Approval · Notice of Compliance 13265 · 2012
BENEFIX: Notice of Compliance 13265
Issued May 7, 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
- 13265
- Date
- May 7, 2012
- Company
- Pfizer Canada UlcKirkland, Quebec, Canada
- Product type
- Biologic
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- Scale-up of drug substance manufacturing process
- Therapeutic class
- Antihemorrhagic Blood Coagulation Factor IX
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| BENEFIX | Not yet assigned | — |
Medicinal ingredients
- COAGULATION FACTOR IX (RECOMBINANT) 250 UNIT per VIAL
- COAGULATION FACTOR IX (RECOMBINANT) 500 UNIT per VIAL
- COAGULATION FACTOR IX (RECOMBINANT) 1,000 UNIT per VIAL
- COAGULATION FACTOR IX (RECOMBINANT) 2,000 UNIT per VIAL