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Brivaracetam

Briviact (in Italy: Nubriveo) · ATC code N03AX23

Also known as: Brivarasetam, Brivaracétam

Key facts
Active substance
Brivaracetam
Drug class
Anticonvulsant agent
ATC code
N03AX23
Authorisation
centrally authorised across the EU (EMA)
Dosage forms
Briviact 10 mg film-coated tablets / Briviact 25 mg film-coated tablets / Briviact 50 mg film-coated tablets · Briviact 10 mg/ml oral solution · Briviact 10 mg/ml solution for injection/infusion
Marketing authorisation holder
UCB Pharma SA
Information as of
2026-11-04

Key facts

Brivaracetam (Briviact) is an antiepileptic drug available in the EU as film-coated tablets, 10 mg/ml oral solution and 10 mg/ml solution for injection/infusion, used as add-on therapy for partial-onset seizures.

What it is used for

  • Adjunctive therapy of partial-onset seizures with or without secondary generalisation in adults, adolescents and children from 2 years of age with epilepsy
  • Solution for injection/infusion: alternative when oral administration is temporarily not feasible

Dosing

  • Daily dose given in two equally divided doses, approximately 12 hours apart
  • Adults and patients weighing 50 kg or more: start with 50 mg/day or 100 mg/day; adolescents and children 50 kg or more have a maintenance dose of 100 mg/day; range 50 mg/day to 200 mg/day
  • Children and adolescents 20 kg to less than 50 kg: start with 1 mg/kg/day (up to 2 mg/kg/day), maintenance 2 mg/kg/day, range 1 – 4 mg/kg/day
  • Children 10 kg to less than 20 kg: start with 1 mg/kg/day (up to 2.5 mg/kg/day), maintenance 2.5 mg/kg/day, range 1 – 5 mg/kg/day
  • Hepatic impairment (all stages): start with 50 mg/day, maximum 150 mg/day (from 50 kg); under 50 kg maximum 3 mg/kg/day (20 kg to less than 50 kg) or 4 mg/kg/day (10 kg to less than 20 kg)
  • No dose adjustment in renal impairment; not recommended in end-stage renal disease on dialysis
  • Intravenous: bolus without dilution or 15-minute infusion, same total daily dose and frequency as oral; no experience beyond 4 days and not recommended in status epilepticus
  • Discontinuation from 16 years of age: reduce by 50 mg/day weekly; tablets swallowed whole with or without food

Contraindications

  • Hypersensitivity to brivaracetam, other pyrrolidone derivatives or any excipient

Important warnings

  • Suicidal ideation and behaviour: monitor for signs and consider appropriate treatment
  • Severe cutaneous adverse reactions including Stevens-Johnson syndrome: withdraw immediately if signs appear
  • Hepatic impairment: limited data, dose adjustment recommended
  • Tablets contain lactose

Side effects

  • Very common: somnolence (14.3 %) and dizziness (11.0 %), usually mild to moderate
  • Common: fatigue, convulsion, vertigo, nausea, vomiting, constipation, decreased appetite
  • Common psychiatric effects: depression, anxiety, insomnia, irritability; uncommon: suicidal ideation, psychotic disorder, aggression, agitation
  • Uncommon: neutropenia, type I hypersensitivity; not known: Stevens-Johnson syndrome

Interactions

  • Alcohol: brivaracetam approximately doubled its effect on psychomotor function, attention and memory; not recommended
  • Rifampicin decreased brivaracetam AUC by 45 %: consider dose adjustment when starting or stopping; caution with St John's wort
  • Strong enzyme-inducing AEDs (carbamazepine, phenobarbital, phenytoin) lower levels without need for dose adjustment; brivaracetam raises carbamazepine-epoxide
  • No observed benefit versus placebo in patients already taking levetiracetam
  • May increase levels of CYP2C19 substrates (e.g. omeprazole, diazepam) and decrease levels of CYP2B6 substrates (e.g. efavirenz)

Pregnancy and breastfeeding

  • Limited data; should not be used during pregnancy unless clinically necessary; family planning and contraception should be discussed with women of childbearing potential
  • Excreted in human breast milk: decide whether to discontinue breast-feeding or brivaracetam

Summary of the official product information, written with AI on 2026-11-05. Every number was checked automatically against the original text. Not reviewed by a physician – the full official text is authoritative.

Full official text →

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For patients

Package leaflet, verbatim

This product has no separate US patient information.

Authorisation and brand names by country

Medicines with exactly this active-substance composition, as listed in the national registers – alphabetical and without ranking. Whether a product is currently available is not shown here.

EU – centrally authorised (all member states)

Source: European Medicines Agency (EMA), product information

Germany

  • AbavalexG.L. Pharma Gmbh · 1 register entry
  • Brivaracetam1 A Pharma Gmbh, Ratiopharm Gmbh, Glenmark Arzneimittel Gmbh, Desitin Arzneimittel Gmbh, Heumann Pharma Gmbh & Co. Generica Kg, Holsten Pharma Gmbh, Vivanta Generics S.R.O., Medical Valley Invest Ab, Zentiva Pharma Gmbh, Amarox Pharma Gmbh, Biomo Pharma Gmbh, Cipla Europe Nv, Stadapharm Gmbh, Betapharm Arzneimittel Gmbh, Aliud Pharma Gmbh · 17 register entries
  • TygatroGlenmark Arzneimittel Gmbh · 1 register entry

Source: EMA – Article 57 product data (EU/EEA), as of 2026-11-04

Austria

  • AbavalexG.L. Pharma Gmbh · 1 register entry
  • Brivaracetam GenericonGenericon Pharma Gesellschaft M.B.H. · 1 register entry

Source: EMA – Article 57 product data (EU/EEA), as of 2026-11-04

Turkey

  • BriviactUCB PHARMA A.Ş. · 17 register entries

Source: TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, as of 2026-11-04

Brand names in 24 more European countries
Belgium
Brivaracetam Teva
Bulgaria
Abavalex
Croatia
Brivaracetam Accord, Brytyn, Clizay, Gemgerta
Cyprus
Brivaracetam Accord
Czechia
Abavalex, Breluncol, Brivaracetam +pharma, Brivaracetam Accord, Brivaracetam Desitin, Brivaracetam Orion, Brivaracetam Sandoz, Brivaracetam Stada, Brivaracetam Teva, Clizay, Eronavis, Vebrofan
Denmark
Abavalex, Brivaracetam Cipla, Brivaracetam Desitin, Brivaracetam Glenmark, Brivaracetam Holsten, Brivaracetam Orion, Brivaracetam Sandoz, Brivaracetam Stada, Brivaracetam Teva, Brivaracetam Vivanta, Brivaracetam Zentiva, Tygatro
Finland
Brabela, Brivaracetam Desitin, Brivaracetam Glenmark, Brivaracetam Orion, Brivaracetam Ratiopharm, Brivaracetam Stada, Eronavis, Tygatro
France
Brivaracetam Biogaran, Brivaracetam La Colina, Brivaracetam Teva, Brivaracetam Zentiva, Brivaracetam Zydus
Greece
Bivoquia, Brivaracetam Anabiosis, Brivaracetam Anfarm, Brivaracetam Ariti, Brivaracetam Pharmapath, Brivaracetam Pharmazac, Pidizix, Vebrofan
Hungary
Abavalex, Breluncol, Brivaracetam Holsten, Brivaracetam Orion, Brivaracetam Pharos, Brivaracetam Sandoz, Brivaracetam Stada, Brivaracetam Teva, Brivelex, Eronavis
Iceland
Brivaracetam, Briviact, Gemgerta
Ireland
Brivaracetam Clonmel
Italy
Brileps, Brivaracetam Amarox, Brivaracetam Doc, Brivaracetam Eg, Brivaracetam Glenmark, Brivaracetam Pensa, Brivaracetam Sandoz, Brivaracetam Teva, Brivaracetam Vivanta, Nubriveo
Liechtenstein
Briviact
Malta
Brivaracetam Anfarm, Brivaracetam Clonmel, Brivaracetam Pharos, Narebicel, Pidizix, Rijepal
Netherlands
Abavalex, Brivaracetam, Tygatro
Norway
Brivaracetam Desitin, Brivaracetam Glenmark, Brivaracetam Orion, Brivaracetam Stada, Brivaracetam Vivanta, Brivaracetam Zentiva, Briviact, Tygatro
Poland
Abavalex, Brabela, Breluncol, Brivaracetam +pharma, Brivaracetam Accord, Brivaracetam Aristo, Brivaracetam Holsten, Brivaracetam Orion, Brivaracetam Teva, Clizay, Eronavis, Gemgerta
Portugal
Brabela, Brivaracetam Anfarm, Brivaracetam Tolife, Pidizix
Romania
Abavalex, Breluncol, Brivaracetam Accord, Brivaracetam Desitin, Brivaracetam Teva, Clizay
Slovakia
Abavalex, Breluncol, Brivaracetam Accord, Brivaracetam Adalvo, Brivaracetam Glenmark, Brivaracetam Teva, Clizay, Eronavis, Tygatro
Slovenia
Clizay
Spain
Brivaracetam Cinfa, Brivaracetam Combix, Brivaracetam Desitin, Brivaracetam Pensa, Brivaracetam Sandoz, Brivaracetam Skm, Brivaracetam Stada, Brivaracetam Tarbis, Brivaracetam Teva, Brivaracetam Viso Farmacéutica, Brivaracetam Vivanta, Paucilex, Tygatro
Sweden
Abavalex, Brivaracetam Amarox, Brivaracetam Desitin, Brivaracetam Glenmark, Brivaracetam Holsten, Brivaracetam Orion, Brivaracetam Stada, Brivaracetam Teva, Brivaracetam Vivanta, Brivaracetam Zentiva, Tygatro

EMA – Article 57 product data (EU/EEA), 2026-11-04

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Sources

  1. European Medicines Agency. Briviact (in Italy: Nubriveo) – EPAR, Product Information. 2026-11-04. https://www.ema.europa.eu/en/documents/product-information/briviact-epar-product-information_en.pdf
  2. EMA – Article 57 product data (EU/EEA), 2026-11-04. https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/data-medicines-iso-idmp-standards-post-authorisation/public-data-article-57-database
  3. EMA – Article 57 product data (EU/EEA), 2026-11-04. https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/data-medicines-iso-idmp-standards-post-authorisation/public-data-article-57-database
  4. TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, 2026-11-04. https://www.titck.gov.tr/dinamikmodul/85
  5. Wikidata (CC0): ATC N03AX.

Editorial: Medelix editorial team · last updated 2026-11-04 · How these pages are made · Report an error

Source: European Medicines Agency (EMA), product information. Not advertising, not a treatment recommendation. For questions about your own treatment, ask your doctor or pharmacist.