Approval · Notice of Compliance 15435 · 2014

ALPROLIX: Notice of Compliance 15435

Issued March 20, 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: 15435
Date: March 20, 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 ix

Products in this notice

Brand	DIN	Status today
ALPROLIX	02422905	Approved
ALPROLIX	02422913	Marketed
ALPROLIX	02422921	Marketed
ALPROLIX	02422948	Marketed
ALPROLIX	02422956	Marketed

Medicinal ingredients

RECOMBINANT HUMAN COAGULATION FACTOR IX, FC FUSION PROTEIN 250 UNIT per VIAL
RECOMBINANT HUMAN COAGULATION FACTOR IX, FC FUSION PROTEIN 500 UNIT per VIAL
RECOMBINANT HUMAN COAGULATION FACTOR IX, FC FUSION PROTEIN 1,000 UNIT per VIAL
RECOMBINANT HUMAN COAGULATION FACTOR IX, FC FUSION PROTEIN 2,000 UNIT per VIAL
RECOMBINANT HUMAN COAGULATION FACTOR IX, FC FUSION PROTEIN 3,000 UNIT per VIAL