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.
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_idEU/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.
- CzechiaRILZABRUTINIB
- SpainWAYRILZ 400 MG COMPRIMIDOS RECUBIERTOS CON PELICULASanofi B.V.
- FinlandWayrilzSanofi B.V.
- IrelandWAYRILZ 400 mg film-coated tabletsSanofi B.V.
- IcelandWayrilzSanofi B.V.
- PolandWayrilzSanofi B.V.
- SwedenWAYRILZ 400 mg Filmdragerad tablettSanofi B.V.
- BelgiumWayrilz 400 mgSanofi
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"
}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.