Approval · Notice of Compliance 12882 · 2011
BOTOX: Notice of Compliance 12882
Issued December 21, 2011
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
- 12882
- Date
- December 21, 2011
- Company
- Allergan IncMarkham, Ontario, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Priority
- Reason
- New Indication: For the treatment of urinary incontinence due to neurogenic detrusor overactivity resulting from neurogenic bladder associated with multiple sclerosis or subcervical spinal cord injury in adults who had an inadequate respone to or are intolerant of anticholinergic medications
- Therapeutic class
- Neuromuscular Paralytic Agent
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| BOTOX | Not yet assigned | — |
Medicinal ingredients
- ONABOTULINUMTOXINA 100 UNIT per VIAL