Iceland· IS-EU/1/24/1859/001
Yuvanci
A macitentan and tadalafil product containing tadalafil,macitentanum inn, registered in Iceland by Janssen-Cilag International NV*. The same ATC class is registered in 11 of our 19 countries.
Checked against Icelandic Medicines Agency (Iceland) 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: Iceland, from Icelandic Medicines Agency (Iceland)
- 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
Icelandic Medicines Agency (Iceland)- Active substance
- Tadalafil,Macitentanum INN
- Manufacturer
- Janssen-Cilag International NV*
- Country
- Iceland (IS)
- ATC code
- C02KX54
- ATC class
- Macitentan and tadalafil
- Reimbursed
- Not published by this register
- Source register
- Icelandic Medicines Agency (Iceland)
- Last checked
- September 29, 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.
- FinlandYuvanciJanssen-Cilag International NV
- CzechiaYUVANCIJanssen-Cilag International N.V., Beerse
- SpainYUVANCI 10 MG/20 MG COMPRIMIDOS RECUBIERTOS CON PELICULAJanssen-Cilag International N.V
- United StatesOPSYNVIActelion Pharmaceuticals US, Inc.
- NetherlandsYuvanci 10 mg/20 mg filmomhulde tablettenJanssen-Cilag International NV
- PolandYuvanciJanssen-Cilag International N.V.
- 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 2 EEA countries. Names it is sold under:
- 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 Icelandic Medicines Agency (Iceland). 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/d16d3d72-d2e0-4074-8125-6b2160395fc9 GET /v1/drugs/d16d3d72-d2e0-4074-8125-6b2160395fc9?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": "Filmuhúðuð tafla",
"source": "lyfjastofnun",
"atc_raw": "C02KX54",
"marketed": false,
"strength": "10 mg/20 mg",
"ma_number": "EU/1/24/1859/001",
"substance": "Tadalafil,Macitentanum INN",
"other_info": "Ávísun lyfsins er bundin við sérfræðinga í lungnalækningum og sérfræðinga í hjartalækningum.\r\nMarkaðssetning á Íslandi er háð því að Lyfjastofnun hafi staðfest að sérstök skilyrði er varða öryggi og verkun við notkun lyfsins séu uppfyllt.",
"legal_status": "(R Z) Sérfræðingsmerkt (og lyfseðilsskylt)",
"ma_issued_serial": "45562"
}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.