Regulatory Decision Summary for Dysport Therapeutic
Review decision
The Regulatory Decision Summary explains Health Canada’s decision for the product seeking market authorization. The Regulatory Decision Summary includes the purpose of the submission and the reason for the decision.
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What was the purpose of this submission?
Dysport Therapeutic is currently indicated for reducing the symptoms of cervical dystonia in adults, symptomatic treatment of focal spasticity affecting the upper limbs in adults and lower limbs in pediatric patients 2 years of age and older.
The intent of this Supplement to a New Drug Submission for Dysport Therapeutic is to add the indication for the symptomatic treatment of focal spasticity affecting the lower limbs in adults.
Why was the decision issued?
Dysport Therapeutic was shown in clinical studies to temporarily relieve focal spasticity affecting the lower limbs in adult subjects following a stroke or traumatic brain injury.
The goal of treatment is to reduce spasticity and pain, prevent complications, and to improve quality of life. Current treatments of spasticity, such as pharmacological antispastic drugs, have limitations of systemic side effects. Dysport Therapeutic can be another option for the treatment of lower limb spasticity.
Dysport Therapeutic was generally well tolerated at the recommended doses. The potential risks are addressed in the product monograph.
Dysport Therapeutic demonstrated a favourable benefit to risk profile for the symptomatic treatment of focal spasticity affecting the lower limbs in adult patients.
Decision issued
Approved; issued a Notice of Compliance in accordance with the Food and Drug Regulations.