首次正式批准 · 原始申请
批准信:Hovilpri (pritelivir) 片剂获批,用于免疫受损成人治疗对阿昔洛韦、伐昔洛韦或泛昔洛韦治疗无效(无论是否有耐药性记录)的单纯疱疹病毒(HSV)引起的黏膜皮肤病变。
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批准信原文要点
This NDA provides for the use of Hovilpri (pritelivir) tablets in immunocompromised adults for the treatment of mucocutaneous lesions caused by herpes simplex virus (HSV) infection that is refractory (with or without documented resistance) to treatment with acyclovir, valacyclovir, or famciclovir.
本申报适应症:用于免疫受损成人治疗对阿昔洛韦、伐昔洛韦或泛昔洛韦治疗无效(无论是否有耐药证据)的单纯疱疹病毒(HSV)感染引起的黏膜皮肤病变。
疾病背景介绍:尚无审评报告
现有治疗手段:阿昔洛韦、伐昔洛韦、泛昔洛韦;静脉注射膦甲酸钠、静脉/局部西多福韦、5%局部咪喹莫特
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