RIVAROXABAN DIN 02518902
Health Canada record
| Active ingredient(s) | RIVAROXABAN 103.4 MG |
|---|---|
| Dosage form | Granules For Suspension |
| Route | Oral |
| Schedule | PRESCRIPTION |
| Class | Human |
| ATC | B01AF01 RIVAROXABAN |
| Original market date | |
| Current status date | 19-Jan-2023 |
| Source | Health Canada DPD |
Establishment licence of the holder
Bayer Inc — licence 101029, currently licensed, last inspection rating C (2023-02-07).
No Canadian shortage report is currently matched to this DIN.
Other Canadian products containing RIVAROXABAN
| DIN | Product | Company | Form | Strength | Status |
|---|---|---|---|---|---|
| 02508133 | ACH-RIVAROXABAN | ACCORD HEALTHCARE INC | Tablet | RIVAROXABAN 15 MG | Approved |
| 02508125 | ACH-RIVAROXABAN | ACCORD HEALTHCARE INC | Tablet | RIVAROXABAN 10 MG | Approved |
| 02508117 | ACH-RIVAROXABAN | ACCORD HEALTHCARE INC | Tablet | RIVAROXABAN 2.5 MG | Approved |
| 02508141 | ACH-RIVAROXABAN | ACCORD HEALTHCARE INC | Tablet | RIVAROXABAN 20 MG | Approved |
| 02528002 | AG-RIVAROXABAN | ANGITA PHARMA INC. | Tablet | RIVAROXABAN 15 MG | Marketed |
| 02527995 | AG-RIVAROXABAN | ANGITA PHARMA INC. | Tablet | RIVAROXABAN 10 MG | Marketed |
| 02528010 | AG-RIVAROXABAN | ANGITA PHARMA INC. | Tablet | RIVAROXABAN 20 MG | Marketed |
| 02470497 | APO-RIVAROXABAN | APOTEX INC | Tablet | RIVAROXABAN 10 MG | Marketed |
| 02470500 | APO-RIVAROXABAN | APOTEX INC | Tablet | RIVAROXABAN 15 MG | Marketed |
| 02470519 | APO-RIVAROXABAN | APOTEX INC | Tablet | RIVAROXABAN 20 MG | Marketed |
| 02516306 | JAMP RIVAROXABAN | JAMP PHARMA CORPORATION | Tablet | RIVAROXABAN 15 MG | Marketed |
| 02516314 | JAMP RIVAROXABAN | JAMP PHARMA CORPORATION | Tablet | RIVAROXABAN 20 MG | Marketed |
| 02516292 | JAMP RIVAROXABAN | JAMP PHARMA CORPORATION | Tablet | RIVAROXABAN 10 MG | Marketed |
| 02515237 | MINT-RIVAROXABAN | MINT PHARMACEUTICALS INC | Tablet | RIVAROXABAN 10 MG | Approved |
| 02515245 | MINT-RIVAROXABAN | MINT PHARMACEUTICALS INC | Tablet | RIVAROXABAN 15 MG | Approved |
| 02515253 | MINT-RIVAROXABAN | MINT PHARMACEUTICALS INC | Tablet | RIVAROXABAN 20 MG | Approved |
| 02518651 | NRA-RIVAROXABAN | NORA PHARMA INC | Tablet | RIVAROXABAN 2.5 MG | Approved |
| 02518686 | NRA-RIVAROXABAN | NORA PHARMA INC | Tablet | RIVAROXABAN 15 MG | Approved |
| 02518694 | NRA-RIVAROXABAN | NORA PHARMA INC | Tablet | RIVAROXABAN 20 MG | Approved |
| 02518678 | NRA-RIVAROXABAN | NORA PHARMA INC | Tablet | RIVAROXABAN 10 MG | Approved |
| 02512041 | PMS-RIVAROXABAN | PHARMASCIENCE INC | Tablet | RIVAROXABAN 10 MG | Marketed |
| 02512076 | PMS-RIVAROXABAN | PHARMASCIENCE INC | Tablet | RIVAROXABAN 20 MG | Marketed |
| 02527537 | PMS-RIVAROXABAN | PHARMASCIENCE INC | Tablet | RIVAROXABAN 2.5 MG | Marketed |
| 02512068 | PMS-RIVAROXABAN | PHARMASCIENCE INC | Tablet | RIVAROXABAN 15 MG | Marketed |
| 02472422 | REDDY-RIVAROXABAN | DR REDDY'S LABORATORIES LTD | Tablet | RIVAROXABAN 20 MG | Marketed |
| 02472430 | REDDY-RIVAROXABAN | DR REDDY'S LABORATORIES LTD | Tablet | RIVAROXABAN 15 MG | Marketed |
| 02524503 | REDDY-RIVAROXABAN | DR REDDY'S LABORATORIES LTD | Tablet | RIVAROXABAN 2.5 MG | Marketed |
| 02472414 | REDDY-RIVAROXABAN | DR REDDY'S LABORATORIES LTD | Tablet | RIVAROXABAN 10 MG | Marketed |
| 02540843 | RIVA RIVAROXABAN | LABORATOIRE RIVA INC. | Tablet | RIVAROXABAN 10 MG | Marketed |
| 02540851 | RIVA RIVAROXABAN | LABORATOIRE RIVA INC. | Tablet | RIVAROXABAN 15 MG | Marketed |
| 02540835 | RIVA RIVAROXABAN | LABORATOIRE RIVA INC. | Tablet | RIVAROXABAN 2.5 MG | Marketed |
| 02482223 | SANDOZ RIVAROXABAN | SANDOZ CANADA INCORPORATED | Tablet | RIVAROXABAN 10 MG | Marketed |
| 02482231 | SANDOZ RIVAROXABAN | SANDOZ CANADA INCORPORATED | Tablet | RIVAROXABAN 15 MG | Marketed |
| 02482258 | SANDOZ RIVAROXABAN | SANDOZ CANADA INCORPORATED | Tablet | RIVAROXABAN 20 MG | Marketed |
| 02537877 | SANDOZ RIVAROXABAN | SANDOZ CANADA INCORPORATED | Tablet | RIVAROXABAN 2.5 MG | Marketed |
| 02483807 | TARO-RIVAROXABAN | TARO PHARMACEUTICALS INC | Tablet | RIVAROXABAN 10 MG | Marketed |
| 02483815 | TARO-RIVAROXABAN | TARO PHARMACEUTICALS INC | Tablet | RIVAROXABAN 15 MG | Marketed |
| 02483823 | TARO-RIVAROXABAN | TARO PHARMACEUTICALS INC | Tablet | RIVAROXABAN 20 MG | Marketed |
| 02526786 | TARO-RIVAROXABAN | TARO PHARMACEUTICALS INC | Tablet | RIVAROXABAN 2.5 MG | Marketed |
| 02507226 | TEVA-RIVAROXABAN | TEVA CANADA LIMITED | Tablet | RIVAROXABAN 20 MG | Marketed |
| 02507196 | TEVA-RIVAROXABAN | TEVA CANADA LIMITED | Tablet | RIVAROXABAN 10 MG | Marketed |
| 02507218 | TEVA-RIVAROXABAN | TEVA CANADA LIMITED | Tablet | RIVAROXABAN 15 MG | Marketed |
| 02510162 | XARELTO | BAYER INC | Granules For Suspension | RIVAROXABAN 51.7 MG | Marketed |
| 02378604 | XARELTO | BAYER INC | Tablet | RIVAROXABAN 15 MG | Marketed |
| 02316986 | XARELTO | BAYER INC | Tablet | RIVAROXABAN 10 MG | Marketed |
| 02480808 | XARELTO | BAYER INC | Tablet | RIVAROXABAN 2.5 MG | Marketed |
| 02378612 | XARELTO | BAYER INC | Tablet | RIVAROXABAN 20 MG | Marketed |
| 02510170 | XARELTO | BAYER INC | Granules For Suspension | RIVAROXABAN 103.4 MG | Marketed |
| 02515873 | PMSC-RIVAROXABAN | PHARMASCIENCE INC | Granules For Suspension | RIVAROXABAN 51.7 MG | Cancelled Pre Market |
| 02508958 | PMSC-RIVAROXABAN | PHARMASCIENCE INC | Tablet | RIVAROXABAN 15 MG | Cancelled Pre Market |
| 02508931 | PMSC-RIVAROXABAN | PHARMASCIENCE INC | Tablet | RIVAROXABAN 10 MG | Cancelled Pre Market |
| 02508923 | PMSC-RIVAROXABAN | PHARMASCIENCE INC | Tablet | RIVAROXABAN 2.5 MG | Cancelled Pre Market |
| 02508966 | PMSC-RIVAROXABAN | PHARMASCIENCE INC | Tablet | RIVAROXABAN 20 MG | Cancelled Pre Market |
| 02515881 | PMSC-RIVAROXABAN | PHARMASCIENCE INC | Granules For Suspension | RIVAROXABAN 103.4 MG | Cancelled Pre Market |
| 02505002 | RIVAROXABAN | BAYER INC | Tablet | RIVAROXABAN 20 MG | Cancelled Pre Market |
| 02518899 | RIVAROXABAN | BAYER INC | Granules For Suspension | RIVAROXABAN 51.7 MG | Cancelled Pre Market |
| 02505010 | RIVAROXABAN | BAYER INC | Tablet | RIVAROXABAN 2.5 MG | Cancelled Pre Market |
| 02504995 | RIVAROXABAN | BAYER INC | Tablet | RIVAROXABAN 15 MG | Cancelled Pre Market |
| 02504987 | RIVAROXABAN | BAYER INC | Tablet | RIVAROXABAN 10 MG | Cancelled Pre Market |
| 02441535 | XARELTO | BAYER INC | Kit; Tablet | RIVAROXABAN 15 MG; RIVAROXABAN 20 MG | Cancelled Post Market |
Notices of Compliance
| NOC | Date | Submission | Reason |
|---|---|---|---|
| 26465 | 2021-08-17 | Supplement to a New Drug Submission (SNDS) | Administrative: Product Name Change. Administrative: Labelling Update (to Match Licensor). Administrative: Additional Product Name |
International API supply for RIVAROXABAN
42 valid EDQM Certificates of Suitability from 41 holders. 69 active FDA Drug Master Files.
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