Finland· FI-REL-REL43063
Opsumit
A macitentan product containing macitentan, registered in Finland by Janssen-Cilag International NV. The same ATC class is registered in 17 of our 19 countries.
Checked against Fimea (Finland) on
Informational only — not a medical device.
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: Finland, from Fimea (Finland)
- 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
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
The record
At a glance
Fimea (Finland)- Active substance
- Macitentan
- Manufacturer
- Janssen-Cilag International NV
- Country
- Finland (FI)
- ATC code
- C02KX04
- ATC class
- Macitentan
- Defined daily dose
- 10 mg, O
- Reimbursed
- Not published by this register
- Source register
- Fimea (Finland)
- Last checked
- September 27, 2026
Packs & prices · 1
1 priced- fi_myyntilupa49346430EUR 2491.46
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.
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.
- CzechiaMACITENTAN ACCORDAccord Healthcare S.L.U., Barcelona
- SwedenMacitentan Accord 10 mg Filmdragerad tablettAccord Healthcare S.L.U.
- SpainMACITENTAN ACCORD 10 MG COMPRIMIDOS RECUBIERTOS CON PELICULA EFGAccord Healthcare S.L.U.
- United StatesmacitentanSandoz Inc
- IcelandCormakyCoripharma ehf
- NetherlandsMacitentan Accord 10 mg filmomhulde tablettenAccord Healthcare S.L.U.
- PolandJesoxadeMSN Labs Europe Limited
- IrelandMacitentan Abdi 10 mg film-coated tabletsAbdi Farma GmbH
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
- 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 Fimea (Finland). 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/c44cf111-73e1-4524-a149-0176866cd0a6 GET /v1/drugs/c44cf111-73e1-4524-a149-0176866cd0a6?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.
{
"ddd": "10",
"form": "tabletti, kalvopäällysteinen",
"route": "Suun kautta",
"ddd_unit": "mg",
"strength": "10 mg",
"atc_label": "masitentaani",
"ma_number": null,
"auth_status": "Myyntilupa myönnetty",
"eu_ma_number": "EU/1/13/893/001-002",
"fimea_rel_id": "REL43063",
"authorised_at": "2013-12-20"
}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.