Spain· ES:113893002
OPSUMIT 10 mg COMPRIMIDOS RECUBIERTOS CON PELICULA
A medicinal product containing macitentán, registered in Spain by Janssen-Cilag International N.V.
Checked against AEMPS CIMA (Spain) on
Informational only — not a medical device.
The record
At a glance
AEMPS CIMA (Spain)- Active substance
- macitentán
- Manufacturer
- Janssen-Cilag International N.V
- Country
- Spain (ES)
- ATC code
- —
- Reimbursed
- Not published by this register
- Source register
- AEMPS CIMA (Spain)
- Last checked
- September 12, 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.
Same medicine, other countries
Macitentán 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 StatesmacitentanSandoz Inc
- FinlandMacitentan AccordAccord Healthcare S.L.U.
- 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
- 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 AEMPS CIMA (Spain). 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/d4ef6b02-f51f-4879-9c8e-358d25050d31 GET /v1/drugs/d4ef6b02-f51f-4879-9c8e-358d25050d31?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.
{
"cpresc": "Uso Hospitalario",
"estado": "{\"aut\":1399413600000}",
"nregistro": "113893002",
"substance": "macitentán"
}See everything about macitentán.
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.