Approval · Notice of Compliance 21418 · 2018
BOTOX: Notice of Compliance 21418
Issued October 16, 2018
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
- 21418
- Date
- October 16, 2018
- Company
- Allergan IncMarkham, Ontario, Canada
- Product type
- Biologic
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- New indication: for the symptomatic treatment of lower limb spasticity associated with stroke in adults
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| BOTOX | Not yet assigned | — |
Medicinal ingredients
- ONABOTULINUMTOXINA 50 LD50 per VIAL
- ONABOTULINUMTOXINA 100 LD50 per VIAL
- ONABOTULINUMTOXINA 200 LD50 per VIAL