马昔腾坦片 | China Drugs ListMacitentan tablets | China Drugs List
本页为公开参考信息，不构成医疗建议、处方或药品供应要约。请向持证专业人士确认当前批准情况、可获得性及适用性。
其他
- 商品名
- Opsumit
- 企业
- Janssen Pharmaceutica NV (欧盟上市许可持有人)Janssen Pharmaceutica NV (EU authorization holder)
- 药品类型
- 化学药Chemical medicine
- 治疗领域
- 心血管Cardiovascular
- 公开来源记录的适应症
- 欧盟：长期治疗成人及2岁及以上儿童WHO功能分级II或III级肺动脉高压，可单药或与其他PAH治疗联合。适当的片剂规格取决于年龄和体重。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.
- 适应症来源与口径
- EMA英文EPAR概述和产品详情 查阅于 2026-11-02. 部分境外适应症；不确立中国批准范围。English EMA EPAR overview and product details accessed 2026-11-02. Selected overseas indications; does not establish the Chinese approved scope.
- 说明书信息局限
- 已链接监管机构产品资料／批准证据；本次核查尚未核实完整的现行处方资料文件。Regulatory product information / approval evidence is linked; a complete current prescribing-information document has not been verified in this review.
- 中国可获得性状态
- 本次导入未独立核实中国批准、当地批准适应症及当前供应情况。Chinese approval, locally approved indications and current availability have not been independently verified in this import.
- 海外状态
- 请参阅所链接的境外监管机构或厂商证据。批准及适应症因司法辖区而异；尚未确认当前供应情况。See the linked overseas regulator / manufacturer evidence. Approval and indications are jurisdiction-specific; current supply is not established.
- 医保分类
- 尚未核实Not yet verified
- 医保版本
- 中国国家医保信息待核实Chinese national insurance review pending
- 医保核查说明
- 本次新增记录尚未确定报销资格；缺少信息不代表未被纳入。No reimbursement determination was made for this addition; missing information is not proof of exclusion.
来源
- https://www.ema.europa.eu/en/medicines/human/EPAR/opsumit
- Opsumit——EMA药品概述和产品详情Opsumit — EMA medicine overview and product details
Regulatory medicine overview · English EMA EPAR overview and product details accessed 2026-11-02
已核查英文一手来源。此证据描述所引用的境外司法辖区情况，不能核实中国批准、适应症、报销或在售情况。English primary source reviewed. This evidence describes the cited overseas jurisdiction and does not verify Chinese approval, indications, reimbursement or market availability.
- HPRA Opsumit许可记录HPRA Opsumit authorization record
Regulatory authorization record · Accessed 2026-11-02
确认欧盟许可持有人；不属于中国批准证据。Identifies EU authorization holder; not Chinese approval evidence.
证据核查日期：