Approval · Notice of Compliance 6629 · 2005
EPREX STERILE SOLUTION: Notice of Compliance 6629
Issued April 27, 2005
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
- 6629
- Date
- April 27, 2005
- Company
- Janssen-Ortho Inc.
- Product type
- Biologic
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- New manufacturing process
- Therapeutic class
- Erythropoiesis regulating hormone
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| EPREX STERILE SOLUTION | Not yet assigned | — |
Medicinal ingredients
- EPOETIN ALFA 1,000 UNIT per 0.5ML
- EPOETIN ALFA 2,000 UNIT per ML
- EPOETIN ALFA 4,000 UNIT per ML
- EPOETIN ALFA 10,000 UNIT per ML
- EPOETIN ALFA 40,000 UNIT per ML