法规知识库 · EMA 集中审评
Ravicti
glycerol phenylbutyrate · EMEA/H/C/003822 · 已授权
获批上市许可
2015-11-26
欧委会决定日
2025-12-05
持有人 / 申请人
Immedica Pharma AB
终止日期字段
无
从产品到官方文件
文件记录
9
官方索引 9
EPAR / 审评
7
assessment / overview 等
产品信息
2
PI / presentations
其他
0
RMP / PIP 等
ATC：A16AX09
治疗领域：Urea Cycle Disorders, Inborn
药理分类：Other alimentary tract and metabolism products
修订号：19 · 最新影响 PI 的程序：VR/0000315867
适应症（原文）：Ravicti is indicated for use as adjunctive therapy for chronic management of patients with urea cycle disorders (UCDs) including deficiencies of carbamoyl phosphate-synthase-I (CPS), ornithine carbamoyltransferase (OTC), argininosuccinate synthetase (ASS), argininosuccinate lyase (ASL), arginase I (ARG) and ornithine translocase deficiency hyperornithinaemia-hyperammonaemia homocitrullinuria syndrome (HHH) who cannot be managed by dietary protein restriction and/or amino acid supplementation alone. Ravicti must be used with dietary protein restriction and, in some cases, dietary supplements (e.g., essential amino acids, arginine, citrulline, protein-free calorie supplements).
关键日期时间轴
来自 EMA medicines JSON 日期字段；缺失字段不展示，不补推结论。
2025-12-05 · 欧委会决定
2015-11-26 · 获批上市许可
2015-09-23 · CHMP 意见通过
说明书、EPAR 与其他文件
仅展示 EMA 官方 document_url；本站不下载或镜像 PDF。
EPAR / 审评资料
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Ravicti : EPAR - Procedural steps taken and scientific information after authorisation
procedural-steps-after · 2025-12-05
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Ravicti : EPAR - Procedural steps taken and scientific information after authorisation (archive)
procedural-steps-after · 2025-12-05
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Ravicti : EPAR - Risk-management-plan summary
rmp-summary · 2023-04-26
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Ravicti-H-C-3822-II-0019 : EPAR - Assessment report - Variation
variation-report · 2019-01-29 · EMA/CHMP/831384/2018
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Ravicti : EPAR - Summary for the public
overview · 2019-01-29
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Ravicti-H-C-3822-P46-0004 : EPAR - Assessment Report
variation-report · 2018-06-19 · EMA/CHMP/415422/2018
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Ravicti : EPAR - Public assessment report
assessment-report · 2015-12-18 · EMA/676925/2015
数据来自 EMA 官方 JSON；最终以 EMA / 欧委会文件为准。本页不自动给出安全或非安全结论。