Is Entacapone registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 0 valid registrations of Entacapone.

Is Entacapone approved by the US FDA?

Drugs@FDA lists 9 application product lines for Entacapone, including COMTAN (Prescription); ENTACAPONE (Prescription); ENTACAPONE (Prescription); ENTACAPONE (Prescription); ENTACAPONE (Prescription).

Is Entacapone authorised in the European Union?

EMA lists 4 centrally authorised medicines containing Entacapone: Comtess, Comtan, Entacapone Teva, Entacapone Orion.

Are there safety signals or safety updates for Entacapone?

US FDA: 6 entries (latest 2026-03-19).

Active substance

Entacapone

SFDA 1
US FDA 9
EMA 4
Health Canada 3
US price lines 1
NHS prices 1
Safety 6

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
COMTAN 200MG F.C TAB	200 mg	Film-coated tablet · Oral use	30 Blister	SAR 125.70	NCE · Prescription	NOVARTIS	Withdrawn by MAH · Not Marketed

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

Product	Strength	Form · route	Applicant	Status	First approved
COMTAN	200MG	tablet · oral	ORION PHARMA	Prescription	19 Oct 1999
ENTACAPONE	200MG	tablet · oral	SUN PHARM	Prescription	16 Jul 2012
ENTACAPONE	200MG	tablet · oral	WOCKHARDT BIO AG	Prescription	16 Aug 2012
ENTACAPONE	200MG	tablet · oral	AUROBINDO PHARMA LTD	Prescription	19 Jun 2015
ENTACAPONE	200MG	tablet · oral	MACLEODS PHARMS	Prescription	5 Jun 2017
ENTACAPONE	200MG	tablet · oral	AJANTA PHARMA LTD	Prescription	31 Aug 2017
ENTACAPONE	200MG	tablet · oral	SUNSHINE	Prescription	3 Oct 2018
ENTACAPONE	200MG	tablet · oral	ALEMBIC	Prescription	4 Jan 2022
ENTACAPONE	200MG	tablet · oral	PHARMOBEDIENT	Discontinued	13 May 2013

EMA European Union — centrally authorised medicines

Comtess Orion Corporation · Authorised · authorised 16 Sep 1998 · ATC N04BX02

Therapeutic indication (EMA)

Entacapone is indicated as an adjunct to standard preparations of levodopa / benserazide or levodopa / carbidopa for use in patients with Parkinson's disease and end-of-dose motor fluctuations, who cannot be stabilised on those combinations.

Comtan Orion Corporation · Authorised · authorised 22 Sep 1998 · ATC N04BX02

Therapeutic indication (EMA)

Entacapone is indicated as an adjunct to standard preparations of levodopa / benserazide or levodopa / carbidopa for use in adult patients with Parkinson's disease and end-of-dose motor fluctuations, who cannot be stabilised on those combinations.

Entacapone Teva Teva Pharma B.V. · Authorised · authorised 18 Feb 2011 · ATC N04BX02

Therapeutic indication (EMA)

Entacapone Orion Orion Corporation · Authorised · authorised 18 Aug 2011 · ATC N04BX02

Therapeutic indication (EMA)

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
MINT-ENTACAPONE	02535939	200 MG	TABLET · ORAL	MINT PHARMACEUTICALS INC
SANDOZ ENTACAPONE	02380005	200 MG	TABLET · ORAL	SANDOZ CANADA INCORPORATED
TEVA-ENTACAPONE	02375559	200 MG	TABLET · ORAL	TEVA CANADA LIMITED

Prices — United States and England

Source	Product as listed	Price	Unit / pack	Date
US NADAC	ENTACAPONE 200 MG TABLET	$0.32457	per EA	23 Sep 2026
NHS Drug Tariff	Entacapone 200mg tablets	£4.91	30 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 19 Mar 2026 STALEVO 100 — 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 19 Mar 2026 STALEVO 125 — 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 19 Mar 2026 STALEVO 150 — 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 19 Mar 2026 STALEVO 200 — 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 19 Mar 2026 STALEVO 50 — 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 19 Mar 2026 STALEVO 75 — 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 entacapone →

Combinations containing Entacapone

Carbidopa + entacapone + levodopa

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.