Is Remibrutinib approved by the US FDA?

Drugs@FDA lists 1 application product line for Remibrutinib, including RHAPSIDO (Prescription).

Is Remibrutinib authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Remibrutinib: Rhapsido.

Active substance

Remibrutinib

US FDA 1
EMA 1
US price lines 1

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

Product	Strength	Form · route	Applicant	Status	First approved
RHAPSIDO	25MG	tablet · oral	NOVARTIS	Prescription	30 Sep 2025

EMA European Union — centrally authorised medicines

Rhapsido Novartis Europharm Limited · Authorised · authorised 23 Apr 2026 · ATC L04AA60

Therapeutic indication (EMA)

Rhapsido is indicated for the treatment of chronic spontaneous urticaria (CSU) in adult patients with inadequate response to H1 antihistamine treatment.

Prices — United States and England

Source	Product as listed	Price	Unit / pack	Date
US NADAC	RHAPSIDO 25 MG TABLET	$72.46221	per EA	23 Sep 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.

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.