欧盟EMA药品数据库(European Medicines Agency Authorisation of Medicines DataBase)
商品名称Vocabria
适用类别Human
治疗领域HIV Infections
通用名/非专利名称cabotegravir
活性成分cabotegavir sodium;cabotegravir
产品号EMEA/H/C/004976
患者安全信息No
许可状态Authorised
ATC编码J05AX
是否额外监管Yes
是否仿制药或hybrid药物No
是否生物类似药No
是否附条件批准No
是否特殊情形No
是否加速审评No
是否罕用药No
上市许可日期2020/12/17
上市许可开发者/申请人/持有人ViiV Healthcare B.V.
人用药物治疗学分组Antivirals for systemic use
兽用药物治疗学分组
审评意见日期2020/10/15
欧盟委员会决定日期2025/08/14
修订号17
治疗适应症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 adoloscents (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.
适用物种
兽用药物ATC编码
首次发布日期2021/01/05
最后更新日期2025/10/30
产品说明书https://www.ema.europa.eu/en/documents/product-information/vocabria-epar-product-information_en.pdf
公共评估报告https://www.ema.europa.eu/en/medicines/human/EPAR/vocabria
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