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Dysport
儿科标签批准日期
2019/9/25 0:00:00
特定指示/秒
Treatment of upper limb spasticity in pediatric patients 2 years and older
标签更改摘要
- Approved for the treatment of upper limb spasticity in pediatric patients 2 years and older, excluding spasticity caused by cerebral palsy
- Safety and effectiveness have been established by evidence from adequate and well-controlled studies in patients 2 years and older with upper limb spasticity.
- A pediatric study demonstrated that Dysport is safe and effective in another pediatric population. However, Dysport 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 dosing, adverse reactions, and clinical trial.
- Postmarketing study.