Is Selexipag registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 12 valid registrations of Selexipag, including Lexipia (400 µg, Film-coated tablet, SAR 7649.05); Lexipia (600 µg, Film-coated tablet, SAR 7649.05); Lexipia (800 µg, Film-coated tablet, SAR 7649.05); Lexipia (200 µg, Film-coated tablet, SAR 7649.05); Uptravi 1000 mcg (1000 µg, Film-coated tablet, SAR 10927.20).

Is Selexipag approved by the US FDA?

Drugs@FDA lists 5 application product lines for Selexipag, including UPTRAVI (Prescription); UPTRAVI (Prescription); SELEXIPAG (Prescription); SELEXIPAG (Prescription); SELEXIPAG (Discontinued).

Is Selexipag authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Selexipag: Uptravi.

Are there safety signals or safety updates for Selexipag?

EMA PRAC: 2 entries; US FDA: 2 entries (latest 2026-05-23).

Active substance

Selexipag

SFDA 12
US FDA 5
EMA 1
Health Canada 8
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
Lexipia	400 µg	Film-coated tablet · Oral use	60 Bottle	SAR 7649.05	Generic · Prescription	SUDAIR PHARMA COMPANY	Valid
Lexipia	600 µg	Film-coated tablet · Oral use	60 Bottle	SAR 7649.05	Generic · Prescription	SUDAIR PHARMA COMPANY	Valid
Lexipia	800 µg	Film-coated tablet · Oral use	60 Bottle	SAR 7649.05	Generic · Prescription	SUDAIR PHARMA COMPANY	Valid
Lexipia	200 µg	Film-coated tablet · Oral use	60 Bottle	SAR 7649.05	Generic · Prescription	SUDAIR PHARMA COMPANY	Valid
Uptravi 1000 mcg	1000 µg	Film-coated tablet · Oral use	60 Blister	SAR 10927.20	NCE · Prescription	Janssen-Cilag International NV	Valid
Uptravi 1200 mcg	1200 µg	Film-coated tablet · Oral use	60 Blister	SAR 10927.20	NCE · Prescription	Janssen-Cilag International NV	Valid
Uptravi 1400 mcg	1400 µg	Film-coated tablet · Oral use	60 Blister	SAR 10927.20	NCE · Prescription	Janssen-Cilag International NV	Valid
Uptravi 1600 mcg	1600 µg	Film-coated tablet · Oral use	60 Blister	SAR 10927.20	NCE · Prescription	Janssen-Cilag International NV	Valid
Uptravi 200 mcg titration pack	200 µg	Film-coated tablet · Oral use	140 Blister	SAR 25496.80	NCE · Prescription	Janssen-Cilag International NV	Valid
Uptravi 400 mcg	400 µg	Film-coated tablet · Oral use	60 Blister	SAR 10927.20	NCE · Prescription	Janssen-Cilag International NV	Valid
Uptravi 600 mcg	600 µg	Film-coated tablet · Oral use	60 Blister	SAR 10927.20	NCE · Prescription	Janssen-Cilag International NV	Valid
Uptravi 800 mcg	800 µg	Film-coated tablet · Oral use	60 Blister	SAR 10927.20	NCE · Prescription	Janssen-Cilag International NV	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
UPTRAVI	0.2MG; 0.4MG; 0.6MG; 0.8MG; 1MG; 1.2MG; 1.4MG; 1.6MG; 0.1MG; 0.15MG	tablet · oral	ACTELION	Prescription	21 Dec 2015
UPTRAVI	1.8MG/VIAL	powder · intravenous	ACTELION	Prescription	29 Jul 2021
SELEXIPAG	0.2MG; 0.4MG; 0.6MG; 0.8MG; 1.4MG; 1.6MG	tablet · oral	ALEMBIC	Prescription	11 Oct 2023
SELEXIPAG	0.2MG; 0.4MG; 0.6MG; 0.8MG; 1MG; 1.2MG; 1.4MG; 1.6MG	tablet · oral	RK PHARMA	Prescription	16 Apr 2026
SELEXIPAG	0.2MG; 0.4MG; 0.6MG; 0.8MG; 1MG; 1.2MG; 1.4MG; 1.6MG	tablet · oral	ZYDUS LIFESCIENCES	Discontinued	21 Dec 2022

EMA European Union — centrally authorised medicines

Uptravi Janssen Cilag International NV · Authorised · authorised 12 May 2016 · ATC B01AC27

Therapeutic indication (EMA)

Uptravi is indicated for the long-term treatment of pulmonary arterial hypertension (PAH) in adult patients with WHO functional class (FC) II–III, either as combination therapy in patients insufficiently controlled with an endothelin receptor antagonist (ERA) and/or a phosphodiesterase type 5 (PDE-5) inhibitor, or as monotherapy in patients who are not candidates for these therapies. Efficacy has been shown in a PAH population including idiopathic and heritable PAH, PAH associated with connective tissue disorders, and PAH associated with corrected simple congenital heart disease.

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
UPTRAVI	02451158	200 MCG	TABLET · ORAL	JANSSEN INC
UPTRAVI	02451166	400 MCG	TABLET · ORAL	JANSSEN INC
UPTRAVI	02451174	600 MCG	TABLET · ORAL	JANSSEN INC
UPTRAVI	02451182	800 MCG	TABLET · ORAL	JANSSEN INC
UPTRAVI	02451190	1000 MCG	TABLET · ORAL	JANSSEN INC
UPTRAVI	02451204	1200 MCG	TABLET · ORAL	JANSSEN INC
UPTRAVI	02451212	1400 MCG	TABLET · ORAL	JANSSEN INC
UPTRAVI	02451220	1600 MCG	TABLET · ORAL	JANSSEN INC

Safety signals and safety-related labeling changes

US FDA 23 May 2026 UPTRAVI — 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 23 May 2026 UPTRAVI — safety-related labeling change
Labeling sections changed: Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
EMA PRAC 6 Apr 2017 PRAC signal: Fatal cases in patients with pulmonary arterial hypertension (PAH)
Action for MAH: update of the product information: No
EMA PRAC 9 Feb 2017 PRAC signal: Fatal cases in patients with pulmonary arterial hypertension (PAH)
Action for MAH: update of the product information: No

All safety entries for selexipag →

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.