GLATIRAMER ACETATE INJECTION DIN 02541440
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 | 11-Apr-2024 |
| Current status date | 11-Apr-2024 |
| Source | Health Canada DPD |
Establishment licence of the holder
Mylan Pharmaceuticals ULC — licence 101774, currently licensed, last inspection rating C (2026-02-24).
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 |
| 02245619 | COPAXONE | TEVA CANADA LIMITED | Solution | GLATIRAMER ACETATE 20 MG | Marketed |
| 02512173 | COPAXONE | TEVA CANADA LIMITED | Solution | GLATIRAMER ACETATE 40 MG | Approved |
| 02460661 | GLATECT | PHARMASCIENCE INC | 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 |
|---|---|---|---|
| 31619 | 2023-09-13 | Abbreviated New Drug Submission (ANDS) |
International API supply for GLATIRAMER ACETATE
6 active FDA Drug Master Files.
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