法规知识库 · EMA 集中审评
NovoSeven
eptacog alfa (activated) · EMEA/H/C/000074 · 已授权
获批上市许可
1996-02-23
欧委会决定日
2023-02-23
持有人 / 申请人
Novo Nordisk A/S
终止日期字段
无
从产品到官方文件
文件记录
11
官方索引 11
EPAR / 审评
9
assessment / overview 等
产品信息
2
PI / presentations
其他
0
RMP / PIP 等
ATC：B02BD08
治疗领域：Hemophilia B;Thrombasthenia;Factor VII Deficiency;Hemophilia A
药理分类：Antihemorrhagics
修订号：38 · 最新影响 PI 的程序：IAIN/0119
适应症（原文）：NovoSeven is indicated for the treatment of bleeding episodes and for the prevention of bleeding in those undergoing surgery or invasive procedures in the following patient groups: in patients with congenital haemophilia with inhibitors to coagulation factors VIII or IX > 5 Bethesda units (BU); in patients with congenital haemophilia who are expected to have a high anamnestic response to factor-VIII or factor-IX administration; in patients with acquired haemophilia; in patients with congenital factor-VII deficiency; in patients with Glanzmann's thrombasthenia with antibodies to platelet glycoprotein (GP) IIb-IIIa and / or human leucocyte antigens (HLA), and with past or present refractoriness to platelet transfusions. in patients with Glanzmann’s thrombasthenia with past or present refractoriness to platelet transfusions, or where platelets are not readily available.
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。
2023-02-23 · 欧委会决定
1996-02-23 · 获批上市许可
说明书、EPAR 与其他文件
仅展示 EMA 官方 document_url；本站不下载或镜像 PDF。
EPAR / 审评资料
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NovoSeven : EPAR - Risk-management-plan summary
rmp-summary · 2023-02-27
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NovoSeven : EPAR - Procedural steps taken and scientific information after authorisation
procedural-steps-after · 2023-02-27
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NovoSeven-H-C-000074-II-0116: EPAR - Assessment report - Variation
variation-report · 2022-07-26 · EMA/CHMP/2055442022
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NovoSeven : EPAR - Medicine overview
overview · 2022-07-26 · EMA/236357/2022
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NovoSeven-H-C-000074-II-0104 : EPAR - Assessment report - Variation
variation-report · 2018-12-18 · EMA/CHMP/800979/2018
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NovoSeven : EPAR - Conditions imposed on member states for safe and effective use - Annex IV
conditions-member-states · 2008-05-07
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NovoSeven : EPAR - Procedural steps taken before authorisation
procedural-steps-before · 2005-10-21
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NovoSeven : EPAR - Steps taken after authorisation when a cutoff date has been used
steps-after-cutoff · 2005-10-21
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NovoSeven : EPAR - Scientific Discussion
scientific-discussion · 2005-10-21
数据来自 EMA 官方 JSON；最终以 EMA / 欧委会文件为准。本页不自动给出安全或非安全结论。