Approval · Notice of Compliance 19878 · 2017
ELOCTATE: Notice of Compliance 19878
Issued October 4, 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
- 19878
- Date
- October 4, 2017
- Company
- Bioverativ Canada Inc
- Product type
- Biologic
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- Alternate drug product manufacturing site
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| ELOCTATE | Not yet assigned | — |
Medicinal ingredients
- ANTIHEMOPHILIC FACTOR (RECOMBINANT BDD), FC FUSION PROTEIN 250 UNIT per VIAL
- ANTIHEMOPHILIC FACTOR (RECOMBINANT BDD), FC FUSION PROTEIN 500 UNIT per VIAL
- ANTIHEMOPHILIC FACTOR (RECOMBINANT BDD), FC FUSION PROTEIN 750 UNIT per VIAL
- ANTIHEMOPHILIC FACTOR (RECOMBINANT BDD), FC FUSION PROTEIN 1,000 UNIT per VIAL
- ANTIHEMOPHILIC FACTOR (RECOMBINANT BDD), FC FUSION PROTEIN 1,500 UNIT per VIAL
- ANTIHEMOPHILIC FACTOR (RECOMBINANT BDD), FC FUSION PROTEIN 2,000 UNIT per VIAL
- ANTIHEMOPHILIC FACTOR (RECOMBINANT BDD), FC FUSION PROTEIN 3,000 UNIT per VIAL