法规知识库 · EMA 集中审评
Ruxolitinib Viatris
ruxolitinib hemifumarate · EMEA/H/C/006618 · 已授权
获批上市许可
2026-09-18
欧委会决定日
未记录
持有人 / 申请人
Viatris Limited
终止日期字段
无
从产品到官方文件
文件记录
5
官方索引 5
EPAR / 审评
3
assessment / overview 等
产品信息
2
PI / presentations
其他
0
RMP / PIP 等
ATC:L01EJ01
治疗领域:Primary Myelofibrosis;Polycythemia Vera;Graft vs Host Disease
药理分类:Antineoplastic agents
修订号:— · 最新影响 PI 的程序:—
适应症(原文):Myelofibrosis (MF) Ruxolitinib Viatris 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) Ruxolitinib Viatris 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 GvHD Ruxolitinib Viatris 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 GvHD Ruxolitinib Viatris 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).
关键日期时间轴
来自 EMA medicines JSON 日期字段;缺失字段不展示,不补推结论。
2026-09-18 · 获批上市许可
2026-07-23 · CHMP 意见通过
说明书、EPAR 与其他文件
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EPAR / 审评资料
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