ABRAXANE FOR INJECTABLE SUSPENSION DIN 02281066
Health Canada record
| Active ingredient(s) | PACLITAXEL 100 MG |
|---|---|
| Dosage form | Powder For Suspension |
| Route | Intravenous |
| Schedule | PRESCRIPTION |
| Class | Human |
| ATC | L01CD01 PACLITAXEL |
| Original market date | 31-Aug-2006 |
| Current status date | 24-Jan-2025 |
| Source | Health Canada DPD |
Establishment licence of the holder
Bristol-Myers Squibb Canada — licence 100100, currently licensed, last inspection rating C (2026-03-18).
No Canadian shortage report is currently matched to this DIN.
Other Canadian products containing PACLITAXEL
| DIN | Product | Company | Form | Strength | Status |
|---|---|---|---|---|---|
| 02244372 | PACLITAXEL FOR INJECTION | BIOLYSE PHARMA CORPORATION | Solution | PACLITAXEL 6 MG | Marketed |
| 02285363 | PACLITAXEL FOR INJECTION | TEVA CANADA LIMITED | Solution | PACLITAXEL 6 MG | Approved |
| 02536056 | PACLITAXEL INJECTION | EUGIA PHARMA INC. | Solution | PACLITAXEL 6 MG | Approved |
| 02529424 | PACLITAXEL INJECTION | AURO PHARMA INC | Solution | PACLITAXEL 6 MG | Approved |
| 02320150 | PACLITAXEL INJECTION USP | SANDOZ CANADA INCORPORATED | Solution | PACLITAXEL 6 MG | Marketed |
| 02391465 | PACLITAXEL INJECTION USP | ACCORD HEALTHCARE INC | Solution | PACLITAXEL 6 MG | Marketed |
| 02496097 | PACLITAXEL POWDER FOR INJECTABLE SUSPENSION NANOPARTICLE, ALBUMIN-BOUND PACLITAXEL | PANACEA BIOTEC PHARMA LIMITED | Powder For Suspension | PACLITAXEL 100 MG | Marketed |
| 02409712 | AJ-PACLITAXEL | AGILA JAMP CANADA INC | Solution | PACLITAXEL 6 MG | Cancelled Pre Market |
| 02248844 | APO-PACLITAXEL INJECTABLE | APOTEX INC | Solution | PACLITAXEL 6 MG | Dormant |
| 02241314 | PACLITAXEL | IVAX PHARMACEUTICALS INCORPORATED | Liquid | PACLITAXEL 6 MG | Cancelled Pre Market |
| 02296624 | PACLITAXEL FOR INJECTION | PFIZER CANADA ULC | Solution | PACLITAXEL 6 MG | Cancelled Post Market |
| 02320010 | PACLITAXEL FOR INJECTION USP | STERIMAX INC | Solution | PACLITAXEL 6 MG | Dormant |
| 02231605 | PACLITAXEL INJECTION | IMMUNEX CORPORATION | Liquid | PACLITAXEL 6 MG | Cancelled Post Market |
| 02241443 | PACLITAXEL INJECTION | DRAXIS HEALTH INC. | Liquid | PACLITAXEL 6 MG | Cancelled (Unreturned Annual) |
| 02408074 | PACLITAXEL INJECTION, USP | MYLAN PHARMACEUTICALS ULC | Solution | PACLITAXEL 6 MG | Cancelled Pre Market |
| 02241957 | PAXENE | BAKER NORTON PHARMACEUTICALS INC. | Liquid | PACLITAXEL 6 MG | Cancelled (Unreturned Annual) |
| 02016796 | TAXOL | BRISTOL-MYERS SQUIBB CANADA | Solution | PACLITAXEL 6 MG | Cancelled Post Market |
| 02243392 | TEVA-PACLITAXEL FOR INJECTION | TEVA CANADA LIMITED | Liquid | PACLITAXEL 6 MG | Cancelled Pre Market |
Notices of Compliance
| NOC | Date | Submission | Reason |
|---|---|---|---|
| 32844 | 2024-03-08 | New Drug Submission (NDS) | Administrative: Change in Product Ownership |
| 13145 | 2012-03-26 | New Drug Submission (NDS) | Manufacturer name change |
| 9521 | 2008-04-28 | New Drug Submission (NDS) | MANUFACTURER NAME CHANGE |
| 9362 | 2008-02-11 | New Drug Submission (NDS) | MANUFACTURER NAME CHANGE |
| 8323 | 2006-10-16 | New Drug Submission (NDS) | MANUFACTURER NAME CHANGE |
| 8087 | 2006-06-30 | New Drug Submission (NDS) | MANUFACTURER NAME CHANGE |
| 8014 | 2006-06-07 | New Drug Submission (NDS) |
International API supply for PACLITAXEL
1 valid EDQM Certificates of Suitability from 1 holders. 31 active FDA Drug Master Files.
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