Approval · Notice of Compliance 28759 · 2022
HULIO: Notice of Compliance 28759
Issued August 12, 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
- 28759
- Date
- August 12, 2022
- Company
- BGP Pharma ULCEtobicoke, Ontario, 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.
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| HULIO | Not yet assigned | — |
Medicinal ingredients
- ADALIMUMAB 20 MG per SYR
- ADALIMUMAB 40 MG per SYR
- ADALIMUMAB 40 MG per PEN