Briviact (in Italy: Nubriveo)

brivaracetam

  • Email
  • Help

About

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.

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), which is used when the medicine cannot be given by mouth.

The recommended starting dose in adults and younger patients weighing more than 50 kg is either 25 mg twice a day or 50 mg twice a day, depending on the patient’s condition. In those weighing less than 50 kg the dose is based on body weight and the usual starting dose is 0.5 mg per kg body weight twice a day. The dose can then be adjusted according to the patient’s needs up to a maximum of 100 mg or 2 mg per kg respectively, twice a day.

The medicine can only be obtained with a prescription.

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

How does Briviact work?

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.

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.

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.

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 side effects of 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 authorised in the EU?

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 4 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?

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.

Other information about Briviact

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

Name Language First published Last updated
Briviact : EPAR - Medicine overview BG = bălgarski 2016-01-25 2018-07-26
Briviact : EPAR - Medicine overview ES = español 2016-01-25 2018-07-26
Briviact : EPAR - Medicine overview CS = čeština 2016-01-25 2018-07-26
Briviact : EPAR - Medicine overview DA = dansk 2016-01-25 2018-07-26
Briviact : EPAR - Medicine overview DE = Deutsch 2016-01-25 2018-07-26
Briviact : EPAR - Medicine overview ET = eesti keel 2016-01-25 2018-07-26
Briviact : EPAR - Medicine overview EL = elliniká 2016-01-25 2018-07-26
Briviact : EPAR - Medicine overview EN = English 2016-01-25 2018-07-26
Briviact : EPAR - Medicine overview FR = français 2016-01-25 2018-07-26
Briviact : EPAR - Medicine overview IT = italiano 2016-01-25 2018-07-26
Briviact : EPAR - Medicine overview LV = latviešu valoda 2016-01-25 2018-07-26
Briviact : EPAR - Medicine overview LT = lietuvių kalba 2016-01-25 2018-07-26
Briviact : EPAR - Medicine overview HU = magyar 2016-01-25 2018-07-26
Briviact : EPAR - Medicine overview MT = Malti 2016-01-25 2018-07-26
Briviact : EPAR - Medicine overview NL = Nederlands 2016-01-25 2018-07-26
Briviact : EPAR - Medicine overview PL = polski 2016-01-25 2018-07-26
Briviact : EPAR - Medicine overview PT = português 2016-01-25 2018-07-26
Briviact : EPAR - Medicine overview RO = română 2016-01-25 2018-07-26
Briviact : EPAR - Medicine overview SK = slovenčina 2016-01-25 2018-07-26
Briviact : EPAR - Medicine overview SL = slovenščina 2016-01-25 2018-07-26
Briviact : EPAR - Medicine overview FI = suomi 2016-01-25 2018-07-26
Briviact : EPAR - Medicine overview SV = svenska 2016-01-25 2018-07-26
Briviact : EPAR - Medicine overview HR = Hrvatski 2016-01-25 2018-07-26
Name Language First published Last updated
Briviact : EPAR - Risk-management-plan summary (English only) 2016-01-25  

This EPAR was last updated on 26/07/2018 .

Authorisation details

Product details

Product details for Briviact (in Italy: Nubriveo)
NameBriviact (in Italy: Nubriveo)
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 (in Italy: Nubriveo)
Marketing-authorisation holder

UCB Pharma SA

Revision6
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

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

Name Language First published Last updated
Briviact : EPAR - Product Information EN = English 2016-01-25 2018-07-26
Briviact : EPAR - Product Information EN = English 2016-01-25 2018-07-26
Briviact : EPAR - Product Information EN = English 2016-01-25 2018-07-26
Briviact : EPAR - Product Information EN = English 2016-01-25 2018-07-26
Briviact : EPAR - Product Information EN = English 2016-01-25 2018-07-26
Briviact : EPAR - Product Information EN = English 2016-01-25 2018-07-26
Briviact : EPAR - Product Information EN = English 2016-01-25 2018-07-26
Briviact : EPAR - Product Information EN = English 2016-01-25 2018-07-26
Briviact : EPAR - Product Information EN = English 2016-01-25 2018-07-26
Briviact : EPAR - Product Information EN = English 2016-01-25 2018-07-26
Briviact : EPAR - Product Information EN = English 2016-01-25 2018-07-26
Briviact : EPAR - Product Information EN = English 2016-01-25 2018-07-26
Briviact : EPAR - Product Information EN = English 2016-01-25 2018-07-26
Briviact : EPAR - Product Information EN = English 2016-01-25 2018-07-26
Briviact : EPAR - Product Information EN = English 2016-01-25 2018-07-26
Briviact : EPAR - Product Information EN = English 2016-01-25 2018-07-26
Briviact : EPAR - Product Information EN = English 2016-01-25 2018-07-26
Briviact : EPAR - Product Information EN = English 2016-01-25 2018-07-26
Briviact : EPAR - Product Information EN = English 2016-01-25 2018-07-26
Briviact : EPAR - Product Information EN = English 2016-01-25 2018-07-26
Briviact : EPAR - Product Information EN = English 2016-01-25 2018-07-26
Briviact : EPAR - Product Information EN = English 2016-01-25 2018-07-26
Briviact : EPAR - Product Information EN = English 2016-01-25 2018-07-26
Briviact : EPAR - Product Information EN = English 2016-01-25 2018-07-26
Briviact : EPAR - Product Information EN = English 2016-01-25 2018-07-26

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 2016-01-25 2018-07-26
Briviact : EPAR - All Authorised presentations EN = English 2016-01-25 2018-07-26
Briviact : EPAR - All Authorised presentations EN = English 2016-01-25 2018-07-26
Briviact : EPAR - All Authorised presentations EN = English 2016-01-25 2018-07-26
Briviact : EPAR - All Authorised presentations EN = English 2016-01-25 2018-07-26
Briviact : EPAR - All Authorised presentations EN = English 2016-01-25 2018-07-26
Briviact : EPAR - All Authorised presentations EN = English 2016-01-25 2018-07-26
Briviact : EPAR - All Authorised presentations EN = English 2016-01-25 2018-07-26
Briviact : EPAR - All Authorised presentations EN = English 2016-01-25 2018-07-26
Briviact : EPAR - All Authorised presentations EN = English 2016-01-25 2018-07-26
Briviact : EPAR - All Authorised presentations EN = English 2016-01-25 2018-07-26
Briviact : EPAR - All Authorised presentations EN = English 2016-01-25 2018-07-26
Briviact : EPAR - All Authorised presentations EN = English 2016-01-25 2018-07-26
Briviact : EPAR - All Authorised presentations EN = English 2016-01-25 2018-07-26
Briviact : EPAR - All Authorised presentations EN = English 2016-01-25 2018-07-26
Briviact : EPAR - All Authorised presentations EN = English 2016-01-25 2018-07-26
Briviact : EPAR - All Authorised presentations EN = English 2016-01-25 2018-07-26
Briviact : EPAR - All Authorised presentations EN = English 2016-01-25 2018-07-26
Briviact : EPAR - All Authorised presentations EN = English 2016-01-25 2018-07-26
Briviact : EPAR - All Authorised presentations EN = English 2016-01-25 2018-07-26
Briviact : EPAR - All Authorised presentations EN = English 2016-01-25 2018-07-26
Briviact : EPAR - All Authorised presentations EN = English 2016-01-25 2018-07-26
Briviact : EPAR - All Authorised presentations EN = English 2016-01-25 2018-07-26
Briviact : EPAR - All Authorised presentations EN = English 2016-01-25 2018-07-26
Briviact : EPAR - All Authorised presentations EN = English 2016-01-25 2018-07-26

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

Initial marketing-authorisation documents

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