AURO-BRIVARACETAM DIN 02539306
Health Canada record
| Active ingredient(s) | BRIVARACETAM 100 MG |
|---|---|
| Dosage form | Tablet |
| Route | Oral |
| Schedule | PRESCRIPTION |
| Class | Human |
| ATC | N03AX23 BRIVARACETAM |
| Original market date | 12-Sep-2024 |
| Current status date | 12-Sep-2024 |
| Source | Health Canada DPD |
Establishment licence of the holder
Auro Pharma Inc — licence 101305, currently licensed, last inspection rating C (2023-09-27).
No Canadian shortage report is currently matched to this DIN.
Other Canadian products containing BRIVARACETAM
| DIN | Product | Company | Form | Strength | Status |
|---|---|---|---|---|---|
| 02538695 | APO-BRIVARACETAM | APOTEX INC | Tablet | BRIVARACETAM 50 MG | Marketed |
| 02538709 | APO-BRIVARACETAM | APOTEX INC | Tablet | BRIVARACETAM 75 MG | Marketed |
| 02538717 | APO-BRIVARACETAM | APOTEX INC | Tablet | BRIVARACETAM 100 MG | Marketed |
| 02538679 | APO-BRIVARACETAM | APOTEX INC | Tablet | BRIVARACETAM 10 MG | Marketed |
| 02538687 | APO-BRIVARACETAM | APOTEX INC | Tablet | BRIVARACETAM 25 MG | Marketed |
| 02568489 | AURO-BRIVARACETAM | AURO PHARMA INC | Tablet | BRIVARACETAM 25 MG | Approved |
| 02568470 | AURO-BRIVARACETAM | AURO PHARMA INC | Tablet | BRIVARACETAM 10 MG | Approved |
| 02539292 | AURO-BRIVARACETAM | AURO PHARMA INC | Tablet | BRIVARACETAM 50 MG | Marketed |
| 02568497 | AURO-BRIVARACETAM | AURO PHARMA INC | Tablet | BRIVARACETAM 75 MG | Approved |
| 02452936 | BRIVLERA | UCB CANADA INC | Tablet | BRIVARACETAM 10 MG | Marketed |
| 02452944 | BRIVLERA | UCB CANADA INC | Tablet | BRIVARACETAM 25 MG | Marketed |
| 02452952 | BRIVLERA | UCB CANADA INC | Tablet | BRIVARACETAM 50 MG | Marketed |
| 02452960 | BRIVLERA | UCB CANADA INC | Tablet | BRIVARACETAM 75 MG | Marketed |
| 02452979 | BRIVLERA | UCB CANADA INC | Tablet | BRIVARACETAM 100 MG | Marketed |
| 02452987 | BRIVLERA | UCB CANADA INC | Solution | BRIVARACETAM 10 MG | Marketed |
| 02452995 | BRIVLERA | UCB CANADA INC | Solution | BRIVARACETAM 10 MG | Marketed |
| 02569655 | MINT-BRIVARACETAM | MINT PHARMACEUTICALS INC | Tablet | BRIVARACETAM 100 MG | Approved |
| 02569612 | MINT-BRIVARACETAM | MINT PHARMACEUTICALS INC | Tablet | BRIVARACETAM 10 MG | Approved |
| 02569620 | MINT-BRIVARACETAM | MINT PHARMACEUTICALS INC | Tablet | BRIVARACETAM 25 MG | Approved |
| 02569639 | MINT-BRIVARACETAM | MINT PHARMACEUTICALS INC | Tablet | BRIVARACETAM 50 MG | Approved |
| 02569647 | MINT-BRIVARACETAM | MINT PHARMACEUTICALS INC | Tablet | BRIVARACETAM 75 MG | Approved |
| 02563940 | ZDS-BRIVARACETAM | ZYDUS LIFESCIENCES LIMITED | Tablet | BRIVARACETAM 75 MG | Approved |
| 02563932 | ZDS-BRIVARACETAM | ZYDUS LIFESCIENCES LIMITED | Tablet | BRIVARACETAM 50 MG | Approved |
| 02563924 | ZDS-BRIVARACETAM | ZYDUS LIFESCIENCES LIMITED | Tablet | BRIVARACETAM 25 MG | Approved |
| 02563959 | ZDS-BRIVARACETAM | ZYDUS LIFESCIENCES LIMITED | Tablet | BRIVARACETAM 100 MG | Approved |
Notices of Compliance
| NOC | Date | Submission | Reason |
|---|---|---|---|
| 33978 | 2024-09-10 | Abbreviated New Drug Submission (ANDS) |
International API supply for BRIVARACETAM
8 valid EDQM Certificates of Suitability from 8 holders. 28 active FDA Drug Master Files.
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