issue of marketing authorisation valid throughout the European Union14/01/2016

Contact address:

UCB Pharma SA
Allée de la Recherche 60 
1070 Bruxelles
Belgium

Product information

Product information

07/04/2016  Briviact -EMEA/H/C/003898 -IAIN/0001

Name Language First published Last updated
Briviact : EPAR - Product Information EN = English 25/01/2016 19/05/2016
Briviact : EPAR - Product Information EN = English 25/01/2016 19/05/2016
Briviact : EPAR - Product Information EN = English 25/01/2016 19/05/2016
Briviact : EPAR - Product Information EN = English 25/01/2016 19/05/2016
Briviact : EPAR - Product Information EN = English 25/01/2016 19/05/2016
Briviact : EPAR - Product Information EN = English 25/01/2016 19/05/2016
Briviact : EPAR - Product Information EN = English 25/01/2016 19/05/2016
Briviact : EPAR - Product Information EN = English 25/01/2016 19/05/2016
Briviact : EPAR - Product Information EN = English 25/01/2016 19/05/2016
Briviact : EPAR - Product Information EN = English 25/01/2016 19/05/2016
Briviact : EPAR - Product Information EN = English 25/01/2016 19/05/2016
Briviact : EPAR - Product Information EN = English 25/01/2016 19/05/2016
Briviact : EPAR - Product Information EN = English 25/01/2016 19/05/2016
Briviact : EPAR - Product Information EN = English 25/01/2016 19/05/2016
Briviact : EPAR - Product Information EN = English 25/01/2016 19/05/2016
Briviact : EPAR - Product Information EN = English 25/01/2016 19/05/2016
Briviact : EPAR - Product Information EN = English 25/01/2016 19/05/2016
Briviact : EPAR - Product Information EN = English 25/01/2016 19/05/2016
Briviact : EPAR - Product Information EN = English 25/01/2016 19/05/2016
Briviact : EPAR - Product Information EN = English 25/01/2016 19/05/2016
Briviact : EPAR - Product Information EN = English 25/01/2016 19/05/2016
Briviact : EPAR - Product Information EN = English 25/01/2016 19/05/2016
Briviact : EPAR - Product Information EN = English 25/01/2016 19/05/2016
Briviact : EPAR - Product Information EN = English 25/01/2016 19/05/2016
Briviact : EPAR - Product Information EN = English 25/01/2016 19/05/2016

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.


Name Language First published Last updated
Briviact : EPAR - All Authorised presentations EN = English 25/01/2016 19/05/2016
Briviact : EPAR - All Authorised presentations EN = English 25/01/2016 19/05/2016
Briviact : EPAR - All Authorised presentations EN = English 25/01/2016 19/05/2016
Briviact : EPAR - All Authorised presentations EN = English 25/01/2016 19/05/2016
Briviact : EPAR - All Authorised presentations EN = English 25/01/2016 19/05/2016
Briviact : EPAR - All Authorised presentations EN = English 25/01/2016 19/05/2016
Briviact : EPAR - All Authorised presentations EN = English 25/01/2016 19/05/2016
Briviact : EPAR - All Authorised presentations EN = English 25/01/2016 19/05/2016
Briviact : EPAR - All Authorised presentations EN = English 25/01/2016 19/05/2016
Briviact : EPAR - All Authorised presentations EN = English 25/01/2016 19/05/2016
Briviact : EPAR - All Authorised presentations EN = English 25/01/2016 19/05/2016
Briviact : EPAR - All Authorised presentations EN = English 25/01/2016 19/05/2016
Briviact : EPAR - All Authorised presentations EN = English 25/01/2016 19/05/2016
Briviact : EPAR - All Authorised presentations EN = English 25/01/2016 19/05/2016
Briviact : EPAR - All Authorised presentations EN = English 25/01/2016 19/05/2016
Briviact : EPAR - All Authorised presentations EN = English 25/01/2016 19/05/2016
Briviact : EPAR - All Authorised presentations EN = English 25/01/2016 19/05/2016
Briviact : EPAR - All Authorised presentations EN = English 25/01/2016 19/05/2016
Briviact : EPAR - All Authorised presentations EN = English 25/01/2016 19/05/2016
Briviact : EPAR - All Authorised presentations EN = English 25/01/2016 19/05/2016
Briviact : EPAR - All Authorised presentations EN = English 25/01/2016 19/05/2016
Briviact : EPAR - All Authorised presentations EN = English 25/01/2016 19/05/2016
Briviact : EPAR - All Authorised presentations EN = English 25/01/2016 19/05/2016
Briviact : EPAR - All Authorised presentations EN = English 25/01/2016 19/05/2016
Briviact : EPAR - All Authorised presentations EN = English 25/01/2016 19/05/2016

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

Changes since initial authorisation of medicine

Name Language First published Last updated
Briviact : EPAR - Procedural steps taken and scientific information after authorisation EN = English 19/05/2016  

Initial marketing-authorisation documents

Name Language First published Last updated
Briviact : EPAR - Public assessment report EN = English 25/01/2016  
CHMP summary of positive opinion for Briviact EN = English 20/11/2015  

Authorised

This medicine is approved for use in the European Union