Approval · Notice of Compliance 4788 · 2004
REFACTO: Notice of Compliance 4788
Issued July 7, 2004
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
- 4788
- Date
- July 7, 2004
- Company
- Wyeth CanadaSt. Laurent, Quebec, Canada
- Product type
- Biologic
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- New manufacturing site
- Therapeutic class
- Antihemorrhagic blood coagulation factor viii
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| REFACTO | Not yet assigned | — |
Medicinal ingredients
- MOROCTOCOG ALFA 250 UNIT per VIAL
- MOROCTOCOG ALFA 500 UNIT per VIAL
- MOROCTOCOG ALFA 1,000 UNIT per VIAL