Approval · Notice of Compliance 17715 · 2016

IDELVION: Notice of Compliance 17715

Issued January 26, 2016

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: 17715
Date: January 26, 2016
Company: Csl Behring Canada IncOttawa, Ontario, Canada
Product type: Biologic
Submission: New Drug Submission (NDS)
Submission class: New Active Substance (NAS)

Products in this notice

Brand	DIN	Status today
IDELVION	02451336	Approved
IDELVION	02451344	Approved
IDELVION	02451352	Dormant
IDELVION	02451360	Approved

Medicinal ingredients

COAGULATION FACTOR IX (RECOMBINANT), ALBUMIN FUSION PROTEIN (RIX-FP) 250 UNIT per VIAL
ALBUTREPENONACOG ALFA 500 UNIT per VIAL
ALBUTREPENONACOG ALFA 1,000 UNIT per VIAL
ALBUTREPENONACOG ALFA 2,000 UNIT per VIAL