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Ireland· IE-PA-EU/1/19/1368/003-004

Ambrisentan Viatris 10 mg film-coated tablets

A ambrisentan product containing ambrisentan, registered in Ireland by Viatris Limited. The same ATC class is registered in 18 of our 19 countries.

ATC C02KX02

Checked against HPRA (Ireland) on

Informational only — not a medical device.

SOURCE REGISTER · IEHPRA (Ireland)normalisedAmbrisentan Viatris 10 mg film-coated…ATCC02KX02REGISTER NO.IE-PA-EU/1/19/1368/00…PACKS LISTED1CHECKEDSeptember 28, 2026

Where it is registered

Ambrisentan is registered in 18 of 19 countries.

Countries holding a registration under ATC C02KX02 (ambrisentan), each read from that country’s own register.

  • This record: Ireland, from HPRA (Ireland)
  • 10 of them publish a price we can compare per daily dose

Ambrisentan · ATC C02KX02

18 / 19 countries

  • Belgiumprice
  • Canada
  • Czechiaprice
  • Denmark
  • Finlandprice
  • Franceprice
  • Germany
  • Icelandprice
  • Ireland
  • Italyprice
  • Japan
  • Netherlands
  • Norwayprice
  • Polandprice
  • Sweden
  • Switzerlandprice
  • United Kingdom
  • 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.

Price per daily dose

What a daily dose of ambrisentan costs, country by country.

Normalised to the WHO defined daily dose (7.5 mg), so markets compare like for like.

  • 1 market with a comparable price for this class
  • Public list prices, converted to USD at the rate date shown

Ambrisentan · price per daily dose (7.5 mg)

USD · FX 28 Sept 2026

  • CH Switzerland$54.19
Median listed price per WHO defined daily dose, in each market that publishes a price. Open the full comparison

The record

At a glance

HPRA (Ireland)
Active substance
Ambrisentan
Manufacturer
Viatris Limited
Country
Ireland (IE)
ATC code
C02KX02
ATC class
Ambrisentan
Defined daily dose
7.5 mg, O
Reimbursed
Not published by this register
Source register
HPRA (Ireland)
Last checked
September 28, 2026

Packs & prices · 1

  • ie_pa_number
    EU/1/19/1368/003-004

Regulatory notes

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

Interactions

155 interactions on record for ambrisentan.

Graded by severity as the source publishes them — 5 severe. Severity grades are free for everyone; mechanism and management come with Growth.

  • Severity for every pair — free, no plan needed
  • The source, licence and sync date on every record
  • Mechanism and what to do for each pair — Growth plan

Ambrisentan · interactions on record

155 records

  • 5 severe
  • 71 moderate
  • 12 minor
  • 67 info

Most severe, free to view

  • LeflunomidL04AA13severe
  • TeriflunomidL04AA31severe
  • CiclosporinL04AD01severe
  • LeflunomideL04AK01severe
  • Interaction severity from DDInter 2.0 (Xiong G. et al., Nucleic Acids Res.), licensed CC BY-NC 4.0 — free for non-commercial use only; not covered by the Drug Database commercial licence.
Mechanism and what to do, in the interaction check
Source: DDInter 2.0 · synced 29 Sept 2026. Grades as the source publishes them.

Same medicine, other countries

Ambrisentan in 16 other countries

What each register calls a product with the same active substance — salts and hydrates count as the same.

All ambrisentan products

Authorised across Europe · EMA

The same active substance is authorised in 26 EEA countries. Names it is sold under:

  • Austria · Ambrisentan Accord, Ambrisentan Aop
  • Belgium · Ambrisentan Accord, Ambrisentan Sandoz
  • Bulgaria · Aмбрисентан Aкорд, Амбрисентан Зентива
  • Cyprus · Ambrisentan Msn, Ambrisentan Sapiens
  • Czechia · Ambrisentan Accord, Ambrisentan Sandoz
  • Germany · Ambripuren, Ambrisentan
  • Denmark · Ambrisentan "sandoz", Ambrisentan Accord
  • Estonia · Ambrisentan Inteli, Ambrisentan Norameda
  • Spain · Ambrisentan Accord, Ambrisentán Aurovitas
  • Finland · Ambrisentan Accord
  • France · Ambrisentan Accord, Ambrisentan Arrow
  • United Kingdom (Northern Ireland) · Ambrisentan Accord, Ambrisentan Axunio
  • Greece · Ambicipen, Ambrisentan Accord
  • Croatia · Ambrisentan Accord
  • Hungary · Ambrisentan Azr
  • Iceland · Ambrisentan Viatris, Volibris
  • Italy · Ambrisentan Accord, Ambrisentan Medac
  • Liechtenstein · Ambrisentan Viatris, Volibris
  • Lithuania · Ambrisentan Aop, Ambrisentan Inteli
  • Latvia · Ambrisentan Inteli, Ambrisentan Norameda
  • Netherlands · Ambrisentan Accord, Ambrisentan Aop
  • Norway · Ambrisentan Accord, Ambrisentan Viatris
  • Portugal · Ambrisentano Accord, Ambrisentano Generis
  • Sweden · Ambrisentan Accord, Ambrisentan Bluefish
  • Slovenia · Ambrisentan Accord
  • Slovakia · Ambrisentan Aop

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/ea226889-740b-4fe0-82d9-56d3e95e1897
GET /v1/drugs/ea226889-740b-4fe0-82d9-56d3e95e1897?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": [
    "C02KX",
    "C02KX02"
  ],
  "strength": null,
  "pa_number": "EU/1/19/1368/003-004",
  "substances": [
    "Ambrisentan"
  ],
  "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)",
  "market_info": "Unknown",
  "authorised_at": "20/06/2019",
  "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 ambrisentan.

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.