Ireland· IE-PA-EU/1/25/1915/001
Datroway 100 mg powder for concentrate for solution for infusion
A datopotamab deruxtecan product containing datopotamab deruxtecan, registered in Ireland by Daiichi Sankyo Europe GmbH. The same ATC class is registered in 9 of our 19 countries.
Checked against HPRA (Ireland) on
Informational only — not a medical device.
Where it is registered
Datopotamab deruxtecan is registered in 9 of 19 countries.
Countries holding a registration under ATC L01FX35 (datopotamab deruxtecan), each read from that country’s own register.
- This record: Ireland, from HPRA (Ireland)
- 6 of them publish a price we can compare per daily dose
Datopotamab deruxtecan · ATC L01FX35
9 / 19 countries
- Belgiumprice
- Czechiaprice
- Denmark
- Finlandprice
- Icelandprice
- Ireland
- Netherlands
- Switzerlandprice
- United Statesprice
The record
At a glance
HPRA (Ireland)- Active substance
- Datopotamab deruxtecan
- Manufacturer
- Daiichi Sankyo Europe GmbH
- Country
- Ireland (IE)
- ATC code
- L01FX35
- ATC class
- Datopotamab deruxtecan
- Defined daily dose
- 20 mg, P
- Reimbursed
- Not published by this register
- Source register
- HPRA (Ireland)
- Last checked
- September 28, 2026
Packs & prices · 1
- ie_pa_numberEU/1/25/1915/001
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same medicine, other countries
Datopotamab deruxtecan in 11 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- BelgiumDatroway 100 mgDaiichi Sankyo Europe
- SwitzerlandDATROWAY 100 mg, Pulver für ein Konzentrat zur Herstellung einer InfusionslösungDaiichi Sankyo (Schweiz) AG
- CzechiaDATROWAYDaiichi Sankyo Europe GmbH, Mnichov
- SpainDATROWAY 100 MG POLVO PARA CONCENTRADO PARA SOLUCION PARA PERFUSIONDaiichi Sankyo Europe Gmbh
- FinlandDatrowayDaiichi Sankyo Europe GmbH
- IcelandDatrowayDAIICHI SANKYO EUROPE GmbH*
- PolandDatrowayDaiichi Sankyo Europe GmbH
- SwedenDatroway 100 mg Pulver till koncentrat till infusionsvätska, lösningDaiichi Sankyo Europe GmbH
Authorised across Europe · EMA
The same active substance is authorised in 3 EEA countries. Names it is sold under:
- Iceland · Datroway
- Liechtenstein · Datroway
- Norway · Datroway
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/cc0623de-fcd8-4036-bc14-a337ae4a63ef GET /v1/drugs/cc0623de-fcd8-4036-bc14-a337ae4a63ef?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": "Powder for concentrate for solution for infusion",
"routes": [
"Intravenous use"
],
"source": "hpra",
"atc_all": [
"L01FX35"
],
"strength": null,
"pa_number": "EU/1/25/1915/001",
"substances": [
"Datopotamab deruxtecan"
],
"legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)",
"market_info": "Unknown",
"authorised_at": "04/04/2025",
"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 datopotamab deruxtecan.
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.