Is Ivabradine 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 Ivabradine, including Bradyva (7.5 mg, Film-coated tablet, SAR 104.60); Bradyva (5 mg, Film-coated tablet, SAR 104.60); PROCORALAN 5 MG F-C TABLETS (5 mg, Film-coated tablet, SAR 149.45); PROCORALAN 7.5 MG F-C TABLET (7.5 mg, Film-coated tablet, SAR 149.45).

Is Ivabradine approved by the US FDA?

Drugs@FDA lists 8 application product lines for Ivabradine, including IVABRADINE HYDROCHLORIDE (Prescription); IVABRADINE HYDROCHLORIDE (Prescription); IVABRADINE HYDROCHLORIDE (Prescription); IVABRADINE HYDROCHLORIDE (Prescription); IVABRADINE HYDROCHLORIDE (Prescription).

Is Ivabradine authorised in the European Union?

EMA lists 5 centrally authorised medicines containing Ivabradine: Procoralan, Corlentor, Ivabradine Anpharm, Ivabradine Zentiva, Ivabradine Accord.

Are there safety signals or safety updates for Ivabradine?

EMA PRAC: 1 entry; US FDA: 2 entries; MHRA: 1 entry (latest 2021-08-04).

Active substance

Ivabradine

SFDA 4
US FDA 8
EMA 6
Health Canada 2
US price lines 4
NHS prices 3
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
Bradyva	7.5 mg	Film-coated tablet · Oral use	56 Blister	SAR 104.60	Generic · Prescription	Tabuk Pharmaceutical Manufacturing Company	Valid
Bradyva	5 mg	Film-coated tablet · Oral use	56 Blister	SAR 104.60	Generic · Prescription	Tabuk Pharmaceutical Manufacturing Company	Valid
PROCORALAN 5 MG F-C TABLETS	5 mg	Film-coated tablet · Oral use	56 Blister	SAR 149.45	NCE · Prescription	SERVIER	Valid
PROCORALAN 7.5 MG F-C TABLET	7.5 mg	Film-coated tablet · Oral use	56 Blister	SAR 149.45	NCE · Prescription	SERVIER	Valid

Indications — CHI Daman Drug Formulary

ARRHYTHMIA; CONGESTIVE HEART FAILURE; CORONARY ARTERY DISEASE; SUPRAVENTRICULAR TACHYCARDIA

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

Product	Strength	Form · route	Applicant	Status	First approved
IVABRADINE HYDROCHLORIDE	EQ 5MG BASE; EQ 7.5MG BASE	tablet · oral	INGENUS PHARMS LLC	Prescription	30 Dec 2021
IVABRADINE HYDROCHLORIDE	EQ 5MG BASE; EQ 7.5MG BASE	tablet · oral	ANNORA PHARMA	Prescription	5 Oct 2022
IVABRADINE HYDROCHLORIDE	EQ 5MG BASE; EQ 7.5MG BASE	tablet · oral	ZYDUS PHARMS	Prescription	29 Nov 2023
IVABRADINE HYDROCHLORIDE	EQ 5MG BASE; EQ 7.5MG BASE	tablet · oral	BIONPHARMA	Prescription	5 Sep 2024
IVABRADINE HYDROCHLORIDE	EQ 5MG BASE; EQ 7.5MG BASE	tablet · oral	ALEMBIC	Prescription	8 Nov 2024
IVABRADINE HYDROCHLORIDE	EQ 5MG BASE; EQ 7.5MG BASE	tablet · oral	MSN	Prescription	28 Apr 2025
CORLANOR	EQ 5MG BASE; EQ 7.5MG BASE	tablet · oral	AMGEN INC	Discontinued	15 Apr 2015
CORLANOR	5MG/5ML (1MG/ML)	solution · oral	AMGEN INC	Discontinued	22 Apr 2019

EMA European Union — centrally authorised medicines

Procoralan Les Laboratoires Servier · Authorised · authorised 25 Oct 2005 · ATC C01EB17

Therapeutic indication (EMA)

Symptomatic treatment of chronic stable angina pectoris Ivabradine is indicated for the symptomatic treatment of chronic stable angina pectoris in coronary artery disease adults with normal sinus rhythm and heart rate ? 70 bpm. Ivabradine is indicated : in adults unable to tolerate or with a contraindication to the use of beta-blockers or in combination with beta-blockers in patients inadequately controlled with an optimal beta-blocker dose. Treatment of chronic heart failure Ivabradine is indicated in chronic heart failure NYHA II to IV class with systolic dysfunction, in patients in sinus rhythm and whose heart rate is ? 75 bpm, in combination with standard therapy including beta-blocker therapy or when beta-blocker therapy is contraindicated or not tolerated.

Corlentor Les Laboratoires Servier · Authorised · authorised 25 Oct 2005 · ATC C01EB17

Therapeutic indication (EMA)

Symptomatic treatment of chronic stable angina pectoris Ivabradine is indicated for the symptomatic treatment of chronic stable angina pectoris in coronary artery disease adults with normal sinus rhythm and heart rate ? 70 bpm. Ivabradine is indicated: in adults unable to tolerate or with a contraindication to the use of beta-blockers or in combination with beta-blockers in patients inadequately controlled with an optimal beta-blocker dose. Treatment of chronic heart failure Ivabradine is indicated in chronic heart failure NYHA II to IV class with systolic dysfunction, in patients in sinus rhythm and whose heart rate is ? 75 bpm, in combination with standard therapy including beta-blocker therapy or when beta-blocker therapy is contraindicated or not tolerated.

Ivabradine Anpharm "Anpharm" Przedsiębiorstwo Farmaceutyczne S.A. · Authorised · authorised 8 Sep 2015 · ATC C01EB17

Therapeutic indication (EMA)

Symptomatic treatment of chronic stable angina pectoris Ivabradine is indicated for the symptomatic treatment of chronic stable angina pectoris in coronary artery disease adults with normal sinus rhythm and heart rate ? 70 bpm. Ivabradine is indicated: in adults unable to tolerate or with a contra-indication to the use of beta-blockers or in combination with beta-blockers in patients inadequately controlled with an optimal betablocker dose. Treatment of chronic heart failure Ivabradine is indicated in chronic heart failure NYHA II to IV class with systolic dysfunction, in patients in sinus rhythm and whose heart rate is ? 75 bpm, in combination with standard therapy including beta-blocker therapy or when beta-blocker therapy is contraindicated or not tolerated.

Ivabradine Zentiva Zentiva k.s. · Authorised · authorised 11 Nov 2016 · ATC C01EB17

Therapeutic indication (EMA)

Symptomatic treatment of chronic stable angina pectoris Ivabradine is indicated for the symptomatic treatment of chronic stable angina pectoris in coronary artery disease adults with normal sinus rhythm and heart rate ? 70 bpm. Ivabradine is indicated: in adults unable to tolerate or with a contra-indication to the use of beta-blockers or in combination with beta-blockers in patients inadequately controlled with an optimal beta-blocker dose. Treatment of chronic heart failure Ivabradine is indicated in chronic heart failure NYHA II to IV class with systolic dysfunction, in patients in sinus rhythm and whose heart rate is ? 75 bpm, in combination with standard therapy including beta-blocker therapy or when beta-blocker therapy is contraindicated or not tolerated.

Ivabradine Accord Accord Healthcare S.L.U. · Authorised · authorised 22 May 2017 · ATC C01EB17

Therapeutic indication (EMA)

Symptomatic treatment of chronic stable angina pectoris Ivabradine is indicated for the symptomatic treatment of chronic stable angina pectoris in coronary artery disease adults with normal sinus rhythm and heart rate ? 70 bpm. Ivabradine is indicated : - in adults unable to tolerate or with a contra-indication to the use of beta-blockers - or in combination with beta-blockers in patients inadequately controlled with an optimal beta-blocker dose. Treatment of chronic heart failure Ivabradine is indicated in chronic heart failure NYHA II to IV class with systolic dysfunction, in patients in sinus rhythm and whose heart rate is ? 75 bpm, in combination with standard therapy including beta-blocker therapy or when beta-blocker therapy is contraindicated or not tolerated. (see section 5.1)

Ivabradine JensonR JensonR+ Limited · Withdrawn · authorised 11 Nov 2016 · ATC C01EB17

Therapeutic indication (EMA)

Symptomatic treatment of chronic stable angina pectoris in coronary artery disease adults with normal sinus rhythm and heart rate ? 70 bpm. Ivabradine is indicated: - in adults unable to tolerate or with a contra-indication to the use of beta-blockers - or in combination with beta-blockers in patients inadequately controlled with an optimal beta-blocker dose. Treatment of chronic heart failure Ivabradine is indicated in chronic heart failure NYHA II to IV class with systolic dysfunction, in patients in sinus rhythm and whose heart rate is ? 75 bpm, in combination with standard therapy including beta-blocker therapy or when beta-blocker therapy is contraindicated or not tolerated.

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
LANCORA	02459973	5 MG	TABLET · ORAL	SERVIER CANADA INC
LANCORA	02459981	7.5 MG	TABLET · ORAL	SERVIER CANADA INC

Prices — United States and England

Source	Product as listed	Price	Unit / pack	Date
US NADAC	CORLANOR 5 MG TABLET	$10.01046	per EA	23 Sep 2026
US NADAC	CORLANOR 7.5 MG TABLET	$9.99769	per EA	23 Sep 2026
US NADAC	IVABRADINE HCL 5 MG TABLET	$0.76068	per EA	23 Sep 2026
US NADAC	IVABRADINE HCL 7.5 MG TABLET	$0.63998	per EA	23 Sep 2026
NHS Drug Tariff	Ivabradine 2.5mg tablets	£57.85	56 tablet	1 Oct 2026
NHS Drug Tariff	Ivabradine 5mg tablets	£3.23	56 tablet	1 Oct 2026
NHS Drug Tariff	Ivabradine 7.5mg tablets	£3.60	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 4 Aug 2021 CORLANOR — safety-related labeling change
Labeling sections changed: Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA 4 Aug 2021 CORLANOR — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions
MHRA 11 Dec 2014 Ivabradine: carefully monitor for bradycardia
Emerging clinical trial evidence of increased cardiovascular risk.
EMA PRAC 8 May 2014 PRAC signal: Cardiovascular risk
Action for MAH: update of the product information: No

All safety entries for ivabradine →

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.