Approval · Notice of Compliance 15991 · 2014
ELOCTATE: Notice of Compliance 15991
Issued August 22, 2014
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
- 15991
- Date
- August 22, 2014
- Company
- Biogen Idec Canada Inc
- Product type
- Biologic
- Submission
- New Drug Submission (NDS)
- Submission class
- New Active Substance (NAS)
- Therapeutic class
- Antihemorrhagic blood coagulation factor viii
Products in this notice
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