Approval · Notice of Compliance 1705 · 2001
BOTOX: Notice of Compliance 1705
Issued October 24, 2001
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
- 1705
- Date
- October 24, 2001
- Company
- Allergan IncMarkham, Ontario, Canada
- Product type
- Biologic
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- New indication: management of focal spasticity, including the treatment of upper limb spasticity associated with stroke in adults
- Therapeutic class
- Neuromuscular paralytic agent
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| BOTOX | Not yet assigned | — |
Medicinal ingredients
- ONABOTULINUMTOXINA 100 UNIT per VIAL