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
注册与基本资料公开可看;交叉发现与价格需要登录
注册与基本资料
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
- US
P040024 首次批准
- US
P040024 · P040024/S144
30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|approval for modifications to the Water for Injection (WFI) system
- US
P040024 · P040024/S142
Panel Track|Labeling Change - Indications/instructions/shelf life/tradename|Approval for Restylane® Lyft with Lidocaine for subcutaneous and…
- 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…
- US
P040024 · P040024/S143
Normal 180 Day Track|Change Design/Components/Specifications/Material|multiple changes including, (1) primary packaging, (2) a new needle an…
- US
P040024 · P040024/S147
30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|changes to the particle size reduction process for Restylane Lyft w…
- 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。
交叉发现 · 价格观测
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