NIVESTYM DIN 02485575
Health Canada record
| Active ingredient(s) | FILGRASTIM 300 MCG |
|---|---|
| Dosage form | Solution |
| Route | Subcutaneous; Intravenous |
| Schedule | PRESCRIPTION; SCHEDULE D |
| Class | Human |
| ATC | L03AA02 FILGRASTIM |
| Original market date | 11-May-2020 |
| Current status date | 11-May-2020 |
| Source | Health Canada DPD |
Establishment licence of the holder
Pfizer Canada ULC — licence 100255, currently licensed, last inspection rating C (2023-08-07).
No Canadian shortage report is currently matched to this DIN.
Other Canadian products containing FILGRASTIM
| DIN | Product | Company | Form | Strength | Status |
|---|---|---|---|---|---|
| 02556537 | FILRA | JAMP PHARMA CORPORATION | Solution | FILGRASTIM 300 MCG | Marketed |
| 02556545 | FILRA | JAMP PHARMA CORPORATION | Solution | FILGRASTIM 480 MCG | Marketed |
| 02441489 | GRASTOFIL | APOTEX INC | Solution | FILGRASTIM 300 MCG | Marketed |
| 02454548 | GRASTOFIL | APOTEX INC | Solution | FILGRASTIM 480 MCG | Marketed |
| 01968017 | NEUPOGEN | AMGEN CANADA INC | Solution | FILGRASTIM 300 MCG | Marketed |
| 02420104 | NEUPOGEN | AMGEN CANADA INC | Solution | FILGRASTIM 600 MCG | Marketed |
| 02420112 | NEUPOGEN | AMGEN CANADA INC | Solution | FILGRASTIM 600 MCG | Marketed |
| 02485591 | NIVESTYM | PFIZER CANADA ULC | Solution | FILGRASTIM 300 MCG | Marketed |
| 02485583 | NIVESTYM | PFIZER CANADA ULC | Solution | FILGRASTIM 480 MCG | Marketed |
| 02485656 | NIVESTYM | PFIZER CANADA ULC | Solution | FILGRASTIM 480 MCG | Marketed |
| 02520990 | NYPOZI | TANVEX BIOPHARMA USA, INC. | Solution | FILGRASTIM 300 MCG | Marketed |
| 02521008 | NYPOZI | TANVEX BIOPHARMA USA, INC. | Solution | FILGRASTIM 480 MCG | Marketed |
Notices of Compliance
| NOC | Date | Submission | Reason |
|---|---|---|---|
| 23487 | 2020-04-16 | New Drug Submission (NDS) |
International API supply for FILGRASTIM
1 active FDA Drug Master Files.
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