欧盟EMA药品数据库(European Medicines Agency Authorisation of Medicines DataBase)
商品名称Phesgo
适用类别Human
治疗领域Breast Neoplasms
通用名/非专利名称pertuzumab;trastuzumab
活性成分pertuzumab;trastuzumab
产品号EMEA/H/C/005386
患者安全信息No
许可状态Authorised
ATC编码L01XY
是否额外监管No
是否仿制药或hybrid药物No
是否生物类似药No
是否附条件批准No
是否特殊情形No
是否加速审评No
是否罕用药No
上市许可日期2020/12/21
上市许可开发者/申请人/持有人Roche Registration GmbH
人用药物治疗学分组Antineoplastic agents
兽用药物治疗学分组
审评意见日期2020/11/12
欧盟委员会决定日期2025/09/22
修订号7
治疗适应症Early breast cancer (EBC) Phesgo is indicated for use in combination with chemotherapy in: the neoadjuvant treatment of adult patients with HER2-positive, locally advanced, inflammatory, or early stage breast cancer at high risk of recurrence the adjuvant treatment of adult patients with HER2-positive early breast cancer at high risk of recurrence Metastatic breast cancer (MBC) Phesgo is indicated for use in combination with docetaxel in adult patients with HER2-positive metastatic or locally recurrent unresectable breast cancer, who have not received previous anti-HER2 therapy or chemotherapy for their metastatic disease.
适用物种
兽用药物ATC编码
首次发布日期2021/01/13
最后更新日期2025/10/28
产品说明书https://www.ema.europa.eu/en/documents/product-information/phesgo-epar-product-information_en.pdf
公共评估报告https://www.ema.europa.eu/en/medicines/human/EPAR/phesgo
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