Notice of Compliance with conditions (NOC/c)

An NOC/c is authorization to market a drug (i.e. a Notice of Compliance (NOC)), with the condition that the sponsor undertake additional studies to verify the clinical benefit. The NOC, qualifying under the NOC/c policy, is issued under section C.08.004 of the Food and Drug Regulations.

NOC/c Fact Sheet - General

Brand Name	Company Name	Active Ingredient	Date of Issuance of NOC/c
CO Memantine	Cobalt Pharmaceuticals Inc.	memantine	November 25, 2009
pms-Memantine	Pharmascience Inc.	memantine hydrochloride	November 4, 2009
ratio-MEMANTINE	ratiopharm inc.	memantine hydrochloride	October 29, 2009
Cayston	Gilead Sciences Canada, Inc.	aztreonam for inhalation solution	July 17, 2009
Avastin	Hoffman-La Roche Ltd.	bevacizumab	February 6, 2009
Tasigna	Novartis Pharmaceuticals Canada Inc.	nilotinib	September 9, 2008
Catena	Santhera Pharmaceuticals	idebenone	July 23, 2008
Vectibix	Amgen Canada Inc.	panitumumab	April 3, 2008
Sutent	Pfizer Canada Inc.	sunitinab malate	May 1, 2008
Revlimid	Celgene	lenalidomide	January 17, 2008
Isentress	Merck Frosst Canada Ltd.	raltegravir potassium	November 27, 2007 Conditions were met on March 4, 2009
Lyrica	Pfizer Canada Inc.	pregabalin	November 9, 2007
Natrecor	Janssen-Ortho Inc.	nesiritide	November 8, 2007
Atriance	GlaxoSmithKline Canada Inc.	nelarabine	September 22, 2007
Sativex	GW Pharma Limited	delta-9-tetrahydrocannabinol (from Tetranabinex - Cannabis sativa L. extract) / Cannabidiol (from Nabidiolex - Cannabis sativa L. extract)	August 1, 2007
Gleevec	Novartis Pharmaceuticals Canada Inc.	imatinib mesylate	May 24, 2007
Sprycel	Bristol-Myers Squibb Canada	dasatinib	March 26, 2007
Duodopa	Solvay Pharma Inc.	levodopa / carbidopa	March 1, 2007
HepaGam B	Cangene Corporation	hepatitis B Immune Globulin	January 19, 2007
Taxotere	Sanofi-aventis Canada Inc.	docetaxel	December 14, 2006
Exjade	Novartis Pharmaceuticals Canada Inc.	deferasirox	October 18, 2006
Femara	Novartis Pharmaceuticals Canada Inc.	letrozole	October 6, 2006
Sutent	Pfizer Canada Inc.	sunitinib malate	August 17, 2006
Prezista	Janssen-Ortho Inc.	darunavir/TMC114	July 28, 2006 Conditions were met on February 22, 2009.
Nexavar	Bayer Inc.	sorafenib tablets	July 28, 2006 Conditions were met on June 12, 2009.
Aromasin	Pfizer Canada Inc.	exemestane	May 12, 2006 Conditions were met on June 6, 2008.
Xeloda	Hoffmann-La Roche Limited	capecitabine	December 7, 2005 Conditions were met on October 23, 2008.
Sativex	GW Pharma Limited	delta-9-tetrahydrocannabinol (from Tetranabinex - Cannabis sativa L. extract) / Cannabidiol (from Nabidiolex - Cannabis sativa L. extract)	April 15, 2005
Femara	Novartis Pharmaceuticals Canada Inc.	letrozole	April 1, 2005
Velcade	Janssen-Ortho Inc.	bortezomib	January 27, 2005 Conditions were met on September 11, 2007
Ebixa	Lundbeck Canada Inc.	memantine hydrochloride	December 8, 2004
Arimidex	AstraZeneca Canada Inc.	anastrozole	June 30, 2004. Conditions were met on December 2, 2008.
Celebrex	Pfizer Canada Inc.	celecoxib	May 20, 2004 Issued under the NOC/c policy *** Celebrex used for the prevention of familial adenomatous polyposis has been suspended as of December 17, 2004.
Replagal	Transkaryotic Therapies, Inc.	agalsidase alfa	February 6, 2004
Iressa	AstraZeneca Canada Inc.	gefitinib	December 17, 2003
Gleevec	Novartis Pharmaceuticals Canada Inc.	imatinib	October 8, 2003
Viread	Gilead Sciences, Inc.	tenofovir disoproxil fumarate	March 18, 2003 Conditions were met on July 20, 2005
Gleevec	Novartis Pharmaceuticals Canada Inc.	imatinib	September 20, 2001
Rilutek	Aventis Pharma Inc.	riluzole	August 30, 2000 Conditions were met on November 29, 2007.
Activase	Hoffmann-La Roche Limited	alteplase	February 16, 1999 Conditions were met on January 26, 2005
NiaStase	Novo Nordisk Canada Inc.	recombinant factor VII activated	February 12, 1999 Conditions were met on May 19, 2006