Approval · Notice of Compliance 13697 · 2012
XYNTHA: Notice of Compliance 13697
Issued October 3, 2012
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
- 13697
- Date
- October 3, 2012
- Company
- Pfizer Canada UlcKirkland, Quebec, Canada
- Product type
- Biologic
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- Update to the Product Monograph
- Therapeutic class
- Antihemorrhaginc Blood Coagulation Factor VIII
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 VIAL
- MOROCTOCOG ALFA 2,000 UNIT per VIAL
- MOROCTOCOG ALFA 250 UNIT per SYR
- MOROCTOCOG ALFA 500 UNIT per SYR
- MOROCTOCOG ALFA 1,000 UNIT per SYR
- MOROCTOCOG ALFA 2,000 UNIT per SYR
- MOROCTOCOG ALFA 3,000 UNIT per SYR