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法规知识库 · EMA 集中审评

Vocabria

cabotegavir sodium;cabotegravir · EMEA/H/C/004976 · 已授权

额外监测

获批上市许可

2020-12-17

欧委会决定日

2026-10-16

持有人 / 申请人

ViiV Healthcare B.V.

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:J05AX

治疗领域:HIV Infections

药理分类:Antivirals for systemic use

修订号:18 · 最新影响 PI 的程序:VR/0000332087

适应症(原文):Vocabria tablets are indicated in combination with rilpivirine tablets for the short-term treatment of Human Immunodeficiency Virus type 1 (HIV-1) infection in adults and adolescents (at least 12 years of age and weighing at least 35 kg) who are virologically suppressed (HIV-1 RNA <50 copies/mL) on a stable antiretroviral regimen without present or past evidence of viral resistance to, and no prior virological failure with agents of the non-nucleoside reverse transcriptase inhibitor (NNRTI) and integrase inhibitor (INI) class for: Oral lead in to assess tolerability of Vocabria and rilpivirine prior to administration of long acting cabotegravir injection plus long acting rilpivirine injection. Oral therapy for adults and adolescents who will miss planned dosing with cabotegravir injection plus rilpivirine injection. Vocabria injection is indicated, in combination with rilpivirine injection, for the treatment of Human Immunodeficiency Virus type 1 (HIV-1) infection in adults and adolescents (at least 12 years of age and weighing at least 35 kg) who are virologically suppressed (HIV-1 RNA <50 copies/mL) on a stable antiretroviral regimen without present or past evidence of viral resistance to, and no prior virological failure with agents of the non-nucleoside reverse trascriptase.

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. 2026-10-16 · 欧委会决定

  2. 2020-12-17 · 获批上市许可

  3. 2020-10-15 · 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 9产品信息 2其他 0

EPAR / 审评资料

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

    procedural-steps-after · 2026-10-27

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  • Vocabria : EPAR - Risk management plan

    rmp · 2026-10-27

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

    procedural-steps-after · 2025-09-09

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  • Vocabria : EPAR - Medicine overview

    overview · 2025-03-12 · EMA/565621/2020

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  • Vocabria-H-C-004976-II-0022 : EPAR - Assessment report - Variation

    variation-report · 2025-01-22 · EMA/1951/2025

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  • Vocabria-H-C-PSUSA-00010900-202403 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation

    scientific-conclusion · 2024-12-19 · EMA/596127/2024

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  • Vocabria-H-C-PSUSA-00010900-202203 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation

    scientific-conclusion · 2023-01-12 · EMA/859633/2022

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  • Vocabria-H-C-PSUSA-00010900-202109 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation

    scientific-conclusion · 2022-01-27 · EMA/10440/2022

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  • Vocabria : EPAR - Public assessment report

    assessment-report · 2021-01-05 · EMA/586324/2020

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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。