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 |
---|