Approval · Notice of Compliance 18269 · 2016
ELOCTATE: Notice of Compliance 18269
Issued July 8, 2016
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
- 18269
- Date
- July 8, 2016
- Company
- Biogen Canada IncToronto, Ontario, Canada
- Product type
- Biologic
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- Addition of a new indication
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| ELOCTATE | Not yet assigned | — |
Medicinal ingredients
- ANTIHEMOPHILIC FACTOR (RECOMBINANT BDD), FC FUSION PROTEIN 250 MG per VIAL
- ANTIHEMOPHILIC FACTOR (RECOMBINANT BDD), FC FUSION PROTEIN 550 MG per VIAL
- ANTIHEMOPHILIC FACTOR (RECOMBINANT BDD), FC FUSION PROTEIN 750 MG per VIAL
- ANTIHEMOPHILIC FACTOR (RECOMBINANT BDD), FC FUSION PROTEIN 1,000 MG per VIAL
- ANTIHEMOPHILIC FACTOR (RECOMBINANT BDD), FC FUSION PROTEIN 1,500 MG per VIAL
- ANTIHEMOPHILIC FACTOR (RECOMBINANT BDD), FC FUSION PROTEIN 2,000 MG per VIAL
- ANTIHEMOPHILIC FACTOR (RECOMBINANT BDD), FC FUSION PROTEIN 3,000 MG per VIAL