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Netherlands· NL-cbaf4018aec8

Spevigo 450 mg concentraat voor oplossing voor infusie

A spesolimab product containing spesolimab, registered in Netherlands by Leo Pharma A/S. The same ATC class is registered in 14 of our 19 countries.

ATC L04AC22

Checked against CBG-MEB (Netherlands) on

Informational only — not a medical device.

SOURCE REGISTER · NLCBG-MEB (Netherlands)normalisedSpevigo 450 mg concentraat voor oplos…ATCL04AC22REGISTER NO.NL-cbaf4018aec8PACKS LISTED1CHECKEDSeptember 29, 2026
Compare price across countriesPer daily dose · free accountAsk the assistant about spesolimabAnswers with sources · free accountCheck interactionsSeverity free · mechanism on Growth

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: Netherlands, from CBG-MEB (Netherlands)
  • 9 of them publish a price we can compare per daily dose
Search spesolimab products by name

Spesolimab · ATC L04AC22

14 / 19 countries

  • Belgiumprice
  • Canada
  • Czechiaprice
  • Denmark
  • Finlandprice
  • Franceprice
  • Icelandprice
  • Ireland
  • Netherlands
  • Norwayprice
  • Polandprice
  • Switzerlandprice
  • United Kingdom
  • United Statesprice
Blue: a registration under this ATC code. The ringed marker is this record’s country. Markets marked price publish a price we can compare per daily dose.

The record

At a glance

CBG-MEB (Netherlands)
Active substance
SPESOLIMAB
Manufacturer
Leo Pharma A/S
Country
Netherlands (NL)
ATC code
L04AC22
ATC class
Spesolimab
Defined daily dose
0.9 g, P
Reimbursed
Not published by this register
Source register
CBG-MEB (Netherlands)
Last checked
September 29, 2026

Packs & prices · 1

  • cbg_meb_id
    EU/1/22/1688

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.

All spesolimab products

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 CBG-MEB (Netherlands). 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/ffa87524-9fe5-4acc-a1ae-b93d82f17ac3
GET /v1/drugs/ffa87524-9fe5-4acc-a1ae-b93d82f17ac3?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": "Concentraat voor oplossing voor infusie",
  "route": "Intraveneus gebruik",
  "soort": null,
  "source": "cbg_meb",
  "smpc_url": "https://www.ema.europa.eu/en/documents/product-information/spevigo-epar-product-information_nl.pdf",
  "strength": null,
  "atc_label": "Spesolimab",
  "detail_url": "https://www.geneesmiddeleninformatiebank.nl/nl/cp129078",
  "excipients": [
    "ARGININEHYDROCHLORIDE, (L-)",
    "AZIJNZUUR (E 260), GECONCENTREERD",
    "NATRIUMACETAAT 3-WATER (E 262)",
    "POLYSORBAAT 20 (E 432)",
    "SACCHAROSE",
    "WATER VOOR INJECTIE"
  ],
  "substances": [
    "SPESOLIMAB"
  ],
  "leaflet_url": null,
  "authorised_at": "2022/12/09",
  "procedure_number": "EMEA/H/C/005874",
  "dispensing_status": "Uitsluitend recept",
  "registration_number": "EU/1/22/1688",
  "additional_monitoring": "Y"
}
API referenceMCP serverPlans

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.

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