VISIPAQUE 270 DIN 02145766
Health Canada record
| Active ingredient(s) | IODIXANOL 550 MG |
|---|---|
| Dosage form | Solution |
| Route | Intravenous; Intra-Arterial |
| Schedule | ETHICAL |
| Class | Human |
| ATC | V08AB09 IODIXANOL |
| Original market date | 31-Dec-1995 |
| Current status date | 08-Sep-2021 |
| Source | Health Canada DPD |
Establishment licence of the holder
GE Healthcare Canada Inc. — licence 101469, currently licensed, last inspection rating C (2023-02-06).
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 |
| 02553961 | IODIXANOL INJECTION 320 | FRESENIUS KABI CANADA LTD | Solution | IODIXANOL 652 MG | Marketed |
| 02145774 | VISIPAQUE 320 | GE HEALTHCARE CANADA INC | Solution | IODIXANOL 652 MG | Marketed |
Notices of Compliance
| NOC | Date | Submission | Reason |
|---|---|---|---|
| 25289 | 2021-02-23 | Supplement to a New Drug Submission (SNDS) | PRODUCT NAME CHANGE. UPDATE THE PRODUCT LABELLING TO INCLUDE A NUMERICAL MODIFIER AS PART OF THE BRAND NAME |
| 19701 | 2017-08-23 | Supplement to a New Drug Submission (SNDS) | TO IMPROVE THE SAFETY INFORMATION IN THE PRODUCT MNOGRAPH FOR VISIPAQUE IN RESPONSE TO HEALTH CANADA'S CLASS LABELLING CHANGE REQUEST FOR ALL IODINE-BASED CONTRAST MEDIA WITH RESPECT TO THYROID DYSFUNCTION |
| 7992 | 2006-05-30 | New Drug Submission (NDS) | MANUFACTURER NAME CHANGE |
| 1454 | 2003-04-23 | New Drug Submission (NDS) | MANUFACTURER NAME CHANGE |
| 5672 | 1994-12-20 | New Drug Submission (NDS) |
International API supply for IODIXANOL
5 valid EDQM Certificates of Suitability from 5 holders. 4 active FDA Drug Master Files.
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