Poland· PL-100506234
Yuvanci
A macitentan and tadalafil product containing macitentanum + tadalafilum, registered in Poland by Janssen-Cilag International N.V.. The same ATC class is registered in 11 of our 19 countries.
Checked against URPL (Poland) on
Informational only — not a medical device.
Where it is registered
Macitentan and tadalafil is registered in 11 of 19 countries.
Countries holding a registration under ATC C02KX54 (macitentan and tadalafil), each read from that country’s own register.
- This record: Poland, from URPL (Poland)
- 7 of them publish a price we can compare per daily dose
Macitentan and tadalafil · ATC C02KX54
11 / 19 countries
- Belgiumprice
- Canada
- Czechiaprice
- Denmark
- Finlandprice
- Icelandprice
- Ireland
- Netherlands
- Polandprice
- Switzerlandprice
- United Statesprice
The record
At a glance
URPL (Poland)- Active substance
- Macitentanum + Tadalafilum
- Manufacturer
- Janssen-Cilag International N.V.
- Country
- Poland (PL)
- ATC code
- C02KX54
- ATC class
- Macitentan and tadalafil
- Reimbursed
- Not published by this register
- Source register
- URPL (Poland)
- Last checked
- September 27, 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
Macitentan and tadalafil in 10 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- CzechiaYUVANCIJanssen-Cilag International N.V., Beerse
- United StatesOPSYNVIActelion Pharmaceuticals US, Inc.
- FinlandYuvanciOrifarm Oy
- SpainYUVANCI 10 MG/20 MG COMPRIMIDOS RECUBIERTOS CON PELICULAJanssen-Cilag International N.V
- IcelandYuvanciJanssen-Cilag International NV*
- NetherlandsYuvanci 10 mg/20 mg filmomhulde tablettenJanssen-Cilag International NV
- SwedenYuvanci 10 mg/20 mg Filmdragerad tablettJanssen-Cilag International NV
- IrelandYuvanci 10 mg/20 mg film-coated tabletsJanssen Pharmaceutica NV
Authorised across Europe · EMA
The same active substance is authorised in 3 EEA countries. Names it is sold under:
- Iceland · Yuvanci
- Liechtenstein · Yuvanci
- Norway · Yuvanci
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/68156703-8ddb-48b3-aaa1-6a5814a8dee0 GET /v1/drugs/68156703-8ddb-48b3-aaa1-6a5814a8dee0?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": "Tabletki powlekane",
"source": "urpl",
"strength": "10 mg + 20 mg",
"packaging": "Rpz ¦ EU/1/24/1859/001 ¦ 158318\n30 tabl. w blistrze perforowanym",
"substance": "Macitentanum 10 mg + Tadalafilum 20 mg",
"common_name": "Macitentanum + Tadalafilum",
"pl_product_id": "100506234",
"pozwolenie_nr": null,
"auth_procedure": "CEN",
"authorisation_validity": null
}See everything about macitentan and tadalafil.
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.