法规知识库 · EMA 集中审评
Puregon
follitropin beta · EMEA/H/C/000086 · 已授权
获批上市许可
1996-05-02
欧委会决定日
2025-12-18
持有人 / 申请人
Organon N.V.
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：G03GA06
治疗领域：Infertility;Hypogonadism
药理分类：Sex hormones and modulators of the genital system
修订号：37 · 最新影响 PI 的程序：VR/0000316030
适应症（原文）：In the female: Puregon is indicated for the treatment of female infertility in the following clinical situations: anovulation (including polycystic ovarian syndrome, PCOS) in women who have been unresponsive to treatment with clomifene citrate; controlled ovarian hyperstimulation to induce the development of multiple follicles in medically assisted reproduction programs (e.g. in-vitro fertilisation / embryo transfer (IVF/ET), gamete intrafallopian transfer (GIFT) and intracytoplasmic sperm injection (ICSI)). In the male: Deficient spermatogenesis due to hypogonadotrophic hypogonadism.
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。
2025-12-18 · 欧委会决定
1996-05-02 · 获批上市许可
1995-12-20 · 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
- 打开官方文件 ↗
Puregon : EPAR - Procedural steps taken and scientific information after authorisation
procedural-steps-after · 2025-12-18
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Puregon : EPAR - Procedural steps taken and scientific information after authorisation (archive)
procedural-steps-after · 2025-10-30
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Puregon-H-C-PSUSA-00001465-202305 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation
scientific-conclusion · 2024-11-28 · EMA/554310/2024
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Puregon : EPAR - Summary for the public
overview · 2009-07-31
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Puregon : EPAR - Procedural steps taken before authorisation
procedural-steps-before · 2008-08-31
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Puregon : EPAR - Scientific Discussion
scientific-discussion · 2008-08-31
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Puregon : EPAR - Steps taken after authorisation when a cutoff date has been used
steps-after-cutoff · 2008-08-31
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。