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法规知识库 · EMA 集中审评

Inhixa

enoxaparin sodium · EMEA/H/C/004264 · 已授权

生物类似药

获批上市许可

2016-09-15

欧委会决定日

2026-07-15

持有人 / 申请人

Techdow Pharma Netherlands B.V.

终止日期字段

无

从产品到官方文件

文件记录

8

官方索引 8

EPAR / 审评

6

assessment / overview 等

产品信息

2

PI / presentations

其他

0

RMP / PIP 等

ATC:B01AB05

治疗领域:Venous Thromboembolism

药理分类:Antithrombotic agents

修订号:32 · 最新影响 PI 的程序:VR/0000361384

适应症(原文):Inhixa is indicated for adults for: Prophylaxis of venous thromboembolism, particularly in patients undergoing orthopaedic, general or oncological surgery. Prophylaxis of venous thromboembolism in patients bedridden due to acute illnesses including acute heart failure, acute respiratory failure, severe infections, as well as exacerbation of rheumatic diseases causing immobilisation of the patient (applies to strengths of 40 mg/0.4 mL). Treatment of deep vein thrombosis (DVT), complicated or uncomplicated by pulmonary embolism. Treatment of unstable angina and non Q wave myocardial infarction, in combination with acetylsalicylic acid (ASA). Treatment of acute ST segment elevation myocardial infarction (STEMI) including patients who will be treated conservatively or who will later undergo percutaneous coronary angioplasty (applies to strengths of 60 mg/0.6 mL, 80 mg/0.8 mL, and 100 mg/1 mL). Blood clot prevention in the extracorporeal circulation during haemodialysis.

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。

  1. 2026-07-15 · 欧委会决定

  2. 2016-09-15 · 获批上市许可

  3. 2016-07-21 · CHMP 意见通过

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 6产品信息 2其他 0

EPAR / 审评资料

  • Inhixa : EPAR - Procedural steps taken and scientific information after authorisation

    procedural-steps-after · 2026-07-16

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  • Inhixa : EPAR - Procedural steps taken and scientific information after authorisation (archive)

    procedural-steps-after · 2025-05-23

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  • Inhixa : EPAR - Summary for the public

    overview · 2022-09-06 · EMA/33241/2022

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  • Inhixa-H-C-PSUSA-00010833-202104 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation

    scientific-conclusion · 2022-01-19 · EMA/617395/2021

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  • Inhixa : EPAR - Risk-management-plan summary

    rmp-summary · 2022-01-04

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  • Inhixa : EPAR - Public assessment report

    assessment-report · 2016-10-26 · EMA/536977/2016

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产品信息

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。