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Drug Highest PhaseApproved |
First Approval Ctry. / Loc. |
First Approval Date22 Aug 2014 |
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MechanismNS3/NS4A inhibitors |
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Drug Highest PhaseApproved |
First Approval Ctry. / Loc.JP |
First Approval Date04 Jul 2014 |
基于盐酸达拉他韦的治疗方案在中国慢性丙型肝炎患者中的安全性监测研究
[Translation] Safety monitoring study of daclatasvir hydrochloride-based treatment regimen in Chinese patients with chronic hepatitis C
这是一项非干预性上市后监测研究,旨在向中国FDA(CFDA)履行一项批准后承诺(PAC)。主要研究以盐酸达拉他韦(DCV)为基础的治疗方案在常规临床应用中用于慢性丙肝(CHC)患者的预期和非预期药物相关不良事件(AE)及严重不良事件(SAE)的发生率。其中即包含对于盐酸达拉他韦(DCV)和阿舒瑞韦(ASV)软胶囊的联合治疗方案的监测。
[Translation] This is a non-interventional post-marketing surveillance study designed to fulfill a post-approval commitment (PAC) to the China FDA (CFDA). The study is focused on the incidence of expected and unexpected drug-related adverse events (AEs) and serious adverse events (SAEs) in routine clinical applications of daclatasvir hydrochloride (DCV)-based treatment regimens for chronic hepatitis C (CHC) patients. This includes monitoring of the combined treatment regimen of daclatasvir hydrochloride (DCV) and asunaprevir (ASV) soft capsules.
基于盐酸达拉他韦的治疗方案在中国慢性丙型肝炎患者中的安全性监测研究
[Translation] Safety monitoring study of daclatasvir hydrochloride-based treatment regimen in Chinese patients with chronic hepatitis C
这是一项非干预性上市后监测研究,旨在向中国FDA(CFDA)履行一项批准后承诺(PAC)。主要研究以盐酸达拉他韦(DCV)为基础的治疗方案在常规临床应用中用于慢性丙肝(CHC)患者的预期和非预期药物相关不良事件(AE)及严重不良事件(SAE)的发生率。
[Translation] This is a non-interventional post-marketing surveillance study designed to fulfill a post-approval commitment (PAC) to the China FDA (CFDA). The study is focused on the incidence of expected and unexpected drug-related adverse events (AEs) and serious adverse events (SAEs) of daclatasvir hydrochloride (DCV)-based regimens in routine clinical use in patients with chronic hepatitis C (CHC).
100 Clinical Results associated with Bristol-Myers Squibb (Singapore) Pte Ltd.
0 Patents (Medical) associated with Bristol-Myers Squibb (Singapore) Pte Ltd.
100 Deals associated with Bristol-Myers Squibb (Singapore) Pte Ltd.
100 Translational Medicine associated with Bristol-Myers Squibb (Singapore) Pte Ltd.