Is Rasagiline registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 3 valid registrations of Rasagiline, including Ragilin (1 mg, Tablet, SAR 324.45); Ralzyo (1 mg, Tablet, SAR 308.25); Ralzyo (0.5 mg, Tablet, SAR 308.25).

Is Rasagiline approved by the US FDA?

Drugs@FDA lists 13 application product lines for Rasagiline, including AZILECT (Prescription); RASAGILINE MESYLATE (Prescription); RASAGILINE MESYLATE (Prescription); RASAGILINE MESYLATE (Prescription); RASAGILINE MESYLATE (Prescription).

Is Rasagiline authorised in the European Union?

EMA lists 3 centrally authorised medicines containing Rasagiline: Azilect, Rasagiline ratiopharm, Rasagiline Viatris (previously Rasagiline Mylan).

Are there safety signals or safety updates for Rasagiline?

US FDA: 1 entry (latest 2020-06-16).

Active substance

Rasagiline

SFDA 3
US FDA 13
EMA 3
Health Canada 8
US price lines 3
NHS prices 1
Safety 1

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
Ragilin	1 mg	Tablet · Oral use	30 Blister	SAR 324.45	Generic · Prescription	Tabuk Pharmaceutical Manufacturing Company	Valid
Ralzyo	1 mg	Tablet · Oral use	30 Bottle	SAR 308.25	Generic · Prescription	MS Pharma Saudi (MSPS)	Valid
Ralzyo	0.5 mg	Tablet · Oral use	30 Bottle	SAR 308.25	Generic · Prescription	MS Pharma Saudi (MSPS)	Valid

Indications — CHI Daman Drug Formulary

PARKINSONISM

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

Product	Strength	Form · route	Applicant	Status	First approved
AZILECT	EQ 0.5MG BASE; EQ 1MG BASE	tablet · oral	TEVA	Prescription	16 May 2006
RASAGILINE MESYLATE	EQ 0.5MG BASE; EQ 1MG BASE	tablet · oral	ORBION PHARMS	Prescription	15 Mar 2016
RASAGILINE MESYLATE	EQ 0.5MG BASE; EQ 1MG BASE	tablet · oral	AUROBINDO PHARMA USA	Prescription	15 May 2017
RASAGILINE MESYLATE	EQ 0.5MG BASE; EQ 1MG BASE	tablet · oral	ALKEM LABS LTD	Prescription	30 Oct 2017
RASAGILINE MESYLATE	EQ 0.5MG BASE; EQ 1MG BASE	tablet · oral	CHARTWELL RX	Prescription	27 Jul 2018
RASAGILINE MESYLATE	EQ 0.5MG BASE; EQ 1MG BASE	tablet · oral	MICRO LABS	Prescription	29 Mar 2019
RASAGILINE MESYLATE	EQ 0.5MG BASE; EQ 1MG BASE	tablet · oral	REGCON HOLDINGS	Prescription	4 Oct 2019
RASAGILINE MESYLATE	EQ 0.5MG BASE; EQ 1MG BASE	tablet · oral	CARNEGIE	Prescription	18 Nov 2021
RASAGILINE MESYLATE	EQ 0.5MG BASE; EQ 1MG BASE	tablet · oral	RISING	Prescription	9 Apr 2024
RASAGILINE MESYLATE	EQ 0.5MG BASE; EQ 1MG BASE	tablet · oral	MACLEODS PHARMS	Prescription	28 Jun 2024
RASAGILINE MESYLATE	EQ 0.5MG BASE; EQ 1MG BASE	tablet · oral	TORRENT	Prescription	5 May 2025
RASAGILINE MESYLATE	EQ 0.5MG BASE; EQ 1MG BASE	tablet · oral	WATSON LABS INC	Discontinued	1 Jul 2013
RASAGILINE MESYLATE	EQ 0.5MG BASE; EQ 1MG BASE	tablet · oral	APOTEX INC	Discontinued	12 Sep 2013

EMA European Union — centrally authorised medicines

Azilect Teva B.V. · Authorised · authorised 21 Feb 2005 · ATC N04BD02

Therapeutic indication (EMA)

Azilect is indicated for the treatment of idiopathic Parkinson's disease (PD) as monotherapy (without levodopa) or as adjunct therapy (with levodopa) in patients with end-of-dose fluctuations.

Rasagiline ratiopharm Teva B.V. · Authorised · authorised 12 Jan 2015 · ATC N04BD02

Therapeutic indication (EMA)

Rasagiline ratiopharm is indicated for the treatment of idiopathic Parkinson’s disease (PD) as monotherapy (without levodopa) or as adjunct therapy (with levodopa) in patients with end of dose fluctuations.

Rasagiline Viatris (previously Rasagiline Mylan) Viatris Limited · Authorised · authorised 4 Apr 2016 · ATC N04BD02

Therapeutic indication (EMA)

Rasagiline Viatris is indicated for the treatment of idiopathic Parkinson’s disease (PD) as monotherapy (without levodopa) or as adjunct therapy (with levodopa) in patients with end of dose fluctuations.

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
APO-RASAGILINE	02404680	0.5 MG	TABLET · ORAL	APOTEX INC
APO-RASAGILINE	02404699	1 MG	TABLET · ORAL	APOTEX INC
AZILECT	02284642	0.5 MG	TABLET · ORAL	TEVA CANADA LIMITED
AZILECT	02284650	1 MG	TABLET · ORAL	TEVA CANADA LIMITED
JAMP RASAGILINE	02491974	0.5 MG	TABLET · ORAL	JAMP PHARMA CORPORATION
JAMP RASAGILINE	02491982	1 MG	TABLET · ORAL	JAMP PHARMA CORPORATION
TEVA-RASAGILINE	02418436	0.5 MG	TABLET · ORAL	TEVA CANADA LIMITED
TEVA-RASAGILINE	02418444	1 MG	TABLET · ORAL	TEVA CANADA LIMITED

Prices — United States and England

Source	Product as listed	Price	Unit / pack	Date
US NADAC	AZILECT 0.5 MG TABLET	$44.04633	per EA	1 Jan 2026
US NADAC	RASAGILINE MESYLATE 0.5 MG TAB	$0.52085	per EA	30 Sep 2026
US NADAC	RASAGILINE MESYLATE 1 MG TAB	$0.92551	per EA	30 Sep 2026
NHS Drug Tariff	Rasagiline 1mg tablets	£1.34	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

US FDA 16 Jun 2020 AZILECT — safety-related labeling change
Labeling sections changed: Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide

All safety entries for rasagiline →

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.