Ireland· IE-PA-PA22865/018/001

Opsaren 10 mg Film-coated Tablets

A macitentan product containing macitentan, registered in Ireland by Renata Pharmaceuticals (Ireland) Limited. The same ATC class is registered in 17 of our 19 countries.

ATC C02KX04

Checked against HPRA (Ireland) on September 28, 2026

Informational only — not a medical device.

Compare price across countriesPer daily dose · free account Ask the assistant about macitentanAnswers with sources · free account Check interactionsSeverity free · mechanism on Growth

Where it is registered

Macitentan is registered in 17 of 19 countries.

Countries holding a registration under ATC C02KX04 (macitentan), each read from that country’s own register.

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

Search macitentan products by name

Macitentan · ATC C02KX04

17 / 19 countries

Belgiumprice
Canada
Czechiaprice
Denmark
Finlandprice
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 macitentan costs, country by country.

Normalised to the WHO defined daily dose (10 mg), so markets compare like for like.

2 markets with a comparable price for this class
Public list prices, converted to USD at the rate date shown

Open the full comparison — free account Drug prices for market access

Macitentan · price per daily dose (10 mg)

USD · FX 28 Sept 2026

IT Italy$161.10
CH Switzerland$108.22

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: Macitentan
Manufacturer: Renata Pharmaceuticals (Ireland) Limited
Country: Ireland (IE)
ATC code: C02KX04
ATC class: Macitentan
Defined daily dose: 10 mg, O
Reimbursed: Not published by this register
Source register: HPRA (Ireland)
Last checked: September 28, 2026

Packs & prices · 1

ie_pa_number
PA22865/018/001

Regulatory notes

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

Interactions

83 interactions on record for macitentan.

Graded by severity as the source publishes them — 17 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

Check macitentan against other medicines How interaction checks work

Macitentan · interactions on record

83 records

17 severe
65 moderate
1 minor

Most severe, free to view

KetoconazoleH02CA03severe
ErythromycinJ01FA01severe
ClarithromycinJ01FA09severe
KetoconazoleJ02AB02severe

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

Macitentan in 15 other countries

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

All macitentan products

Authorised across Europe · EMA

The same active substance is authorised in 29 EEA countries. Names it is sold under:

Austria · Macepulan, Macicon
Belgium · Macitentan Ab, Macitentan Eg
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
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 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/e554a671-a48f-43fa-84d6-cdbd016dab49
GET /v1/drugs/e554a671-a48f-43fa-84d6-cdbd016dab49?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": [
    "C02KX04"
  ],
  "strength": null,
  "pa_number": "PA22865/018/001",
  "substances": [
    "Macitentan"
  ],
  "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)",
  "market_info": "Not marketed",
  "authorised_at": "06/02/2026",
  "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
}

API reference MCP server Plans

See everything about macitentan.

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.

Try it free Open in the console