Ireland· IE-PA-EU/1/24/1856/001-002
Vyloy 100 mg powder for concentrate for solution for infusion.
A zolbetuximab product containing zolbetuximab, registered in Ireland by Astellas Pharma Europe B.V.. The same ATC class is registered in 13 of our 19 countries.
Checked against HPRA (Ireland) on
Informational only — not a medical device.
Where it is registered
Zolbetuximab is registered in 13 of 19 countries.
Countries holding a registration under ATC L01FX31 (zolbetuximab), each read from that country’s own register.
- This record: Ireland, from HPRA (Ireland)
- 8 of them publish a price we can compare per daily dose
Zolbetuximab · ATC L01FX31
13 / 19 countries
- Belgiumprice
- Canada
- Czechiaprice
- Denmark
- Finlandprice
- Franceprice
- Icelandprice
- Ireland
- Netherlands
- Norwayprice
- Switzerlandprice
- United Kingdom
- United Statesprice
The record
At a glance
HPRA (Ireland)- Active substance
- Zolbetuximab
- Manufacturer
- Astellas Pharma Europe B.V.
- Country
- Ireland (IE)
- ATC code
- L01FX31
- ATC class
- Zolbetuximab
- Defined daily dose
- 51.4 mg, P
- Reimbursed
- Not published by this register
- Source register
- HPRA (Ireland)
- Last checked
- September 28, 2026
Packs & prices · 1
- ie_pa_numberEU/1/24/1856/001-002
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same medicine, other countries
Zolbetuximab in 15 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- CzechiaVYLOYAstellas Pharma Europe B.V., Leiden
- SwitzerlandVyloy 100 mg, Pulver für ein Konzentrat zur Herstellung einer InfusionslösungAstellas Pharma AG
- FinlandVyloyAstellas Pharma Europe B.V.
- United KingdomVyloy 100mg powder for concentrate for solution for infusion vialsAstellas Pharma Ltd
- IcelandVyloyAstellas Pharma Europe B.V.
- NorwayVyloyAstellas Pharma Europe B.V
- PolandVyloyAstellas Pharma Europe B.V.
- BelgiumVyloy 100 mgAstellas Pharma Europe
Authorised across Europe · EMA
The same active substance is authorised in 3 EEA countries. Names it is sold under:
- Iceland · Vyloy
- Liechtenstein · Vyloy
- Norway · Vyloy
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/b7ec31fa-de5f-42c1-a388-d8b1dba8d327 GET /v1/drugs/b7ec31fa-de5f-42c1-a388-d8b1dba8d327?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": "Powder for concentrate for solution for infusion",
"routes": [
"Intravenous use"
],
"source": "hpra",
"atc_all": [
"L01FX31"
],
"strength": null,
"pa_number": "EU/1/24/1856/001-002",
"substances": [
"Zolbetuximab"
],
"legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)",
"market_info": "Unknown",
"authorised_at": "19/09/2024",
"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 zolbetuximab.
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.