FLUMAZENIL INJECTION DIN 02249561
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 | 21-Apr-2004 |
| Current status date | 15-Sep-2005 |
| Source | Health Canada DPD |
Establishment licence of the holder
Sandoz Canada Incorporated — licence 101370, currently licensed, last inspection rating C (2025-02-25).
No Canadian shortage report is currently matched to this DIN.
Other Canadian products containing FLUMAZENIL
| DIN | Product | Company | Form | Strength | Status |
|---|---|---|---|---|---|
| 02266342 | FLUMAZENIL INJECTION, USP | FRESENIUS KABI CANADA LTD | 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 |
|---|---|---|---|
| 7369 | 2005-09-14 | Abbreviated New Drug Submission (ANDS) | MANUFACTURER NAME CHANGE |
| 285 | 2004-03-22 | 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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