France· FR:68300246
SPEVIGO 450 mg, solution à diluer pour perfusion
A spesolimab product containing spésolimab, registered in France by LEO PHARMA A/S (DANEMARK). The same ATC class is registered in 14 of our 19 countries.
Checked against Base de données publique des médicaments — BDPM (France) 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: France, from Base de données publique des médicaments — BDPM (France)
- 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
Base de données publique des médicaments — BDPM (France)- Active substance
- SPÉSOLIMAB
- Manufacturer
- LEO PHARMA A/S (DANEMARK)
- Country
- France (FR)
- ATC code
- L04AC22
- ATC class
- Spesolimab
- Defined daily dose
- 0.9 g, P
- Reimbursed
- No
- Source register
- Base de données publique des médicaments — BDPM (France)
- Last checked
- September 12, 2026
Packs & prices · 1
- cip1334009550924832 flacon(s) en verre de 7,5 ml
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.
- NetherlandsSpevigo 450 mg concentraat voor oplossing voor infusieLeo Pharma A/S
- United StatesSPEVIGOBoehringer Ingelheim Pharmaceuticals, Inc.
- IrelandSpevigo 150 mg solution for injection in pre-filled syringeLEO Pharma A/S
- FinlandSpevigoLeo Pharma A/S
- BelgiumSpevigo 150 mgLeo Pharma
- IcelandSpevigoLEO Pharma A/S*
- PolandSpevigoBoehringer Ingelheim International GmbH
- SwedenSpevigo 150 mg Injektionsvätska, lösning i förfylld sprutaLEO Pharma A/S
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 Base de données publique des médicaments — BDPM (France). 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/0c02bff9-ab9e-4560-b7fb-96907008a42d GET /v1/drugs/0c02bff9-ab9e-4560-b7fb-96907008a42d?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.
{
"cis": "68300246",
"date_amm": "2022-12-09",
"type_amm": "Procédure centralisée",
"numero_ue": "EU/1/22/1688",
"substance": "SPÉSOLIMAB",
"atc_source": "fr_atc_restore_2026-09-06",
"statut_amm": "Autorisation active",
"statut_bdm": null,
"forme_pharmaceutique": "solution à diluer pour perfusion",
"voies_administration": "intraveineuse",
"etat_commercialisation": "Commercialisée",
"surveillance_renforcee": "Oui"
}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.