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Belgium· BE-AMP-SAM663361-00

Yuvanci 10 mg - 20 mg

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

ATC C02KX54

Checked against FAMHP / AFMPS (Belgium) on

Informational only — not a medical device.

SOURCE REGISTER · BEFAMHP / AFMPS (Belgium)normalisedYuvanci 10 mg - 20 mgATCC02KX54REGISTER NO.BE-AMP-SAM663361-00PACKS LISTED2CHECKEDSeptember 26, 2026
Compare price across countriesPer daily dose · free accountAsk the assistant about macitentanAnswers 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: Belgium, from FAMHP / AFMPS (Belgium)
  • 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

FAMHP / AFMPS (Belgium)
Active substance
Macitentan
Manufacturer
Janssen-Cilag International
Country
Belgium (BE)
ATC code
C02KX54
ATC class
Macitentan and tadalafil
Reimbursed
Not published by this register
Source register
FAMHP / AFMPS (Belgium)
Last checked
September 26, 2026

Packs & prices · 2

  • be_apb
    4860326
  • be_apb
    7743206

Regulatory notes

No shortage, Orange Book or US label notes for this record.

Same medicine, other countries

Macitentan and tadalafil in 15 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 29 EEA countries. Names it is sold under:

  • Austria · Macepulan, Macicon
  • Bulgaria · Мацитентан Зентива, Мацитентан Тева
  • Cyprus · Macitentan Sandoz
  • Czechia · Macitentan Olpha, Macitentan Teva
  • Germany · Macitentan 1 A Pharma, Macitentan Abdi
  • Denmark · Macitentan "sandoz", Macitentan Devatis
  • Estonia · Macitentan Norameda, Macitentan Olpha
  • Spain · Macitentan Dr. Reddys, Macitentán Glenmark
  • Finland · Macitentan Devatis, Macitentan Glenmark
  • France · Macitentan Olpha, Opsaren
  • United Kingdom (Northern Ireland) · Macitentan, Macitentan Accord Healthcare
  • Greece · Macitentan Bioars, Macitentan Pharmapath
  • Croatia · Jesoxade, Macitentan Teva
  • Hungary · Cidevia, Macepulan
  • Ireland · Macitentan Abdi, Macitentan Clonmel
  • Iceland · Macitentan Accord, Macitentan Accordpharma
  • Italy · Macitentan Abdi, Macitentan Aurobindo
  • Liechtenstein · Macitentan Accord, Macitentan Accordpharma
  • Lithuania · Macitentan Norameda, Macitentan Olpha
  • Luxembourg · Macitentan Ab, Macitentan Eg
  • Latvia · Macitentan Norameda, Macitentan Olpha
  • Malta · Cidevia, Macitentan Clonmel
  • Netherlands · Macitentan Aurobindo, Macitentan Cf
  • Norway · Macitentan Accord, Macitentan Accordpharma
  • Poland · Jesoxade, Macitentan Olpha
  • Portugal · Macitentan Onkogen, Macitentano
  • Romania · Jesoxade, Macitentan Stada
  • Sweden · Macitentan Amarox, Macitentan Bioglan
  • Slovakia · Macitentan Olpha, Macitentan Stada

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 FAMHP / AFMPS (Belgium). 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/aecdedd8-59f3-4b25-b597-992bcd8f77bb
GET /v1/drugs/aecdedd8-59f3-4b25-b597-992bcd8f77bb?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",
  "source": "afmps",
  "status": "AUTHORIZED",
  "name_en": "Yuvanci 10 mg - 20 mg",
  "name_fr": "Yuvanci 10 mg - 20 mg",
  "name_nl": "Yuvanci 10 mg - 20 mg",
  "amp_code": "SAM663361-00",
  "strengths": [
    "10.0000",
    "10.0000",
    "20.0000",
    "20.0000",
    "147.0000"
  ],
  "pack_count": 1,
  "substances": [
    "Macitentan",
    "Tadalafil",
    "Lactose",
    "Lactose Monohydrate",
    "Sodium Laurilsulfate",
    "Sodium Starch Glycolate",
    "Polysorbate 80"
  ],
  "medicine_type": "ALLOPATHIC",
  "atc_description": "Macitentan and Tadalafil",
  "authorisation_numbers": [
    "EU/1/24/1859/001"
  ]
}
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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