Poland· PL-100466998

Tepmetko

A tepotinib product containing tepotinibum, registered in Poland by Merck Europe B.V.. The same ATC class is registered in 3 of our 19 countries.

ATC L01EX21

Checked against URPL (Poland) on

Informational only — not a medical device.

SOURCE REGISTER · PLURPL (Poland)normalisedTepmetkoATCL01EX21REGISTER NO.PL-100466998PACKS LISTED1CHECKEDSeptember 27, 2026

Where it is registered

Tepotinib is registered in 3 of 19 countries.

Countries holding a registration under ATC L01EX21 (tepotinib), each read from that country’s own register.

  • This record: Poland, from URPL (Poland)
  • 1 of them publish a price we can compare per daily dose

Tepotinib · ATC L01EX21

3 / 19 countries

  • Canada
  • Ireland
  • Polandprice
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

URPL (Poland)
Active substance
Tepotinibum
Manufacturer
Merck Europe B.V.
Country
Poland (PL)
ATC code
L01EX21
ATC class
Tepotinib
Reimbursed
Not published by this register
Source register
URPL (Poland)
Last checked
September 27, 2026

Packs & prices · 1

  • gtin
    04065267923918

Regulatory notes

No shortage, Orange Book or US label notes for this record.

Same medicine, other countries

Tepotinib in 13 other countries

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

All tepotinib products

Authorised across Europe · EMA

The same active substance is authorised in 3 EEA countries. Names it is sold under:

  • Iceland · Tepmetko
  • Liechtenstein · Tepmetko
  • Norway · Tepmetko

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/abd67bfd-17f4-4cbe-97b0-33aa87bbb658
GET /v1/drugs/abd67bfd-17f4-4cbe-97b0-33aa87bbb658?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": "Tabletki powlekane",
  "source": "urpl",
  "strength": "225 mg",
  "packaging": "Rpz ¦ EU/1/21/1596/001 ¦ 144739\n60 tabl.\n¦ UR/Z/4c/187/24 ¦ UR/Z/4c/047/24 - 04065267923918 ¦ UR/Z/4c/037/24 - 04065267923918 ¦ UR/Z/4c/085/22 - 04065267923918 ¦ UR/Z/4c/060/24 - 04065267923918 ¦ UR/Z/4c/232/26 - 04065267923918",
  "substance": "Tepotinibum 225 mg",
  "common_name": "Tepotinibum",
  "pl_product_id": "100466998",
  "pozwolenie_nr": null,
  "auth_procedure": "CEN",
  "authorisation_validity": null
}

See everything about tepotinib.

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.