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. To obtain information on the status of the product, consult the Drug Product Database.

NOC/c Fact Sheet - General

A

Abecma

Company name: Celgene Inc.
Active ingredient: Idecabtagene vicleucel
Date of issuance of NOC/c: May 26, 2021.

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.

Albrioza

Company name: Amylyx Pharmaceuticals Inc.
Active ingredient: Sodium Phenylbutyrate, Ursodoxicoltaurine
Date of issuance of NOC/c: June 10, 2022.

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.
Conditions were met on July 20, 2022

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: March 9, 2012.
Conditions were met on January 17, 2017.

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.

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.

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: May 4, 2018.

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.

Blincyto

Company name: Amgen Canada Inc.
Active ingredient: blinatumomab
Date of issuance of NOC/c: April 28, 2017.

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.

C

Carvykti

Company name: Janssen Inc.
Active ingredient: Ciltacabtagene autoleucel
Date of issuance of NOC/c: February 9, 2023.

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

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.

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.

Gardasil 9

Company name: Merck Canada Inc.
Active ingredient: Recombinant human papillomavirus type 6 L1 protein; Recombinant human papillomavirus type 11 L1 protein; Recombinant human papillomavirus type 16 L1 protein; Recombinant human papillomavirus type 18 L1 protein; Recombinant human papillomavirus type 31 L1 protein; Recombinant human papillomavirus type 33 L1 protein; Recombinant human papillomavirus type 45 L1 protein; Recombinant human papillomavirus type 52 L1 protein; Recombinant human papillomavirus type 58 L1 protein
Date of issuance of NOC/c: April 6, 2022.

Related documentation

Gardasil 9: Qualifying notice

Gavreto

Company name: Hoffmann-La Roche Limited
Active ingredient: pralsetinib
Date of issuance of NOC/c: June 30, 2021.

Related documentation

Gavreto: Qualifying notice

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: KI Biopharma LLC
Active ingredient: Hepatitis B Immunoglobulin [Human] Injection
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.
- October 19, 2022: The product has been transferred from Saol Therapeutics Research Limited to KI Biopharma LLC.

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: Takeda Pharmaceuticals U.S.A., Inc.
Active ingredient: ponatinib hydrochloride
Date of issuance of NOC/c: April 2, 2015.
Conditions were met on October 3, 2022

Idhifa

Company name: Celgene Inc.
Active ingredient: enasidenib (as enasidenib mesylate)
Date of issuance of NOC/c: February 6, 2019.

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.

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.

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.

Jemperli

Company name:GlaxoSmithKline Inc.
Active ingredient: Dostarlimab
Date of issuance of NOC/c: December 23, 2021.

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: November 19, 2021.
Conditions were met on January 25, 2023.

Keytruda

Company name: Merck Canada Inc.
Active ingredient: pembrolizumab
Date of issuance of NOC/c: February 5, 2021.

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.

Keytruda

Company name: Merck Canada Inc.
Active ingredient: pembrolizumab
Date of issuance of NOC/c: September 20, 2019.

Keytruda

Company name: Merck Canada Inc.
Active ingredient: pembrolizumab
Date of issuance of NOC/c: April 11, 2019.

Keytruda

Company name: Merck Canada Inc.
Active ingredient: pembrolizumab
Date of issuance of NOC/c: April 18, 2019.

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.

Kymriah

Company name: Novartis Pharmaceuticals Canada Inc.
Active ingredient: tisagenlecleucel
Date of issuance of NOC/c: December 19, 2022.

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.

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.

Lorbrena

Company name: Pfizer Canada ULC
Active ingredient: lorlatinib
Date of issuance of NOC/c: February 22, 2019.
Conditions were met on May 20, 2022.

Lucentis

Company name: Novartis Pharmaceuticals Canada Inc.
Active ingredient: ranibizumab
Date of issuance of NOC/c: November 22, 2021.

Lumakras

Company name: Amgen Canada Inc.
Active ingredient: sotorasib
Date of issuance of NOC/c: September 10, 2021.

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.

Lynparza

Company name: AstraZeneca Canada Inc.
Active ingredient: olaparib
Date of issuance of NOC/c: July 27, 2022.

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

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 by company 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.

Opdivo

Company name: Bristol-Myers Squibb Canada
Active ingredient: nivolumab
Date of issuance of NOC/c: June 27, 2022.

Opdivo

Company name: Bristol-Myers Squibb Canada
Active ingredient: nivolumab
Date of issuance of NOC/c: February 11, 2021.

Opdivo

Company name: Bristol-Myers Squibb Canada
Active ingredient: nivolumab
Date of issuance of NOC/c: March 23, 2018.

Opdivo

Company name: Bristol-Myers Squibb Canada
Active ingredient: nivolumab
Date of issuance of NOC/c: November 10, 2017.

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.

P

Pemazyre

Company name: Incyte Corporation
Active ingredient: pemigatinib
Date of issuance of NOC/c: September 17, 2021.

Polivy

Company name: Hoffman-La Roche Limited
Active ingredient: polatuzumab vedotin
Date of issuance of NOC/c: July 9, 2020.
Conditions were met on January 20, 2023.

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.

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 by company 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.

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.

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.

Rybrevant

Company name: Janssen Inc.
Active ingredient: Amivantamab
Date of issuance of NOC/c: March 30, 2022.

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

Tabrecta

Company name: Novartis Pharmaceuticals Canada Inc.
Active ingredient: capmatinib hydrochloride
Date of issuance of NOC/c: May 26, 2022.

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.

Tecentriq

Company name: Hoffmann-La Roche Limited
Active ingredient: atezolizumab
Date of issuance of NOC/c: September 19, 2019.
Conditions were met on December 21, 2022

Tecentriq

Company name: Hoffmann-La Roche Limited
Active ingredient: atezolizumab
Date of issuance of NOC/c: April 12, 2017.
Tecentriq, for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum containing chemotherapy or have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum containing chemotherapy, has been withdrawn as of March 29, 2022.

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.

Thiotepa for Injection USP

Company name: Sterimax Inc.
Active ingredient: thiotépa
Date of issuance of NOC/c: May 18, 2022.

Truseltiq

Company name: QED Therapeutics, Inc.
Active ingredient: infigratinib
Date of issuance of NOC/c: September 27, 2021.

V

Vectibix

Company name: Amgen Canada Inc.
Active ingredient: panitumumab
Date of issuance of NOC/c: April 3, 2008.
Conditions were met on February 19, 2015.

Veklury

Company name: Gilead Sciences Canada Inc.
Active ingredient: remdesivir
Date of issuance of NOC/c: July 27, 2020.

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

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.

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.

Y

Yescarta

Company name: Gilead Sciences Canada Inc.
Active ingredient: Axicabtagene ciloleucel
Date of issuance of NOC/c: September 29, 2022.

Z

Zepzelca

Company name: Jazz Pharmaceuticals Ireland Limited
Active ingredient: lurbinectedin
Date of issuance of NOC/c: September 29, 2021.

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.

Zykadia

Company name: Novartis Pharmaceuticals Canada Inc.
Active ingredient: ceritinib
Date of issuance of NOC/c: March 27, 2015.