Iceland· IS-EU/1/25/1950/004-005

Ezmekly

A mirdametinib product containing mirdametinib, registered in Iceland by Merck Europe B.V.*. The same ATC class is registered in 11 of our 19 countries.

ATC L01EE05

Checked against Icelandic Medicines Agency (Iceland) on

Informational only — not a medical device.

SOURCE REGISTER · ISIcelandic Medicines Agency (Iceland)normalisedEzmeklyATCL01EE05REGISTER NO.IS-EU/1/25/1950/004-0…PACKS LISTED0CHECKEDSeptember 29, 2026

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: Iceland, from Icelandic Medicines Agency (Iceland)
  • 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
Blue: a registration under this ATC code. The ringed marker is this record’s country. Markets marked price publish a price we can compare per daily dose.

The record

At a glance

Icelandic Medicines Agency (Iceland)
Active substance
Mirdametinib
Manufacturer
Merck Europe B.V.*
Country
Iceland (IS)
ATC code
L01EE05
ATC class
Mirdametinib
Reimbursed
Not published by this register
Source register
Icelandic Medicines Agency (Iceland)
Last checked
September 29, 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

Mirdametinib in 12 other countries

What each register calls a product with the same active substance — salts and hydrates count as the same.

All mirdametinib products

Authorised across Europe · EMA

The same active substance is authorised in 2 EEA countries. Names it is sold under:

  • 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 Icelandic Medicines Agency (Iceland). 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/d29cdf9f-dbe0-486a-97cf-9618116d2715
GET /v1/drugs/d29cdf9f-dbe0-486a-97cf-9618116d2715?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": "Hart hylki",
  "source": "lyfjastofnun",
  "atc_raw": "L01EE05",
  "marketed": false,
  "strength": "2 mg",
  "ma_number": "EU/1/25/1950/004-005",
  "substance": "Mirdametinib",
  "other_info": "Ávísun lyfsins er bundin við sérfræðinga í krabbameinslækningum.",
  "legal_status": "(R Z) Sérfræðingsmerkt (og lyfseðilsskylt)",
  "ma_issued_serial": "45855"
}

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.