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法规知识库 · EMA 集中审评

Daptomycin Hospira

daptomycin · EMEA/H/C/004310 · 已授权

仿制药

获批上市许可

2017-03-22

欧委会决定日

2026-01-19

持有人 / 申请人

Pfizer Europe MA EEIG

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

4

assessment / overview 等

产品信息

3

PI / presentations

其他

0

RMP / PIP 等

ATC:J01XX09

治疗领域:Soft Tissue Infections;Skin Diseases, Bacterial

药理分类:Antibacterials for systemic use

修订号:16 · 最新影响 PI 的程序:N/0000323428

适应症(原文):Daptomycin is indicated for the treatment of the following infections. Adult and paediatric (1 to 17 years of age) patients with complicated skin and soft-tissue infections (cSSTI). Adult patients with right-sided infective endocarditis (RIE) due to Staphylococcus aureus. It isrecommended that the decision to use daptomycin should take into account the antibacterial susceptibility of the organism and should be based on expert advice. Adult and paediatric (1 to 17 years of age) patients with Staphylococcus aureus bacteraemia (SAB). In adults, use in bacteraemia should be associated with RIE or with cSSTI, while in paediatric patients, use in bacteraemia should be associated with cSSTI. Daptomycin is active against Gram positive bacteria only. In mixed infections where Gram negative and/or certain types of anaerobic bacteria are suspected, daptomycin should be co-administered with appropriate antibacterial agent(s). Consideration should be given to official guidance on the appropriate use of antibacterial agents.

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. 2026-01-19 · 欧委会决定

  2. 2017-03-22 · 获批上市许可

  3. 2017-01-26 · 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 4产品信息 3其他 0

EPAR / 审评资料

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

    procedural-steps-after · 2026-01-20

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

    procedural-steps-after · 2025-02-17

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  • Daptomycin Hospira : EPAR - Medicine overview

    overview · 2019-12-11 · EMA/574748/2019

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  • Daptomycin Hospira : EPAR - Public assessment report

    assessment-report · 2017-04-24 · EMA/109959/2017

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产品信息

  • Daptomycin Hospira : EPAR - Product Information

    product-information · 2026-01-20

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  • Daptomycin Hospira : EPAR - Product information - tracked changes

    product-information-tracked-changes · 2025-09-17

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  • Daptomycin Hospira : EPAR - All Authorised presentations

    all-authorised-presentations · 2017-04-24

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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。