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Molecule

Brivaracetam

Epoxide Hydrolase Inhibitors
Available on requestControlled substanceNeurology
Presentations
14
Brands
1
Manufacturers
1
Available from stock
0

Brivaracetam is a prescription medicine indicated for the treatment of partial-onset seizures in patients 1 month of age and older. It is available as tablets, oral solution and injection for intravenous use. MedsAcross supplies Brivaracetam for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.

Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review

Key facts

Pharmacological class
Epoxide Hydrolase Inhibitors
ATC classification
N03AX23 Brivaracetam · Anticonvulsant agent, subgroup N03AX
US FDA first approval
18 February 2016
EU status
Authorised
Orphan designation
No
WHO essential medicine
Not recorded
India (CDSCO)
Not yet confirmed against CDSCO approval lists
Routes
Oral, Intravenous
Dosage forms
Tablet, Oral solution, Injection, Injectable suspension
Identifiers
UNII U863JGG2IARxCUI 1739745CAS 357336-20-0DrugBank DB05541Q408099

Clinical information

From the regulator-approved product information. Each section names its source.

How it works

The precise mechanism by which BRIVIACT exerts its anticonvulsant activity is not known. Brivaracetam displays a high and selective affinity for synaptic vesicle protein 2A (SV2A) in the brain, which may contribute to the anticonvulsant effect.

Source: US FDA prescribing information

Dosing overview

Adults (16 Years and Older): The recommended starting dosage for monotherapy or adjunctive therapy is 50 mg twice daily (100 mg per day). Based on individual patient tolerability and therapeutic response, the dosage may be adjusted down to 25 mg twice daily (50 mg per day) or up to 100 mg twice daily (200 mg per day). Pediatric Patients (1 Month to less than 16 Years): The recommended dosage is based on body weight and is administered orally twice daily. Injection: for intravenous use only when oral administration is temporarily not feasible, dosing is the same as oral regimen. Hepatic Impairment: Dose adjustment is recommended for all stages of hepatic impairment.

Source: US FDA prescribing information

Contraindications

Hypersensitivity to brivaracetam or any of the inactive ingredients in BRIVIACT (bronchospasm and angioedema have occurred). Hypersensitivity to brivaracetam or any of the inactive ingredients in BRIVIACT.

Source: US FDA prescribing information

Warnings and precautions

Suicidal Behavior and Ideation: Monitor patients for suicidal behavior and ideation. Neurological Adverse Reactions: Monitor for somnolence and fatigue, and advise patients not to drive or operate machinery until they have gained sufficient experience on BRIVIACT. Psychiatric Adverse Reactions: Behavioral reactions including psychotic symptoms, irritability, depression, aggressive behavior, and anxiety, monitor patients for symptoms. Hypersensitivity: Bronchospasm and Angioedema: Advise patients to seek immediate medical care. Discontinue and do not restart BRIVIACT if hypersensitivity occurs. Serious Dermatologic Reactions: Discontinue BRIVIACT unless an alternative etiology is established. Withdrawal of Antiepileptic Drugs: BRIVIACT should be gradually withdrawn.

Source: US FDA prescribing information

Side effects

The following serious adverse reactions are described elsewhere in labeling: Suicidal Behavior and Ideation Neurological Adverse Reactions Psychiatric Adverse Reactions Hypersensitivity: Bronchospasm and Angioedema Serious Dermatologic Reactions Withdrawal of Antiepileptic Drugs Adults: Most common adverse reactions (at least 5% for BRIVIACT and at least 2% more frequently than placebo) are somnolence/sedation, dizziness, fatigue, and nausea/vomiting. Pediatric Patients: Most common adverse reactions are similar to those seen in adult patients.

Source: US FDA prescribing information

Interactions

Rifampin: Because of decreased concentrations, increasing BRIVIACT dosage in patients on concomitant rifampin is recommended. Carbamazepine: Because of increased exposure to carbamazepine metabolite, if tolerability issues arise, consider reducing carbamazepine dosage in patients on concomitant BRIVIACT. Phenytoin: Because phenytoin concentrations can increase, phenytoin levels should be monitored in patients on concomitant BRIVIACT. Levetiracetam: BRIVIACT had no added therapeutic benefit when co-administered with levetiracetam.

Source: US FDA prescribing information

Storage

Store at 25°C (77°F), excursions permitted between 15°C to 30°C (59°F to 86°F). See USP Controlled Room Temperature. Do not freeze BRIVIACT injection or oral solution.

Source: US FDA prescribing information

For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.

All presentations

14 presentations of Brivaracetam, sorted by availability.

MedicineManufacturerRegisterAvailability
Brivaracetam 100 mg tabletOralGeneric name—US FDAAvailable on request
Brivaracetam 25 mg tabletOralGeneric name—US FDAAvailable on request
Brivaracetam 50 mg tabletOralGeneric name—US FDAAvailable on request
Brivaracetam 75 mg tabletOralGeneric name—US FDAAvailable on request
Brivaracetam 10 mg tabletOralGeneric name—US FDAAvailable on request
Brivaracetam 10 mg/mL oral solutionOralGeneric name—US FDAAvailable on request
Brivaracetam 50 mg/5 mL injectionIntravenousGeneric name—US FDAAvailable on request
Briviact 100 mg tabletOralUCBUS FDAAvailable on request
Briviact 25 mg tabletOralUCBUS FDAAvailable on request
Briviact 50 mg tabletOralUCBUS FDAAvailable on request
Briviact 10 mg tabletOralUCBUS FDAAvailable on request
Briviact 10 mg/mL oral solutionOralUCBUS FDAAvailable on request
Briviact 50 mg/5 mL injectable suspensionIntravenousUCBUS FDAAvailable on request
Briviact 75 mg tabletOralUCBUS FDAAvailable on request

Brands by market

1 brand names across 1 markets.

Brand names by country

United States

Manufacturers

Regulatory status

Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.

RegisterStatusSource
US FDAFirst approved 18 February 2016Drugs@FDA
EU (EMA)AuthorisedEMA medicines data
India (CDSCO)Not yet confirmed against CDSCO approval lists—
AustriaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
BelgiumRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
BulgariaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
CroatiaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
CyprusRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
CzechiaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
DenmarkRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
EstoniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
FinlandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
FranceRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
GermanyRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
GreeceRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
HungaryRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
IcelandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
IrelandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
ItalyRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LatviaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LiechtensteinRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LithuaniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LuxembourgRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
MaltaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
NetherlandsRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
NorwayRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
PolandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
PortugalRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
RomaniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SlovakiaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SloveniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SpainRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SwedenRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
United StatesRegisteredUS FDA (NDC directory, openFDA)Checked 12 November 2026

Conditions

Conditions linked to Brivaracetam in public data. This is not a list of approved uses, see the clinical information.

Questions and answers

Is Brivaracetam available for export from India?

Yes, on request. MedsAcross lists 14 presentations of Brivaracetam and sources them for licensed hospitals, importers and physicians against valid import documents.

What brand names does Brivaracetam have?

The catalogue lists 1 brand names for Brivaracetam, including Briviact.

Is Brivaracetam approved by the US FDA?

Yes. The US FDA first approved Brivaracetam on 18 February 2016, according to Drugs@FDA.

Is Brivaracetam authorised in the European Union?

Yes. Brivaracetam has a central EU marketing authorisation (status: authorised), according to European Medicines Agency data.

Does Brivaracetam need cold chain shipping?

No listed presentation of Brivaracetam is recorded as needing a cold chain. Storage conditions are shown on each presentation page.

Which ATC class is Brivaracetam in?

Brivaracetam is classified under ATC code N03AX23 (Brivaracetam).

References

  1. Briviact prescribing information (UCB). U.S. National Library of Medicine, DailyMed. Retrieved 5 November 2026
  2. Briviact (in Italy: Nubriveo): European public assessment report (EPAR). European Medicines Agency. Retrieved 27 January 2026

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