Approval · Notice of Compliance 35484 · 2025
FRAGMIN: Notice of Compliance 35484
Issued June 6, 2025
A Notice of Compliance is Health Canada’s approval of a drug submission: a new drug, a new use or form, or a change to an approved one. The product itself is in the Drug Product Database, with its current status.
- Notice number
- 35484
- Date
- June 6, 2025
- Company
- Pfizer Canada UlcKirkland, Quebec, Canada
- Product type
- Biologic
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- Updates to the Product Monograph
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| FRAGMIN | Not yet assigned | — |
Medicinal ingredients
- DALTEPARIN SODIUM 25,000 UNIT per ML
- DALTEPARIN SODIUM 2,500 UNIT per 0.2ML
- DALTEPARIN SODIUM 3,500 UNIT per 0.28ML
- DALTEPARIN SODIUM 5,000 UNIT per 0.2ML
- DALTEPARIN SODIUM 7,500 UNIT per 0.3ML
- DALTEPARIN SODIUM 10,000 UNIT per 0.4ML
- DALTEPARIN SODIUM 12,500 UNIT per 0.5ML
- DALTEPARIN SODIUM 15,000 UNIT per 0.6ML
- DALTEPARIN SODIUM 16,500 UNIT per 0.66ML
- DALTEPARIN SODIUM 18,000 UNIT per 0.72ML