产品档案由注册证、说明书原文与平台整理数据生成

Restylane Injectable GelP040024

Restylane Injectable Gel是一款玻尿酸填充产品,注册人 Q-Med AB。库里关联的注册证:美国 P040024。美国首次批准于 2005-03-25(P040024)。数据截至 2026-10-19。

  • 监管属性玻尿酸填充 · 监管属性未定
  • 注册人Q-Med AB
  • 辖区US
  • 档案更新于2026-10-19 · v1

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注册与基本资料

Restylane Injectable Gel

产品
监管属性
未定(还没有核实过的注册证关联)未能核实
品类
玻尿酸填充
美国 · FDA PMA
P040024
证上名称
RESTYLANE INJECTABLE GEL
注册人
Q-Med AB
首次批准
2005-03-25
本证核发
2005-03-25
官网核对
还没有与官网现页逐字段核对

公开信息:注册证原文字段。

说明书对照(分辖区)

同一属性在不同辖区说明书里的原文;没写的标「原文未报告」,不适用的标「不适用」

暂无数据

注册时间线

  1. US

    P040024 首次批准

  2. US

    P040024 · P040024/S144

    30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|approval for modifications to the Water for Injection (WFI) system

  3. US

    P040024 · P040024/S142

    Panel Track|Labeling Change - Indications/instructions/shelf life/tradename|Approval for Restylane® Lyft with Lidocaine for subcutaneous and…

  4. US

    P040024 · P040024/S146

    Normal 180 Day Track No User Fee|Postapproval Study Protocol|Approval for the postapproval study (PAS) protocol submitted to comply with the…

  5. US

    P040024 · P040024/S143

    Normal 180 Day Track|Change Design/Components/Specifications/Material|multiple changes including, (1) primary packaging, (2) a new needle an…

  6. US

    P040024 · P040024/S147

    30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|changes to the particle size reduction process for Restylane Lyft w…

  7. US

    P040024 · P040024/S148

    30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|changes in analytical test methods used in the quality control test…

分开写首次批准、本证核发(延续或变更后会更新)、变更与有效期;首次批准为空表示未从官方来源取到。每张证只列最近 6 条变更,完整记录点编号看注册证原文。

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最近变化

5
  • P040024:30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|changes…2026-03-12
  • P040024:30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|changes…2026-02-05
  • P040024:Normal 180 Day Track|Change Design/Components/Specifications/Material|multiple c…2026-01-29
  • P040024:Normal 180 Day Track No User Fee|Postapproval Study Protocol|Approval for the po…2025-12-23
  • P040024:Panel Track|Labeling Change - Indications/instructions/shelf life/tradename|Appr…2025-11-04

资料

1