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法规知识库 · EMA 集中审评

Ovaleap

follitropin alfa · EMEA/H/C/002608 · 已授权

生物类似药

获批上市许可

2013-09-27

欧委会决定日

2025-04-16

持有人 / 申请人

Theramex Ireland Limited

终止日期字段

无

从产品到官方文件

文件记录

6

官方索引 6

EPAR / 审评

4

assessment / overview 等

产品信息

2

PI / presentations

其他

0

RMP / PIP 等

ATC:G03GA05

治疗领域:Anovulation

药理分类:Sex hormones and modulators of the genital system

修订号:13 · 最新影响 PI 的程序:VR/0000248727

适应症(原文):In adult women Anovulation (including polycystic ovarian syndrome) in women who have been unresponsive to treatment with clomifene citrate; Stimulation of multifollicular development in women undergoing superovulation for assisted reproductive technologies (ART) such as in vitro fertilisation (IVF), gamete intra-fallopian transfer and zygote intra-fallopian transfer; Ovaleap in association with a luteinising hormone (LH) preparation is recommended for the stimulation of follicular development in women with severe LH and FSH deficiency. In clinical trials these patients were defined by an endogenous serum LH level < 1.2 IU/L. In adult men Ovaleap is indicated for the stimulation of spermatogenesis in men who have congenital or acquired hypogonadotropic hypogonadism with concomitant human chorionic gonadotropin (hCG) therapy.

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。

  1. 2025-04-16 · 欧委会决定

  2. 2013-09-27 · 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 4产品信息 2其他 0

EPAR / 审评资料

  • Ovaleap : EPAR - Procedural steps taken and scientific information after authorisation

    procedural-steps-after · 2025-05-27

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  • Ovaleap : EPAR - Procedural steps taken and scientific information after authorisation (archive)

    procedural-steps-after · 2024-12-05

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  • Ovaleap : EPAR - Public assessment report

    assessment-report · 2013-10-23 · EMA/CHMP/41467/2013

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  • Ovaleap : EPAR - Summary for the public

    overview · 2013-10-23 · EMA/562331/2013

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产品信息

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。