Sweden· SE-20231009000171
Opsumit 2,5 mg Dispergerbar tablett
A medicinal product containing macitentan, registered in Sweden by Janssen-Cilag International NV.
Checked against Swedish Medical Products Agency (Sweden) on
Informational only — not a medical device.
The record
At a glance
Swedish Medical Products Agency (Sweden)- Active substance
- Macitentan
- Manufacturer
- Janssen-Cilag International NV
- Country
- Sweden (SE)
- ATC code
- —
- Reimbursed
- Not published by this register
- Source register
- Swedish Medical Products Agency (Sweden)
- Last checked
- October 1, 2026
Packs & prices · 1
- se_varunummer20231009000171
Regulatory notes
No shortage, Orange Book or US label notes for this record.
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.
- BelgiumOpsumit 2.5 mgJanssen-Cilag International
- FinlandOpsumitJanssen-Cilag International NV
- United KingdomOpsumit 2.5mg dispersible tabletsJanssen-Cilag Ltd
- IrelandOpsumit 2.5 mg film-coated tabletsJanssen Pharmaceutica NV
- NetherlandsOpsumit 2,5 mg, dispergeerbare tablettenJanssen-Cilag International NV
- PolandOpsumitJanssen-Cilag International N.V.
- CzechiaMACITENTAN ACCORDAccord Healthcare S.L.U., Barcelona
- United StatesmacitentanTeva Pharmaceuticals, Inc.
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/db15d10b-b04d-43cd-8878-397c4a054b05 GET /v1/drugs/db15d10b-b04d-43cd-8878-397c4a054b05?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": [
"EMA",
"EPAR"
],
"se_npl_id": "20231009000171",
"product_page": "https://www.lakemedelsverket.se/sv/sok-lakemedelsfakta/lakemedel?id=20231009000171",
"product_doc_link": "https://www.ema.europa.eu/en/medicines/human/EPAR/opsumit"
}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.