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Netherlands· NL-4ec1010a748c

Yuvanci 10 mg/20 mg filmomhulde tabletten

A macitentan and tadalafil product containing macitentan + tadalafil, registered in Netherlands by Janssen-Cilag International NV. The same ATC class is registered in 11 of our 19 countries.

ATC C02KX54

Checked against CBG-MEB (Netherlands) on

Informational only — not a medical device.

SOURCE REGISTER · NLCBG-MEB (Netherlands)normalisedYuvanci 10 mg/20 mg filmomhulde table…ATCC02KX54REGISTER NO.NL-4ec1010a748cPACKS LISTED1CHECKEDSeptember 29, 2026
Compare price across countriesPer daily dose · free accountAsk the assistant about macitentan + tadalafilAnswers with sources · free accountCheck interactionsSeverity free · mechanism on Growth

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: Netherlands, from CBG-MEB (Netherlands)
  • 7 of them publish a price we can compare per daily dose
Search macitentan and tadalafil products by name

Macitentan and tadalafil · ATC C02KX54

11 / 19 countries

  • Belgiumprice
  • Canada
  • Czechiaprice
  • Denmark
  • Finlandprice
  • Icelandprice
  • Ireland
  • Netherlands
  • Polandprice
  • Switzerlandprice
  • United Statesprice
Blue: a registration under this ATC code. The ringed marker is this record’s country. Markets marked price publish a price we can compare per daily dose.

The record

At a glance

CBG-MEB (Netherlands)
Active substance
MACITENTAN + TADALAFIL
Manufacturer
Janssen-Cilag International NV
Country
Netherlands (NL)
ATC code
C02KX54
ATC class
Macitentan and tadalafil
Reimbursed
Not published by this register
Source register
CBG-MEB (Netherlands)
Last checked
September 29, 2026

Packs & prices · 1

  • cbg_meb_id
    EU/1/24/1859

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.

All macitentan and tadalafil products

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 CBG-MEB (Netherlands). 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/b217f793-0ea4-4fb2-938c-4e75f6764bd9
GET /v1/drugs/b217f793-0ea4-4fb2-938c-4e75f6764bd9?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": "Filmomhulde tablet",
  "route": "Oraal gebruik",
  "soort": null,
  "source": "cbg_meb",
  "smpc_url": "https://www.ema.europa.eu/en/documents/product-information/yuvanci-epar-product-information_nl.pdf",
  "strength": null,
  "atc_label": "Macitentan and Tadalafil",
  "detail_url": "https://www.geneesmiddeleninformatiebank.nl/nl/cp131787",
  "excipients": [
    "CELLULOSE, MICROKRISTALLIJN (E 460(i))",
    "GLYCEROLTRIACETAAT (E 1518)",
    "HYDROXYPROPYLCELLULOSE, LAAG GESUBSTITUEERD (E 463a)",
    "HYPROLOSE (E 463)",
    "HYPROMELLOSE (E 464)",
    "IJZEROXIDE GEEL (E 172)",
    "IJZEROXIDE ROOD  (E 172)",
    "LACTOSE 1-WATER",
    "MAGNESIUMSTEARAAT (E 470b)",
    "NATRIUMLAURILSULFAAT",
    "NATRIUMZETMEELGLYCOLAAT",
    "POLYSORBAAT 80 (E 433)",
    "POVIDON K 30 (E 1201)",
    "TALK (E 553b)",
    "TITAANDIOXIDE (E 171)"
  ],
  "substances": [
    "MACITENTAN",
    "TADALAFIL"
  ],
  "leaflet_url": null,
  "authorised_at": "2024/09/27",
  "procedure_number": "EMEA/H/C/005001",
  "dispensing_status": "Uitsluitend recept",
  "registration_number": "EU/1/24/1859",
  "additional_monitoring": "N"
}
API referenceMCP serverPlans

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.

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