FLUMAZENIL INJECTION, USP DIN 02266342
Health Canada record
| Active ingredient(s) | FLUMAZENIL 0.1 MG |
|---|---|
| Dosage form | Solution |
| Route | Intravenous |
| Schedule | ETHICAL |
| Class | Human |
| ATC | V03AB25 FLUMAZENIL |
| Original market date | 05-Nov-2007 |
| Current status date | 20-Sep-2025 |
| Source | Health Canada DPD |
Establishment licence of the holder
Fresenius Kabi Canada Ltd. — licence 102232, currently licensed, last inspection rating C (2025-10-01).
No Canadian shortage report is currently matched to this DIN.
Other Canadian products containing FLUMAZENIL
| DIN | Product | Company | Form | Strength | Status |
|---|---|---|---|---|---|
| 02249561 | FLUMAZENIL INJECTION | SANDOZ CANADA INCORPORATED | Solution | FLUMAZENIL 0.1 MG | Marketed |
| 02431750 | JAMP-FLUMAZENIL | JAMP PHARMA CORPORATION | Solution | FLUMAZENIL 0.1 MG | Approved |
| 00874019 | ANEXATE INJ 0.1MG/ML | HOFFMANN-LA ROCHE LIMITED | Solution | FLUMAZENIL 0.1 MG | Cancelled Post Market |
| 02388995 | FLUMAZENIL INJECTION SDZ | SANDOZ CANADA INCORPORATED | Solution | FLUMAZENIL 0.1 MG | Cancelled Pre Market |
| 02430169 | FLUMAZENIL INJECTION, USP | MYLAN PHARMACEUTICALS ULC | Solution | FLUMAZENIL 0.1 MG | Cancelled Pre Market |
Notices of Compliance
| NOC | Date | Submission | Reason |
|---|---|---|---|
| 35326 | 2025-05-08 | Supplement to an Abbreviated New Drug Submission (SANDS) | Change in product name. Update to package labels |
| 16887 | 2015-05-08 | Abbreviated New Drug Submission (ANDS) | MANUFACTURER AND PRODUCT NAME CHANGE |
| 9364 | 2008-02-12 | Abbreviated New Drug Submission (ANDS) | MANUFACTURER NAME CHANGE |
| 8344 | 2006-10-24 | Abbreviated New Drug Submission (ANDS) | MANUFACTURER NAME CHANGE |
| 6808 | 2005-05-18 | Supplement to an Abbreviated New Drug Submission (SANDS) | PRODUCT NAME CHANGE |
| 6381 | 2005-03-30 | Abbreviated New Drug Submission (ANDS) |
International API supply for FLUMAZENIL
4 valid EDQM Certificates of Suitability from 4 holders. 4 active FDA Drug Master Files.
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