Approval · Notice of Compliance 34842 · 2025
HADLIMA: Notice of Compliance 34842
Issued January 15, 2025
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
- 34842
- Date
- January 15, 2025
- Company
- Samsung Bioepis Co., LtdIncheon, Incheon, Korea, Republic Of
- Product type
- Biologic
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- Inducing and maintaining clinical remission in pediatric patients 5 years of age and older weighing = 40 kg 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 |
|---|---|---|
| HADLIMA | Not yet assigned | — |
| HADLIMA PUSHTOUCH | Not yet assigned | — |
Medicinal ingredients
- ADALIMUMAB 40 MG per 0.4ML
- ADALIMUMAB 40 MG per 0.8ML
- ADALIMUMAB 80 MG per 0.8ML