Briviact (in Italy: Nubriveo)
Authorised
This medicine is authorised for use in the European Union
brivaracetam
MedicineHumanAuthorised
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- Application under evaluation
- CHMP opinion
- European Commission decision
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.
Product information
Latest procedure affecting product information:VR/0000266248
19/05/2025
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).
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
AntiepilepticsTherapeutic 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
News on Briviact (in Italy: Nubriveo)
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