产品档案由注册证、说明书原文与平台整理数据生成
SCULPTRA® (injectable poly-L Lactic acid)P030050
SCULPTRA® (injectable poly-L Lactic acid)是一款聚左旋乳酸（PLLA）产品，注册人 Q-Med AB。库里关联的注册证：美国 P030050。美国首次批准于 2004-08-03（P030050）。数据截至 2026-10-19。
- 监管属性聚左旋乳酸（PLLA） · 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
P030050 首次批准
- US
P030050 · P030050/S052
30-Day Notice｜Process Change - Manufacturer/Sterilizer/Packager/Supplier｜to increase the sieving maximum batch size to 30kg for PLLA
- US
P030050 · P030050/S051
Normal 180 Day Track No User Fee｜Location Change - Manufacturer/Sterilizer/Packager/Supplier｜approval for an alternate sterilization manufac…
- US
P030050 · P030050/S053
30-Day Notice｜Process Change - Manufacturer/Sterilizer/Packager/Supplier｜to revamp Grade B, C and D clean rooms used for washing equipment/u…
- US
P030050 · P030050/S054
Real-Time Process｜Change Design/Components/Specifications/Material｜Approval to terminate elemental impurity testing for Sculptra vial stoppe…
- US
P030050 · P030050/S055
30-Day Notice｜Process Change - Manufacturer/Sterilizer/Packager/Supplier｜addition of a secondary autoclave for the sterilization of compound…
- US
P030050 · P030050/S056
30-Day Notice｜Process Change - Manufacturer/Sterilizer/Packager/Supplier｜Approval to modify compounding reactors R11 and R12 to be consisten…
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- P030050：30-Day Notice｜Process Change - Manufacturer/Sterilizer/Packager/Supplier｜Approva…2026-09-17
- P030050：30-Day Notice｜Process Change - Manufacturer/Sterilizer/Packager/Supplier｜additio…2026-06-22
- P030050：Real-Time Process｜Change Design/Components/Specifications/Material｜Approval to t…2026-04-15
- P030050：30-Day Notice｜Process Change - Manufacturer/Sterilizer/Packager/Supplier｜to reva…2024-11-13
- P030050：Normal 180 Day Track No User Fee｜Location Change - Manufacturer/Sterilizer/Packa…2024-10-09