Approval · Notice of Compliance 4893 · 1995
BOTOX: Notice of Compliance 4893
Issued March 29, 1995
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
- 4893
- Date
- March 29, 1995
- Company
- Allergan IncMarkham, Ontario, Canada
- Product type
- Biologic
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- Revised product monograph, new indication: to reduce the subjective symptoms and objective signs of cervical dystonia (spasmodic torticollis) in adults
- Therapeutic class
- Neuromuscular paralytic agent
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| BOTOX | 01981501 | Marketed |
Medicinal ingredients
- ONABOTULINUMTOXINA 100 UNIT per VIAL