Regulatory Decision Summary for Nuceiva
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.
Product type:
Medicinal ingredient(s):
Therapeutic area:
Type of submission:
Control number:
What was the purpose of this submission?
The purpose of this submission is to seek marketing authorization of NUCEIVA (PrabotulinumtoxinA for injection) for the indication of the temporary improvement in the appearance of moderate to severe glabellar (frown) lines in adults.
Why was the decision issued?
The safety and efficacy of Nuceiva (prabotulinumtoxinA for injection) in the temporary improvement in the appearance of glabellar lines (frown lines) were shown in healthy adults with moderate to severe wrinkles at maximum frown. Over a thousand people, predominantly women with an average age of 50 years, were evaluated in four clinical trials, including a one year safety study.
Side effects following treatment with Nuceiva were generally mild to moderate in severity and resolved without sequelae. The most common side effects considered related to treatment were headache, drooping eyelid or brow, and injection site reactions (e.g. pain, bruising, itchy skin, swelling).
The benefit in the cosmetic use of Nuceiva is considered favorable over the risks as described in the Product Monograph.
Decision issued
Approved; issued a Notice of Compliance in accordance with the Food and Drug Regulations.
Related Drug Products
| Product name | DIN | Company name | Active ingredient(s) & strength |
|---|---|---|---|
| NUCEIVA | 02480158 | EVOLUS INCORPORATED | PRABOTULINUMTOXINA 100 UNIT / VIAL |