Back to search

Sweden· SE-20240502000199

Macitentan Sandoz 10 mg Filmdragerad tablett

A macitentan product containing macitentan, registered in Sweden by Sandoz A/S. The same ATC class is registered in 17 of our 19 countries.

ATC C02KX04

Checked against Swedish Medical Products Agency (Sweden) on

Informational only — not a medical device.

SOURCE REGISTER · SESwedish Medical Products Agency (Sweden)normalisedMacitentan Sandoz 10 mg Filmdragerad …ATCC02KX04REGISTER NO.SE-20240502000199PACKS LISTED1CHECKEDOctober 1, 2026

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: Sweden, from Swedish Medical Products Agency (Sweden)
  • 9 of them publish a price we can compare per daily dose

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

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

Swedish Medical Products Agency (Sweden)
Active substance
Macitentan
Manufacturer
Sandoz A/S
Country
Sweden (SE)
ATC code
C02KX04
ATC class
Macitentan
Defined daily dose
10 mg, O
Reimbursed
Not published by this register
Source register
Swedish Medical Products Agency (Sweden)
Last checked
October 1, 2026

Packs & prices · 1

  • se_varunummer
    20240502000199

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

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
  • 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
  • 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 Swedish Medical Products Agency (Sweden). 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/a8d3192c-0eba-4075-a79a-64f4ea27e981
GET /v1/drugs/a8d3192c-0eba-4075-a79a-64f4ea27e981?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.

{
  "source": "lakemedelsverket",
  "doc_types": [
    "PL",
    "SmPC"
  ],
  "se_npl_id": "20240502000199",
  "product_page": "https://www.lakemedelsverket.se/sv/sok-lakemedelsfakta/lakemedel?id=20240502000199",
  "product_doc_link": "https://docetp.mpa.se/LMF/Macitentan%20Sandoz%20film-coated%20tablet%20SmPC_09001bee84e0062b.pdf"
}

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.