Approval · Notice of Compliance 29226 · 2022
XEOMIN: Notice of Compliance 29226
Issued September 22, 2022
A Notice of Compliance is Health Canada’s approval of a drug submission: a new drug, a new use or form, or a change to an approved one. The product itself is in the Drug Product Database, with its current status.
- Notice number
- 29226
- Date
- September 22, 2022
- Company
- Merz Pharmaceuticals GmbhFrankfurt, Hessen, Germany
- Product type
- Biologic
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- Xeomin: - New indication: Xeomin (incobotulinumtoxinA) is indicated for the treatment of chronic sialorrhea associated with neurological disorders in pediatric patients (age 2¿17 years weighing 12 kg or more). Xeomin and Xeomin Cosmetic: - Product Monograph update
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| XEOMIN | Not yet assigned | — |
| XEOMIN COSMETIC | Not yet assigned | — |
Medicinal ingredients
- INCOBOTULINUMTOXINA 50 UNIT per VIAL
- INCOBOTULINUMTOXINA 100 UNIT per VIAL