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Drugs and Health Products

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

A

Activase

  • Company Name: Hoffmann-La Roche Limited
  • Active Ingredient: alteplase
  • February 16, 1999
    Conditions were met on January 26, 2005

Adcetris

  • Company Name: Seattle Genetics, Inc.
  • Active Ingredient: brentuximab vedotin
  • Date of Issuance of NOC/c: February 1, 2013

Related Documentation

Afinitor

  • Company Name: Novartis Pharmaceuticals Canada. Inc.
  • Active Ingredient: everolimus
  • Date of Issuance of NOC/c: June 30, 2011

Related Documentation

Apo-Letrozole

  • Company Name: Apotex Incorporated
  • Active Ingredient: letrozole
  • Date of Issuance of NOC/c: December 9, 2010. Conditions were met on September 6, 2013.

Arimidex

  • Company Name: AstraZeneca Canada Inc.
  • Active Ingredient: anastrozole
  • Date of Issuance of NOC/c: June 30, 2004.
    Conditions were met on December 2, 2008.

Aromasin

  • Company Name: Pfizer Canada Inc.
  • Active Ingredient: exemestane
  • Date of Issuance of NOC/c: May 12, 2006
    Conditions were met on June 6, 2008.

Arzerra

  • Company Name: GlaxoSmithKline
  • Active Ingredient: ofatumumab
  • Date of Issuance: February 15, 2012

Related Documentation

Atriance

  • Company Name: Novartis Pharmaceuticals Canada Inc.
  • Active Ingredient: nelarabine
  • Date of Issuance of NOC/c: September 22, 2007. July 31, 2015: The product has been transferred from GlaxoSmithKline Inc. to Novartis Pharmaceuticals Canada Inc.

Related Documentation

Avastin

  • Company Name: Hoffmann-La Roche Ltd.
  • Active Ingredient: bevacizumab
  • Date of Issuance of NOC/c: March 24, 2010

Related Documentation

Avastin

  • Company Name: Hoffman-La Roche Ltd.
  • Active Ingredient: bevacizumab
  • Date of Issuance of NOC/c: February 6, 2009
    Avastin used in combination with paclitaxel is indicated for the treatment of patients with metastatic HER2-negative breast cancer and who are ECOG Class 0-1, has been suspended as of November 25, 2011.

B

Blincyto

  • Company Name: Amgen Canada Inc.
  • Active Ingredient: blinatumomab
  • Date of Issuance: December 22, 2015

Related Documentation

Bosulif

  • Company Name: Pfizer Canada Inc.
  • Active Ingredient: bosutinib
  • Date of Issuance: March 7, 2014

Related Documentation

C

Casodex

  • Company Name: Astrazeneca Canada Inc.
  • Active Ingredient: bicalutamide
  • Date of Issuance of NOC/c: November 25, 2002.
    The Notice of Compliance with Conditions was suspended on August 13, 2003 under section C.08.006(2)(a) of the Food and Drug Regulations due to submitted evidence from pivotal clinical trials demonstrating that Casodex used at a dosage of 150 mg for the treatment of localized early prostate cancer as immediate therapy is associated with increased mortality.

Catena

  • Company Name: Santhera Pharmaceuticals
  • Active Ingredient: idebenone
  • Date of Issuance of NOC/c: July 23, 2008. Discontinued by company April 30, 2013.

Cayston

  • Company Name: Gilead Sciences Canada, Inc.
  • Active Ingredient: aztreonam for inhalation solution
  • Date of Issuance of NOC/c: July 17, 2009
    Conditions were met on May 17, 2011

Celebrex

  • Company Name: Pfizer Canada Inc.
  • Active Ingredient: celecoxib
  • Date of Issuance of NOC/c: 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.

CO Memantine

  • Company Name: Cobalt Pharmaceuticals Inc.
  • Active Ingredient: memantine hydrochloride
  • Date of Issuance of NOC/c: November 25, 2009
    Conditions removed as of April 21, 2011 due to challenges with patient recruitment based on availability of generics and alternative treatments, and the ethics of enrolling Alzheimer's patients into placebo-controlled trials. Conditions were met on March 23, 2012. Company name change from Cobalt Pharmaceuticals Inc. to Actavis Pharma Company, and product name change from CO Memantine to ACT Memantine, August 14, 2014.

D

Darzalex

  • Company Name: Janssen Inc.
  • Active Ingredient: daratumumab
  • Date of Issuance: June 29 2016

Related Documentation

Docetaxel for Injection

  • Company Name: Hospira Healthcare Corporation
  • Active Ingredient: docetaxel
  • Date of Issuance of NOC/c: February 25, 2011. Conditions were met October 10, 2013.

Duodopa

  • Company Name: AbbVie Corporation, an Abbott Company
  • Active Ingredient: levodopa / carbidopa
  • Date of Issuance of NOC/c: March 1, 2007. Company name change November 23, 2012. Conditions were met on March 12, 2014.

E

Ebixa

  • Company Name: Lundbeck Canada Inc.
  • Active Ingredient: memantine hydrochloride
  • Date of Issuance of NOC/c: December 8, 2004
    Conditions removed as of April 21, 2011 due to challenges with patient recruitment based on availability of generics and alternative treatments, and the ethics of enrolling Alzheimer's patients into placebo-controlled trials.

Exjade

  • Company Name: Novartis Pharmaceuticals Canada Inc.
  • Active Ingredient: deferasirox
  • Date of Issuance of NOC/c: October 18, 2006. Conditions were met on December 2, 2016.

F

Femara

  • Company Name: Novartis Pharmaceuticals Canada Inc.
  • Active Ingredient: letrozole
  • Date of Issuance of NOC/c: October 6, 2006
    Conditions were met on December 17, 2010.

Femara

  • Company Name: Novartis Pharmaceuticals Canada Inc.
  • Active Ingredient: letrozole
  • Date of Issuance of NOC/c: April 1, 2005
    Conditions were met on Decemberá17,á2010.

G

GALEXOS

  • Company Name: Janssen Inc.
  • Active Ingredient: simeprevir
  • Date of Issuance of NOC/c: January 30, 2015. Conditions were met on November 29, 2016.

Gleevec

  • Company Name: Novartis Pharmaceuticals Canada Inc.
  • Active Ingredient: imatinib mesylate
  • Date of Issuance of NOC/c: December 22, 2009

Related Documentation

Gleevec

  • Company Name: Novartis Pharmaceuticals Canada Inc.
  • Active Ingredient: imatinib mesylate
  • Date of Issuance of NOC/c: May 24, 2007. Conditions were met February 21, 2013

Gleevec

  • Company Name: Novartis Pharmaceuticals Canada Inc.
  • Active Ingredient: imatinib
  • Date of Issuance of NOC/c: October 8, 2003. Conditions were met June 17, 2010

Gleevec

  • Company Name: Novartis Pharmaceuticals Canada Inc.
  • Active Ingredient: imatinib
  • Date of Issuance of NOC/c: September 20, 2001. Conditions were met December 29, 2004.

H

HepaGamáB

  • Company Name: Cangene Corporation
  • Active Ingredient: hepatitis B Immune Globulin
  • Date of Issuance of NOC/c: January 19, 2007

I

IBRANCE

  • Company Name: Pfizer Canada Inc.
  • Active Ingredient: palbociclib
  • Date of Issuance: March 16, 2016

Related Documentation

Iclusig

  • Company Name: ARIAD Pharmaceuticals Inc.
  • Active Ingredient: ponatinib hydrochloride
  • Date of Issuance: April 2, 2015

Related Documentation

IMBRUVICA

  • Company Name: Janssen Inc
  • Active Ingredient: ibrutinib
  • Date of Issuance: July 28, 2015

Related Documentation

Iressa

  • Company Name: AstraZeneca Canada Inc.
  • Active Ingredient: gefitinib
  • Date of Issuance of NOC/c: December 17, 2003
    Conditions were met on Decemberá18,á2009.

Isentress

  • Company Name: Merck Frosst Canada Ltd.
  • Active Ingredient: raltegravir potassium
  • Date of Issuance of NOC/c: November 27,á2007
    Conditions were met on March 4, 2009

Istodax

  • Company Name: Celgene Inc.
  • Active Ingredient: romidepsin
  • Date of Issuance: October 16, 2013

Related Documentation

J

Jadenu

  • Company Name: Novartis Pharmaceuticals Canada Inc.
  • Active Ingredient: deferasirox
  • Date of Issuance: February 24, 2016. Conditions were met on January 10, 2017.

K

Keytruda

  • Company Name: Merck Canada Inc.
  • Active Ingredient: pembrolizumab
  • Date of Issuance: March 7, 2016

Related Documentation


  • Company Name: Merck Canada Inc.
  • Active Ingredient: pembrolizumab
  • Date of Issuance: May 19, 2015

Related Documentation

L

Letrozole

  • Company Name: Cobalt Pharmaceuticals Inc.
  • Active Ingredient: letrozole
  • Date of Issuance of NOC/c: April 28, 2010. Conditions were met on November 17, 2011.

Letrozole

  • Company Name: Teva Canada Limited
  • Active Ingredient: letrozole
  • Date of Issuance of NOC/c: April 28, 2010. Discontinued by company December 10, 2013.

Letrozole Tablets USP

  • Company Name: Accord Healthcare Inc.
  • Active Ingredient: letrozole
  • Date of Issuance of NOC/c: April 28, 2010. Conditions were met on August 16, 2011.

LYNPARZA

  • Company Name: AstraZeneca Canada Inc.
  • Active Ingredient: olaparib
  • Date of Issuance: April 29, 2016.

Related Documentation

Lyrica

  • Company Name: Pfizer Canada Inc.
  • Active Ingredient: pregabalin
  • Date of Issuance of NOC/c: November 9, 2007
    Conditions were met on June 29, 2010

M

MED-Letrozole

  • Company Name: Generic Medical Partners
  • Active Ingredient: letrozole
  • Date of Issuance of NOC/c: April 28, 2010. Conditions were met on June 14, 2011.

Mekinist

  • Company Name: Novartis Pharmaceuticals Canada Inc.
  • Active Ingredient: trametinib
  • Date of Issuance: March 11, 2016. Conditions were met on May 13, 2016.

Memantine

  • Company Name: MeliaPharm Inc.
  • Active Ingredient: memantine hydrochloride
  • Date of Issuance of NOC/c: October 5, 2010. Conditions were met on December 21, 2011.

Mylan-Letrozole

  • Company Name: Mylan Pharmaceuticals ULC
  • Active Ingredient: letrozole
  • Date of Issuance of NOC/c: April 28, 2010. Conditions were met on June 24, 2011.

N

Natrecor

  • Company Name: Janssen-Ortho Inc.
  • Active Ingredient: nesiritide
  • Date of Issuance of NOC/c: November 8, 2007. Discontinued from the market on August 1, 2012.

Nexavar

  • Company Name: Bayer Inc.
  • Active Ingredient: sorafenib tablets
  • Date of Issuance of NOC/c: July 28, 2006
    Conditions were met on June 12, 2009.

NiaStase

  • Company Name: Novo Nordisk Canada Inc.
  • Active Ingredient: recombinant factor VII activated
  • Date of Issuance of NOC/c: February 12, 1999
    Conditions were met on May 19, 2006

Novo-Letrozole

  • Company Name: Novopharm Limited
  • Active Ingredient: letrozole
  • Date of Issuance of NOC/c: April 28, 2010. Conditions were met on June 22, 2011. Company name change from Novopharm Limited to Teva Canada Limited, and product name change from Novo-Letrozole to Teva-Letrozole, May 8, 2013.

O

OPDIVO

  • Company Name: Bristol-Myers Squibb Canada
  • Active Ingredient: nivolumab
  • Date of Issuance of NOC/c: April 29, 2016.

Related Documentation

OPDIVO

  • Company Name: Bristol-Myers Squibb Canada
  • Active Ingredient: nivolumab
  • Date of Issuance: October 26, 2016.

Related Documentation

P

pms-LETROZOLE

  • Company Name: Pharmascience Inc.
  • Active Ingredient: letrozole
  • Date of Issuance of NOC/c: August 27, 2010. Conditions were met on May 20, 2011.

pms-Memantine

  • Company Name: Pharmascience Inc.
  • Active Ingredient: memantine hydrochloride
  • Date of Issuance of NOC/c: November 4, 2009
    Conditions removed as of April 21, 2011 due to challenges with patient recruitment based on availability of generics and alternative treatments, and the ethics of enrolling Alzheimer's patients into placebo-controlled trials. Conditions were met on September 1, 2011.

Praxbind

  • Company Name: Boehringer Ingelheim Canada Ltd
  • Active Ingredient: idarucizumab
  • Date of Issuance of NOC/c: April 29, 2016.

Related Documentation

Prezista

  • Company Name: Janssen-Ortho Inc.
  • Active Ingredient: darunavir/TMC114
  • Date of Issuance of NOC/c: July 28, 2006
    Conditions were met on Februaryá22,á2009.

Prochymal

  • Company Name: Osiris Therapeutics, Inc.
  • Active Ingredient: remestemcel-L
  • Date of Issuance of NOC/c: May 17, 2012

Related Documentation

R

ratio-Memantine

  • Company Name: ratiopharm inc.
  • Active Ingredient: memantine hydrochloride
  • Date of Issuance of NOC/c: October 29, 2009
    Conditions removed as of April 21, 2011 due to challenges with patient recruitment based on availability of generics and alternative treatments, and the ethics of enrolling Alzheimer's patients into placebo-controlled trials. Conditions were met on August 11, 2011.

Replagal

  • Company Name: Transkaryotic Therapies, Inc.
  • Active Ingredient: agalsidase alfa
  • Date of Issuance of NOC/c: February 6, 2004. Discontinued from the market on June 20, 2014.

Replagal

  • Company Name: Shire Human Genetic Therapies, Inc.
  • Active Ingredient: agalsidase alfa
  • Date of Issuance of NOC/c: February 10, 2017.

Related Documentation

Revlimid

  • Company Name: Celgene
  • Active Ingredient: lenalidomide
  • Date of Issuance of NOC/c: January 17, 2008
    Conditions were met on June 6, 2013.

Rilutek

  • Company Name: Aventis Pharma Inc.
  • Active Ingredient: riluzole
  • Date of Issuance of NOC/c: August 30, 2000
    Conditions were met on November 29, 2007.

Riva-Memantine

  • Company Name: Laboratoire Riva Inc.
  • Active Ingredient: memantine hydrochloride
  • Date of Issuance of NOC/c: March 13, 2010. The conditions were met on December 21, 2013.

S

Sandoz Letrozole

  • Company Name: Sandoz Canada Incorporated
  • Active Ingredient: letrozole
  • Date of Issuance of NOC/c: April 7, 2010. Conditions were met on February 14, 2013.

Sandoz Memantine

  • Company Name: Sandoz Canada Incorporated
  • Active Ingredient: memantine hydrochloride
  • Date of Issuance of NOC/c: April 16, 2010. Conditions were met on December 20, 2011.

Sativex

  • Company Name: GW Pharma Limited
  • Active Ingredient: delta-9-tetrahydrocannabinol (from Tetranabinex - Cannabis sativa L. extract) / Cannabidiol (from Nabidiolex - Cannabis sativa L. extract)
  • Date of Issuance of NOC/c: August 1, 2007

Related Documentation

Sativex

  • Company Name: GW Pharma Limited
  • Active Ingredient: delta-9-tetrahydrocannabinol (from Tetranabinex - Cannabis sativa L. extract) / Cannabidiol (from Nabidiolex - Cannabis sativa L. extract)
  • Date of Issuance of NOC/c: April 15, 2005

Related Documentation

Soliris

  • Company Name: Alexion Pharmaceuticals, Inc.
  • Active Ingredient: eculizumab
  • Date of Issuance of NOC/c: March 1, 2013. Conditions were met on June 30, 2015.

Sprycel

  • Company name: Bristol-Myers Squibb Canada
  • Active Ingredient: dasatinib
  • NOC/c Issued: March 26, 2007, Conditions were met on November 19, 2009

Sprycel

  • Company Name: Bristol-Myers Squibb Canada
  • Active Ingredient: dasatinib
  • Date of Issuance of NOC/c: July 19, 2011. Conditions were met on November 26, 2015.

Strensiq

  • Company Name: Alexion Pharma International SÓrl
  • Active Ingredient: asfotase alfa
  • Date of Issuance: August 14, 2015

Related Documentation

Sutent

  • Company Name: Pfizer Canada Inc.
  • Active Ingredient: sunitinab malate
  • Date of Issuance of NOC/c: May 1, 2008
    Conditions were met on April 23, 2010.

Sutent

  • Company Name: Pfizer Canada Inc.
  • Active Ingredient: sunitinib malate
  • Date of Issuance of NOC/c: August 17, 2006
    Conditions were met on April 23, 2010.

T

Tafinlar

  • Company Name: Novartis Pharmaceuticals Canada Inc.
  • Active Ingredient: dabrafenib
  • Date of Issuance: March 6, 2015. July 31, 2015: The product has been transferred from GlaxoSmithKline Inc. to Novartis Pharmaceuticals Canada Inc. Conditions were met on May 13, 2016.

Tagrisso

  • Company Name: AstraZeneca Canada Inc.
  • Active Ingredient: osimertinib
  • Date of Issuance: July 5 2016.

Related Documentation

Tasigna

  • Company Name: Novartis Pharmaceuticals Canada Inc.
  • Active Ingredient: nilotinib hydrochloride monohydrate
  • Date of Issuance of NOC/c: June 23, 2011. Conditions were met on August 19, 2015

Tasigna

  • Company Name: Novartis Pharmaceuticals Canada Inc.
  • Active Ingredient: nilotinib hydrochloride monohydrate
  • Date of Issuance of NOC/c: July 22, 2010.
    Conditions were met on August 18, 2011.

Tasigna

  • Company Name: Novartis Pharmaceuticals Canada Inc.
  • Active Ingredient: nilotinib hydrochloride monohydrate
  • Date of Issuance of NOC/c: September 9, 2008
    Conditions were met on Novemberá30,á2011.

Taxotere

  • Company Name: Sanofi-aventis Canada Inc.
  • Active Ingredient: docetaxel
  • Date of Issuance of NOC/c: December 14, 2006

Related Documentation

Tecentriq

  • Company Name: Hoffmann-La Roche Limited
  • Active Ingredient: atezolizumab
  • Date of Issuance of NOC/c: April 12, 2017

Related Documentation

V

Vectibix

  • Company Name: Amgen Canada Inc.
  • Active Ingredient: panitumumab
  • Date of Issuance of NOC/c: April 3, 2008

Related Documentation

Velcade

  • Company Name: Janssen-Ortho Inc.
  • Active Ingredient: bortezomib
  • Date of Issuance of NOC/c: January 27, 2005
    Conditions were met on September 11, 2007

VENCLEXTA

  • Company Name: AbbVie Corporation
  • Active Ingredient: venetoclax
  • Date of Issuance: September 30, 2016

Related Documentation

Viread

  • Company Name: Gilead Sciences, Inc.
  • Active Ingredient: tenofovir disoproxil fumarate
  • Date of Issuance of NOC/c: March 18, 2003
    Conditions were met on July 20, 2005

X

Xalkori

  • Company Name: Pfizer Canada Inc.
  • Active Ingredient: crizotinib
  • Date of Issuance of NOC/c: April 25, 2012
    Conditions were met on November 18, 2015.

Xeloda

  • Company Name: Hoffmann-La Roche Limited
  • Active Ingredient: capecitabine
  • Date of Issuance of NOC/c: December 7, 2005
    Conditions were met on October 23, 2008.

Z

Zydelig

  • Company Name: Gilead Sciences Canada, Inc. (Gilead Canada)
  • Active Ingredient: idelalisib
  • Date of Issuance: March 27, 2015

Related Documentation

Zykadia

  • Company Name: Novartis Pharmaceuticals Canada Inc.
  • Active Ingredient: ceritinib
  • Date of Issuance: March 27, 2015

Related Documentation