Is Riociguat registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 9 valid registrations of Riociguat, including ADEMPAS 0.5 mg film-coated tablets (0.5 mg, Film-coated tablet, SAR 5020.50); ADEMPAS 1 mg film-coated tablets (1 mg, Film-coated tablet, SAR 5020.50); ADEMPAS 1.5 mg film-coated tablets (1.5 mg, Film-coated tablet, SAR 5020.50); ADEMPAS 2 mg film-coated tablets (2 mg, Film-coated tablet, SAR 5020.50); ADEMPAS 2.5 mg film-coated tablets (2.5 mg, Film-coated tablet, SAR 5020.50).

Is Riociguat approved by the US FDA?

Drugs@FDA lists 2 application product lines for Riociguat, including ADEMPAS (Prescription); RIOCIGUAT (Prescription).

Is Riociguat authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Riociguat: Adempas.

Are there safety signals or safety updates for Riociguat?

EMA PRAC: 2 entries; US FDA: 1 entry; MHRA: 1 entry (latest 2026-08-04).

Active substance

Riociguat

SFDA 14
US FDA 2
EMA 2
Health Canada 10
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
ADEMPAS 0.5 mg film-coated tablets	0.5 mg	Film-coated tablet · Oral use	42 Blister	SAR 5020.50	NCE · Prescription	BAYER AG	Valid
ADEMPAS 1 mg film-coated tablets	1 mg	Film-coated tablet · Oral use	42 Blister	SAR 5020.50	NCE · Prescription	BAYER AG	Valid
ADEMPAS 1.5 mg film-coated tablets	1.5 mg	Film-coated tablet · Oral use	42 Blister	SAR 5020.50	NCE · Prescription	BAYER AG	Valid
ADEMPAS 2 mg film-coated tablets	2 mg	Film-coated tablet · Oral use	42 Blister	SAR 5020.50	NCE · Prescription	BAYER AG	Valid
ADEMPAS 2.5 mg film-coated tablets	2.5 mg	Film-coated tablet · Oral use	42 Blister	SAR 5020.50	NCE · Prescription	BAYER AG	Valid
Remollio	0.5 mg	Film-coated tablet · Oral use	50 Blister	SAR 4183.75	Generic · Prescription	SUDAIR PHARMA COMPANY	Valid
Remollio	1 mg	Film-coated tablet · Oral use	50 Blister	SAR 4183.75	Generic · Prescription	SUDAIR PHARMA COMPANY	Valid
Remollio	1.5 mg	Film-coated tablet · Oral use	50 Blister	SAR 4183.75	Generic · Prescription	SUDAIR PHARMA COMPANY	Valid
Remollio	2.5 mg	Film-coated tablet · Oral use	50 Blister	SAR 4183.75	Generic · Prescription	SUDAIR PHARMA COMPANY	Valid
ADEMPAS 0.5 mg film-coated tablets	0.5 mg	Film-coated tablet · Oral use	42 Blister	SAR 6543.95	NCE · Prescription	BAYER PHARMA AG	Withdrawn by MAH · Not Marketed
ADEMPAS 1 mg film-coated tablets	1 mg	Film-coated tablet · Oral use	42 Blister	SAR 6543.95	NCE · Prescription	BAYER PHARMA AG	Withdrawn by MAH · Not Marketed
ADEMPAS 1.5 mg film-coated tablets	1.5 mg	Film-coated tablet · Oral use	42 Blister	SAR 6543.95	NCE · Prescription	BAYER PHARMA AG	Withdrawn by MAH · Not Marketed
ADEMPAS 2 mg film-coated tablets	2 mg	Film-coated tablet · Oral use	42 Blister	SAR 6543.95	NCE · Prescription	BAYER PHARMA AG	Withdrawn by MAH · Not Marketed
ADEMPAS 2.5 mg film-coated tablets	2.5 mg	Film-coated tablet · Oral use	42 Blister	SAR 6543.95	NCE · Prescription	BAYER PHARMA AG	Withdrawn by MAH · Not Marketed

Indications — CHI Daman Drug Formulary

PULMONARY ARTERIAL HYPERTENSION

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

Product	Strength	Form · route	Applicant	Status	First approved
ADEMPAS	0.5MG; 1MG; 1.5MG; 2MG; 2.5MG	tablet · oral	BAYER HLTHCARE	Prescription	8 Oct 2013
RIOCIGUAT	0.5MG; 1MG; 1.5MG; 2MG; 2.5MG	tablet · oral	MSN	Prescription	1 Sep 2022

EMA European Union — centrally authorised medicines

Adempas Bayer AG · Authorised · authorised 27 Mar 2014 · ATC C02KX05

Therapeutic indication (EMA)

Chronic thromboembolic pulmonary hypertension (CTEPH) Adempas is indicated for the treatment of adult patients with WHO Functional Class (FC) II to III with inoperable CTEPH, persistent or recurrent CTEPH after surgical treatment, to improve exercise capacity. Pulmonary arterial hypertension (PAH) AdultsAdempas, as monotherapy or in combination with endothelin receptor antagonists, is indicated for the treatment of adult patients with pulmonary arterial hypertension (PAH) with WHO Functional Class (FC) II to III to improve exercise capacity. Efficacy has been shown in a PAH population including aetiologies of idiopathic or heritable PAH or PAH associated with connective tissue disease. PaediatricsAdempas is indicated for the treatment of PAH in paediatric patients aged less than 18 years of age and body weight ? 50 kg with WHO Functional Class (FC) II to III in combination with endothelin receptor antagonists.

Riociguat Accord Accord Healthcare S.L.U. · Opinion · ATC C02KX05

Therapeutic indication (EMA)

Treatment of Chronic thromboembolic pulmonary hypertension (CTEPH) in adults and treatment of Pulmonary arterial hypertension (PAH) in adults and children from 6 years of age.

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
ADEMPAS	02412764	0.5 MG	TABLET · ORAL	BAYER INC
ADEMPAS	02412772	1 MG	TABLET · ORAL	BAYER INC
ADEMPAS	02412799	1.5 MG	TABLET · ORAL	BAYER INC
ADEMPAS	02412802	2 MG	TABLET · ORAL	BAYER INC
ADEMPAS	02412810	2.5 MG	TABLET · ORAL	BAYER INC
SANDOZ RIOCIGUAT	02533545	0.5 MG	TABLET · ORAL	SANDOZ CANADA INCORPORATED
SANDOZ RIOCIGUAT	02533561	1 MG	TABLET · ORAL	SANDOZ CANADA INCORPORATED
SANDOZ RIOCIGUAT	02533588	1.5 MG	TABLET · ORAL	SANDOZ CANADA INCORPORATED
SANDOZ RIOCIGUAT	02533596	2 MG	TABLET · ORAL	SANDOZ CANADA INCORPORATED
SANDOZ RIOCIGUAT	02533618	2.5 MG	TABLET · ORAL	SANDOZ CANADA INCORPORATED

Safety signals and safety-related labeling changes

US FDA 4 Aug 2026 ADEMPAS — safety-related labeling change
Labeling sections changed: Boxed Warning; Contraindications; Warnings and Precautions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
EMA PRAC 27 Oct 2016 PRAC signal: Increased mortality and serious adverse events (SAEs) in patients with pulmonary hypertension (PH) associated with idiopathic interstitial pneumonias (IIP) in a single clinical trial
Action for MAH: update of the product information: No
MHRA 8 Aug 2016 Riociguat (Adempas): not for use in patients with pulmonary hypertension associated with idiopathic interstitial pneumonias
Patients with pulmonary hypertension associated with idiopathic interstitial pneumonias should not be treated with riociguat in light of interim results from a recently terminated study.
EMA PRAC 9 Jun 2016 PRAC signal: Increased mortality and serious adverse events (SAEs) in patients with pulmonary hypertension (PH) associated with idiopathic interstitial pneumonias (IIP) in a single clinical trial
Action for MAH: update of the product information: Yes

All safety entries for riociguat →

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.