Poland· PL-100464076
Imcivree
A setmelanotide product containing setmelanotidum, registered in Poland by Rhythm Pharmaceuticals Netherlands B.V.. The same ATC class is registered in 12 of our 19 countries.
Checked against URPL (Poland) 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: Poland, from URPL (Poland)
- 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
URPL (Poland)- Active substance
- Setmelanotidum
- Manufacturer
- Rhythm Pharmaceuticals Netherlands B.V.
- Country
- Poland (PL)
- ATC code
- A08AA12
- ATC class
- Setmelanotide
- Defined daily dose
- 1.5 mg, P
- Reimbursed
- Not published by this register
- Source register
- URPL (Poland)
- Last checked
- September 27, 2026
Packs & prices · 1
- gtin04150178963839
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
- BelgiumImcivree 10 mg/mlRhythm Pharmaceuticals Netherlands
- SwitzerlandIMCIVREE 10 mg/ml, InjektionslösungRhythm Pharmaceuticals Switzerland GmbH
- SpainIMCIVREE 10 MG/ML SOLUCION INYECTABLERhythm 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 URPL (Poland). 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/182378db-b7e2-4abd-9cb5-a4095922c65b GET /v1/drugs/182378db-b7e2-4abd-9cb5-a4095922c65b?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": "Roztwór do wstrzykiwań",
"source": "urpl",
"strength": "10 mg/ml",
"packaging": "Rpz ¦ EU/1/21/1564/0001 ¦ 143676\n1 fiol. 1 ml\n¦ UR/Z/4b/213/24 - 04150178963839 ¦ UR/Z/4b/031/26 - 04150178963839 ¦ UR/Z/4b/227/25 - 04150178963839 ¦ UR/Z/4b/299/25 - 04150178963839 ¦ UR/Z/4b/163/26 - 04150178963839\nRpz ¦ EU/1/21/1564/0002 ¦ 152463\n10 fiol. 1 ml",
"substance": "Setmelanotidum 10 mg/ml",
"common_name": "Setmelanotidum",
"pl_product_id": "100464076",
"pozwolenie_nr": null,
"auth_procedure": "CEN",
"authorisation_validity": null
}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.