法规知识库 · EMA 集中审评
Ammonaps
sodium phenylbutyrate · EMEA/H/C/000219 · 已授权
获批上市许可
1999-12-07
欧委会决定日
2022-12-12
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：A16AX03
治疗领域：Ornithine Carbamoyltransferase Deficiency Disease;Citrullinemia;Carbamoyl-Phosphate Synthase I Deficiency Disease
药理分类：Other alimentary tract and metabolism products
修订号：21 · 最新影响 PI 的程序：IAIN/0063
适应症（原文）：Ammonaps is indicated as adjunctive therapy in the chronic management of urea cycle disorders, involving deficiencies of carbamylphosphate synthetase, ornithine transcarbamylase orargininosuccinate synthetase. It is indicated in all patients with neonatal-onset presentation (complete enzyme deficiencies, presenting within the first 28 days of life). It is also indicated in patients with late-onset disease(partial enzyme deficiencies, presenting after the first month of life) who have a history of hyperammonaemic encephalopathy.
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。
2022-12-12 · 欧委会决定
1999-12-07 · 获批上市许可
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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Ammonaps : EPAR - Procedural steps taken and scientific information after authorisation
procedural-steps-after · 2022-12-16
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Ammonaps : EPAR - Assessment Report - Article 31
variation-report · 2016-12-14 · EMA/732186/2016
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Ammonaps : EPAR - Scientific Conclusion
scientific-conclusion · 2016-12-14
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Ammonaps : EPAR - Summary for the public
overview · 2009-11-09
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Ammonaps : EPAR - Steps taken after authorisation when a cutoff date has been used
steps-after-cutoff · 2006-11-10
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Ammonaps : EPAR - Procedural steps taken before authorisation
procedural-steps-before · 2006-11-10
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Ammonaps : EPAR - Scientific Discussion
scientific-discussion · 2006-11-10
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。