Approval · Notice of Compliance 29206 · 2022
HYRIMOZ: Notice of Compliance 29206
Issued October 11, 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
- 29206
- Date
- October 11, 2022
- Company
- Sandoz Canada Inc.Saint-Hubert, Quebec, Canada
- Product type
- Biologic
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- New Indication: Pediatric Ulcerative Colitis Inducing and maintaining clinical remission in pediatric patients 5 years of age and older with moderately to severely active ulcerative colitis who have had an inadequate response to conventional therapy including corticosteroids and/or azathioprine or 6- mercaptopurine (6-MP) or who are intolerant to such therapies.
- Canadian reference product
- HUMIRA
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| HYRIMOZ | Not yet assigned | — |
Medicinal ingredients
- ADALIMUMAB 20 MG per SYR
- ADALIMUMAB 40 MG per PEN
- ADALIMUMAB 40 MG per SYR