欧盟EMA药品数据库(European Medicines Agency Authorisation of Medicines DataBase)
商品名称Viramune
适用类别Human
治疗领域HIV Infections
通用名/非专利名称nevirapine
活性成分nevirapine
产品号EMEA/H/C/000183
患者安全信息No
许可状态Authorised
ATC编码J05AG01
是否额外监管No
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1998/02/04
上市许可开发者/申请人/持有人Boehringer Ingelheim International GmbH
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1997/10/22
欧盟委员会决定日期2024/10/15
修订号45
治疗适应症Viramune 50 mg/5 mL oral suspension and 200 mg tablets Viramune is indicated in combination with other anti-retroviral medicinal products for the treatment of HIV-1 infected adults, adolescents, and children of any age.Most of the experience with Viramune is in combination with nucleoside reverse transcriptase inhibitors (NRTIs). The choice of a subsequent therapy after Viramune should be based on clinical experience and resistance testing. Viramune 400 mg prolonged-release tablets Viramune is indicated in combination with other anti-retroviral medicinal products for the treatment of HIV-1 infected adults, adolescents, and children three years and above and able to swallow tablets (see section 4.2). Prolonged-release tablets are not suitable for the 14-day lead-in phase for patients starting nevirapine. Other nevirapine formulations, such as immediate-release tablets or oral suspension should be used (see section 4.2). Most of the experience with Viramune is in combination with nucleoside reverse transcriptase inhibitors (NRTIs). The choice of a subsequent therapy after Viramune should be based on clinical experience and resistance testing (see section 5.1).
适用物种
兽用药物ATC编码
首次发布日期2018/05/01
最后更新日期2025/03/04
产品说明书https://www.ema.europa.eu/en/documents/product-information/viramune-epar-product-information_en.pdf
公共评估报告https://www.ema.europa.eu/en/medicines/human/EPAR/viramune
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