法规知识库 · EMA 集中审评
Prezista
darunavir · EMEA/H/C/000707 · 已授权
获批上市许可
2007-02-11
欧委会决定日
2024-07-24
持有人 / 申请人
Janssen-Cilag International NV
终止日期字段
无
从产品到官方文件
文件记录
27
官方索引 27
EPAR / 审评
25
assessment / overview 等
产品信息
2
PI / presentations
其他
0
RMP / PIP 等
ATC:J05AE10
治疗领域:HIV Infections
药理分类:Antivirals for systemic use
修订号:55 · 最新影响 PI 的程序:N/0123
适应症(原文):PREZISTA, co administered with low dose ritonavir is indicated in combination with other antiretroviral medicinal products for the treatment of human immunodeficiency virus (HIV 1) infection in adult and paediatric patients from the age of 3 years and at least 15 kg body weight. PREZISTA, co administered with cobicistat is indicated in combination with other antiretroviral medicinal products for the treatment of human immunodeficiency virus (HIV 1) infection in adults and adolescents (aged 12 years and older, weighing at least 40 kg). In deciding to initiate treatment with PREZISTA co administered with cobicistat or low dose ritonavir, careful consideration should be given to the treatment history of the individual patient and the patterns of mutations associated with different agents. Genotypic or phenotypic testing (when available) and treatment history should guide the use of PREZISTA. PREZISTA, co administered with low dose ritonavir is indicated in combination with other antiretroviral medicinal products for the treatment of patients with human immunodeficiency virus (HIV 1) infection. PREZISTA 75 mg, 150 mg, and 600 mg tablets may be used to provide suitable dose regimens: For the treatment of HIV 1 infection in antiretroviral treatment (ART) experienced adult patients, including those that have been highly pre treated. For the treatment of HIV 1 infection in paediatric patients from the age of 3 years and at least 15 kg body weight. In deciding to initiate treatment with PREZISTA co administered with low dose ritonavir, careful consideration should be given to the treatment history of the individual patient and the patterns of mutations associated with different agents. Genotypic or phenotypic testing (when available) and treatment history should guide the use of PREZISTA. PREZISTA, co administered with low dose ritonavir is indicated in combination with other antiretroviral medicinal products for the treatment of patients with human immunodeficiency virus (HIV 1) infection. PREZISTA, co administered with cobicistat is indicated in combination with other antiretroviral medicinal products for the treatment of human immunodeficiency virus (HIV 1) infection in adults and adolescents (aged 12 years and older, weighing at least 40 kg). PREZISTA 400 mg and 800 mg tablets may be used to provide suitable dose regimens for the treatment of HIV 1 infection in adult and paediatric patients from the age of 3 years and at least 40 kg body weight who are: antiretroviral therapy (ART) naïve. ART experienced with no darunavir resistance associated mutations (DRV RAMs) and who have plasma HIV 1 RNA < 100,000 copies/ml and CD4+ cell count ? 100 cells x 106/L. In deciding to initiate treatment with PREZISTA in such ART experienced patients, genotypic testing should guide the use of PREZISTA.
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。
2024-07-24 · 欧委会决定
2007-02-11 · 获批上市许可
2006-12-14 · 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
- 打开官方文件 ↗
Prezista : EPAR - Procedural steps taken and scientific information after authorisation
procedural-steps-after · 2024-07-26
- 打开官方文件 ↗
Prezista : EPAR - Risk-management-plan summary
rmp-summary · 2023-03-03
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Prezista-H-C-707-II-0107 : EPAR - Assessment Report - Variation
variation-report · 2020-09-16 · EMA/425517/2020
- 打开官方文件 ↗
Prezista : EPAR - Risk-management-plan summary
rmp-summary · 2020-09-16
- 打开官方文件 ↗
Prezista : EPAR - Summary for the public
overview · 2020-09-16 · EMA/413582/2020
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Prezista-H-C-707-WS-1544-0101 : EPAR - Assessment Report - Variation
variation-report · 2019-05-16 · EMA/256624/2019
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Prezista-H-C-707-P46-0072.1: EPAR - Assessment Report
variation-report · 2019-01-08 · EMA/CHMP/885348/2018
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Prezista-H-C-707-P46-0073: EPAR - Assessment Report
variation-report · 2018-01-29 · EMA/21294/2018
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Prezista-H-C-707-P46-071 : EPAR - Assessment report
variation-report · 2016-01-05 · EMA/2830/2016
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Prezista-H-C-707-P46-0064 : EPAR - Assessment Report
variation-report · 2015-04-07 · EMA/100490/2013
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Prezista-H-C-707-P46-0066 : EPAR - Assessment Report
variation-report · 2015-04-07 · EMA/100690/2013
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Prezista-H-C-707-II-0063 : EPAR - Assessment Report - Variation
variation-report · 2014-12-01 · EMA/664598/2014
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Prezista-H-C-707-II-0064 : EPAR - Assessment Report
variation-report · 2014-11-28 · EMA/664620/2014
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Prezista : EPAR - Paediatric investigation plan compliance statement
pip-compliance · 2013-10-29 · EMA/631299/2013
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Prezista-H-C-707-PSU-0059 : EPAR - Scientific conclusions and grounds recommending the variation to the terms of the marketing authorisation
scientific-conclusion · 2013-10-29 · EMA/CHMP/601218/2013
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Prezista-H-C-707-II-0054 : EPAR - Assessment Report - Variation
variation-report · 2013-10-29 · EMA/604105/2013
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Prezista-H-C-707-X-0046 : EPAR - Assessment Report - Extension
variation-report · 2013-09-20 · EMA/805909/2012
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Prezista-H-C-707-P46-0063 : EPAR - Assessment Report
variation-report · 2013-03-27 · EMA/100380/2013
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Prezista-H-C-707-X-0041-G : EPAR - Assessment Report - Extension
variation-report · 2012-11-14 · EMA/CHMP/304651/2012
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Prezista-H-C-707-II-0032 : EPAR - Assessment Report - Variation
variation-report · 2011-03-22 · EMA/CHMP/834202/2010
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Prezista-H-C-707-X-0020-0021 : EPAR - Assessment Report - Extension
variation-report · 2009-07-10
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Prezista-H-C-707-X-0016 : EPAR - Assessment Report - Extension
variation-report · 2009-02-12
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Prezista-H-C-707-II-0014 : EPAR - Assessment Report - Variation
variation-report · 2008-12-16
- 打开官方文件 ↗
Prezista : EPAR - Procedural steps taken before authorisation
procedural-steps-before · 2008-11-25
- 打开官方文件 ↗
Prezista : EPAR - Scientific Discussion
scientific-discussion · 2008-11-25
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。