Is Macitentan + Tadalafil registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 2 valid registrations of Macitentan + Tadalafil, including Opsynvi (20,10 mg,mg, Film-coated tablet, SAR 8812.05); Opsynvi (40,10 mg,mg, Film-coated tablet, SAR 8812.05).

Is Macitentan + Tadalafil approved by the US FDA?

Drugs@FDA lists 1 application product line for Macitentan + Tadalafil, including OPSYNVI (Prescription).

Is Macitentan + Tadalafil authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Macitentan + Tadalafil: Yuvanci.

Active substances

Macitentan + Tadalafil

SFDA 2
US FDA 1
EMA 1
Health Canada 1

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
Opsynvi	20,10 mg,mg	Film-coated tablet · Oral use	30 Blister	SAR 8812.05	NCE · Prescription	Janssen Cilag	Valid
Opsynvi	40,10 mg,mg	Film-coated tablet · Oral use	30 Blister	SAR 8812.05	NCE · Prescription	Janssen Cilag	Valid

Indications — CHI Daman Drug Formulary

PULMONARY ARTERIAL HYPERTENSION

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

Product	Strength	Form · route	Applicant	Status	First approved
OPSYNVI	10MG;20MG; 10MG;40MG	tablet · oral	ACTELION	Prescription	22 Mar 2024

EMA European Union — centrally authorised medicines

Yuvanci Janssen-Cilag International NV · Authorised · authorised 27 Sep 2024 · ATC C02KX54

Therapeutic indication (EMA)

Yuvanci is indicated as substitution therapy for the long-term treatment of pulmonary arterial hypertension (PAH) in adult patients of WHO Functional Class (FC) II to III, who are already treated with the combination of macitentan and tadalafil given concurrently as separate tablets.

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
OPSYNVI	02521083	40 MG; 10 MG	TABLET · ORAL	JANSSEN INC

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.