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法规知识库 · EMA 集中审评

Posaconazole AHCL

posaconazole · EMEA/H/C/005028 · 已授权

仿制药

获批上市许可

2019-07-25

欧委会决定日

2025-01-16

持有人 / 申请人

Accord Healthcare S.L.U.

终止日期字段

无

从产品到官方文件

文件记录

7

官方索引 7

EPAR / 审评

5

assessment / overview 等

产品信息

2

PI / presentations

其他

0

RMP / PIP 等

ATC:J02AC04

治疗领域:Mycoses

药理分类:Antimycotics for systemic use

修订号:10 · 最新影响 PI 的程序:VR/0000244236

适应症(原文):Posaconazole AHCL oral suspension is indicated for use in the treatment of the following fungal infections in adults: Invasive aspergillosis in patients with disease that is refractory to amphotericin B or itraconazole or in patients who are intolerant of these medicinal products; Fusariosis in patients with disease that is refractory to amphotericin B or in patients who are intolerant of amphotericin B; Chromoblastomycosis and mycetoma in patients with disease that is refractory to itraconazole or in patients who are intolerant of itraconazole; Coccidioidomycosis in patients with disease that is refractory to amphotericin B, itraconazole or fluconazole or in patients who are intolerant of these medicinal products. Oropharyngeal candidiasis: as first-line therapy in patients who have severe disease or are immunocompromised, in whom response to topical therapy is expected to be poor. Refractoriness is defined as progression of infection or failure to improve after a minimum of 7 days of prior therapeutic doses of effective antifungal therapy. Posaconazole AHCL oral suspension is also indicated for prophylaxis of invasive fungal infections in the following patients: Patients receiving remission-induction chemotherapy for acute myelogenous leukemia (AML) or myelodysplastic syndromes (MDS) expected to result in prolonged neutropenia and who are at high risk of developing invasive fungal infections; Hematopoietic stem cell transplant (HSCT) recipients who are undergoing high-dose immunosuppressive therapy for graft versus host disease and who are at high risk of developing invasive fungal infections.

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. 2025-01-16 · 欧委会决定

  2. 2019-07-25 · 获批上市许可

  3. 2019-05-29 · 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 5产品信息 2其他 0

EPAR / 审评资料

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

    procedural-steps-after · 2025-01-21

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

    procedural-steps-after · 2024-11-12

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  • Posaconazole AHCL : EPAR - Risk-management-plan summary

    rmp-summary · 2022-08-19

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  • Posaconazole AHCL : EPAR - Public assessment report

    assessment-report · 2019-08-28 · EMA/354180/2019

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  • Posaconazole AHCL : EPAR - Medicine overview

    overview · 2019-08-28 · EMA/323099/2019

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产品信息

  • Posaconazole AHCL : EPAR - Product information

    product-information · 2025-01-21

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  • Posaconazole AHCL : EPAR - All authorised presentations

    all-authorised-presentations · 2019-08-28

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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。