Approval · Notice of Compliance 29015 · 2022
COSENTYX: Notice of Compliance 29015
Issued September 20, 2022
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
- 29015
- Date
- September 20, 2022
- Company
- Novartis Pharmaceuticals Canada Inc.Montreal, Quebec, Canada
- Product type
- Biologic
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- New presentation and new indications for: Enthesitis-Related Arthritis (ERA): COSENTYX is indicated for the treatment of active enthesitis-related arthritis in patients 6 years and older whose disease has responded inadequately to, or who cannot tolerate, conventional therapy. Juvenile Psoriatic Arthritis (JPsA): COSENTYX is indicated for the treatment of active juvenile psoriatic arthritis in patients 6 years and older whose disease has responded inadequately to, or who cannot tolerate, conventional therapy
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| COSENTYX | Not yet assigned | — |
Medicinal ingredients
- SECUKINUMAB 150 MG per ML
- SECUKINUMAB 150 MG per VIAL
- SECUKINUMAB 75 MG per 0.5ML
- SECUKINUMAB 300 MG per 2ML