Approval · Notice of Compliance 19133 · 2017
XYNTHA: Notice of Compliance 19133
Issued April 6, 2017
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
- 19133
- Date
- April 6, 2017
- Company
- Pfizer Canada UlcKirkland, Quebec, Canada
- Product type
- Biologic
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- Labelling updates
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| XYNTHA | Not yet assigned | — |
| XYNTHA SOLOFUSE | Not yet assigned | — |
Medicinal ingredients
- MOROCTOCOG ALFA 250 UNIT per VIAL
- MOROCTOCOG ALFA 500 UNIT per VIAL
- MOROCTOCOG ALFA 1,000 UNIT per SYR
- MOROCTOCOG ALFA 2,000 UNIT per SYR
- MOROCTOCOG ALFA 3,000 UNIT per SYR