Approval · Notice of Compliance 26465 · 2021
RIVAROXABAN: Notice of Compliance 26465
Issued August 17, 2021
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
- 26465
- Date
- August 17, 2021
- Company
- Bayer Inc.Elkhart, Indiana, United States
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Admin
- Reason
- Administrative: Product Name Change. Administrative: Labelling Update (to Match Licensor). Administrative: Additional Product Name
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| RIVAROXABAN | 02505010 | Cancelled Pre Market |
| RIVAROXABAN | 02504987 | Cancelled Pre Market |
| RIVAROXABAN | 02504995 | Cancelled Pre Market |
| RIVAROXABAN | 02505002 | Cancelled Pre Market |
| RIVAROXABAN | 02518899 | Cancelled Pre Market |
| RIVAROXABAN | 02518902 | Cancelled Pre Market |
Medicinal ingredients
- RIVAROXABAN 2.5 MG per TAB
- RIVAROXABAN 10 MG per TAB
- RIVAROXABAN 15 MG per TAB
- RIVAROXABAN 20 MG per TAB
- RIVAROXABAN 51.7 MG per BOTTL
- RIVAROXABAN 103.4 MG per BOTTL