Approval · Notice of Compliance 12788 · 2011
SIMPONI: Notice of Compliance 12788
Issued November 18, 2011
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
- 12788
- Date
- November 18, 2011
- Company
- Janssen Inc.Toronto, Ontario, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- Expanded Indication: Psoriatic Arthritis (PsA); Reducing signs and symptoms, inhibiting the progresssion of structural damage and improving physical function in adult patients with moderately to severely active psoriatic arthritis. Simpponi can be used in combination with MTX in patients who do not respond adequately to MTX alone.
- Therapeutic class
- Tumour Necrosis Factor Alpha Inhibitor
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| SIMPONI | Not yet assigned | — |
Medicinal ingredients
- GOLIMUMAB 50 MG per SYR