Approval · Notice of Compliance 20438 · 2018
GRASTOFIL: Notice of Compliance 20438
Issued February 2, 2018
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
- 20438
- Date
- February 2, 2018
- Company
- Apotex Inc.Toronto, Ontario, Canada
- Product type
- Biologic
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- Labelling updates
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| GRASTOFIL | Not yet assigned | — |
Medicinal ingredients
- FILGRASTIM (R-METHUG-CSF) 300 MCG per 0.5ML
- FILGRASTIM (R-METHUG-CSF) 480 MCG per 0.8ML