Approval · Notice of Compliance 31270 · 2023
RINVOQ: Notice of Compliance 31270
Issued July 21, 2023
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
- 31270
- Date
- July 21, 2023
- Company
- AbbVie CorporationSaint-Laurent, Quebec, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- New indication for moderately to severely active ulcerative colitis. Addition of a 45 mg extended-release tablet strength
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| RINVOQ | Not yet assigned | — |
| RINVOQ | 02539721 | Marketed |
Medicinal ingredients
- UPADACITINIB 15 MG per TAB
- UPADACITINIB 30 MG per TAB
- UPADACITINIB 45 MG per TAB