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Revance(复星万邦)注射用A型肉毒毒素 100单位/支

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Revance(复星万邦) is a Botulinum toxin type A product (Drug), registered by Revance Therapeutics, Inc.. Linked registrations: China 国药准字SJ20240041. Data as of 2026-10-23.

  • Regulatory classBotulinum toxin type A · Drug
  • HolderRevance Therapeutics, Inc.
  • JurisdictionsCN · US
  • Updated2026-10-23 · v1

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

Registration and basics

Revance(复星万邦)

Product
Regulatory class
Drug
Category
Botulinum toxin type A
China · NMPA drug approval
国药准字SJ20240041
Name on registration
注射用A型肉毒毒素
Registrant
Revance Therapeutics, Inc.
Manufacturer
Revance Therapeutics, Inc.; PCI San Diego, Inc.
China agent
复星万邦（江苏）健康发展有限公司
First approval
Not obtained from an official source
This certificate issued
2024-09-03
Valid until
2029-09-02
Models and sizes
100单位/支
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

AttributeUS label (not China-approved)
Indications颈部肌张力障碍：用于成人颈部肌张力障碍的治疗; 眉间纹：用于成人因皱眉肌和/或降眉间肌活动导致的中度至重度眉间纹外观的暂时性改善
Contraindications拟注射部位存在感染; 已知对任何肉毒毒素制剂、DAXXIFY 或 DAXXIFY 制剂中任何成分过敏
Composition每瓶含daxibotulinumtoxinA-lanm 50单位或100单位，以及L-组氨酸0.14 mg、L-组氨酸盐酸盐一水合物0.65 mg、聚山梨酯20 0.1 mg、RTP004肽11.7 mcg、海藻糖二水合物36 mg; 含35个氨基酸的肽类赋形剂（RTP004），可防止表面吸附并提高DAXXIFY的热稳定性
Storage未开封的DAXXIFY药瓶应于室温20°C至25°C（68°F至77°F）或冷藏2°C至8°C（36°F至46°F）保存，并置于原纸盒内避光
Shelf life原文未报告Not reported
Injection depth眉间纹：用无菌注射器从瓶中抽取至少0.5 mL复溶溶液，并将抽液用针头更换为30至33G无菌针头进行注射; 复溶后的DAXXIFY仅供肌内注射; 眉间纹：用手指按压眶上内侧缘，将针头穿过皮肤推进至其下肌肉内; 颈部肌张力障碍：颈部肌张力障碍推荐剂量为125单位至250单位，肌内注射，在受累肌肉间分配给药; 眉间纹：不得在距眶上缘小于1厘米处注射DAXXIFY
Recommended dose颈部肌张力障碍：需要调整剂量时可按患者反应以50至75单位为幅度调整；单次治疗总剂量建议在125单位至250单位之间; 所有适应症：任何适应症给药频率不应高于每3个月一次; 颈部肌张力障碍：推荐剂量为125单位至250单位，肌内注射，在受累肌肉间分配给药; 眉间纹：推荐剂量为每个注射点肌内注射0.1 mL（8单位），共5个注射点，总剂量40单位
Duration原文未报告Not reported
Adverse reactions眉间纹（84周开放标签重复给药研究）：84周开放标签重复给药安全性研究（眉间纹）中，2691例接受40单位治疗，535例（20%）报告不良反应; 颈部肌张力障碍：颈部肌张力障碍最常见不良反应（≥5%）：头痛9%、注射部位疼痛8%、注射部位红斑5%、肌无力5%、上呼吸道感染5%; 使用肉毒毒素产品后曾报告严重吞咽困难导致死亡的病例；吞咽困难可持续数月; 眉间纹（GL-1、GL-2安慰剂对照试验）：眉间纹最常见不良反应（≥1%）：头痛6%、眼睑下垂2%、面瘫1%
Warnings使用包括DAXXIFY在内的肉毒毒素可能出现泪液生成减少、眨眼减少和角膜病变; 尚无孕妇使用DAXXIFY的数据，无法评估药物相关的重大出生缺陷、流产或不良母婴结局风险; 对有既存心血管疾病的患者应慎用; 尚未确定DAXXIFY在18岁以下患者中的安全性和有效性; 神经肌肉疾病患者使用常规剂量的DAXXIFY可能增加临床显著效应的风险，包括全身性肌无力、复视、上睑下垂、发声困难、构音障碍、严重吞咽困难和呼吸功能受损; DAXXIFY的效价单位与其他肉毒毒素制剂不可互换; 黑框警告：包括DAXXIFY在内的所有肉毒毒素产品的作用可能自注射部位播散，产生与肉毒毒素作用相符的症状；这些症状在注射后数小时至数周内报告；吞咽和呼吸困难可危及生命，并已有死亡报告; 毒素作用播散、吞咽和呼吸困难可导致死亡；若出现呼吸、言语或吞咽困难应立即就医
preparation100单位瓶：100单位瓶：成人眉间纹加1.2 mL，所得剂量为8单位/0.1 mL；成人颈部肌张力障碍加1 mL或2 mL，所得剂量为10单位或5单位/0.1 mL; 肌内注射前，用所需量的无菌、无防腐剂0.9%氯化钠注射液复溶各瓶，以获得表1和表2所述适当浓度的复溶溶液; 眉间纹（50单位瓶）：50单位瓶用于成人眉间纹：加入0.6 mL稀释液，所得剂量为8单位/0.1 mL; 将稀释液缓慢注入瓶中；若真空未将稀释液吸入瓶内，则丢弃该瓶；弃去任何未使用的稀释液；旋转瓶身轻柔混合DAXXIFY与0.9%氯化钠注射液
storage after preparation复溶后72小时内给药；在此期间未使用的复溶DAXXIFY应于2°C至8°C（36°F至46°F）冷藏并避光；不得冷冻复溶后的DAXXIFY; 复溶后每瓶仅用于一次注射、仅用于一名患者；给药后立即丢弃瓶中剩余溶液

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

Registration timeline

  1. CN

    国药准字SJ20240041 this certificate issued

    Issue date of this certificate, not the first approval

  2. CN

    国药准字SJ20240041 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
  • 国药准字SJ20240041: certificate issued2024-09-03

Sources

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