COPAXONE DIN 02245619
Health Canada record
| Active ingredient(s) | GLATIRAMER ACETATE 20 MG |
|---|---|
| Dosage form | Solution |
| Route | Subcutaneous |
| Schedule | PRESCRIPTION |
| Class | Human |
| ATC | L03AX13 GLATIRAMER ACETATE |
| Original market date | 01-May-2002 |
| Current status date | 28-Jan-2016 |
| Source | Health Canada DPD |
Establishment licence of the holder
Teva Canada Limited — licence 101810, currently licensed, last inspection rating C (2025-03-04).
No Canadian shortage report is currently matched to this DIN.
Other Canadian products containing GLATIRAMER ACETATE
| DIN | Product | Company | Form | Strength | Status |
|---|---|---|---|---|---|
| 02456915 | COPAXONE | TEVA CANADA LIMITED | Solution | GLATIRAMER ACETATE 40 MG | Marketed |
| 02512173 | COPAXONE | TEVA CANADA LIMITED | Solution | GLATIRAMER ACETATE 40 MG | Approved |
| 02460661 | GLATECT | PHARMASCIENCE INC | Solution | GLATIRAMER ACETATE 20 MG | Marketed |
| 02541440 | GLATIRAMER ACETATE INJECTION | MYLAN PHARMACEUTICALS ULC | Solution | GLATIRAMER ACETATE 20 MG | Marketed |
| 02481510 | TEVA-GLATIRAMER ACETATE | TEVA CANADA LIMITED | Solution | GLATIRAMER ACETATE 40 MG | Approved |
| 02441446 | TEVA-GLATIRAMER ACETATE | TEVA CANADA LIMITED | Solution | GLATIRAMER ACETATE 20 MG | Approved |
| 02233014 | COPAXONE | TEVA PHARMACEUTICAL INDUSTRIES LTD | Powder For Solution | GLATIRAMER ACETATE 20 MG | Cancelled Post Market |
Notices of Compliance
| NOC | Date | Submission | Reason |
|---|---|---|---|
| 17685 | 2016-01-19 | New Drug Submission (NDS) | TRANSFER OF DRUG IDENTIFICATION NUMBER |
| 8410 | 2006-11-15 | New Drug Submission (NDS) | MANUFACTURER NAME CHANGE |
| 570 | 2002-03-20 | Supplement to a New Drug Submission (SNDS) | NEW DOSAGE FORMAT: PRE-FILLED SYRINGE |
International API supply for GLATIRAMER ACETATE
6 active FDA Drug Master Files.
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