In other countries
The same active substances on other registers, the same brand first.
- OpsumitBrazil · Janssen-Cilag Farmacêutica LtdaSame form
- OpsumitBrazil · Actelion Pharmaceuticals do Brasil LtdaSame form
- Macitentan AccordEuropean Union · Accord HealthcareSame form
- Macitentan AccordPharmaEuropean Union · Accord HealthcareSame form
- OpsumitEuropean Union · Janssen-Cilag International N.V.Same form
- OPSUMIT 10 mgRomania · 10mg · compr. film. · Jansen-Cilag International NVSame form
- OPSUMIT 10mgRomania · 10mg · compr. film. · Actelion Pharmaceuticals Deutschland GMBHSame form
- MaacySaudi Arabia · MSN Laboratories Private LimitedSame form
- MacimitSaudi Arabia · Aizant Drug Research Solutions Pvt.LtdSame form
- OpsumitSaudi Arabia · EXCELLA GmbH & Co. KGSame form
- OPSUMIT(CM) Dispersible Tablets 2.5mgTaiwan · 可溶錠 · 嬌生股份有限公司Same form
- Opsumit film-coated tablets 10mgTaiwan · 膜衣錠 · 嬌生股份有限公司Same form
- Opsumit®(CM) film-coated tablets 10 mgTaiwan · 膜衣錠 · 嬌生股份有限公司Same form
- OpsumitCanada · 10 MG · Tablet · Janssen INCSame substance
- OpsumitCanada · 2.5 MG · Tablet For Suspension · Janssen INCSame substance
- OPSUMIT 10 mg COMPRIMIDOS RECUBIERTOS CON PELICULASpain · 10 mg · comprimido recubierto con película · Janssen-Cilag International N.VSame substance
- Macitentan Accord 10 MG Comprimidos Recubiertos con Pelicula EfgSpain · 10 mg · comprimido recubierto con película · Accord Healthcare S.L.U.Same substance
- Macitentan Accordpharma 10 MG Comprimidos Recubiertos con Pelicula EfgSpain · 10 mg · comprimido recubierto con película · Accord Healthcare S.L.U.Same substance
- Macitentan AbdiItaly · Compressa rivestita con film · Abdi Farma GmbHSame substance
- Macitentan AurobindoItaly · Compressa rivestita con film · Aurobindo Pharma (Italia) S.R.L.Same substance
- Macitentan EgItaly · Compressa rivestita con film · Eg S.P.A.Same substance
- Macitentan Accord 10 mg filmomhulde tablettenNetherlands · Filmomhulde tablet · Accord Healthcare S.L.U.Same substance
- Macitentan AccordPharma 10 mg filmomhulde tablettenNetherlands · Filmomhulde tablet · Accord Healthcare S.L.U.Same substance
- Macitentan Aurobindo 10 mg, filmomhulde tablettenNetherlands · Filmomhulde tablet · Aurobindo Pharma B.V.Same substance
- Opsumit®Serbia · 10mg · film tableta · PredstavniŠTvo Janssen-Cilag KFT BeogradSame substance
- Opsumit Film-Coated Tablet 10MGSingapore · 10.00mg · tablet, film coated · Johnson & Johnson International (Singapore) Pte LTDSame substance
- MacitentanUnited States · 10MG · tablet · Seasons BiotechSame substance
- OpsumitUnited States · 10MG · tablet · ActelionSame substance
Sources and licences
Compiled by Prognia from the public register below; the register’s text is the official one.
HALMED — Agencija za lijekove i medicinske proizvode RH
HALMED, Baza lijekova, source export 08.10.2026., acquired 2026-10-08; factual structured adaptation; Otvorena dozvola RH, NN 67/2017.
Licence: Otvorena dozvola RH NN 67/2017 · Added 8 Oct 2026
Report an error or request removalCorrections from the holder or the register are welcome.
Prognia shows this product information for reference and learning. It is not treatment advice and can lag behind the official text. Always check the current product information and local protocols before prescribing.
At a glance
- Active substance
- Macitentan
- Register
- Croatia (HALMED)
- Status
- Authorised
- Registration
- 17891
- ATC code
- C02KX04
- Procedure
- EU centralised
- Supply
- na recept; u ljekarni