Ireland· IE-PA-EU/1/26/2015/001-002
REZUROCK 200 mg film-coated tablets
A belumosudil product containing belumosudil mesilate, registered in Ireland by Sanofi Winthrop Industrie. The same ATC class is registered in 12 of our 19 countries.
Checked against HPRA (Ireland) on
Informational only — not a medical device.
Where it is registered
Belumosudil is registered in 12 of 19 countries.
Countries holding a registration under ATC L04AA48 (belumosudil), 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
Belumosudil · ATC L04AA48
12 / 19 countries
- Belgiumprice
- Canada
- Czechiaprice
- Denmark
- Finlandprice
- Icelandprice
- Ireland
- Japan
- Netherlands
- Spainprice
- United Kingdom
- United Statesprice
The record
At a glance
HPRA (Ireland)- Active substance
- Belumosudil mesIlate
- Manufacturer
- Sanofi Winthrop Industrie
- Country
- Ireland (IE)
- ATC code
- L04AA48
- ATC class
- Belumosudil
- Reimbursed
- Not published by this register
- Source register
- HPRA (Ireland)
- Last checked
- September 28, 2026
Packs & prices · 1
- ie_pa_numberEU/1/26/2015/001-002
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same medicine, other countries
Belumosudil in 10 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- CzechiaREZUROCKSanofi Winthrop Industrie, Gentilly
- SpainREZUROCK 200 MG COMPRIMIDOS RECUBIERTOS CON PELICULASanofi Winthrop Industrie
- BelgiumRezurock 200 mgSanofi Winthrop Industrie
- IcelandREZUROCKSanofi Winthrop Industrie
- NetherlandsREZUROCK 200 mg, filmomhulde tablettenSanofi Winthrop Industrie
- SwedenREZUROCK 200 mg Filmdragerad tablettSanofi Winthrop Industrie
- FinlandREZUROCKSanofi Winthrop Industrie
- CanadaREZUROCKSANOFI-AVENTIS CANADA INC
Authorised across Europe · EMA
The same active substance is authorised in 3 EEA countries. Names it is sold under:
- Iceland · Rezurock
- Liechtenstein · Rezurock
- Norway · Rezurock
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/6485246a-1b44-4cad-892f-cc8f3f24ace8 GET /v1/drugs/6485246a-1b44-4cad-892f-cc8f3f24ace8?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": [
"L04AA48"
],
"strength": null,
"pa_number": "EU/1/26/2015/001-002",
"substances": [
"Belumosudil mesIlate"
],
"legal_basis": "Known active substance (Article 8(3) of Directive No 2001/83/EC)",
"market_info": "Unknown",
"authorised_at": "24/03/2026",
"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 belumosudil.
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.