Ireland· IE-PA-EU/1/22/1695/001
Zynlonta 10 mg powder for concentrate for solution for infusion
A loncastuximab tesirine product containing loncastuximab tesirine, registered in Ireland by Swedish Orphan Biovitrum AB. The same ATC class is registered in 11 of our 19 countries.
Checked against HPRA (Ireland) on
Informational only — not a medical device.
Where it is registered
Loncastuximab tesirine is registered in 11 of 19 countries.
Countries holding a registration under ATC L01FX22 (loncastuximab tesirine), each read from that country’s own register.
- This record: Ireland, from HPRA (Ireland)
- 7 of them publish a price we can compare per daily dose
Loncastuximab tesirine · ATC L01FX22
11 / 19 countries
- Belgiumprice
- Czechiaprice
- Denmark
- Finlandprice
- Icelandprice
- Ireland
- Netherlands
- Norwayprice
- Polandprice
- United Kingdom
- United Statesprice
The record
At a glance
HPRA (Ireland)- Active substance
- Loncastuximab Tesirine
- Manufacturer
- Swedish Orphan Biovitrum AB
- Country
- Ireland (IE)
- ATC code
- L01FX22
- ATC class
- Loncastuximab tesirine
- Defined daily dose
- 0.25 mg, P
- Reimbursed
- Not published by this register
- Source register
- HPRA (Ireland)
- Last checked
- September 28, 2026
Packs & prices · 1
- ie_pa_numberEU/1/22/1695/001
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same medicine, other countries
Loncastuximab tesirine in 10 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- BelgiumZynlonta 10 mgSwedish Orphan Biovitrum (Publ)
- CzechiaZYNLONTASwedish Orphan Biovitrum AB (publ), Stockholm
- SpainZYNLONTA 10 MG POLVO PARA CONCENTRADO PARA SOLUCION PARA PERFUSIONSwedish Orphan Biovitrum Ab (Publ)
- FinlandZynlontaSwedish Orphan Biovitrum AB (publ)
- United KingdomZynlonta 10mg powder for concentrate for solution for infusion vialsSwedish Orphan Biovitrum Ltd
- IcelandZynlontaSwedish Orphan Biovitrum AB (publ)
- PolandZynlontaSwedish Orphan Biovitrum AB (publ)
- SwedenZynlonta 10 mg Pulver till koncentrat till infusionsvätska, lösningSwedish Orphan Biovitrum AB (publ)
Authorised across Europe · EMA
The same active substance is authorised in 3 EEA countries. Names it is sold under:
- Iceland · Zynlonta
- Liechtenstein · Zynlonta
- Norway · Zynlonta
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/3c0ebdbe-8b69-4993-a54e-57d64dbeab3d GET /v1/drugs/3c0ebdbe-8b69-4993-a54e-57d64dbeab3d?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": [
"L01FX22",
"L01XC"
],
"strength": null,
"pa_number": "EU/1/22/1695/001",
"substances": [
"Loncastuximab Tesirine"
],
"legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)",
"market_info": "Unknown",
"authorised_at": "20/12/2022",
"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 loncastuximab tesirine.
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.