Approval · Notice of Compliance 33262 · 2024
COSENTYX: Notice of Compliance 33262
Issued May 17, 2024
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
- 33262
- Date
- May 17, 2024
- 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 indication: COSENTYX is indicated for the treatment of adult patients with moderate to severe hidradenitis suppurativa (acne inversa) who have responded inadequately to conventional systemic hidradenitis suppurativa therapy.Splitting of the existing Drug Identification Number for the pre-filled pen and pre-filled syringe presentations.
Products in this notice
Medicinal ingredients
- SECUKINUMAB 150 MG per ML
- SECUKINUMAB 150 MG per VIAL
- SECUKINUMAB 75 MG per 0.5ML
- SECUKINUMAB 300 MG per 2ML
- SECUKINUMAB 300 MG per PEN