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AlluzienceAlluzience (abobotulinumtoxinA solution for injection)

Alluzience is a Botulinum toxin type A product (Drug), registered by Galderma SA. Linked registrations: UK PL 03070/0009. Data as of 2026-11-09.

  • Regulatory classBotulinum toxin type A · Drug
  • HolderGalderma SA
  • JurisdictionsUK
  • Updated2026-11-09 · v1

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

Registration and basics

Alluzience

Product
Regulatory class
Drug
Category
Botulinum toxin type A
UK · MHRA marketing authorisation
PL 03070/0009
Name on registration
ALLUZIENCE 200 SPEYWOOD UNITS/ML SOLUTION FOR INJECTION
Registrant
Ipsen Biopharm Limited
First authorisation
Not obtained from an official source
Models and sizes
Solution for injection. Clear, colourless solution.
Checked against official page
Not yet checked field by field against the live official page

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

AttributeUK label (not China-approved)
Indications眉间纹:用于成人(65岁以下)患者,当中至重度眉间纹(两眉之间的竖纹)在最大皱眉时的严重程度对患者造成重要心理影响时,暂时改善其外观。
Contraindications存在重症肌无力、Eaton Lambert综合征或肌萎缩侧索硬化。; 对活性物质或第6.1节所列任何辅料过敏。; 拟注射部位存在感染。
Composition每125单位瓶含钠少于1 mmol(23 mg),即基本为“无钠”。; 辅料:L-组氨酸、蔗糖、氯化钠、聚山梨酯80、用于调节pH的盐酸、注射用水。; 活性成分为A型肉毒毒素血凝素复合物,200 Speywood单位/ml。
Storage冷藏保存(2℃-8℃),不得冷冻,小瓶应保存在外盒中以避光。
Shelf life有效期12个月。
Injection depth眉间纹:肌内注射应使用合适规格的无菌针头进行。; 眉间纹(皱眉肌):应注射于皱眉肌中央部分,距眶缘至少1 cm。; 眉间纹:注射时针头斜面应朝向上方和内侧。; 眉间纹:为降低上睑下垂风险,应避免在提上睑肌附近注射,尤其是眉部降肌复合体(降眉肌)较大的患者。
眉间纹:推荐剂量为0.25 ml溶液(50 Speywood单位),分5个注射点,每点肌内注射0.05 ml溶液(10 Speywood单位):每侧皱眉肌2次注射,鼻根角附近的降眉间肌1次注射。; 每瓶:每瓶含125 Speywood单位,装于0.625 ml溶液中。
Duration眉间纹:注射后疗效已证实可持续长达6个月。; 眉间纹(重复注射周期,研究者判定应答率):在重复注射周期中,注射后1个月由研究者判定的最大皱眉时应答者比例维持在82.2%至87.8%之间。
Adverse reactions临床试验(常见,≥1/100至<1/10):眼部不良反应(常见):眼睑下垂、眼睑水肿、眉下垂、干眼、流泪增多、视疲劳、眼周肌肉抽动。; 肉毒毒素类:与毒素效应扩散至给药部位远处相关的不良反应在肉毒毒素中报告得非常罕见(肌无力过度、吞咽困难、吸入性肺炎,部分病例结局致命)。; 临床试验:临床试验中,Alluzience报告的大多数不良反应为轻至中度且可逆;最常报告的不良反应为头痛和注射部位反应。
Warnings应告知患者,如出现吞咽、言语或呼吸困难应立即就医。; 吞咽和呼吸困难是严重的,可导致死亡。; 妊娠:作为预防措施,妊娠期间不应使用Alluzience。; 儿童:不推荐18岁以下患者使用Alluzience。; 与氨基糖苷类或其他影响神经肌肉传递的药物(如箭毒样药物)合用应谨慎,因为肉毒毒素效应可能被增强。; 应注意确保不将Alluzience注入血管。; 哺乳:尚不清楚Alluzience是否经人乳汁排泄;哺乳期不应使用Alluzience。; 有吞咽困难和误吸史的患者不推荐注射Alluzience。
preparation原文未报告Not reported
storage after preparation从冷藏取出后:未开封并避光时,可在最高25℃下放置单次12小时;从冷藏取出后12小时内未使用则应丢弃。; 开启后:瓶开启后应立即使用。

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

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