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Ireland· IE-PA-EU/1/26/2024/001-003

Rhapsido 25 mg film-coated tablets

A remibrutinib product containing remibrutinib, registered in Ireland by Novartis Europharm Limited. The same ATC class is registered in 9 of our 19 countries.

ATC L04AA60

Checked against HPRA (Ireland) on

Informational only — not a medical device.

SOURCE REGISTER · IEHPRA (Ireland)normalisedRhapsido 25 mg film-coated tabletsATCL04AA60REGISTER NO.IE-PA-EU/1/26/2024/00…PACKS LISTED1CHECKEDSeptember 28, 2026

Where it is registered

Remibrutinib is registered in 9 of 19 countries.

Countries holding a registration under ATC L04AA60 (remibrutinib), each read from that country’s own register.

  • This record: Ireland, from HPRA (Ireland)
  • 6 of them publish a price we can compare per daily dose

Remibrutinib · ATC L04AA60

9 / 19 countries

  • Belgiumprice
  • Czechiaprice
  • Denmark
  • Finlandprice
  • Icelandprice
  • Ireland
  • Netherlands
  • Switzerlandprice
  • United Statesprice
Blue: a registration under this ATC code. The ringed marker is this record’s country. Markets marked price publish a price we can compare per daily dose.

The record

At a glance

HPRA (Ireland)
Active substance
Remibrutinib
Manufacturer
Novartis Europharm Limited
Country
Ireland (IE)
ATC code
L04AA60
ATC class
Remibrutinib
Reimbursed
Not published by this register
Source register
HPRA (Ireland)
Last checked
September 28, 2026

Packs & prices · 1

  • ie_pa_number
    EU/1/26/2024/001-003

Regulatory notes

No shortage, Orange Book or US label notes for this record.

Same medicine, other countries

Remibrutinib in 10 other countries

What each register calls a product with the same active substance — salts and hydrates count as the same.

All remibrutinib products

Authorised across Europe · EMA

The same active substance is authorised in 3 EEA countries. Names it is sold under:

  • Iceland · Rhapsido
  • Liechtenstein · Rhapsido
  • Norway · Rhapsido

Source: European Medicines Agency, Article 57 product data.

Sourced from a public register and reproduced with attribution. Drug Database is not affiliated with, endorsed by, or a partner of HPRA (Ireland). This is an informational data service and not a medical device — verify against the official source of record before any clinical decision.

For developers

The same record over the API, and the raw payload
GET /v1/drugs/1344c43e-dfd7-401a-b2b3-6f6090ae78ae
GET /v1/drugs/1344c43e-dfd7-401a-b2b3-6f6090ae78ae?format=fhir

Every response carries last_synced_at, so freshness is a field rather than a promise. Below is exactly what the ingestion wrote, before any presentation — the same JSON the API returns under payload.

{
  "form": "Film-coated tablet",
  "routes": [
    "Oral use"
  ],
  "source": "hpra",
  "atc_all": [
    "L04AA60"
  ],
  "strength": null,
  "pa_number": "EU/1/26/2024/001-003",
  "substances": [
    "Remibrutinib"
  ],
  "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)",
  "market_info": "Unknown",
  "authorised_at": "23/04/2026",
  "dispensing_status": "Product subject to prescription which may not be renewed (A)",
  "registration_status": "AU",
  "supply_legal_status": "Supply through pharmacies only",
  "interchangeable_code": null
}

See everything about remibrutinib.

This page is the registration. A free account adds the label text as the regulator wrote it, what it costs per daily dose across the markets that publish a price, a feed of what changes in the registers, and an assistant that answers with its sources. Interaction severity is free; mechanism and management are on the Growth plan. No card, nothing to install.