Approval · Notice of Compliance 3762 · 1997
EPREX STERILE SOLUTION: Notice of Compliance 3762
Issued February 12, 1997
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
- 3762
- Date
- February 12, 1997
- Company
- Janssen-Ortho Inc.
- Product type
- Biologic
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- New pre-filled syringe presentation
- Therapeutic class
- Erythropoiesis regulating hormone
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| EPREX STERILE SOLUTION | 02126583 | Cancelled Post Market |
| EPREX STERILE SOLUTION | 02126591 | Cancelled Post Market |
| EPREX STERILE SOLUTION | 02231583 | Marketed |
| EPREX STERILE SOLUTION | 02231584 | Marketed |
| EPREX STERILE SOLUTION | 02231585 | Marketed |
| EPREX STERILE SOLUTION | 02231586 | Marketed |
| EPREX STERILE SOLUTION | 02231587 | Marketed |
| EPREX STERILE SOLUTION | 02126575 | 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 1,000 UNIT per 0.5ML
- EPOETIN ALFA 2,000 UNIT per 0.5ML
- EPOETIN ALFA 3,000 UNIT per 0.3ML
- EPOETIN ALFA 4,000 UNIT per 0.4ML
- EPOETIN ALFA 10,000 UNIT per 1ML