Belgium· BE-AMP-SAM663865-00

Opsumit 2.5 mg

A macitentan product containing macitentan, registered in Belgium by Janssen-Cilag International. The same ATC class is registered in 17 of our 19 countries.

ATC C02KX04

Checked against FAMHP / AFMPS (Belgium) on September 26, 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: Belgium, from FAMHP / AFMPS (Belgium)
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

FAMHP / AFMPS (Belgium)

Active substance: Macitentan
Manufacturer: Janssen-Cilag International
Country: Belgium (BE)
ATC code: C02KX04
ATC class: Macitentan
Defined daily dose: 10 mg, O
Reimbursed: Not published by this register
Source register: FAMHP / AFMPS (Belgium)
Last checked: September 26, 2026

Packs & prices · 2

be_apb
4860334
be_apb
7743891

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
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/f461fe66-aca0-4d2e-b804-3cb58c29efc3
GET /v1/drugs/f461fe66-aca0-4d2e-b804-3cb58c29efc3?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": "Dispersible tablet",
  "source": "afmps",
  "status": "AUTHORIZED",
  "name_en": "Opsumit 2.5 mg",
  "name_fr": "Opsumit 2.5 mg",
  "name_nl": "Opsumit 2.5 mg",
  "amp_code": "SAM663865-00",
  "strengths": [
    "2.5000",
    "2.5000",
    "25.0000"
  ],
  "pack_count": 1,
  "substances": [
    "Macitentan",
    "Isomalt",
    "Mannitol",
    "Lactose Monohydrate",
    "Sodium Starch Glycolate (Type A)",
    "Polysorbate 80"
  ],
  "medicine_type": "ALLOPATHIC",
  "atc_description": "Macitentan",
  "authorisation_numbers": [
    "EU/1/13/893/004"
  ]
}

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.

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