Belgium· BE-AMP-SAM588426-00
Imcivree 10 mg/ml
A setmelanotide product containing setmelanotide, registered in Belgium by Rhythm Pharmaceuticals Netherlands. The same ATC class is registered in 12 of our 19 countries.
Checked against FAMHP / AFMPS (Belgium) on
Informational only — not a medical device.
Where it is registered
Setmelanotide is registered in 12 of 19 countries.
Countries holding a registration under ATC A08AA12 (setmelanotide), each read from that country’s own register.
- This record: Belgium, from FAMHP / AFMPS (Belgium)
- 8 of them publish a price we can compare per daily dose
Setmelanotide · ATC A08AA12
12 / 19 countries
- Belgiumprice
- Canada
- Czechiaprice
- Denmark
- Finlandprice
- Franceprice
- Icelandprice
- Netherlands
- Polandprice
- Switzerlandprice
- United Kingdom
- United Statesprice
The record
At a glance
FAMHP / AFMPS (Belgium)- Active substance
- Setmelanotide
- Manufacturer
- Rhythm Pharmaceuticals Netherlands
- Country
- Belgium (BE)
- ATC code
- A08AA12
- ATC class
- Setmelanotide
- Defined daily dose
- 1.5 mg, P
- Reimbursed
- Not published by this register
- Source register
- FAMHP / AFMPS (Belgium)
- Last checked
- September 26, 2026
Packs & prices · 2
- be_apb7747512
- be_apb4987020
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same medicine, other countries
Setmelanotide in 13 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- CzechiaIMCIVREERhythm Pharmaceuticals Netherlands B.V., Amsterdam
- IcelandIMCIVREERhythm Pharmaceuticals Netherlands B.V
- SwitzerlandIMCIVREE 10 mg/ml, InjektionslösungRhythm Pharmaceuticals Switzerland GmbH
- SpainIMCIVREE 10 MG/ML SOLUCION INYECTABLERhythm Pharmaceuticals Netherlands B.V.
- PolandImcivreeRhythm Pharmaceuticals Netherlands B.V.
- SwedenIMCIVREE 10 mg/ml Injektionsvätska, lösningRhythm Pharmaceuticals Netherlands B.V.
- FinlandImcivreeRhythm Pharmaceuticals Netherlands B.V.
- FranceIMCIVREE 10 mg/ml, solution injectableRHYTHM PHARMACEUTICALS NETHERLANDS (PAYS-BAS)
Authorised across Europe · EMA
The same active substance is authorised in 3 EEA countries. Names it is sold under:
- Iceland · Imcivree
- Liechtenstein · Imcivree
- Norway · Imcivree
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/fa6f6ac8-a3cd-4b08-9331-4549f02a128a GET /v1/drugs/fa6f6ac8-a3cd-4b08-9331-4549f02a128a?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": "Solution for injection",
"source": "afmps",
"status": "AUTHORIZED",
"name_en": "Imcivree 10 mg/ml",
"name_fr": "Imcivree 10 mg/ml",
"name_nl": "Imcivree 10 mg/ml",
"amp_code": "SAM588426-00",
"strengths": [
"10.0000",
"10.0000",
"10.0000",
"10.0000"
],
"pack_count": 2,
"substances": [
"Setmelanotide",
"Benzyl Alcohol",
"Disodium Edetate",
"Mannitol"
],
"medicine_type": "ALLOPATHIC",
"atc_description": "Setmelanotide",
"authorisation_numbers": [
"EU/1/21/1564/001",
"EU/1/21/1564/002"
]
}See everything about setmelanotide.
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.