Approval · Notice of Compliance 19689 · 2017
ARANESP: Notice of Compliance 19689
Issued August 21, 2017
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
- 19689
- Date
- August 21, 2017
- Company
- Amgen Canada IncMississauga, Ontario, Canada
- Product type
- Biologic
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- Alternate drug product manufacturing facility for prefilled syringe and manufacturing process improvement for prefilled syriunge and single-use vials
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| ARANESP | Not yet assigned | — |
Medicinal ingredients
- DARBEPOETIN ALFA 15 MCG per ML
- DARBEPOETIN ALFA 60 MCG per ML
- DARBEPOETIN ALFA 325 MCG per ML
- DARBEPOETIN ALFA 25 MCG per ML
- DARBEPOETIN ALFA 40 MCG per ML
- DARBEPOETIN ALFA 100 MCG per ML
- DARBEPOETIN ALFA 200 MCG per ML
- DARBEPOETIN ALFA 500 MCG per ML