Approval · Notice of Compliance 16408 · 2014

ZONOVATE: Notice of Compliance 16408

Issued December 8, 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: 16408
Date: December 8, 2014
Company: Novo Nordisk Canada IncMississauga, Ontario, Canada
Product type: Biologic
Submission: New Drug Submission (NDS)
Submission class: New Active Substance (NAS)
Therapeutic class: Coagulation factor viii

Products in this notice

Brand	DIN	Status today
ZONOVATE	02435187	Dormant
ZONOVATE	02435195	Dormant
ZONOVATE	02435209	Dormant
ZONOVATE	02435217	Dormant
ZONOVATE	02435225	Dormant
ZONOVATE	02435233	Dormant

Medicinal ingredients

TUROCTOCOG ALFA 250 UNIT per VIAL
TUROCTOCOG ALFA 500 UNIT per VIAL
TUROCTOCOG ALFA 1,000 UNIT per VIAL
TUROCTOCOG ALFA 1,500 UNIT per VIAL
TUROCTOCOG ALFA 2,000 UNIT per VIAL
TUROCTOCOG ALFA 3,000 UNIT per VIAL