Approval · Notice of Compliance 20697 · 2018
SIMPONI I.V.: Notice of Compliance 20697
Issued April 5, 2018
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
- 20697
- Date
- April 5, 2018
- Company
- Janssen Inc.Toronto, Ontario, Canada
- Product type
- Biologic
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- New indications: psoriatic arthritis (psa): simponi I.V. alone or in combination with methotrexate is indicated for the treatment of adult patients with moderately to severely active psoriatic arthritis ankylosing spondyliitis (as): simponi I.V. is indicated for the treatment of adult patients with ankylosing spondylitis who have had inadequate response or intolerance to conventional therapies
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| SIMPONI I.V. | Not yet assigned | — |
Medicinal ingredients
- GOLIMUMAB 50 MG per 4ML