Is Iptacopan registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 1 valid registration of Iptacopan, including Fabhalta (200 mg, Capsule, hard, SAR 134144.80).

Is Iptacopan approved by the US FDA?

Drugs@FDA lists 1 application product line for Iptacopan, including FABHALTA (Prescription).

Is Iptacopan authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Iptacopan: Fabhalta.

Are there safety signals or safety updates for Iptacopan?

US FDA: 1 entry (latest 2026-07-16).

Active substance

Iptacopan

SFDA 1
US FDA 1
EMA 1
Health Canada 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
Fabhalta	200 mg	Capsule, hard · Oral use	56 Blister	SAR 134144.80	NCE · Prescription	Novartis Europharm Limited	Valid

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

Product	Strength	Form · route	Applicant	Status	First approved
FABHALTA	EQ 200MG BASE	capsule · oral	NOVARTIS	Prescription	5 Dec 2023

EMA European Union — centrally authorised medicines

Fabhalta Novartis Europharm Limited · Authorised · authorised 17 May 2024 · ATC L04A

Therapeutic indication (EMA)

Paroxysmal nocturnal haemoglobinuria Fabhalta is indicated as monotherapy in the treatment of adult patients with paroxysmal nocturnal haemoglobinuria (PNH) who have haemolytic anaemia. Complement 3 glomerulopathy Fabhalta is indicated for the treatment of adult patients with complement 3 glomerulopathy (C3G) in combination with a renin-angiotensin system (RAS) inhibitor, or in patients who are RAS-inhibitor intolerant, or for whom a RAS inhibitor is contraindicated (see section 5.1).

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
FABHALTA	02554313	200 MG	CAPSULE · ORAL	NOVARTIS PHARMACEUTICALS CANADA INC

Safety signals and safety-related labeling changes

US FDA 16 Jul 2026 FABHALTA — safety-related labeling change
Labeling sections changed: Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide

All safety entries for iptacopan →

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.