欧盟EMA药品数据库(European Medicines Agency Authorisation of Medicines DataBase)
商品名称Zolsketil pegylated liposomal
适用类别Human
治疗领域Ovarian Neoplasms; Sarcoma, Kaposi; Multiple Myeloma
通用名/非专利名称doxorubicin
活性成分doxorubicin hydrochloride, liposomal
产品号EMEA/H/C/005320
患者安全信息no
授权状态Authorised
ATC编码L01DB01
是否额外监管no
是否仿制药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
批准上市日期2022/05/31
上市许可持有人/公司名称Accord Healthcare S.L.U.
人用药物治疗分组doxorubicin
审评意见发布日期2022/03/24
决定日期2023/08/23
修订号2
适应症Zolsketil pegylated liposomal is a medicine used to treat the following types of cancer in adults:• breast cancer that has spread to other parts of the body in patients at risk of heart problems. Zolsketil pegylated liposomal is used on its own for this disease;• advanced ovarian cancer in women whose previous treatment including a platinum-based cancer medicine has stopped working;• multiple myeloma (a cancer of the white blood cells in the bone marrow), in patients with progressive disease who have received at least one other treatment in the past and have already had, or are unsuitable for, a bone marrow transplantation. Zolsketil pegylated liposomal is used in combination with bortezomib (another cancer medicine);• Kaposi’s sarcoma in patients with AIDS who have a very damaged immune system. Kaposi’s sarcoma is a cancer that causes abnormal tissue to grow under the skin, on moist body surfaces or on internal organs.Zolsketil pegylated liposomal contains the active substance doxorubicin and is a ‘hybrid medicine’. This means that it is similar to a ‘reference medicine’ containing the same active substance called Adriamycin. However, in Zolsketil pegylated liposomal the active substance is enclosed in tiny fatty spheres called liposomes, whereas this is not the case for Adriamycin.
首次发布日期2022/06/20
修订日期2023/09/05
产品信息https://www.ema.europa.eu/en/documents/product-information/zolsketil-pegylated-liposomal-epar-product-information_en.pdf
公共评估报告https://www.ema.europa.eu/en/medicines/human/EPAR/zolsketil-pegylated-liposomal
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