Approval · Notice of Compliance 5490 · 1994
EPREX STERILE SOLUTION: Notice of Compliance 5490
Issued February 15, 1994
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
- 5490
- Date
- February 15, 1994
- Company
- Ortho-Mcneil Inc.Toronto, Ontario, Canada
- Product type
- Biologic
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- Alternate manufacturing site
- Therapeutic class
- Haematopoietic agent
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| EPREX STERILE SOLUTION | 02003058 | — |
| EPREX STERILE SOLUTION | 02003066 | — |
| EPREX STERILE SOLUTION | 02003074 | — |
Medicinal ingredients
- RECOMBINANT HUMAN ERYTHROPOIETIN 2,000 UNIT per ML
- RECOMBINANT HUMAN ERYTHROPOIETIN 4,000 UNIT per ML
- RECOMBINANT HUMAN ERYTHROPOIETIN 10,000 UNIT per ML