Approval · Notice of Compliance 10030 · 2009

PUREGON: Notice of Compliance 10030

Issued February 4, 2009

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: 10030
Date: February 4, 2009
Company: Schering-Plough Canada Inc.Pointe-Claire, Quebec, Canada
Product type: Biologic
Submission: New Drug Submission (NDS)
Submission class: Admin
Reason: Manufacturer name change
Therapeutic class: Human gonadotropin

Products in this notice

Brand	DIN	Status today
PUREGON	02242439	Cancelled Post Market
PUREGON	02242441	Cancelled Post Market
PUREGON	02243948	Marketed
PUREGON	02242440	—
PUREGON	02242442	—

Medicinal ingredients

FOLLITROPIN BETA 50 UNIT per 0.5ML
FOLLITROPIN BETA 100 UNIT per 0.5ML
FOLLITROPIN BETA 833 UNIT per ML
FOLLITROPIN BETA 75 UNIT per 0.5ML
FOLLITROPIN BETA 150 UNIT per 0.5ML