Approval · Notice of Compliance 4405 · 1996
NEUPOGEN: Notice of Compliance 4405
Issued March 11, 1996
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
- 4405
- Date
- March 11, 1996
- Company
- Amgen Canada IncMississauga, Ontario, Canada
- Product type
- Biologic
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- New indication - to reduce the duration of neutropenia and neutropenia-related clinical sequelae, in patients undergoing myeloablative therapy followed by bone marrow transplantation
- Therapeutic class
- Haematopoietic agent
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| NEUPOGEN | 01968017 | Marketed |
Medicinal ingredients
- FILGRASTIM (R-METHUG-CSF) 300 MCG per ML