Approval · Notice of Compliance 5348 · 2003
EPREX STERILE SOLUTION: Notice of Compliance 5348
Issued June 17, 2003
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
- 5348
- Date
- June 17, 2003
- Company
- Janssen-Ortho Inc.
- Product type
- Biologic
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- Changes to manufacturing facility and process for pre-filled syringes
- 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 0.5ML
- EPOETIN ALFA 3,000 UNIT per 0.3ML
- EPOETIN ALFA 4,000 UNIT per 0.4ML
- EPOETIN ALFA 5,000 UNIT per 0.5ML
- EPOETIN ALFA 6,000 UNIT per 0.6ML
- EPOETIN ALFA 7,000 UNIT per 0.7ML
- EPOETIN ALFA 8,000 UNIT per 0.8ML
- EPOETIN ALFA 9,000 UNIT per 0.9ML
- EPOETIN ALFA 10,000 UNIT per ML
- EPOETIN ALFA 20,000 UNIT per 0.5ML
- EPOETIN ALFA 40,000 UNIT per ML