Germany· DE-A57-8ba0f51fc0b6a27c
Macitentan Zentiva
A macitentan product containing macitentan, registered in Germany by Zentiva Pharma Gmbh. The same ATC class is registered in 17 of our 19 countries.
Checked against EMA Article 57 (European Union) 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: Germany, from EMA Article 57 (European Union)
- 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
EMA Article 57 (European Union)- Active substance
- Macitentan
- Manufacturer
- Zentiva Pharma Gmbh
- Country
- Germany (DE)
- ATC code
- C02KX04
- ATC class
- Macitentan
- Defined daily dose
- 10 mg, O
- Reimbursed
- Not published by this register
- Source register
- EMA Article 57 (European Union)
- Last checked
- September 30, 2026
Packs & prices · 0
No packs listed by the register for this record.
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.
- United StatesmacitentanTeva Pharmaceuticals, Inc.
- SpainMACITENTAN ACCORD 10 MG COMPRIMIDOS RECUBIERTOS CON PELICULA EFGAccord Healthcare S.L.U.
- FinlandMacitentan AccordAccord Healthcare S.L.U.
- IcelandCormakyCoripharma ehf
- NetherlandsMacitentan Accord 10 mg filmomhulde tablettenAccord Healthcare S.L.U.
- PolandJesoxadeMSN Labs Europe Limited
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
- 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 EMA Article 57 (European Union). 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/e9d169ed-fdd1-42e3-b969-50deee7713b7 GET /v1/drugs/e9d169ed-fdd1-42e3-b969-50deee7713b7?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.
{
"pzn": null,
"route": "Oral Use",
"source": "ema_art57_de",
"ma_number": null,
"substance": "Macitentan",
"atc_from_source": null,
"authorisation_country": "Germany"
}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.