Approval · Notice of Compliance 9503 · 2008
XYNTHA: Notice of Compliance 9503
Issued April 23, 2008
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
- 9503
- Date
- April 23, 2008
- Company
- Wyeth CanadaSt. Laurent, Quebec, Canada
- Product type
- Biologic
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- New manufacturing facility, new manufacturing process, new 2000 iu presentation, name change from refacto to xyntha
- Therapeutic class
- Antihemophilic factor (recombinant)
Products in this notice
Medicinal ingredients
- MOROCTOCOG ALFA 250 UNIT per VIAL
- MOROCTOCOG ALFA 500 UNIT per VIAL
- MOROCTOCOG ALFA 1,000 UNIT per VIAL
- MOROCTOCOG ALFA 2,000 UNIT per VIAL