In other countries
The same active substances on other registers, the same brand first.
- OpsumitBrazil · Actelion Pharmaceuticals do Brasil LtdaSame brand
- OpsumitBrazil · Janssen-Cilag Farmacêutica LtdaSame brand
- OpsumitCanada · 10 MG · Tablet · Janssen INCSame brand
- OpsumitCanada · 2.5 MG · Tablet For Suspension · Janssen INCSame brand
- OPSUMIT 10 mg COMPRIMIDOS RECUBIERTOS CON PELICULASpain · 10 mg · comprimido recubierto con película · Janssen-Cilag International N.VSame brand
- OpsumitEuropean Union · Janssen-Cilag International N.V.Same brand
- OpsumitCroatiaSame brand
- OpsumitItaly · Compressa rivestita con film · Janssen-Cilag International N.V.Same brand
- Opsumit 10 mg, filmomhulde tabletNetherlands · Filmomhulde tablet · Janssen-Cilag International NVSame brand
- Opsumit 2,5 mg, dispergeerbare tablettenNetherlands · Dispergeerbare tablet · Janssen-Cilag International NVSame brand
- OPSUMIT 10 mgRomania · 10mg · compr. film. · Jansen-Cilag International NVSame brand
- OPSUMIT 10mgRomania · 10mg · compr. film. · Actelion Pharmaceuticals Deutschland GMBHSame brand
- Opsumit®Serbia · 10mg · film tableta · PredstavniŠTvo Janssen-Cilag KFT BeogradSame brand
- OpsumitSaudi Arabia · EXCELLA GmbH & Co. KGSame brand
- Opsumit Film-Coated Tablet 10MGSingapore · 10.00mg · tablet, film coated · Johnson & Johnson International (Singapore) Pte LTDSame brand
- OpsumitUnited States · 10MG · tablet · ActelionSame brand
- Macitentan AccordEuropean Union · Accord HealthcareSame form
- Macitentan AccordPharmaEuropean Union · Accord HealthcareSame form
- Macitentan AccordCroatiaSame form
- Macitentan AccordPharmaCroatiaSame form
- MaacySaudi Arabia · MSN Laboratories Private LimitedSame form
- MacimitSaudi Arabia · Aizant Drug Research Solutions Pvt.LtdSame form
- 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 Accord 10 mg filmomhulde tablettenNetherlands · Filmomhulde tablet · Accord Healthcare S.L.U.Same substance
- MacitentanUnited States · 10MG · tablet · Seasons BiotechSame substance
Sources and licences
Compiled by Prognia from the public register below; the register’s text is the official one.
Taiwan Food and Drug Administration
TFDA, dataset 9122, Government Open Data Licence 1.0; source update and retrieval dates
Licence: Taiwan Government Open Data Licence 1.0 · Added 7 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
- Dosage form
- 可溶錠
- Register
- Taiwan (TFDA)
- Status
- Authorised
- Authorised
- 14 Nov 2025
- Registration
- 衛部藥輸字第029056號
- Marketing authorisation holder
- 嬌生股份有限公司
- Procedure
- 製 劑