他拉唑帕利胶囊 | China Drugs ListTalazoparib capsules | 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
- Talzenna
- 企业
- Pfizer Europe MA EEIG (欧盟上市许可持有人)Pfizer Europe MA EEIG (EU authorization holder)
- 药品类型
- 化学药Chemical medicine
- 治疗领域
- 肿瘤科Oncology
- 公开来源记录的适应症
- 欧盟：单药用于成人胚系BRCA1/2突变、HER2阴性的局部晚期或转移性乳腺癌，除不适合外，须既往接受蒽环类和/或紫杉类治疗；激素受体阳性疾病还要求既往接受内分泌治疗或不适合该治疗。与恩扎卢胺联合，用于临床上无化疗指征的成人转移性去势抵抗性前列腺癌。EU: Used alone for adults with germline BRCA1/2-mutated, HER2-negative locally advanced or metastatic breast cancer after an anthracycline and/or taxane unless unsuitable; hormone receptor-positive disease also requires prior endocrine therapy or unsuitability. With enzalutamide for adults with metastatic castration-resistant prostate cancer when chemotherapy is not clinically indicated.
- 适应症来源与口径
- 欧盟药品特征概要（SmPC） 查阅于 2026-11-02； 当前链接版本. 部分境外适应症；不确立中国批准范围。EU SmPC accessed 2026-11-02; current linked revision. Selected overseas indications; does not establish the Chinese approved scope.
- 说明书信息局限
- 已链接境外官方处方资料；尚未核实完整的现行中国说明书。Overseas official prescribing information linked; a complete current Chinese label has not been verified.
- 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/documents/product-information/talzenna-epar-product-information_en.pdf
- Talzenna——官方处方资料Talzenna — official prescribing information
Official prescribing information · EU SmPC accessed 2026-11-02; current linked revision
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.
证据核查日期：