Approval · Notice of Compliance 35878 · 2025
RINVOQ: Notice of Compliance 35878
Issued August 21, 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
- 35878
- Date
- August 21, 2025
- Company
- AbbVie CorporationSaint-Laurent, Quebec, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- Addition of new indication: RINVOQ is indicated for the treatment of adult patients with giant cell arteritis (GCA). RINVOQ is used in combination with a tapering course of corticosteroids and as monotherapy following discontinuation of corticosteroids.
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| RINVOQ | Not yet assigned | — |
Medicinal ingredients
- UPADACITINIB 15 MG per TAB
- UPADACITINIB 30 MG per TAB
- UPADACITINIB 45 MG per TAB