Macitentan tablets | China Drugs List
Public reference information, not medical advice, a prescription or an offer to supply a medicine. Confirm current approval, availability and suitability with licensed professionals.
Others
- Brand
- Opsumit
- Company
- Janssen Pharmaceutica NV (EU authorization holder)
- Medicine type
- Chemical medicine
- Therapeutic area
- Cardiovascular
- Indications recorded in the public source
- EU: Long-term treatment of pulmonary arterial hypertension in adults and children aged 2 years or older with WHO functional class II or III, alone or with other PAH therapy. The appropriate tablet presentation depends on age and body weight.
- Indication source and scope
- English EMA EPAR overview and product details accessed 2026-11-02. Selected overseas indications; does not establish the Chinese approved scope.
- Prescribing-information limitations
- Regulatory product information / approval evidence is linked; a complete current prescribing-information document has not been verified in this review.
- China availability status
- Chinese approval, locally approved indications and current availability have not been independently verified in this import.
- Overseas status
- See the linked overseas regulator / manufacturer evidence. Approval and indications are jurisdiction-specific; current supply is not established.
- Insurance classification
- Not yet verified
- Insurance edition
- Chinese national insurance review pending
- Insurance verification notes
- No reimbursement determination was made for this addition; missing information is not proof of exclusion.
Sources
- https://www.ema.europa.eu/en/medicines/human/EPAR/opsumit
- Opsumit — EMA medicine overview and product details
Regulatory medicine overview · English EMA EPAR overview and product details accessed 2026-11-02
English primary source reviewed. This evidence describes the cited overseas jurisdiction and does not verify Chinese approval, indications, reimbursement or market availability.
- HPRA Opsumit authorization record
Regulatory authorization record · Accessed 2026-11-02
Identifies EU authorization holder; not Chinese approval evidence.
Evidence reviewed:
Open the interactive record, public price references and discussions