Is Carbidopa + Entacapone + Levodopa registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 4 valid registrations of Carbidopa + Entacapone + Levodopa, including STALEVO 100-25-200MG FILM COATED TAB. (200,100,25 mg,mg,mg, Film-coated tablet, SAR 107.10); STALEVO 150-37.5-200MG FILM COATED TAB. (200,150,37.5 mg,mg,mg, Film-coated tablet, SAR 107.10); STALEVO 200-50-200MG FILM COATED TAB. (200,200,50 mg,mg,mg, Film-coated tablet, SAR 107.10); STALEVO 50-12.5-200MG FILM COATED TAB. (200,50,12.5 mg,mg,mg, Film-coated tablet, SAR 107.10).

Is Carbidopa + Entacapone + Levodopa approved by the US FDA?

Drugs@FDA lists 13 application product lines for Carbidopa + Entacapone + Levodopa, including STALEVO 50 (Prescription); STALEVO 100 (Prescription); STALEVO 150 (Prescription); STALEVO 200 (Prescription); STALEVO 75 (Prescription).

Is Carbidopa + Entacapone + Levodopa authorised in the European Union?

EMA lists 3 centrally authorised medicines containing Carbidopa + Entacapone + Levodopa: Stalevo, Levodopa/Carbidopa/Entacapone Orion, Corbilta (previously Levodopa/Carbidopa/Entacapone Sandoz).

Active substances

Carbidopa + Entacapone + Levodopa

SFDA 7
US FDA 13
EMA 3
Health Canada 5
US price lines 6
NHS prices 14

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
STALEVO 100-25-200MG FILM COATED TAB.	200,100,25 mg,mg,mg	Film-coated tablet · Oral use	30 Blister	SAR 107.10	NCE · Prescription	Exeltis Healthcare S.L	Valid
STALEVO 150-37.5-200MG FILM COATED TAB.	200,150,37.5 mg,mg,mg	Film-coated tablet · Oral use	30 Blister	SAR 107.10	NCE · Prescription	Exeltis Healthcare S.L	Valid
STALEVO 200-50-200MG FILM COATED TAB.	200,200,50 mg,mg,mg	Film-coated tablet · Oral use	30 Bottle	SAR 107.10	Generic · Prescription	Exeltis Healthcare S.L	Valid
STALEVO 50-12.5-200MG FILM COATED TAB.	200,50,12.5 mg,mg,mg	Film-coated tablet · Oral use	30 Blister	SAR 107.10	NCE · Prescription	Exeltis Healthcare S.L	Valid
PARKYN 100 mg /25 mg / 200 mg Film Coated Tablet	100, 25, 200 mg	Film-coated tablet · Oral use	100 Bottle	SAR 249.55	Generic · Prescription	DEEF PHARMACEUTICAL INDUSTRIES	Withdrawn by regulatory authority · Not Marketed
PARKYN 150 mg /37.5 mg / 200 mg Film Coated Tablet	150, 37.5, 200 mg	Film-coated tablet · Oral use	100 Bottle	SAR 249.55	Generic · Prescription	DEEF PHARMACEUTICAL INDUSTRIES	Withdrawn by regulatory authority · Not Marketed
PARKYN 50 mg /12.5 mg / 200 mg Film Coated Tablet	50, 12.5, 200 mg	Film-coated tablet · Oral use	100 Bottle	SAR 249.55	Generic · Prescription	DEEF PHARMACEUTICAL INDUSTRIES	Withdrawn by regulatory authority · Not Marketed

Indications — CHI Daman Drug Formulary

PARKINSONISM

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

Product	Strength	Form · route	Applicant	Status	First approved
STALEVO 50	12.5MG;200MG;50MG	tablet · oral	ORION PHARMA	Prescription	11 Jun 2003
STALEVO 100	25MG;200MG;100MG	tablet · oral	ORION PHARMA	Prescription	11 Jun 2003
STALEVO 150	37.5MG;200MG;150MG	tablet · oral	ORION PHARMA	Prescription	11 Jun 2003
STALEVO 200	50MG;200MG;200MG	tablet · oral	ORION PHARMA	Prescription	11 Jun 2003
STALEVO 75	18.75MG;200MG;75MG	tablet · oral	ORION PHARMA	Prescription	11 Jun 2003
STALEVO 125	31.25MG;200MG;125MG	tablet · oral	ORION PHARMA	Prescription	11 Jun 2003
CARBIDOPA, LEVODOPA AND ENTACAPONE	12.5MG;200MG;50MG; 18.75MG;200MG;75MG; 25MG;200MG;100MG; 31.25MG;200MG;125MG; 37.5MG;200MG;150MG; 50MG;200MG;200MG	tablet · oral	RISING	Prescription	25 Jan 2022
CARBIDOPA, LEVODOPA AND ENTACAPONE	12.5MG;200MG;50MG; 18.75MG;200MG;75MG; 25MG;200MG;100MG; 31.25MG;200MG;125MG; 37.5MG;200MG;150MG; 50MG;200MG;200MG	tablet · oral	MACLEODS PHARMS	Prescription	15 Apr 2025
CARBIDOPA, LEVODOPA AND ENTACAPONE	12.5MG;200MG;50MG; 18.75MG;200MG;75MG; 25MG;200MG;100MG; 31.25MG;200MG;125MG; 37.5MG;200MG;150MG; 50MG;200MG;200MG	tablet · oral	ALEMBIC	Prescription	5 Feb 2026
CARBIDOPA, LEVODOPA AND ENTACAPONE	25MG;200MG;100MG; 37.5MG;200MG;150MG	tablet · oral	SUN PHARM	Discontinued	10 May 2012
CARBIDOPA, LEVODOPA AND ENTACAPONE	12.5MG;200MG;50MG	tablet · oral	WOCKHARDT LTD	Discontinued	20 Nov 2012
CARBIDOPA, LEVODOPA AND ENTACAPONE	18.75MG;200MG;75MG; 25MG;200MG;100MG; 31.25MG;200MG;125MG; 37.5MG;200MG;150MG; 50MG;200MG;200MG	tablet · oral	WOCKHARDT LTD	Discontinued	20 Nov 2012
CARBIDOPA, LEVODOPA AND ENTACAPONE	12.5MG;200MG;50MG; 18.75MG;200MG;75MG; 25MG;200MG;100MG; 31.25MG;200MG;125MG; 37.5MG;200MG;150MG; 50MG;200MG;200MG	tablet · oral	PHARMOBEDIENT	Discontinued	13 Aug 2020

EMA European Union — centrally authorised medicines

Stalevo Orion Corporation · Authorised · authorised 17 Oct 2003 · ATC N04BA03

Therapeutic indication (EMA)

Stalevo is indicated for the treatment of adult patients with Parkinson's disease and end-of-dose motor fluctuations not stabilised on levodopa / dopa-decarboxylase (DDC)-inhibitor treatment.

Levodopa/Carbidopa/Entacapone Orion Orion Corporation · Authorised · authorised 23 Aug 2011 · ATC N04BA03

Therapeutic indication (EMA)

Levodopa/Carbidopa/Entacapone Orion is indicated for the treatment of adult patients with Parkinson's disease and end-of-dose motor fluctuations not stabilised on levodopa / dopa-decarboxylase (DDC)-inhibitor treatment.

Corbilta (previously Levodopa/Carbidopa/Entacapone Sandoz) Orion Corporation · Authorised · authorised 11 Nov 2013 · ATC N04BA03

Therapeutic indication (EMA)

Corbilta is indicated for the treatment of adult patients with Parkinson’s disease and end-of-dose motor fluctuations not stabilised on levodopa/dopa decarboxylase (DDC) inhibitor treatment.

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
STALEVO	02305933	50 MG; 12.5 MG; 200 MG	TABLET · ORAL	SANDOZ CANADA INCORPORATED
STALEVO	02305941	100 MG; 25 MG; 200 MG	TABLET · ORAL	SANDOZ CANADA INCORPORATED
STALEVO	02305968	37.5 MG; 200 MG; 150 MG	TABLET · ORAL	SANDOZ CANADA INCORPORATED
STALEVO	02337827	75 MG; 200 MG; 18.75 MG	TABLET · ORAL	SANDOZ CANADA INCORPORATED
STALEVO	02337835	125 MG; 31.25 MG; 200 MG	TABLET · ORAL	SANDOZ CANADA INCORPORATED

Prices — United States and England

Source	Product as listed	Price	Unit / pack	Date
US NADAC	CARBIDOPA-LEVODOPA-ENTACAPONE 12.5-50-200 MG TAB	$0.57913	per EA	23 Sep 2026
US NADAC	CARBIDOPA-LEVODOPA-ENTACAPONE 18.75-75-200 MG TAB	$0.62814	per EA	23 Sep 2026
US NADAC	CARBIDOPA-LEVODOPA-ENTACAPONE 25-100-200 MG TAB	$0.69542	per EA	23 Sep 2026
US NADAC	CARBIDOPA-LEVODOPA-ENTACAPONE 31.25-125-200 MG TAB	$0.6409	per EA	23 Sep 2026
US NADAC	CARBIDOPA-LEVODOPA-ENTACAPONE 37.5-150-200 MG TAB	$0.80237	per EA	23 Sep 2026
US NADAC	CARBIDOPA-LEVODOPA-ENTACAPONE 50-200-200 MG TAB	$0.75691	per EA	23 Sep 2026
NHS Drug Tariff	Levodopa 100mg / Carbidopa 25mg / Entacapone 200mg tablets	£20.79	30 tablet	1 Oct 2026
NHS Drug Tariff	Levodopa 100mg / Carbidopa 25mg / Entacapone 200mg tablets	£69.31	100 tablet	1 Oct 2026
NHS Drug Tariff	Levodopa 125mg / Carbidopa 31.25mg / Entacapone 200mg tablets	£20.79	30 tablet	1 Oct 2026
NHS Drug Tariff	Levodopa 125mg / Carbidopa 31.25mg / Entacapone 200mg tablets	£69.31	100 tablet	1 Oct 2026
NHS Drug Tariff	Levodopa 150mg / Carbidopa 37.5mg / Entacapone 200mg tablets	£20.79	30 tablet	1 Oct 2026
NHS Drug Tariff	Levodopa 150mg / Carbidopa 37.5mg / Entacapone 200mg tablets	£69.31	100 tablet	1 Oct 2026
NHS Drug Tariff	Levodopa 175mg / Carbidopa 43.75mg / Entacapone 200mg tablets	£20.79	30 tablet	1 Oct 2026
NHS Drug Tariff	Levodopa 175mg / Carbidopa 43.75mg / Entacapone 200mg tablets	£69.31	100 tablet	1 Oct 2026
NHS Drug Tariff	Levodopa 200mg / Carbidopa 50mg / Entacapone 200mg tablets	£20.79	30 tablet	1 Oct 2026
NHS Drug Tariff	Levodopa 200mg / Carbidopa 50mg / Entacapone 200mg tablets	£69.31	100 tablet	1 Oct 2026
NHS Drug Tariff	Levodopa 50mg / Carbidopa 12.5mg / Entacapone 200mg tablets	£20.79	30 tablet	1 Oct 2026
NHS Drug Tariff	Levodopa 50mg / Carbidopa 12.5mg / Entacapone 200mg tablets	£69.31	100 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.

Components

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.