MITOMYCIN FOR INJECTION USP DIN 02464691
Health Canada record
| Active ingredient(s) | MITOMYCIN 20 MG |
|---|---|
| Dosage form | Powder For Solution |
| Route | Intravenous; Intravesical |
| Schedule | PRESCRIPTION |
| Class | Human |
| ATC | L01DC03 MITOMYCIN |
| Original market date | 30-Apr-2018 |
| Current status date | 30-Apr-2018 |
| Source | Health Canada DPD |
Establishment licence of the holder
Accord Healthcare Inc. — licence 101566, currently licensed, last inspection rating C (2024-11-26).
No Canadian shortage report is currently matched to this DIN.
Other Canadian products containing MITOMYCIN
| DIN | Product | Company | Form | Strength | Status |
|---|---|---|---|---|---|
| 02557762 | MITOMYCIN FOR INJECTION | EUGIA PHARMA INC. | Powder For Solution | MITOMYCIN 20 MG | Approved |
| 02230451 | MITOMYCIN FOR INJECTION | TEVA CANADA LIMITED | Powder For Solution | MITOMYCIN 20 MG | Marketed |
| 02531941 | MITOMYCIN FOR INJECTION, USP | HIKMA CANADA LIMITED | Powder For Solution | MITOMYCIN 20 MG | Marketed |
| 02230450 | MITOMYCIN FOR INJECTION | TEVA CANADA LIMITED | Powder For Solution | MITOMYCIN 5 MG | Cancelled Post Market |
| 02230729 | MITOMYCIN FOR INJECTION USP | PFIZER CANADA ULC | Powder For Solution | MITOMYCIN 20 MG | Cancelled Post Market |
| 02237745 | MITOMYCIN FOR INJECTION USP | PFIZER CANADA ULC | Powder For Solution | MITOMYCIN 5 MG | Cancelled Post Market |
| 00587710 | MUTAMYCIN INJ 20MG/VIAL | BRISTOL-MYERS SQUIBB CANADA | Powder For Solution | MITOMYCIN 20 MG | Cancelled Post Market |
| 00381799 | MUTAMYCIN INJ 5MG/VIAL | BRISTOL-MYERS SQUIBB CANADA | Powder For Solution | MITOMYCIN 0.5 MG | Cancelled Post Market |
Notices of Compliance
| NOC | Date | Submission | Reason |
|---|---|---|---|
| 19395 | 2017-06-09 | Abbreviated New Drug Submission (ANDS) |
International API supply for MITOMYCIN
4 valid EDQM Certificates of Suitability from 4 holders. 6 active FDA Drug Master Files.
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