GADOPENTETATE DIMEGLUMINE INJECTION DIN 02497883
Health Canada record
| Active ingredient(s) | GADOPENTETATE DIMEGLUMINE 469 MG |
|---|---|
| Dosage form | Solution |
| Route | Intravenous |
| Schedule | ETHICAL |
| Class | Human |
| ATC | V08CA01 GADOPENTETIC ACID |
| Original market date | |
| Current status date | 23-Jun-2021 |
| Source | Health Canada DPD |
Establishment licence of the holder
Avir Pharma Inc. — licence 3-002361, currently licensed, last inspection rating C (2025-07-07).
No Canadian shortage report is currently matched to this DIN.
Other Canadian products containing GADOPENTETATE DIMEGLUMINE
| DIN | Product | Company | Form | Strength | Status |
|---|---|---|---|---|---|
| 01989987 | MAGNEVIST | BAYER INC | Solution | GADOPENTETATE DIMEGLUMINE 469 MG | Marketed |
| 02431513 | GADOPENTETATE DIMEGLUMINE INJECTION, USP | JUBILANT DRAXIMAGE INC. DBA JUBILANT RADIOPHARMA | Solution | GADOPENTETATE DIMEGLUMINE 469 MG | Cancelled Pre Market |
Notices of Compliance
| NOC | Date | Submission | Reason |
|---|---|---|---|
| 23429 | 2020-04-08 | Abbreviated New Drug Submission (ANDS) |
International API supply for GADOPENTETATE DIMEGLUMINE
2 active FDA Drug Master Files.
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