NEUPOGEN DIN 02420104
Health Canada record
| Active ingredient(s) | FILGRASTIM 600 MCG |
|---|---|
| Dosage form | Solution |
| Route | Subcutaneous; Intravenous |
| Schedule | PRESCRIPTION; SCHEDULE D |
| Class | Human |
| ATC | L03AA02 FILGRASTIM |
| Original market date | 28-Jan-2016 |
| Current status date | 28-Jan-2016 |
| Source | Health Canada DPD |
Establishment licence of the holder
Amgen Canada Inc — licence 100048, currently licensed, last inspection rating C (2023-03-01).
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 |
| 02454548 | GRASTOFIL | APOTEX INC | Solution | FILGRASTIM 480 MCG | Marketed |
| 02441489 | GRASTOFIL | APOTEX INC | Solution | FILGRASTIM 300 MCG | Marketed |
| 01968017 | NEUPOGEN | AMGEN CANADA INC | Solution | FILGRASTIM 300 MCG | Marketed |
| 02420112 | NEUPOGEN | AMGEN CANADA INC | Solution | FILGRASTIM 600 MCG | Marketed |
| 02485583 | NIVESTYM | PFIZER CANADA ULC | Solution | FILGRASTIM 480 MCG | Marketed |
| 02485591 | NIVESTYM | PFIZER CANADA ULC | Solution | FILGRASTIM 300 MCG | Marketed |
| 02485575 | NIVESTYM | PFIZER CANADA ULC | Solution | FILGRASTIM 300 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 |
|---|---|---|---|
| 15162 | 2014-01-28 | Supplement to a New Drug Submission (SNDS) | NEW DRUG PRODUCT PRESENTATION, PREFILLED SYRINGE, NEW STRENGTH |
International API supply for FILGRASTIM
1 active FDA Drug Master Files.
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