Belgium· BE-AMP-SAM661146-00
Spevigo 450 mg
A spesolimab product containing spesolimab, registered in Belgium by Leo Pharma. The same ATC class is registered in 14 of our 19 countries.
Checked against FAMHP / AFMPS (Belgium) 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: Belgium, from FAMHP / AFMPS (Belgium)
- 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
FAMHP / AFMPS (Belgium)- Active substance
- Spesolimab
- Manufacturer
- Leo Pharma
- Country
- Belgium (BE)
- ATC code
- L04AC22
- ATC class
- Spesolimab
- Defined daily dose
- 0.9 g, P
- Reimbursed
- Not published by this register
- Source register
- FAMHP / AFMPS (Belgium)
- Last checked
- September 26, 2026
Packs & prices · 0
No packs listed by the register for this record.
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.
- CzechiaSPEVIGOLEO Pharma A/S, Ballerup
- FinlandSpevigoLeo Pharma A/S
- IrelandSpevigo 450 mg concentrate for solution for infusionLEO 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 StatesSPEVIGOBoehringer Ingelheim Pharmaceuticals, 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 FAMHP / AFMPS (Belgium). 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/cdc3d40c-d3c3-4ac5-9266-d106964a7921 GET /v1/drugs/cdc3d40c-d3c3-4ac5-9266-d106964a7921?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",
"source": "afmps",
"status": "AUTHORIZED",
"name_en": "Spevigo 450 mg",
"name_fr": "Spevigo 450 mg",
"name_nl": "Spevigo 450 mg",
"amp_code": "SAM661146-00",
"strengths": [
"60.0000",
"60.0000",
"60.0000"
],
"pack_count": 1,
"substances": [
"Spesolimab",
"Sodium Acetate Trihydrate",
"Sucrose",
"Polysorbate 20"
],
"medicine_type": "ALLOPATHIC",
"atc_description": "Spesolimab",
"authorisation_numbers": [
"EU/1/22/1688/001"
]
}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.