Approval · Notice of Compliance 4385 · 1996
EPREX STERILE SOLUTION: Notice of Compliance 4385
Issued July 9, 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
- 4385
- Date
- July 9, 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 indication: surgery patients in an autologous blood donation (abd) program - to facilitate autologous blood collection within a predeposit program and may decrese the risk of receiving allogeneic blood transfusions in patients with hematocrits of 33-39% who are scheduled for major elective surgery and are expected to require more blood than that which can be obtained through autologous blood collection techniques in the absence of epoetin alfa
- Therapeutic class
- Erythropoiesis regulating hormone
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| EPREX STERILE SOLUTION | 02126575 | Cancelled Post Market |
| EPREX STERILE SOLUTION | 02126583 | Cancelled Post Market |
| EPREX STERILE SOLUTION | 02126591 | Cancelled Post Market |
| EPREX STERILE SOLUTION | 02206072 | Cancelled Post Market |
Medicinal ingredients
- EPOETIN ALFA 2,000 UNIT per ML
- EPOETIN ALFA 4,000 UNIT per ML
- EPOETIN ALFA 10,000 UNIT per ML
- EPOETIN ALFA 20,000 UNIT per ML