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Netherlands· NL-61eed4990949

WAYRILZ 400 mg filmomhulde tabletten

A medicinal product containing rilzabrutinib, registered in Netherlands by Sanofi B.V..

Checked against CBG-MEB (Netherlands) on

Informational only — not a medical device.

SOURCE REGISTER · NLCBG-MEB (Netherlands)normalisedWAYRILZ 400 mg filmomhulde tablettenATC—REGISTER NO.NL-61eed4990949PACKS LISTED1CHECKEDSeptember 29, 2026
Compare price across countriesPer daily dose · free accountAsk the assistant about rilzabrutinibAnswers with sources · free accountCheck interactionsSeverity free · mechanism on Growth

The record

At a glance

CBG-MEB (Netherlands)
Active substance
RILZABRUTINIB
Manufacturer
Sanofi B.V.
Country
Netherlands (NL)
ATC code
—
Reimbursed
Not published by this register
Source register
CBG-MEB (Netherlands)
Last checked
September 29, 2026

Packs & prices · 1

  • cbg_meb_id
    EU/1/25/1974

Regulatory notes

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

Same medicine, other countries

Rilzabrutinib in 10 other countries

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

All rilzabrutinib products

Authorised across Europe · EMA

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

  • Iceland · Wayrilz
  • Liechtenstein · Wayrilz
  • Norway · Wayrilz

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 CBG-MEB (Netherlands). 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/5bf3ab5c-3909-40c5-80ec-13a1df0941fe
GET /v1/drugs/5bf3ab5c-3909-40c5-80ec-13a1df0941fe?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": "Filmomhulde tablet",
  "route": "Oraal gebruik",
  "soort": null,
  "source": "cbg_meb",
  "smpc_url": "https://www.ema.europa.eu/en/documents/product-information/wayrilz-epar-product-information_nl.pdf",
  "strength": null,
  "atc_label": null,
  "detail_url": "https://www.geneesmiddeleninformatiebank.nl/nl/cp134162",
  "excipients": [
    "CELLULOSE, MICROKRISTALLIJN (E 460(i))",
    "CROSPOVIDON (E 1202)",
    "MACROGOL 4000",
    "NATRIUMSTEARYLFUMARAAT",
    "POLYVINYLALCOHOL (E 1203)",
    "TALK (E 553b)",
    "TITAANDIOXIDE (E 171)",
    "ZONNEGEEL FCF ALUMINIUMLAK (E 110)"
  ],
  "substances": [
    "RILZABRUTINIB"
  ],
  "leaflet_url": null,
  "authorised_at": "2025/12/22",
  "procedure_number": "EMEA/H/C/006425",
  "dispensing_status": "Uitsluitend recept",
  "registration_number": "EU/1/25/1974",
  "additional_monitoring": "Y"
}
API referenceMCP serverPlans

See everything about rilzabrutinib.

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.

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