Approval · Notice of Compliance 18181 · 2016
DYSPORT: Notice of Compliance 18181
Issued June 15, 2016
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
- 18181
- Date
- June 15, 2016
- Company
- Ipsen Biopharm LimitedWrexham, Wales, United Kingdom
- Product type
- Biologic
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- New indication: to reduce the subjective symptoms and objective signs of cervical dystonia (spasmodic tortocollis) in adults. new presentation: 500 units per vial
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| DYSPORT | Not yet assigned | — |
Medicinal ingredients
- ABOBOTULINUMTOXINA 300 UNIT per VIAL
- ABOBOTULINUMTOXINA 500 UNIT per VIAL