| 商品名称 | Jakavi |
|---|
| 适用类别 | Human |
|---|
| 治疗领域 | Myeloproliferative Disorders;Polycythemia Vera;Graft vs Host Disease |
|---|
| 通用名/非专利名称 | ruxolitinib |
|---|
| 活性成分 | ruxolitinib phosphate |
|---|
| 产品号 | EMEA/H/C/002464 |
|---|
| 患者安全信息 | No |
|---|
| 许可状态 | Authorised |
|---|
| ATC编码 | L01EJ01 |
|---|
| 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 | 2012/08/23 |
|---|
| 上市许可开发者/申请人/持有人 | Novartis Europharm Limited |
|---|
| 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 | 2012/04/19 |
|---|
| 欧盟委员会决定日期 | 2025/11/10 |
|---|
| 修订号 | 38 |
|---|
| 治疗适应症 | Myelofibrosis (MF)Jakavi is indicated for the treatment of disease related splenomegaly or symptoms in adult patients with primary myelofibrosis (also known as chronic idiopathic myelofibrosis), post polycythaemia vera myelofibrosis or post essential thrombocythaemia myelofibrosis.Polycythaemia vera (PV)Jakavi is indicated for the treatment of adult patients with polycythaemia vera who are resistant to or intolerant of hydroxyurea.Graft versus host disease (GvHD)Acute GvHDJakavi is indicated for the treatment of adults and paediatric patients aged 28 days and older with acute graft versus host disease who have inadequate response to corticosteroids or other systemic therapies (see section 5.1).Chronic GvHDJakavi is indicated for the treatment of adults and paediatric patients aged 6 months and older with chronic graft versus host disease who have inadequate response to corticosteroids or other systemic therapies (see section 5.1). Myelofibrosis (MF)Jakavi is indicated for the treatment of disease related splenomegaly or symptoms in adult patients with primary myelofibrosis (also known as chronic idiopathic myelofibrosis), post polycythaemia vera myelofibrosis or post essential thrombocythaemia myelofibrosis.Polycythaemia vera (PV)Jakavi is indicated for the treatment of adult patients with polycythaemia vera who are resistant to or intolerant of hydroxyurea.Graft versus host disease (GvHD)Acute GvHDJakavi is indicated for the treatment of adults and paediatric patients aged 28 days and older with acute graft versus host disease who have inadequate response to corticosteroids or other systemic therapies (see section 5.1).Chronic GvHDJakavi is indicated for the treatment of adults and paediatric patients aged 6 months and older with chronic graft versus host disease who have inadequate response to corticosteroids or other systemic therapies (see section 5.1). |
|---|
| 适用物种 | |
|---|
| 兽用药物ATC编码 | |
|---|
| 首次发布日期 | 2018/05/22 |
|---|
| 最后更新日期 | 2025/11/10 |
|---|
| 产品说明书 | https://www.ema.europa.eu/en/documents/product-information/jakavi-epar-product-information_en.pdf |
|---|
| 公共评估报告 | https://www.ema.europa.eu/en/medicines/human/EPAR/jakavi |
|---|