Approval · Notice of Compliance 22386 · 2019

ESPEROCT: Notice of Compliance 22386

Issued July 4, 2019

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: 22386
Date: July 4, 2019
Company: Novo Nordisk Canada IncMississauga, Ontario, Canada
Product type: Biologic
Submission: New Drug Submission (NDS)
Submission class: New Active Substance (NAS)

Products in this notice

Brand	DIN	Status today
ESPEROCT	02490064	Marketed
ESPEROCT	02490072	Marketed
ESPEROCT	02490080	Approved
ESPEROCT	02490099	Marketed
ESPEROCT	02490102	Marketed

Medicinal ingredients

ANTIHEMOPHILIC FACTOR VIII (RECOMBINANT, B-DOMAIN TRUNCATED), PEGYLATED 500 UNIT per VIAL
ANTIHEMOPHILIC FACTOR VIII (RECOMBINANT, B-DOMAIN TRUNCATED), PEGYLATED 1,000 UNIT per VIAL
ANTIHEMOPHILIC FACTOR VIII (RECOMBINANT, B-DOMAIN TRUNCATED), PEGYLATED 1,500 UNIT per VIAL
ANTIHEMOPHILIC FACTOR VIII (RECOMBINANT, B-DOMAIN TRUNCATED), PEGYLATED 2,000 UNIT per VIAL
ANTIHEMOPHILIC FACTOR VIII (RECOMBINANT, B-DOMAIN TRUNCATED), PEGYLATED 3,000 UNIT per VIAL