Ireland· IE-PA-EU/1/21/1596/001
TEPMETKO 225 mg film-coated tablets
A tepotinib product containing tepotinib hydrochloride monohydrate, registered in Ireland by Merck Europe B.V.. The same ATC class is registered in 3 of our 19 countries.
Checked against HPRA (Ireland) on
Informational only — not a medical device.
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: Ireland, from HPRA (Ireland)
- 1 of them publish a price we can compare per daily dose
Tepotinib · ATC L01EX21
3 / 19 countries
- Canada
- Ireland
- Polandprice
The record
At a glance
HPRA (Ireland)- Active substance
- Tepotinib hydrochloride monohydrate
- Manufacturer
- Merck Europe B.V.
- Country
- Ireland (IE)
- ATC code
- L01EX21
- ATC class
- Tepotinib
- Reimbursed
- Not published by this register
- Source register
- HPRA (Ireland)
- Last checked
- September 28, 2026
Packs & prices · 1
- ie_pa_numberEU/1/21/1596/001
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.
- FinlandTEPMETKOAbacus Medicine A/S
- SwitzerlandTepmetko 225 mg, FilmtablettenMerck (Schweiz) AG
- CzechiaTEPMETKOMerck Europe B.V., Amsterdam
- SpainTEPMETKO 225 MG COMPRIMIDOS RECUBIERTOS CON PELICULAMerck Europe B.V.
- IcelandTEPMETKOMerck Europe B.V.*
- NetherlandsTepmetko 225 mg, filmomhulde tablettenMerck Europe B.V.
- NorwayTepmetkoMerck Europe B.V.
- PolandTepmetkoMerck Europe B.V.
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 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/47e1f775-c2aa-489a-8521-527007621bd2 GET /v1/drugs/47e1f775-c2aa-489a-8521-527007621bd2?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": [
"L01",
"L01EX21"
],
"strength": null,
"pa_number": "EU/1/21/1596/001",
"substances": [
"Tepotinib hydrochloride monohydrate"
],
"legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)",
"market_info": "Unknown",
"authorised_at": "16/02/2022",
"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 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.