Approval · Notice of Compliance 19312 · 2017

ELOCTATE: Notice of Compliance 19312

Issued May 17, 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: 19312
Date: May 17, 2017
Company: Bioverativ Canada Inc
Product type: Biologic
Submission: New Drug Submission (NDS)
Submission class: Admin
Reason: Merger - buyout

Products in this notice

Brand	DIN	Status today
ELOCTATE	02430290	Marketed
ELOCTATE	02430304	Marketed
ELOCTATE	02430312	Marketed
ELOCTATE	02430320	Marketed
ELOCTATE	02430339	Marketed
ELOCTATE	02430347	Marketed
ELOCTATE	02430355	Marketed

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