Ireland· IE-PA-EU/1/25/1962/003
Rezdiffra 100 mg film-coated tablets
A resmetirom product containing resmetirom, registered in Ireland by Madrigal Pharmaceuticals EU Limited. The same ATC class is registered in 9 of our 19 countries.
Checked against HPRA (Ireland) on
Informational only — not a medical device.
Where it is registered
Resmetirom is registered in 9 of 19 countries.
Countries holding a registration under ATC A05BA11 (resmetirom), 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
Resmetirom · ATC A05BA11
9 / 19 countries
- Belgiumprice
- Czechiaprice
- Denmark
- Finlandprice
- Franceprice
- Icelandprice
- Ireland
- Netherlands
- United Statesprice
The record
At a glance
HPRA (Ireland)- Active substance
- Resmetirom
- Manufacturer
- Madrigal Pharmaceuticals EU Limited
- Country
- Ireland (IE)
- ATC code
- A05BA11
- ATC class
- Resmetirom
- Reimbursed
- Not published by this register
- Source register
- HPRA (Ireland)
- Last checked
- September 28, 2026
Packs & prices · 1
- ie_pa_numberEU/1/25/1962/003
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same medicine, other countries
Resmetirom in 10 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- BelgiumRezdiffra 100 mgMadrigal Pharmaceuticals EU
- CzechiaREZDIFFRAMadrigal Pharmaceuticals EU Limited, Dublin
- SpainREZDIFFRA 100 MG COMPRIMIDOS RECUBIERTOS CON PELICULAMadrigal Pharmaceuticals Eu Limited
- FinlandRezdiffraMadrigal Pharmaceuticals EU Limited
- FranceREZDIFFRA 100 mg, comprimé pelliculéMADRIGAL PHARMACEUTICALS EU (IRLANDE)
- IcelandRezdiffraMadrigal Pharmaceuticals EU Limited
- NetherlandsRezdiffra 100 mg filmomhulde tablettenMadrigal Pharmaceuticals EU Limited
- PolandRezdiffraMadrigal Pharmaceuticals EU Limited
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/3403ea5e-9a28-48fe-a4a5-d689bff06334 GET /v1/drugs/3403ea5e-9a28-48fe-a4a5-d689bff06334?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": [
"A05BA11"
],
"strength": null,
"pa_number": "EU/1/25/1962/003",
"substances": [
"Resmetirom"
],
"legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)",
"market_info": "Unknown",
"authorised_at": "18/08/2025",
"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 resmetirom.
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.