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常州药物研究所有限公司含利多卡因注射用交联透明质酸钠凝胶

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常州药物研究所有限公司 is a Hyaluronic acid filler product (Class III device), registered by 常州药物研究所有限公司. Linked registrations: China 国械注准20253131610. Data as of 2026-10-23.

  • Regulatory classHyaluronic acid filler · Class III device
  • Holder常州药物研究所有限公司
  • JurisdictionsCN
  • Updated2026-10-23 · v1

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

Registration and basics

常州药物研究所有限公司

Product
Regulatory class
Class III device
Category
Hyaluronic acid filler
China · NMPA device registration
国械注准20253131610
Name on registration
含利多卡因注射用交联透明质酸钠凝胶
Registrant
常州药物研究所有限公司
First approval
Not obtained from an official source
This certificate issued
2025-08-22
Valid until
2030-08-21
Models and sizes
0.5mL、0.75mL、1.0mL、1.25mL、1.5mL、1.75mL、2.0mL
Checked against official page
2026-10-23

Public: fields from the registration record.

Label facts by jurisdiction

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

AttributeChina label
Indications颈部：适用于真皮组织中层至深层注射，以纠正颈部中重度横纹
Contraindications该产品多次注射、重复注射、多疗程注射的安全有效性未经验证; 18周岁以下患者禁用; 不能注射到已有永久性皮肤填充物或植入物的区域; 对利多卡因类局部麻醉剂过敏的患者禁用; 有严重过敏史及注射透明质酸钠后易患肥大性疤痕的患者禁用; 不得与化学剥脱、激光镭射或去疤痕手术同时进行，应保证二类手术有一定时间的间隔; 凝血机制异常的患者，或在2周内接受过血栓溶解剂、抗凝剂或血小板凝结抑制剂治疗的患者禁用; 活动性皮肤病、炎症、感染及相关疾病的部位，或其他邻近部位禁止使用本产品; 禁止将本产品与其他产品混合后注射入体内
Composition凝胶颗粒悬液主要由交联透明质酸钠、盐酸利多卡因、氯化钠、磷酸二氢钠、磷酸氢二钠以及注射用水组成，其中透明质酸钠由微生物发酵法制备，交联剂为1,4-丁二醇二缩水甘油醚（BDDE）; 透明质酸钠标示浓度15mg/mL，盐酸利多卡因标示浓度3mg/mL
Storage原文未报告Not reported
Shelf life货架有效期为2年
Injection depth颈部：真皮组织中层至深层注射; 注射针材质为不锈钢、规格为30G、形状为直形锐针
Recommended dose原文未报告Not reported
Duration原文未报告Not reported
Adverse reactions临床试验（试验组97例，对照组95例，安全性随访至360±15天）：临床试验安全性评价中，试验组共发生不良事件85例243例次，其中可能无关36例49例次，可能有关1例2例次；对照组共发生81例219例次，其中可能无关29例31例次，可能有关0例0例次；两组合计166例462例次，组间差异均无统计学意义; 注射后早期：注射后早期可能出现由注射操作引起的短期炎症，此症状持续时间短于7天; 临床试验：严重不良事件：对照组受试者发生1例，试验组未发生，组间差异无统计学意义
Warnings本产品不得用于乳房部位及臀部的注射; 本产品严禁注射入血管中，注射入血管后可能堵塞血管，导致梗塞或栓塞; 巴比妥类药物可促进盐酸利多卡因代谢，两药合用可引起心动过缓、窦性停搏; 本产品在治疗除中重度颈部横纹外的有效性和安全性尚未经临床试验验证; 透明质酸钠产品对季铵盐（如苯扎氯铵）具有一定不相容性，应确保注射物不与这些化学品或含此成分的产品直接接触; 注射器内产品已经高压蒸汽灭菌、注射针已经γ射线灭菌，注射器和注射针外表面为非无菌状态，本产品禁止二次灭菌和二次使用; 本产品在孕妇和哺乳期妇女中使用的安全性尚未得到验证; 建议接受激光治疗、化学剥脱等治疗2至4周前不要接受本产品注射，已接受上述治疗者应在皮肤完全愈合后再注射
preparation不适用N/A
storage after preparation不适用N/A

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. 31 of them are not yet reviewed by a person.

Registration timeline

  1. CN

    国械注准20253131610 this certificate issued

    Issue date of this certificate, not the first approval

  2. CN

    国械注准20253131610 valid until

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

1
  • 国械注准20253131610: certificate issued2025-08-22

Sources

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