Approval · Notice of Compliance 4383 · 1996
EPREX STERILE SOLUTION: Notice of Compliance 4383
Issued February 19, 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
- 4383
- Date
- February 19, 1996
- Company
- Ortho-Mcneil Inc.Toronto, Ontario, Canada
- Product type
- Biologic
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- New strength - preserved with benzyl alcohol
- Therapeutic class
- Erythropoiesis regulating hormone
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| EPREX STERILE SOLUTION | 02206072 | Cancelled Post Market |
Medicinal ingredients
- EPOETIN ALFA 20,000 UNIT per ML