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Xeomin injection
儿科标签批准日期
2020/8/18 0:00:00
特定指示/秒
Upper limb spasticity in pediatric patients 2 to 17 years, excluding spasticity caused by cerebral palsy
标签更改摘要
- Safety and effectiveness have been established by evidence from adequate and well-controlled studies in patients 2 to 17 years with upper limb spasticity.
- A pediatric assessment for Xeomin demonstrates that the drug is safe and effective in another pediatric population. However, Xeomin is not approved for such patient population due to marketing exclusivity for another botulinum toxin.
- Safety and effectiveness in pediatric patients below the age of 2 years have not been established.
- Information on safety profile, and clinical study.
- Postmarketing requirement.
研究设计
Multicenter,Randomized,Double-Blind,Parallel Group,Dose Response
国家
United States,Argentina,Mexico,Poland,Russian Federation,Ukraine