IODIXANOL INJECTION 320 DIN 02553961
Health Canada record
| Active ingredient(s) | IODIXANOL 652 MG |
|---|---|
| Dosage form | Solution |
| Route | Intra-Arterial; Intravenous |
| Schedule | ETHICAL |
| Class | Human |
| ATC | V08AB09 IODIXANOL |
| Original market date | 29-May-2025 |
| Current status date | 29-May-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 IODIXANOL
| DIN | Product | Company | Form | Strength | Status |
|---|---|---|---|---|---|
| 02553953 | IODIXANOL INJECTION 270 | FRESENIUS KABI CANADA LTD | Solution | IODIXANOL 550 MG | Marketed |
| 02145766 | VISIPAQUE 270 | GE HEALTHCARE CANADA INC | Solution | IODIXANOL 550 MG | Marketed |
| 02145774 | VISIPAQUE 320 | GE HEALTHCARE CANADA INC | Solution | IODIXANOL 652 MG | Marketed |
Notices of Compliance
| NOC | Date | Submission | Reason |
|---|---|---|---|
| 34564 | 2024-12-17 | Abbreviated New Drug Submission (ANDS) |
International API supply for IODIXANOL
5 valid EDQM Certificates of Suitability from 5 holders. 4 active FDA Drug Master Files.
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