Is Perampanel registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 6 valid registrations of Perampanel, including FYCOMPA 10 mg Film-Coated Tablet (10 mg, Film-coated tablet, SAR 527.70); FYCOMPA 12 mg Film-Coated Tablet (12 mg, Film-coated tablet, SAR 527.70); FYCOMPA 2 mg Film-Coated Tablet (2 mg, Film-coated tablet, SAR 64.20); FYCOMPA 4 mg Film-Coated Tablet (4 mg, Film-coated tablet, SAR 428.00); FYCOMPA 6 mg Film-Coated Tablet (6 mg, Film-coated tablet, SAR 428.00).

Is Perampanel approved by the US FDA?

Drugs@FDA lists 8 application product lines for Perampanel, including FYCOMPA (Prescription); FYCOMPA (Prescription); PERAMPANEL (Prescription); PERAMPANEL (Prescription); PERAMPANEL (Prescription).

Is Perampanel authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Perampanel: Fycompa.

Are there safety signals or safety updates for Perampanel?

EMA PRAC: 2 entries; US FDA: 2 entries (latest 2019-09-05).

Active substance

Perampanel

SFDA 6
US FDA 8
EMA 1
Health Canada 12
US price lines 14
NHS prices 8
Safety 4

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
FYCOMPA 10 mg Film-Coated Tablet	10 mg	Film-coated tablet · Oral use	28 Blister	SAR 527.70	NCE · Prescription	EISAI EUROPE LIMITED	Valid
FYCOMPA 12 mg Film-Coated Tablet	12 mg	Film-coated tablet · Oral use	28 Blister	SAR 527.70	NCE · Prescription	EISAI EUROPE LIMITED	Valid
FYCOMPA 2 mg Film-Coated Tablet	2 mg	Film-coated tablet · Oral use	7 Blister	SAR 64.20	NCE · Prescription	EISAI EUROPE LIMITED	Valid
FYCOMPA 4 mg Film-Coated Tablet	4 mg	Film-coated tablet · Oral use	28 Blister	SAR 428.00	NCE · Prescription	EISAI EUROPE LIMITED	Valid
FYCOMPA 6 mg Film-Coated Tablet	6 mg	Film-coated tablet · Oral use	28 Blister	SAR 428.00	NCE · Prescription	EISAI EUROPE LIMITED	Valid
FYCOMPA 8 mg Film-Coated Tablet	8 mg	Film-coated tablet · Oral use	28 Blister	SAR 498.10	NCE · Prescription	EISAI EUROPE LIMITED	Valid

Indications — CHI Daman Drug Formulary

FOCAL SEIZURES

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

Product	Strength	Form · route	Applicant	Status	First approved
FYCOMPA	2MG; 4MG; 6MG; 8MG; 10MG; 12MG	tablet · oral	CATALYST PHARMS	Prescription	22 Oct 2012
FYCOMPA	0.5MG/ML	suspension · oral	CATALYST PHARMS	Prescription	29 Apr 2016
PERAMPANEL	2MG; 4MG; 6MG; 8MG; 10MG; 12MG	tablet · oral	TEVA PHARMS USA INC	Prescription	23 May 2025
PERAMPANEL	0.5MG/ML	suspension · oral	MSN	Prescription	11 Jul 2025
PERAMPANEL	2MG; 4MG; 6MG; 8MG; 10MG; 12MG	tablet · oral	TARO	Prescription	25 Nov 2025
PERAMPANEL	2MG; 4MG; 6MG; 8MG; 10MG; 12MG	tablet · oral	MSN	Prescription	25 Nov 2025
PERAMPANEL	0.5MG/ML	suspension · oral	TARO	Prescription	15 Jun 2026
PERAMPANEL	2MG; 4MG; 6MG; 8MG; 10MG; 12MG	tablet · oral	AUROBINDO PHARMA LTD	Prescription	2 Oct 2026

EMA European Union — centrally authorised medicines

Fycompa Eisai GmbH · Authorised · authorised 23 Jul 2012 · ATC N03AX22

Therapeutic indication (EMA)

Fycompa is indicated for the adjunctive treatment of partial-onset seizures with or without secondarily generalised seizures in adult and adolescent patients from 12 years of age with epilepsy. Fycompa is indicated for the adjunctive treatment of primary generalised tonic-clonic seizures in adult and adolescent patients from 12 years of age with idiopathic generalised epilepsy.

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
FYCOMPA	02404516	2 MG	TABLET · ORAL	EISAI LIMITED
FYCOMPA	02404524	4.0 MG	TABLET · ORAL	EISAI LIMITED
FYCOMPA	02404532	6.0 MG	TABLET · ORAL	EISAI LIMITED
FYCOMPA	02404540	8.0 MG	TABLET · ORAL	EISAI LIMITED
FYCOMPA	02404559	10.0 MG	TABLET · ORAL	EISAI LIMITED
FYCOMPA	02404567	12.0 MG	TABLET · ORAL	EISAI LIMITED
TARO-PERAMPANEL	02522632	2 MG	TABLET · ORAL	TARO PHARMACEUTICALS INC
TARO-PERAMPANEL	02522640	4 MG	TABLET · ORAL	TARO PHARMACEUTICALS INC
TARO-PERAMPANEL	02522659	6 MG	TABLET · ORAL	TARO PHARMACEUTICALS INC
TARO-PERAMPANEL	02522667	8 MG	TABLET · ORAL	TARO PHARMACEUTICALS INC
TARO-PERAMPANEL	02522675	10 MG	TABLET · ORAL	TARO PHARMACEUTICALS INC
TARO-PERAMPANEL	02522683	12 MG	TABLET · ORAL	TARO PHARMACEUTICALS INC

Prices — United States and England

Source	Product as listed	Price	Unit / pack	Date
US NADAC	FYCOMPA 0.5 MG/ML ORAL SUSP	$4.45662	per ML	23 Sep 2026
US NADAC	FYCOMPA 10 MG TABLET	$39.11546	per EA	23 Sep 2026
US NADAC	FYCOMPA 12 MG TABLET	$39.10963	per EA	23 Sep 2026
US NADAC	FYCOMPA 2 MG TABLET	$19.75426	per EA	23 Sep 2026
US NADAC	FYCOMPA 4 MG TABLET	$39.14028	per EA	23 Sep 2026
US NADAC	FYCOMPA 6 MG TABLET	$39.13335	per EA	23 Sep 2026
US NADAC	FYCOMPA 8 MG TABLET	$39.08722	per EA	23 Sep 2026
US NADAC	PERAMPANEL 0.5 MG/ML ORAL SUSP	$3.94521	per ML	23 Sep 2026
US NADAC	PERAMPANEL 10 MG TABLET	$15.64335	per EA	23 Sep 2026
US NADAC	PERAMPANEL 12 MG TABLET	$14.39738	per EA	23 Sep 2026
US NADAC	PERAMPANEL 2 MG TABLET	$6.43174	per EA	23 Sep 2026
US NADAC	PERAMPANEL 4 MG TABLET	$14.43393	per EA	23 Sep 2026
NHS Drug Tariff	Perampanel 10mg tablets	£140.00	28 tablet	1 Oct 2026
NHS Drug Tariff	Perampanel 12mg tablets	£140.00	28 tablet	1 Oct 2026
NHS Drug Tariff	Perampanel 2mg tablets	£35.00	7 tablet	1 Oct 2026
NHS Drug Tariff	Perampanel 2mg tablets	£140.00	28 tablet	1 Oct 2026
NHS Drug Tariff	Perampanel 4mg tablets	£140.00	28 tablet	1 Oct 2026
NHS Drug Tariff	Perampanel 500micrograms/ml oral suspension sugar free	£127.50	340 ml	1 Oct 2026
NHS Drug Tariff	Perampanel 6mg tablets	£140.00	28 tablet	1 Oct 2026
NHS Drug Tariff	Perampanel 8mg tablets	£140.00	28 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

EMA PRAC 5 Sep 2019 PRAC signal: Hepatotoxicity
Action for MAH: update of the product information: No
US FDA 31 May 2019 FYCOMPA — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA 30 May 2019 FYCOMPA — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
EMA PRAC 11 Apr 2019 PRAC signal: Hepatotoxicity
Action for MAH: update of the product information: No

All safety entries for perampanel →

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.