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

Abecma

  • Company Name: Celgene Inc.
  • Active Ingredient: Idecabtagene vicleucel
  • Date of Issuance of NOC/c: May 26, 2021.

Related Documentation

Abecma: Qualifying Notice

Activase

  • Company Name: Hoffmann-La Roche Limited
  • Active Ingredient: alteplase
  • Date of Issuance of NOC/c: 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.
    Conditions were met on May 12, 2020.

Afinitor

  • Company Name: Novartis Pharmaceuticals Canada Inc.
  • Active Ingredient: everolimus
  • Date of Issuance of NOC/c: June 30, 2011.
    Conditions were met on September 23, 2016.

Agenerase

  • Company Name: GlaxoSmithKline Inc
  • Active Ingredient: amprenavir
  • Date of Issuance of NOC/c: March 1, 2001.
    November 21, 2001: The product has been transferred from Glaxo Wellcome Inc to GlaxoSmithKline Inc.
    Conditions were met on July 5, 2004.

Alecensaro

  • Company Name: Hoffman La Roche Limited
  • Active Ingredient: alectinib
  • Date of Issuance of NOC/c: September 28, 2016.
    Conditions were met on September 26, 2018.

Alunbrig

  • Company Name: Takeda Canada Inc.
  • Active Ingredient: brigatinib
  • Date of Issuance of NOC/c: July 26, 2018.

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 of NOC/c: 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.
    Conditions were met on January 22, 2020.

Related Documentation

Avastin

  • Company Name: Hoffmann-La Roche Ltd.
  • Active Ingredient: bevacizumab
  • Date of Issuance of NOC/c: March 24, 2010.
    Avastin, as a single agent, for the treatment of patients with glioblastoma (GBM) after relapse or disease progression, following prior therapy, has been withdrawn as of May 23, 2018.

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

Balversa

  • Company Name: Janssen Inc.
  • Active Ingredient: erdafitinib
  • Date of Issuance of NOC/c: October 25, 2019.

Related Documentation

Bavencio

  • Company Name: EMD Serono, a Division of EMD Inc., Canada
  • Active Ingredient: avelumab
  • Date of Issuance of NOC/c: December 18, 2017.
    Conditions were met on January 13, 2021.

Bavencio

  • Company Name: EMD Serono, a Division of EMD Inc., Canada
  • Active Ingredient: avelumab
  • Date of Issuance of NOC/c: November 6, 2019.
    Conditions were met on January 13, 2021.

Blincyto

  • Company Name: Amgen Canada Inc.
  • Active Ingredient: blinatumomab
  • Date of Issuance of NOC/c: December 19, 2019.

Related Documentation

Blincyto

  • Company Name: Amgen Canada Inc.
  • Active Ingredient: blinatumomab
  • Date of Issuance of NOC/c: April 28, 2017.

Related Documentation

Blincyto

  • Company Name: Amgen Canada Inc.
  • Active Ingredient: blinatumomab
  • Date of Issuance of NOC/c: December 22, 2015.
    Conditions were met on November 16, 2017.

Bosulif

  • Company Name: Pfizer Canada Inc.
  • Active Ingredient: bosutinib
  • Date of Issuance of NOC/c: March 7, 2014.
    Conditions were met on August 2, 2017.

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 Imatinib

  • Company Name: Cobalt Pharmaceuticals Company
  • Active Ingredient: imatinib mesylate
  • Date of Issuance of NOC/c: April 24, 2014.
    Conditions removed as of May 26, 2014 due to withdrawal of indication.

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

Daklinza

  • Company Name: Bristol-Myers Squibb Canada
  • Active Ingredient: daclatasvir
  • Date of Issuance of NOC/c: August 13, 2015.
    Conditions were met on November 9, 2016.

Darzalex

  • Company Name: Janssen Inc.
  • Active Ingredient: daratumumab
  • Date of Issuance of NOC/c: June 29 2016.
    Conditions were met Oct 10, 2018.

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.

Enhertu

  • Company Name: Astrazeneca Canada Inc.
  • Active Ingredient: Trastuzumab Deruxtecan
  • Date of Issuance of NOC/c: April 15, 2021

Related Documentation

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 December 17, 2010.

Folotyn

  • Company Name: Servier Canada Inc.
  • Active Ingredient: pralatrexate
  • Date of Issuance of NOC/c: October 26, 2018.

Related Documentation

G

GALEXOS

  • Company Name: Janssen Inc.
  • Active Ingredient: simeprevir
  • Date of Issuance of NOC/c: December 22, 2009.
    Conditions were met on November 24, 2017.

Gavreto

  • Company Name: Hoffmann-La Roche Limited
  • Active Ingredient: pralsetinib
  • Date of Issuance of NOC/c: June 30, 2021.

Related Documentation

Gleevec

  • Company Name: Novartis Pharmaceuticals Canada Inc.
  • Active Ingredient: imatinib mesylate
  • Date of Issuance of NOC/c: December 22, 2009.
    Conditions were met on November 24, 2017.

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

HepaGam B

  • Company Name: Saol Therapeutics Research Limited
  • Active Ingredient: hepatitis B Immune Globulin
  • Date of Issuance of NOC/c: January 19, 2007.
    May 20, 2016: The product has been transferred from Cangene Corporation to Aptevo Biotherapeutics LLC.
    December 20, 2017: The product has been transferred from Aptevo Biotherapeutics LLC. to Saol Therapeutics Research Limited.

I

IBRANCE

  • Company Name: Pfizer Canada Inc.
  • Active Ingredient: palbociclib
  • Date of Issuance of NOC/c: March 16, 2016.
    Conditions were met on November 17, 2016.

Iclusig

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

Related Documentation

Idhifa

  • Company Name: Celgene Inc.
  • Active Ingredient: enasidenib (as enasidenib mesylate)
  • Date of Issuance of NOC/c: February 6, 2019.

Related Documentation

Imbruvica

  • Company Name: Janssen Inc
  • Active Ingredient: ibrutinib
  • Date of Issuance of NOC/c: July 28, 2015.
    Conditions were met on September 12, 2017.

Imfinzi

  • Company Name: AstraZeneca Canada Inc.
  • Active Ingredient: durvalumab for injection
  • Date of Issuance of NOC/c: November 03, 2017.

Related Documentation

Imfinzi

  • Company Name: AstraZeneca Canada Inc.
  • Active Ingredient: durvalumab
  • Date of Issuance of NOC/c: May 4, 2018.
    Conditions were met on August 23, 2019.

Iressa

  • Company Name: AstraZeneca Canada Inc.
  • Active Ingredient: gefitinib
  • Date of Issuance of NOC/c: December 17, 2003.
    Conditions were met on December 18, 2009.

Isentress

  • Company Name: Merck Frosst Canada Ltd.
  • Active Ingredient: raltegravir potassium
  • Date of Issuance of NOC/c: November 27, 2007.
    Conditions were met on March 4, 2009.

Istodax

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

Related Documentation

J

Jadenu

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

K

Kanuma

  • Company Name: Alexion Pharma GmbH
  • Active Ingredient: sebelipase alfa
  • Date of Issuance of NOC/c: December 15, 2017.
    Conditions were met on September 8, 2021.

Keytruda

  • Company Name: Merck Canada Inc.
  • Active Ingredient: pembrolizumab
  • Date of Issuance of NOC/c: February 5, 2021.

Related Documentation

Keytruda

  • Company Name: Merck Canada Inc.
  • Active Ingredient: pembrolizumab
  • Date of Issuance of NOC/c: September 8, 2017.
    Keytruda, as a monotherapy, for the treatment for adult patients with refractory or relapsed classical Hodgkin Lymphoma (cHL) who have failed autologous stem cell transplant (ASCT) and brentuximab vedotin (BV) or who are not ASCT candidates and have failed BV, has been withdrawn as of February 3, 2021.

Keytruda

  • Company Name: Merck Canada Inc.
  • Active Ingredient: pembrolizumab
  • Date of Issuance of NOC/c: December 14, 2020.

Related Documentation

Keytruda

  • Company Name: Merck Canada Inc.
  • Active Ingredient: pembrolizumab
  • Date of Issuance of NOC/c: September 20, 2019.

Related Documentation

Keytruda

  • Company Name: Merck Canada Inc.
  • Active Ingredient: pembrolizumab
  • Date of Issuance of NOC/c: April 11, 2019.

Related Documentation

Keytruda

  • Company Name: Merck Canada Inc.
  • Active Ingredient: pembrolizumab
  • Date of Issuance of NOC/c: April 18, 2019.

Related Documentation

Keytruda

  • Company Name: Merck Canada Inc.
  • Active Ingredient: pembrolizumab
  • Date of Issuance of NOC/c: April 15, 2016.
    Conditions were met on September 10, 2019.

Keytruda

  • Company Name: Merck Canada Inc.
  • Active Ingredient: pembrolizumab
  • Date of Issuance of NOC/c: May 19, 2015.
    Conditions were met on December 22, 2017.

Keytruda

  • Company Name: Merck Canada Inc.
  • Active Ingredient: pembrolizumab
  • Date of Issuance of NOC/c: September 21, 2018.

Related Documentation

L

Lartruvo

  • Company Name: Eli Lilly Canada Inc.
  • Active Ingredient: olaratumab
  • Date of Issuance of NOC/c: November 23, 2017.

Discontinued by company October 8, 2020.

Lenvima

  • Company Name: Eisai Limited
  • Active Ingredient: lenvatinib mesylate
  • Date of Issuance of NOC/c: September 20, 2019.

Related Documentation

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.

Libtayo

  • Company Name: Sanofi-Aventis Canada Inc.
  • Active Ingredient: cemiplimab
  • Date of Issuance of NOC/c: April 10, 2019.

Related Documentation

Lorbrena

  • Company Name: Pfizer Canada ULC
  • Active Ingredient: lorlatinib
  • Date of Issuance of NOC/c: February 22, 2019.

Related Documentation

Lumakras

  • Company Name: Amgen Canada Inc.
  • Active Ingredient: sotorasib
  • Date of Issuance of NOC/c: September 10, 2021.

Related Documentation

LYNPARZA

  • Company Name: AstraZeneca Canada Inc.
  • Active Ingredient: olaparib
  • Date of Issuance of NOC/c: April 29, 2016.
    Conditions were met on May 2, 2018.

LYNPARZA

  • Company Name: AstraZeneca Canada Inc.
  • Active Ingredient: olaparib
  • Date of Issuance of NOC/c: May 4, 2018.

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 of NOC/c: 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.

Minjuvi

  • Company Name: Incyte Corporation
  • Active Ingredient: Tafasitamab
  • Date of Issuance of NOC/c: August 19, 2021

Related documentation

Mylan-Imatinib

Company Name: Mylan Pharmaceuticals ULC

Active Ingredient: imatinib mesylate

Date of Issuance of NOC/c: July 7, 2014.
Discontinued by company April 25, 2016.

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

Ocaliva

Company Name: Intercept Pharmaceuticals Inc

Active Ingredient: obeticholic acid

Date of Issuance of NOC/c: May 24, 2017.

OCREVUS

Company Name: Hoffmann-La Roche Limited

Active Ingredient: ocrelizumab

Date of Issuance of NOC/c: February 14, 2018.

Related Documentation

OCREVUS: Qualifying Notice

Opdivo

Company Name: Bristol-Myers Squibb Canada

Active Ingredient: nivolumab

Date of Issuance of NOC/c: February 11, 2021.

Related Documentation

OPDIVO: Qualifying Notice

OPDIVO

Company Name: Bristol-Myers Squibb Canada

Active Ingredient: nivolumab

Date of Issuance of NOC/c: March 23, 2018.

Related Documentation

OPDIVO: Qualifying Notice

OPDIVO

Company Name: Bristol-Myers Squibb Canada

Active Ingredient: nivolumab

Date of Issuance of NOC/c: November 10, 2017.

Related Documentation

OPDIVO: Qualifying Notice

OPDIVO

Company Name: Bristol-Myers Squibb Canada

Active Ingredient: nivolumab

Date of Issuance of NOC/c: April 29, 2016.
Conditions were met on February 21, 2018.

OPDIVO

Company Name: Bristol-Myers Squibb Canada

Active Ingredient: nivolumab

Date of Issuance of NOC/c: October 26, 2016.

Related Documentation

OPDIVO: Qualifying Notice

P

Pemazyre

Company Name: Incyte Corporation

Active Ingredient: pemigatinib

Date of Issuance of NOC/c: September 17, 2021.

Related Documentation

Pemazyre: Qualifying Notice

Polivy

Company Name: Hoffman-La Roche Limited

Active Ingredient: polatuzumab vedotin

Date of Issuance of NOC/c: July 9, 2020.

Related Documentation

Polivy: Qualifying Notice

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.
Conditions were met on June 28, 2018.

Prezista

Company Name: Janssen-Ortho Inc.

Active Ingredient: darunavir/TMC114

Date of Issuance of NOC/c: July 28, 2006.
Conditions were met on February 22, 2009.

Prochymal

Company Name: Osiris Therapeutics, Inc.

Active Ingredient: remestemcel-L

Date of Issuance of NOC/c: May 17, 2012.

Related Documentation

Prochymal: Qualifying Notice

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.

Relenza

Company Name: GlaxoSmithKline Inc

Active Ingredient: zanamivir

Date of Issuance of NOC/c: November 2, 1999.
February 13, 2003: The product has been transferred from Galaxo Wellcome Inc to GlaxoSmithKline Inc.
Conditions were met on August 26, 2003.

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

Replagal: Qualifying Notice

Rescriptor

Company Name: Agouron Pharmaceuticals Canada Inc.

Active Ingredient: delavirdine

Date of Issuance of NOC/c: July 22, 1998.
April 25, 2000: The product has been transferred from Pharmacia & Upjohn Inc. to Agouron Pharmaceuticals Canada Inc.
Conditions were met on July 22, 2003.

Retevmo

Company Name: Loxo Oncology Inc.

Active Ingredient: selpercatinib

Date of Issuance of NOC/c: June 15, 2021.

Related Documentation

Retevmo: Qualifying Notice

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.

Rozlytrek

Company Name: Hoffmann-La Roche Limited

Active Ingredient: entrectinib

Date of Issuance of NOC/c: February 10, 2020.

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
December 12, 2019: Indication for adjunctive analgesic treatment in adult patients with advanced cancer removed because three large-scale confirmatory studies did not support this use.

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
December 12, 2019: Indication for the adjunctive treatment for symptomatic relief of neuropathic pain in multiple sclerosis in adults removed because the confirmatory study did not support this use.

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

Date of Issuance of NOC/c: 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 Sàrl

Active Ingredient: asfotase alfa

Date of Issuance of NOC/c: August 14, 2015.
Conditions were met on May 26, 2020.

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 of NOC/c: 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 of NOC/c: July 5 2016. 
Conditions were met on January 19, 2018.

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 November 30, 2011.

Taxotere

Company Name: Sanofi-aventis Canada Inc.

Active Ingredient: docetaxel

Date of Issuance of NOC/c: December 14, 2006.
Conditions were met on September 26, 2012.

Related Documentation

Taxotere: Product Specific Fact Sheet

Dear Health Care Professional Letter - Approval of Taxotere with conditions

Taxotere: Qualifying Notice

Tecentriq

Company Name: Hoffmann-La Roche Limited

Active Ingredient: atezolizumab

Date of Issuance of NOC/c: August 21, 2019.

Related Documentation

Tecentriq: Qualifying Notice

Tecentriq

Company Name: Hoffmann-La Roche Limited

Active Ingredient: atezolizumab

Date of Issuance of NOC/c: April 12, 2017.

Related Documentation

Tecentriq: Qualifying Notice

Tecentriq: Qualifying Notice Amendment

Tepadina

Company Name: Adienne SA

Active Ingredient: thiotepa

Date of Issuance of NOC/c: March 29, 2017.

Tepmetko

Company Name: EMD Serono, a Division of EMD Inc., Canada

Active Ingredient: tepotinib

Date of Issuance of NOC/c: May 27, 2021.

Related Documentation

Tepmetko: Qualifying Notice

Truseltiq

  • Company Name: QED Therapeutics, Inc.
  • Active Ingredient: infigratinib
  • Date of Issuance of NOC/c: September 27, 2021.

Related Documentation

Truseltiq: Qualifying Notice

V

Vectibix

Company Name: Amgen Canada Inc.

Active Ingredient: panitumumab

Date of Issuance of NOC/c: April 3, 2008.

Related Documentation

Vectibix: Product Specific Fact Sheet

Dear Health Care Professional Letter - Approval of VECTIBIX with conditions

Vectibix: Qualifying Notice

Vectibix: Qualifying Notice Amendment

Veklury

Company Name: Gilead Sciences Canada Inc.

Active Ingredient: remdesivir

Date of Issuance of NOC/c: July 27, 2020.

Related Documentation

Veklury: Qualifying Notice

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 of NOC/c: September 30, 2016.
Conditions were met on January 13, 2020.

Verity-BCG

Company Name: Verity Pharmaceuticals Inc.

Active Ingredient: Bacillus Calmette-Guérin (BCG): Strain Russian BCG-I

Date of Issuance of NOC/c: December 24, 2020

Related Documentation

Verity-BCG: Qualifying Notice

Viramune

Company Name: Boehringer Ingelheim Canada Ltd

Active Ingredient: nevirapine

Date of Issuance of NOC/c: September 4, 1998.
Conditions were met on September 13, 2004.

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.

Vitrakvi

Company Name: Bayer Inc.

Active Ingredient: larotrectinib

Date of Issuance of NOC/c: July 10, 2019.

Related Documentation

Vitrakvi: Qualifying Notice

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

Zepzelca

Company Name: Jazz Pharmaceuticals Ireland Limited

Active Ingredient: lurbinectedin

Date of Issuance of NOC/c: September 29, 2021.

Related Documentation

Zepzelca: Qualifying Notice

Ziagen

Company Name: Glaxo Wellcome Inc.

Active Ingredient: abacavir sulfate

Date of Issuance of NOC/c: June 4, 1999.
Conditions were met on September 10, 2001.

Zydelig

Company Name: Gilead Sciences Canada, Inc. (Gilead Canada)

Active Ingredient: idelalisib

Date of Issuance of NOC/c: March 27, 2015.
The conditions were met on April 21, 2020.

Related Documentation

Dear Health Care Professional Letter - Approval of Zydelig with conditions

Zydelig: Qualifying Notice

Zykadia

Company Name: Novartis Pharmaceuticals Canada Inc.

Active Ingredient: ceritinib

Date of Issuance of NOC/c: March 27, 2015.

Related Documentation

Dear Health Care Professional Letter - Approval of Zykadia with conditions

Zykadia: Qualifying Notice

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