Ireland· IE-PA-EU/1/22/1688/001
Spevigo 450 mg concentrate for solution for infusion
A spesolimab product containing spesolimab, registered in Ireland by LEO Pharma A/S. The same ATC class is registered in 14 of our 19 countries.
Checked against HPRA (Ireland) on
Informational only — not a medical device.
Where it is registered
Spesolimab is registered in 14 of 19 countries.
Countries holding a registration under ATC L04AC22 (spesolimab), each read from that country’s own register.
- This record: Ireland, from HPRA (Ireland)
- 9 of them publish a price we can compare per daily dose
Spesolimab · ATC L04AC22
14 / 19 countries
- Belgiumprice
- Canada
- Czechiaprice
- Denmark
- Finlandprice
- Franceprice
- Icelandprice
- Ireland
- Netherlands
- Norwayprice
- Polandprice
- Switzerlandprice
- United Kingdom
- United Statesprice
The record
At a glance
HPRA (Ireland)- Active substance
- Spesolimab
- Manufacturer
- LEO Pharma A/S
- Country
- Ireland (IE)
- ATC code
- L04AC22
- ATC class
- Spesolimab
- Defined daily dose
- 0.9 g, P
- Reimbursed
- Not published by this register
- Source register
- HPRA (Ireland)
- Last checked
- September 28, 2026
Packs & prices · 1
- ie_pa_numberEU/1/22/1688/001
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same medicine, other countries
Spesolimab in 15 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- BelgiumSpevigo 450 mgLeo Pharma
- CzechiaSPEVIGOLEO Pharma A/S, Ballerup
- FinlandSpevigoLeo Pharma A/S
- IcelandSpevigoLEO Pharma A/S*
- NorwaySpevigoLEO PHARMA A/S (Danmark)
- PolandSpevigoBoehringer Ingelheim International GmbH
- SwedenSpevigo 450 mg Koncentrat till infusionsvätska, lösningLEO Pharma A/S
- United StatesSPEVIGOLEO Pharma Inc.
Authorised across Europe · EMA
The same active substance is authorised in 3 EEA countries. Names it is sold under:
- Iceland · Spevigo
- Liechtenstein · Spevigo
- Norway · Spevigo
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/ae45ac08-1c9b-4f51-a193-1401994af758 GET /v1/drugs/ae45ac08-1c9b-4f51-a193-1401994af758?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": "Concentrate for solution for infusion",
"routes": [
"Intravenous use"
],
"source": "hpra",
"atc_all": [
"L04AC",
"L04AC22"
],
"strength": null,
"pa_number": "EU/1/22/1688/001",
"substances": [
"Spesolimab"
],
"legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)",
"market_info": "Unknown",
"authorised_at": "09/12/2022",
"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 spesolimab.
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.