Ireland· IE-PA-EU/1/25/1950/003
Ezmekly 1 mg hard capsules
A mirdametinib product containing mirdametinib, registered in Ireland by Merck Europe B.V.. The same ATC class is registered in 11 of our 19 countries.
Checked against HPRA (Ireland) on
Informational only — not a medical device.
Where it is registered
Mirdametinib is registered in 11 of 19 countries.
Countries holding a registration under ATC L01EE05 (mirdametinib), each read from that country’s own register.
- This record: Ireland, from HPRA (Ireland)
- 9 of them publish a price we can compare per daily dose
Mirdametinib · ATC L01EE05
11 / 19 countries
- Belgiumprice
- Czechiaprice
- Finlandprice
- Franceprice
- Icelandprice
- Ireland
- Netherlands
- Norwayprice
- Spainprice
- Switzerlandprice
- United Statesprice
The record
At a glance
HPRA (Ireland)- Active substance
- Mirdametinib
- Manufacturer
- Merck Europe B.V.
- Country
- Ireland (IE)
- ATC code
- L01EE05
- ATC class
- Mirdametinib
- Reimbursed
- Not published by this register
- Source register
- HPRA (Ireland)
- Last checked
- September 28, 2026
Packs & prices · 1
- ie_pa_numberEU/1/25/1950/003
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same medicine, other countries
Mirdametinib in 12 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- United StatesGomekliSpringWorks Therapeutics, Inc.
- SwitzerlandEzmekly
- CzechiaEZMEKLYMerck Europe B.V., Amsterdam
- SpainEZMEKLY 1 MG CAPSULAS DURASMerck Europe B.V.
- FinlandEzmeklyMerck Europe B.V.
- BelgiumEzmekly 1 mgMerck Europe
- NetherlandsEzmekly 1 mg harde capsulesMerck Europe B.V.
- NorwayEzmeklyMerck Europe B.V.
Authorised across Europe · EMA
The same active substance is authorised in 3 EEA countries. Names it is sold under:
- Iceland · Ezmekly
- Liechtenstein · Ezmekly
- Norway · Ezmekly
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/91ddd406-0a76-41cb-8015-4bea13c6125b GET /v1/drugs/91ddd406-0a76-41cb-8015-4bea13c6125b?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": "Capsule, hard",
"routes": [
"Oral use"
],
"source": "hpra",
"atc_all": [
"L01EE05"
],
"strength": null,
"pa_number": "EU/1/25/1950/003",
"substances": [
"Mirdametinib"
],
"legal_basis": "Known active substance (Article 8(3) of Directive No 2001/83/EC)",
"market_info": "Unknown",
"authorised_at": "17/07/2025",
"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 mirdametinib.
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.