Rhapsido
- Prescription status not stated
- Cancer treatments and immune-system medicines
- Active substance
- Remibrutinib
- Made by
- Novartis Europharm Limited
- Source
- Official label
Quoted from the official source. Not yet reviewed by Mediclarum — the leaflet in your pack is authoritative.
What it is for
- Rhapsido is indicated for the treatment of chronic spontaneous urticaria (CSU) in adult patients with inadequate response to H1 antihistamine treatment.
From the official label · 2026-09-30 · European Medicines Agency
How it works
From the US prescribing label for the same active substance (RHAPSIDO). It describes the substance, not this exact product.
Remibrutinib is an oral, small molecule kinase inhibitor that inhibits Bruton’s tyrosine kinase (BTK).
BTK is an intracellular protein expressed in mast cells, basophils, B cells, macrophages, and thrombocytes.
Remibrutinib is primarily metabolized by CYP3A4.
Effect of food No clinically significant differences in remibrutinib pharmacokinetics were observed following administration of a high-fat meal (1000 calories, 50% fat).
Quoted from the prescribing label, sections “Mechanism of Action” and “Pharmacokinetics”. DailyMed · 2026-03-23
Same active substance, strength and form in other countries
Matched on active substance, strength and kind of form only. This is not a statement that the products are equivalent or interchangeable: other ingredients, release and approved uses can differ — ask a pharmacist before swapping.
Medicine passport: one printable page to show a pharmacist abroad
United StatesNo exact match for this strength and form
SpainNo exact match for this strength and form
CanadaNo exact match for this strength and form
NetherlandsNo exact match for this strength and form
Details
| Made by | Novartis Europharm Limited |
|---|---|
| Active substance | Remibrutinib |
| Used in | Cancer treatments and immune-system medicines |
| Classification | L04AA60 · Cancer treatments and immune-system medicines |
| Additional monitoring ▼ | Yes — under additional monitoring (black triangle). Report suspected side effects. |
| Authorised on | 2026-04-23 |
| Last updated by the regulator | 2026-05-05 |
| EMA product number | EMEA/H/C/006313 |
Source: European Medicines Agency — medicine data · 2026-09-30 · not reviewed by a clinician
Source: European Medicines Agency (EMA). Product information as published by EMA. Reuse terms: EMA legal notice (reproduction authorised).