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COSMODERM/ COSMOPLAST COLLAGEN IMPLANT, COSMODERM COSMOPLAST HUMAN-BASED COLLAGEN IMPLANTP800022

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COSMODERM/ COSMOPLAST COLLAGEN IMPLANT, COSMODERM COSMOPLAST HUMAN-BASED COLLAGEN IMPLANT is a Hyaluronic acid filler product, registered by Allergan. Linked registrations: US P800022. First approved in US on 1981-07-22 (P800022). Data as of 2026-10-19.

  • Regulatory classHyaluronic acid filler · class not determined
  • HolderAllergan
  • JurisdictionsUS · TW
  • Updated2026-10-19 · v1

Registration and basics are public; findings and prices need an account

Registration and basics

COSMODERM/ COSMOPLAST COLLAGEN IMPLANT, COSMODERM COSMOPLAST HUMAN-BASED COLLAGEN IMPLANT

Product
Regulatory class
Not determined (no verified registration linked)Could not verify
Category
Hyaluronic acid filler
US · FDA PMA
P800022 (cancelled)
Name on registration
ZYDERM COLLAGEN IMPLANT (ZYDERM CI)
Registrant
Allergan
First approval
1981-07-22
This certificate issued
1981-07-22
Checked against official page
Not yet checked field by field against the live official page

Public: fields from the registration record.This product record is still pending review.

Label facts by jurisdiction

What each jurisdiction's label says for the same attribute; gaps are marked Not reported, irrelevant ones N/A

AttributeTaiwan label (not China-approved)
Indications注射于真皮的上层位置, 用来矫正软组织的缺陷, 如皱纹和青春痘疤痕等
Contraindications患者有严重的过敏病史或明显过敏状者；患者知道对局部麻醉药(利多卡因 Lidocaine)有敏感性者；禁止用于隆乳或植入骨、筋、韧带及肌肉内；【警语】绝对禁止植入血管内, 避免用力猛注射到脸部或头皮表皮层的动脉分枝血管, 以免进入视网膜血管导致血管闭合；【注意】对使用牛制品胶原蛋白有敏感症状者, 使用本产品的安全性尚未研究；【注意】注射部位正在发炎(皮肤出疹、肿疮、丘疹、猩红热疹、荨麻疹)或有感染者, 须治愈后才可治疗；【注意】孕妇、婴儿、孩童使用本产品的安全性未有研究；【注意】正在使用免疫抑制治疗、抗凝血药物(阿司匹林、非固醇类消炎药)者需特别小心, 注射部位易瘀青出血；【注意】本剂使用于嘴唇填补的安全性和有效性尚未确认
Composition可赐美得萌1(CosmoDerm 1): 纯人类胶原蛋白(人类纤维母细胞培养), 调制于磷酸盐缓冲生理盐水, 含0.3%利多卡因 35 mg/ml；可赐美得萌2(CosmoDerm 2): 纯人类胶原蛋白, 调制于磷酸盐缓冲生理盐水, 含0.3%利多卡因 65 mg/ml
Injection depth真皮上层
Adverse reactions注射部位短暂或轻微的肿大、红肿和不舒服; 如持续且红肿扩大应立即就医；注射后注射部位短暂无痛的瘀青或变色, 可由一个注射位置扩大至多点, 随时间自然解除；局部坏死事件很少, 只是使用牛制品胶原蛋白注射于眉间纹位置时有发生(临床监视少数病例)；临床研究: 428位病人前臂皮内注射后观察2个月, 发生率较高的不良反应为感冒症状4.1%、类流感症状2.0%、尿道感染1.0%等；1例受试者首次注射一周后注射部位红肿疼痛, 10天后自然痊愈

Each cell is extracted from that jurisdiction's label; click the number for the original passage. “—” means nothing has been extracted for it yet, not that the label is silent. Columns other than China reflect what was approved there, for reference only, not what China approved. 5 of them are not yet reviewed by a person.

Registration timeline

  1. US

    P800022 first approved

  2. US

    P800022 · P800022/S048

    Normal 180 Day Track｜Process Change - Manufacturer/Sterilizer/Packager/Supplier｜APPROVAL FOR A MANUFACTURING CHANGE

  3. US

    P800022 · P800022/S050

    Panel Track｜Change Design/Components/Specifications/Material｜APPROVAL FOR COSMODERM 1 HUMAN-BASED COLLAGEN, COSMODERM 2 HUMAN-BASED COLLAGEN…

  4. US

    P800022 · P800022/S052

    Normal 180 Day Track｜Change Design/Components/Specifications/Material｜APPROVAL FOR A NEW RAW MATERIAL SUPPLIER FOR THE HUMAN COLLAGEN COMPON…

  5. US

    P800022 · P800022/S054

    30-Day Notice｜Process Change - Manufacturer/Sterilizer/Packager/Supplier｜CHANGE OF COMPONENT SUPPLIER.

  6. US

    P800022 · P800022/S053

    Normal 180 Day Track No User Fee｜Location Change - Manufacturer/Sterilizer/Packager/Supplier｜APPROVAL FOR A STERILIZATION SITE AND METHOD CH…

  7. US

    P800022 · P800022/S055

    Normal 180 Day Track｜Change Design/Components/Specifications/Material｜APPROVAL FOR A CHANGE IN THE GLUTARALDEHYDE CROSSLINKER CONCENTRATION.

First approval, this certificate's issue date (updated after renewals or changes), changes and expiry are listed separately; a missing first approval means it was not obtained from an official source. Up to 6 recent changes per registration; click the number for the full record.

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Recent changes

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  • P800022: Normal 180 Day Track｜Change Design/Components/Specifications/Material｜APPROVAL F…2006-12-19
  • P800022: Normal 180 Day Track No User Fee｜Location Change - Manufacturer/Sterilizer/Packa…2006-11-03
  • P800022: 30-Day Notice｜Process Change - Manufacturer/Sterilizer/Packager/Supplier｜CHANGE …2006-03-22
  • P800022: Normal 180 Day Track｜Change Design/Components/Specifications/Material｜APPROVAL F…2004-05-11
  • P800022: Panel Track｜Change Design/Components/Specifications/Material｜APPROVAL FOR COSMOD…2003-03-11

Sources

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