Approval · Notice of Compliance 18759 · 2016

ORFADIN: Notice of Compliance 18759

Issued December 13, 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: 18759
Date: December 13, 2016
Company: Swedish Orphan Biovitrum Ab (Publ)Stockholm, --, Sweden
Product type: Prescription Pharmaceutical
Submission: New Drug Submission (NDS)
Submission class: Priority-NAS

Products in this notice

Brand	DIN	Status today
ORFADIN	02459698	Marketed
ORFADIN	02459701	Marketed
ORFADIN	02459728	Marketed
ORFADIN	02459736	Marketed

Medicinal ingredients

NITISINONE 2 MG per CAP
NITISINONE 5 MG per CAP
NITISINONE 10 MG per CAP
NITISINONE 20 MG per CAP