Is Brivaracetam registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 14 valid registrations of Brivaracetam, including BRIVIACT 10MG F.C.TABLET (10 mg, Film-coated tablet, SAR 74.90); BRIVIACT 10MG/ML ORAL SOLUTION (10 mg/ml, Oral solution, SAR 307.05); BRIVIACT 10MG/ML VIAL (10 mg/ml, Solution for injection/infusion, SAR 744.35); BRIVIACT 25MG F.C.TABLET (25 mg, Film-coated tablet, SAR 286.55); BRIVIACT 50MG F.C.TABLET (50 mg, Film-coated tablet, SAR 286.55).

Is Brivaracetam approved by the US FDA?

Drugs@FDA lists 22 application product lines for Brivaracetam, including BRIVIACT (Prescription); BRIVIACT (Prescription); BRIVIACT (Prescription); BRIVARACETAM (Prescription); BRIVARACETAM (Prescription).

Is Brivaracetam authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Brivaracetam: Briviact (in Italy: Nubriveo).

Are there safety signals or safety updates for Brivaracetam?

US FDA: 3 entries (latest 2025-08-28).

Active substance

Brivaracetam

SFDA 14
US FDA 22
EMA 1
Health Canada 14
US price lines 11
NHS prices 6
Safety 3

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
BRIVIACT 10MG F.C.TABLET	10 mg	Film-coated tablet · Oral use	14 Blister	SAR 74.90	NCE · Prescription	UCB Pharma S.A.	Valid
BRIVIACT 10MG/ML ORAL SOLUTION	10 mg/ml	Oral solution · Oral use	1 Bottle	SAR 307.05	NCE · Prescription	UCB Pharma S.A.	Valid
BRIVIACT 10MG/ML VIAL	10 mg/ml	Solution for injection/infusion · Intravenous use	10 Vial	SAR 744.35	NCE · Prescription	UCB Pharma S.A.	Valid
BRIVIACT 25MG F.C.TABLET	25 mg	Film-coated tablet · Oral use	56 Blister	SAR 286.55	NCE · Prescription	UCB Pharma S.A.	Valid
BRIVIACT 50MG F.C.TABLET	50 mg	Film-coated tablet · Oral use	56 Blister	SAR 286.55	NCE · Prescription	UCB Pharma S.A.	Valid
Brevie	25 mg	Film-coated tablet · Oral use	60 Blister	SAR 266.05	Generic · Prescription	SUDAIR PHARMA COMPANY	Valid
Brevie	50 mg	Film-coated tablet · Oral use	60 Blister	SAR 266.05	Generic · Prescription	SUDAIR PHARMA COMPANY	Valid
Brevie	10 mg/ml	Solution for injection/infusion · Intravenous use	1 Vial	SAR 69.45	Generic · Prescription	SUDAIR PHARMA COMPANY	Valid
Provecta	50 mg	Film-coated tablet · Oral use	60 Blister	SAR 268.60	Generic · Prescription	Jazeera Pharmaceutical Industries (JPI)	Valid
Provecta	25 mg	Film-coated tablet · Oral use	60 Blister	SAR 268.60	Generic · Prescription	Jazeera Pharmaceutical Industries (JPI)	Valid
Provecta	10 mg	Film-coated tablet · Oral use	14 Blister	SAR 70.85	Generic · Prescription	Jazeera Pharmaceutical Industries (JPI)	Valid
Provecta	100 mg	Film-coated tablet · Oral use	60 Blister	SAR 268.60	Generic · Prescription	Jazeera Pharmaceutical Industries (JPI)	Valid
Provecta	75 mg	Film-coated tablet · Oral use	60 Blister	SAR 268.60	Generic · Prescription	Jazeera Pharmaceutical Industries (JPI)	Valid
Provecta	10 mg/ml	Oral solution · Oral use	1 Bottle	SAR 143.30	Generic · Prescription	Jazeera Pharmaceutical Industries (JPI)	Valid

Indications — CHI Daman Drug Formulary

FOCAL SEIZURES

US FDA United States — FDA approvals (Drugs@FDA)

Product	Strength	Form · route	Applicant	Status	First approved
BRIVIACT	10MG; 25MG; 50MG; 75MG; 100MG	tablet · oral	UCB INC	Prescription	18 Feb 2016
BRIVIACT	50MG/5ML (10MG/ML)	solution · intravenous	UCB INC	Prescription	18 Feb 2016
BRIVIACT	10MG/ML	solution · oral	UCB INC	Prescription	18 Feb 2016
BRIVARACETAM	10MG; 25MG; 50MG; 75MG; 100MG	tablet · oral	SUNSHINE	Prescription	9 Jun 2022
BRIVARACETAM	10MG; 25MG; 50MG; 75MG; 100MG	tablet · oral	ZYDUS PHARMS	Prescription	3 Oct 2022
BRIVARACETAM	50MG; 100MG; 10MG; 25MG; 75MG	tablet · oral	AUROBINDO PHARMA LTD	Prescription	6 Jan 2023
BRIVARACETAM	10MG; 25MG; 50MG; 75MG; 100MG	tablet · oral	MSN	Prescription	13 Nov 2025
BRIVARACETAM	10MG/ML	solution · oral	MSN	Prescription	19 Feb 2026
BRIVARACETAM	10MG; 25MG; 50MG; 75MG; 100MG	tablet · oral	APOTEX	Prescription	23 Feb 2026
BRIVARACETAM	50MG/5ML (10MG/ML)	solution · intravenous	MICRO LABS	Prescription	23 Feb 2026
BRIVARACETAM	50MG/5ML (10MG/ML)	solution · intravenous	MSN	Prescription	23 Feb 2026
BRIVARACETAM	50MG/5ML (10MG/ML)	solution · intravenous	HAINAN POLY	Prescription	23 Feb 2026
BRIVARACETAM	10MG/ML	solution · oral	ZHEJIANG POLY PHARM	Prescription	23 Feb 2026
BRIVARACETAM	10MG/ML	solution · oral	ALKEM LABS LTD	Prescription	23 Feb 2026
BRIVARACETAM	10MG/ML	solution · oral	LUPIN	Prescription	23 Feb 2026
BRIVARACETAM	10MG/ML	solution · oral	REGCON HOLDINGS	Prescription	23 Feb 2026
BRIVARACETAM	10MG; 25MG; 50MG; 75MG; 100MG	tablet · oral	SCIEGEN PHARMS	Prescription	1 Jul 2026
BRIVARACETAM	50MG/5ML (10MG/ML)	solution · intravenous	SHANDONG	Prescription	13 Jul 2026
BRIVARACETAM	10MG/ML	solution · oral	AUROBINDO PHARMA	Prescription	10 Aug 2026
BRIVARACETAM	25MG; 50MG; 100MG	tablet · oral	ZHEJIANG JUTAI PHARM	Prescription	8 Sep 2026
BRIVARACETAM	10MG; 25MG; 50MG; 75MG; 100MG	tablet · oral	LUPIN	Discontinued	20 Dec 2022
BRIVARACETAM	10MG; 25MG; 50MG; 75MG; 100MG	tablet · oral	BRECKENRIDGE	Discontinued	23 Feb 2026

EMA European Union — centrally authorised medicines

Briviact (in Italy: Nubriveo) UCB Pharma SA · Authorised · authorised 13 Jan 2016 · ATC N03AX23

Therapeutic indication (EMA)

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.

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
APO-BRIVARACETAM	02538679	10 MG	TABLET · ORAL	APOTEX INC
APO-BRIVARACETAM	02538687	25 MG	TABLET · ORAL	APOTEX INC
APO-BRIVARACETAM	02538695	50 MG	TABLET · ORAL	APOTEX INC
APO-BRIVARACETAM	02538709	75 MG	TABLET · ORAL	APOTEX INC
APO-BRIVARACETAM	02538717	100 MG	TABLET · ORAL	APOTEX INC
AURO-BRIVARACETAM	02539292	50 MG	TABLET · ORAL	AURO PHARMA INC
AURO-BRIVARACETAM	02539306	100 MG	TABLET · ORAL	AURO PHARMA INC
BRIVLERA	02452936	10 MG	TABLET · ORAL	UCB CANADA INC
BRIVLERA	02452944	25 MG	TABLET · ORAL	UCB CANADA INC
BRIVLERA	02452952	50 MG	TABLET · ORAL	UCB CANADA INC
BRIVLERA	02452960	75 MG	TABLET · ORAL	UCB CANADA INC
BRIVLERA	02452979	100 MG	TABLET · ORAL	UCB CANADA INC
BRIVLERA	02452987	10 MG / ML	SOLUTION · ORAL	UCB CANADA INC
BRIVLERA	02452995	10 MG / ML	SOLUTION · INTRAVENOUS	UCB CANADA INC

Prices — United States and England

Source	Product as listed	Price	Unit / pack	Date
US NADAC	BRIVARACETAM 10 MG/ML ORAL SOL	$0.26682	per ML	23 Sep 2026
US NADAC	BRIVARACETAM 100 MG TABLET	$0.25862	per EA	7 Oct 2026
US NADAC	BRIVARACETAM 25 MG TABLET	$0.22236	per EA	7 Oct 2026
US NADAC	BRIVARACETAM 50 MG TABLET	$0.18877	per EA	7 Oct 2026
US NADAC	BRIVARACETAM 75 MG TABLET	$0.266	per EA	7 Oct 2026
US NADAC	BRIVIACT 10 MG TABLET	$23.98643	per EA	23 Sep 2026
US NADAC	BRIVIACT 10 MG/ML ORAL SOLN	$4.8099	per ML	23 Sep 2026
US NADAC	BRIVIACT 100 MG TABLET	$24.06984	per EA	23 Sep 2026
US NADAC	BRIVIACT 25 MG TABLET	$24.06598	per EA	23 Sep 2026
US NADAC	BRIVIACT 50 MG TABLET	$24.07445	per EA	23 Sep 2026
US NADAC	BRIVIACT 75 MG TABLET	$24.05799	per EA	23 Sep 2026
NHS Drug Tariff	Brivaracetam 100mg tablets	£129.64	56 tablet	1 Oct 2026
NHS Drug Tariff	Brivaracetam 10mg tablets	£34.64	14 tablet	1 Oct 2026
NHS Drug Tariff	Brivaracetam 25mg tablets	£129.64	56 tablet	1 Oct 2026
NHS Drug Tariff	Brivaracetam 50mg tablets	£129.64	56 tablet	1 Oct 2026
NHS Drug Tariff	Brivaracetam 50mg/5ml oral solution sugar free	£115.83	300 ml	1 Oct 2026
NHS Drug Tariff	Brivaracetam 75mg tablets	£129.64	56 tablet	1 Oct 2026

NADAC: average price US retail pharmacies pay to buy the medicine. NHS Drug Tariff Part VIIIA: basic price reimbursed to pharmacies in England and Wales.

Safety signals and safety-related labeling changes

US FDA 28 Aug 2025 BRIVIACT — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA 28 Aug 2025 BRIVIACT — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA 28 Aug 2025 BRIVIACT — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide

All safety entries for brivaracetam →

Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.