欧盟EMA药品数据库(European Medicines Agency Authorisation of Medicines DataBase)
商品名称Poherdy
适用类别Human
治疗领域Breast Neoplasms
通用名/非专利名称pertuzumab
活性成分pertuzumab
产品号EMEA/H/C/006583
患者安全信息No
许可状态Authorised
ATC编码L01FD02
是否额外监管Yes
是否仿制药或hybrid药物No
是否生物类似药Yes
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2026/04/23
上市许可开发者/申请人/持有人Organon N.V.
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2026/02/26
欧盟委员会决定日期2026/05/21
修订号1
治疗适应症Early breast cancerPoherdy is indicated for use in combination with trastuzumab and 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 recurrenceMetastatic breast cancerPoherdy is indicated for use in combination with trastuzumab and 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2026/02/27
最后更新日期2026/05/27
产品说明书https://www.ema.europa.eu/en/documents/product-information/poherdy-epar-product-information_en.pdf
公共评估报告https://www.ema.europa.eu/en/medicines/human/EPAR/poherdy
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