Regulatory Decision Summary for Dysport Aesthetic
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 Aesthetic (abobotulinumtoxinA) is indicated for the temporary improvement in the appearance of moderate to severe glabellar (frown) lines in adults. The purpose of this submission is to expand the indication for the treatment of moderate to severe lateral canthal lines (crows feet) in adults.
Why was the decision issued?
Dysport Aesthetic (abobotulinumtoxinA) was shown in clinical studies to temporarily improve the appearance of crows feet lines in adults with moderate to severe wrinkles at maximum smile.
The treatment of crows feet lines with Dysport Aesthetic is considered safe, as most side effects were mild to moderate and resolved without sequelae. Individuals re-treated with Dysport Aesthetic over a one year period for both frown and crows feet lines did not show evidence of an increase in side effects.
The benefit in the use of Dysport Aesthetic is considered favorable over the risks as described in the Product Monograph. The potential risks are addressed in the Product Monograph with safety warnings and administration instructions.
Decision issued
Approved; issued a Notice of Compliance in accordance with the Food and Drug Regulations.