EPIRUBICIN HYDROCHLORIDE INJECTION DIN 02312093
Health Canada record
| Active ingredient(s) | EPIRUBICIN HYDROCHLORIDE 2.0 MG |
|---|---|
| Dosage form | Solution |
| Route | Intravenous |
| Schedule | PRESCRIPTION |
| Class | Human |
| ATC | L01DB03 EPIRUBICIN |
| Original market date | 24-Mar-2009 |
| Current status date | 19-Jun-2015 |
| 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 EPIRUBICIN HYDROCHLORIDE
| DIN | Product | Company | Form | Strength | Status |
|---|---|---|---|---|---|
| 02413221 | EPIRUBICIN HYDROCHLORIDE INJECTION | STRIDES PHARMA CANADA INC | Solution | EPIRUBICIN HYDROCHLORIDE 2 MG | Approved |
| 02322242 | EPIRUBICIN HYDROCHLORIDE INJECTION | UMAN PHARMA INC | Solution | EPIRUBICIN HYDROCHLORIDE 2 MG | Approved |
| 02324091 | EPIRUBICIN HYDROCHLORIDE INJECTION | TEVA CANADA LIMITED | Solution | EPIRUBICIN HYDROCHLORIDE 2 MG | Marketed |
| 02409372 | EPIRUBICIN HYDROCHLORIDE INJECTION | OMEGA LABORATORIES LIMITED | Solution | EPIRUBICIN HYDROCHLORIDE 2 MG | Approved |
| 02301067 | EPIRUBICIN HYDROCHLORIDE FOR INJECTION | HOSPIRA HEALTHCARE ULC | Powder For Solution | EPIRUBICIN HYDROCHLORIDE 50 MG | Cancelled Post Market |
| 02387379 | EPIRUBICIN HYDROCHLORIDE INJECTION | SANDOZ CANADA INCORPORATED | Solution | EPIRUBICIN HYDROCHLORIDE 2 MG | Cancelled Pre Market |
| 02303892 | EPIRUBICIN HYDROCHLORIDE INJECTION | ACCORD HEALTHCARE INC | Solution | EPIRUBICIN HYDROCHLORIDE 2 MG | Cancelled Post Market |
| 02264927 | EPIRUBICIN HYDROCHLORIDE INJECTION | PFIZER CANADA ULC | Solution | EPIRUBICIN HYDROCHLORIDE 2 MG | Cancelled Post Market |
| 02323001 | EPIRUBICIN HYDROCHLORIDE INJECTION | PHARMACEUTICAL PARTNERS OF CANADA INC | Solution | EPIRUBICIN HYDROCHLORIDE 2 MG | Cancelled Pre Market |
| 02065703 | PHARMORUBICIN PFS | PHARMASCIENCE INC | Solution | EPIRUBICIN HYDROCHLORIDE 2 MG | Cancelled Post Market |
| 02069512 | PHARMORUBICIN RDF | PFIZER CANADA ULC | Powder For Solution | EPIRUBICIN HYDROCHLORIDE 50 MG | Cancelled Post Market |
| 02065746 | PHARMORUBICIN RDF | PFIZER CANADA ULC | Powder For Solution | EPIRUBICIN HYDROCHLORIDE 10 MG | Cancelled Post Market |
| 00640069 | PHARMORUBICIN RDF INJ 50MG/VIAL | ADRIA LABORATORIES OF CANADA LTD. | Powder For Solution | EPIRUBICIN HYDROCHLORIDE 50 MG | Cancelled Post Market |
| 02410400 | PMS-EPIRUBICIN | PHARMASCIENCE INC | Solution | EPIRUBICIN HYDROCHLORIDE 2 MG | Cancelled Post Market |
Notices of Compliance
| NOC | Date | Submission | Reason |
|---|---|---|---|
| 17016 | 2015-06-19 | Abbreviated New Drug Submission (ANDS) | MANUFACTURER NAME CHANGE |
| 9926 | 2008-12-04 | Abbreviated New Drug Submission (ANDS) | MANUFACTURER NAME CHANGE |
| 9849 | 2008-10-23 | Abbreviated New Drug Submission (ANDS) |
International API supply for EPIRUBICIN HYDROCHLORIDE
7 valid EDQM Certificates of Suitability from 7 holders. 7 active FDA Drug Master Files.
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