Approval · Notice of Compliance 14812 · 2013
BOTOX: Notice of Compliance 14812
Issued October 10, 2013
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
- 14812
- Date
- October 10, 2013
- Company
- Allergan IncMarkham, Ontario, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- New indication: for the treatment of overactive bladder with symptoms of urinary incontinence, urgency and frequency, in adult patients who have an inadequate response to or are intolerant of anticholinergic medication
- Therapeutic class
- Nueromuscluar paralytic agent
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| BOTOX | Not yet assigned | — |
Medicinal ingredients
- ONABOTULINUMTOXINA 100 UNIT per VIAL