Irish Medicines Database · HPRA register

Rhapsido 25 mg film-coated tablets

Authorisation EU/1/26/2024/001-003 · Novartis Europharm Limited

Licence EU/1/26/2024/001-003 · Unknown

Licence holder: Novartis Europharm Limited (all products →)
Active substance: Remibrutinib
Dosage form: Film-coated tablet
Route of administration: Oral use
ATC code: L04AA60
First authorised: 23/04/2026
Prescription status: Product subject to prescription which may not be renewed (A)
Supply: Supply through pharmacies only
Legal basis: Full application (Article 8(3) of Directive No 2001/83/EC)

Data: Health Products Regulatory Authority (HPRA) open dataset, licensed CC BY 4.0, published 16 Sep 2026. This listing is regulatory information, not medical advice — consult the package leaflet, SPC, or a healthcare professional. For the authoritative record see the HPRA register.