Approval · Notice of Compliance 32659 · 2024
BOTOX: Notice of Compliance 32659
Issued February 7, 2024
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
- 32659
- Date
- February 7, 2024
- Company
- AbbVie CorporationSaint-Laurent, Quebec, Canada
- Product type
- Biologic
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- Updates to the Product Monograph and expansion of the indication: BOTOX (onabotulinumtoxiA) is indicated: - in the management of focal spasticity, including the treatment of upper limb spasticity in adults, - for the symptomatic treatment of lower limb spasticity in adults,
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| BOTOX | Not yet assigned | — |
Medicinal ingredients
- ONABOTULINUMTOXINA 50 UNIT per VIAL
- ONABOTULINUMTOXINA 200 UNIT per VIAL
- ONABOTULINUMTOXINA 100 UNIT per VIAL