Ireland· IE-PA-EU/1/24/1859/001
Yuvanci 10 mg/20 mg film-coated tablets
A macitentan and tadalafil product containing macitentan + tadalafil, registered in Ireland by Janssen Pharmaceutica NV. The same ATC class is registered in 11 of our 19 countries.
Checked against HPRA (Ireland) 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: Ireland, from HPRA (Ireland)
- 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
HPRA (Ireland)- Active substance
- Macitentan + Tadalafil
- Manufacturer
- Janssen Pharmaceutica NV
- Country
- Ireland (IE)
- ATC code
- C02KX54
- ATC class
- Macitentan and tadalafil
- Reimbursed
- Not published by this register
- Source register
- HPRA (Ireland)
- Last checked
- September 28, 2026
Packs & prices · 1
- ie_pa_numberEU/1/24/1859/001
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.
- FinlandYuvanciOrifarm Oy
- SwedenYuvanci 10 mg/20 mg Filmdragerad tablettJanssen-Cilag International NV
- United StatesOPSYNVIActelion Pharmaceuticals US, Inc.
- SpainYUVANCI 10 MG/20 MG COMPRIMIDOS RECUBIERTOS CON PELICULAJanssen-Cilag International N.V
- CzechiaYUVANCIJanssen-Cilag International N.V., Beerse
- IcelandYuvanciJanssen-Cilag International NV*
- PolandYuvanciJanssen-Cilag International N.V.
- NetherlandsYuvanci 10 mg/20 mg filmomhulde tablettenJanssen-Cilag International 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 HPRA (Ireland). 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/209c662b-4cf9-4e35-973c-c3ae4a3c938d GET /v1/drugs/209c662b-4cf9-4e35-973c-c3ae4a3c938d?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": "Film-coated tablet",
"routes": [
"Oral use"
],
"source": "hpra",
"atc_all": [
"C02KX54"
],
"strength": null,
"pa_number": "EU/1/24/1859/001",
"substances": [
"Macitentan",
"Tadalafil"
],
"legal_basis": "Fixed combination application (Article 10b of Directive No 2001/83/EC)",
"market_info": "Unknown",
"authorised_at": "27/09/2024",
"dispensing_status": "Product subject to prescription which may not be renewed (A)",
"registration_status": "AU",
"supply_legal_status": "Supply through pharmacies only",
"interchangeable_code": 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.