Belgium· BE-AMP-SAM665571-00
Wayrilz 400 mg
A medicinal product containing rilzabrutinib, registered in Belgium by Sanofi.
Checked against FAMHP / AFMPS (Belgium) on
Informational only — not a medical device.
The record
At a glance
FAMHP / AFMPS (Belgium)- Active substance
- Rilzabrutinib
- Manufacturer
- Sanofi
- Country
- Belgium (BE)
- ATC code
- —
- Reimbursed
- Not published by this register
- Source register
- FAMHP / AFMPS (Belgium)
- Last checked
- September 26, 2026
Packs & prices · 0
No packs listed by the register for this record.
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.
- NetherlandsWAYRILZ 400 mg filmomhulde tablettenSanofi B.V.
- PolandWayrilzSanofi B.V.
- SwedenWAYRILZ 400 mg Filmdragerad tablettSanofi B.V.
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 FAMHP / AFMPS (Belgium). 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/96a48984-2d33-4d22-bb1d-fa82914f9405 GET /v1/drugs/96a48984-2d33-4d22-bb1d-fa82914f9405?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",
"source": "afmps",
"status": "AUTHORIZED",
"name_en": "Wayrilz 400 mg",
"name_fr": "Wayrilz 400 mg",
"name_nl": "Wayrilz 400 mg",
"amp_code": "SAM665571-00",
"strengths": [
"400.0000",
"400.0000",
"0.8000",
"0.8000"
],
"pack_count": 3,
"substances": [
"Rilzabrutinib",
"E 110",
"Sodium Stearyl Fumarate"
],
"medicine_type": "ALLOPATHIC",
"atc_description": null,
"authorisation_numbers": [
"EU/1/25/1974/002",
"EU/1/25/1974/001",
"EU/1/25/1974/003"
]
}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.