根据DESTINY-Gastric01和/或DESTINY-Gastric02试验的结果,Enhertu(DS-8201)已在多个国家获批用于治疗既往接受过基于曲妥珠单抗治疗方案的局部晚期或转移性HER2阳性胃或胃食管交界处(GEJ)腺癌成人患者。 参考资料:ENHERTU® Type II Variation Application Validated by EMA for the Treatment of HER2 Mutant Metastatic...
In addition, any other change which may have a significant impact on the quality, safety or efficacy of the medicinal product must be submitted as a Type II variation. Please refer also to question "When will my variation application be considered a Type II variation or an extension ...
根据DESTINY-Gastric01和/或DESTINY-Gastric02试验的结果,Enhertu(DS-8201)已在多个国家获批用于治疗既往接受过基于曲妥珠单抗治疗方案的局部晚期或转移性HER2阳性胃或胃食管交界处(GEJ)腺癌成人患者。 参考资料:ENHERTU® Type II Variation Application Validated by EMA for the Treatment of HER2 Mutant Metastatic...
GW Pharmaceuticals submits Type II Variation Application to the European Medicines Agency (EMA) to expand the use of EPIDYOLEX®, (cannabidiol) oral solution, for the treatment of seizures associated with Tuberous Sclerosis Complex (TSC) GW Pharmicals 向欧洲药品管理局 (EMA) 提交了 II 型变异...
EMA validates Type II variation app. for Truvada for PrEPGilead Sciences
参考资料:ENHERTU® Type II Variation Application Validated by EMA for the Treatment of HER2 Mutant Metastatic Non-Small Cell Lung Cancer 版权/免责说明:本文来自香港迈极康医疗内容团队,欢迎个人转发至朋友圈。香港迈极康医疗内容团队专注介绍传播最新医药学术资讯。本文仅作信息交流之目的,文中观点不代表香...
Improving the understanding ofPARs, normal of 问答：提⾼对NOR、PAR、DSp和⼯艺参数的正常波动的理解 1. What is a Normal Operating Range (NOR) and how should NORs bepresented in the marketing authorisation dossier? 什么是NOR（正常运⾏范围）？NOR在上市许可⽂件中应如 何呈现？Answer: 答...
The Type II(a) variation application in Europe marks the culmination of Esperion's landmarkCholesterolLowering via bempedoic acid, anACL-InhibitingRegimen (CLEAR) Outcomes trial in which NILEMDO demonstrated significant cardiovascular risk reduction across a range of important clinical events including a...
The CHMP performed a re-evaluation of the type II variation application data. A discussion on the appropriateness of initial maintenance therapy with the fixed dose combination took place in CHMP based on the Rapporteur’s and Co-Rapporteur’s Assessment Reports and the data presented by the ...
, specification, variation 关键词 稳定性,稳定性试验,稳定性数据,化学活性物质,质量标准,变更 Table of contents Executive summary 实施摘要 1. Introduction (background) 介绍(背景) 2. Scope 范围 3. Legal basis 法规依据 4. General requirements 一般要求 5. Type I variations 第1类变更 6. Type ...