Ireland· IE-PA-EU/1/16/1101/004
DARZALEX 1800 mg solution for injection
A monoklonale antikörper product containing daratumumab, registered in Ireland by Janssen-Cilag International NV. The same ATC class is registered in 2 of our 19 countries.
Checked against HPRA (Ireland) on
Informational only — not a medical device.
Where it is registered
Daratumumab is registered in 2 of 19 countries.
Countries holding a registration under ATC L01XC (monoklonale antikörper), 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
Daratumumab · ATC L01XC
2 / 19 countries
- Ireland
- Polandprice
The record
At a glance
HPRA (Ireland)- Active substance
- Daratumumab
- Manufacturer
- Janssen-Cilag International NV
- Country
- Ireland (IE)
- ATC code
- L01XC
- ATC class
- Monoklonale Antikörper
- Reimbursed
- Not published by this register
- Source register
- HPRA (Ireland)
- Last checked
- September 28, 2026
Packs & prices · 1
- ie_pa_numberEU/1/16/1101/004
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same medicine, other countries
Daratumumab in 15 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- FranceDARZALEX 1800 mg, solution injectableJANSSEN CILAG INTERNATIONAL NV
- SpainDARZALEX 1.800 MG SOLUCION INYECTABLEJanssen-Cilag International N.V
- United StatesDARZALEXJanssen Biotech, Inc.
- FinlandDarzalexJanssen-Cilag International NV
- BelgiumDarzalex 1800 mgJanssen-Cilag International
- CzechiaDARZALEXJanssen-Cilag International N.V., Beerse
- SwitzerlandDarzalex
- United KingdomDarzalex 100mg/5ml concentrate for solution for infusion vialsJanssen-Cilag Ltd
Authorised across Europe · EMA
The same active substance is authorised in 3 EEA countries. Names it is sold under:
- Iceland · Darzalex
- Liechtenstein · Darzalex
- Norway · Darzalex
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/0057cef1-75c0-4341-b04a-e4fb214b78b7 GET /v1/drugs/0057cef1-75c0-4341-b04a-e4fb214b78b7?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": "Solution for injection",
"routes": [
"Subcutaneous use"
],
"source": "hpra",
"atc_all": [
"L01XC"
],
"strength": null,
"pa_number": "EU/1/16/1101/004",
"substances": [
"Daratumumab"
],
"legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)",
"market_info": "Unknown",
"authorised_at": "03/06/2020",
"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 daratumumab.
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.