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法规知识库 · EMA 集中审评

Cinacalcet Accordpharma

cinacalcet hydrochloride · EMEA/H/C/005236 · 已授权

仿制药

获批上市许可

2020-04-03

欧委会决定日

2026-08-26

持有人 / 申请人

Accord Healthcare S.L.U.

终止日期字段

无

从产品到官方文件

文件记录

7

官方索引 7

EPAR / 审评

5

assessment / overview 等

产品信息

2

PI / presentations

其他

0

RMP / PIP 等

ATC:H05BX01

治疗领域:Hyperparathyroidism

药理分类:Calcium homeostasis

修订号:6 · 最新影响 PI 的程序:VR/0000349358

适应症(原文):Secondary hyperparathyroidism AdultsTreatment of secondary hyperparathyroidism (HPT) in adult patients with end-stage renal disease (ESRD) on maintenance dialysis therapy. Paediatric populationTreatment of secondary hyperparathyroidism (HPT) in children aged 3 years and older with end-stage renal disease (ESRD) on maintenance dialysis therapy in whom secondary HPT is not adequately controlled with standard of care therapy (see section 4.4). Cinacalcet Accordpharma may be used as part of a therapeutic regimen including phosphate binders and/or Vitamin D sterols, as appropriate (see section 5.1). Parathyroid carcinoma and primary hyperparathyroidism in adults Reduction of hypercalcaemia in adult patients with: parathyroid carcinoma. primary HPT for whom parathyroidectomy would be indicated on the basis of serum calcium levels (as defined by relevant treatment guidelines), but in whom parathyroidectomy is not clinically appropriate or is contraindicated.

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. 2026-08-26 · 欧委会决定

  2. 2020-04-03 · 获批上市许可

  3. 2020-01-30 · 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 5产品信息 2其他 0

EPAR / 审评资料

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

    procedural-steps-after · 2026-09-02

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

    procedural-steps-after · 2026-03-31

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  • Cinacalcet Accordpharma : EPAR - Risk management plan

    rmp · 2024-06-27

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  • Cinacalcet Accordpharma : EPAR - Medicine overview

    overview · 2020-04-15 · EMA/65298/2020

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  • Cinacalcet Accordpharma : EPAR - Public assessment report

    assessment-report · 2020-04-15 · EMA/92635/2020

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产品信息

  • Cinacalcet Accordpharma : EPAR - Product information

    product-information · 2026-09-02

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  • Cinacalcet Accordpharma : EPAR - All authorised presentations

    all-authorised-presentations · 2026-09-02

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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。