Poland· PL-100522200
Ezmekly
A mitogen-activated protein kinase (mek) inhibitors product containing mirdametinib, registered in Poland by SpringWorks Therapeutics Ireland Limited.
Checked against URPL (Poland) on
Informational only — not a medical device.
The record
At a glance
URPL (Poland)- Active substance
- Mirdametinib
- Manufacturer
- SpringWorks Therapeutics Ireland Limited
- Country
- Poland (PL)
- ATC code
- L01EE
- ATC class
- Mitogen-activated protein kinase (MEK) inhibitors
- Reimbursed
- Not published by this register
- Source register
- URPL (Poland)
- Last checked
- September 27, 2026
Packs & prices · 2
- gtin04150198721518
- gtin04150198721457
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.
- CzechiaEZMEKLYMerck Europe B.V., Amsterdam
- SwitzerlandEzmekly
- BelgiumEzmekly 2 mgMerck Europe
- IcelandEzmeklyMerck Europe B.V.*
- NetherlandsEzmekly 2 mg harde capsulesMerck Europe B.V.
- NorwayEzmeklyMerck Europe B.V.
- SwedenEzmekly 2 mg Kapsel, hårdMerck 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 URPL (Poland). 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/097be975-acc2-42ca-a869-767cd87c3266 GET /v1/drugs/097be975-acc2-42ca-a869-767cd87c3266?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": "Kapsułki twarde",
"source": "urpl",
"strength": "2 mg",
"packaging": "Rpz ¦ EU/1/25/1950/004 ¦ 163111\n42 kaps.\n¦ UR/Z/4b/106/26 - 04150198721518 ¦ UR/Z/4b/190/26 - 04150198721518\nRpz ¦ EU/1/25/1950/005 ¦ 163112\n84 kaps.\n¦ UR/Z/4b/107/26 - 04150198721457 ¦ UR/Z/4b/191/26 - 04150198721457",
"substance": "Mirdametinib 2 mg",
"common_name": "Mirdametinib",
"pl_product_id": "100522200",
"pozwolenie_nr": null,
"auth_procedure": "CEN",
"authorisation_validity": 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.