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.
  • Control number: 244266

Related documentation

Activase

  • Company name: Hoffmann-La Roche Limited
  • Active ingredient: alteplase
  • Date of issuance of NOC/c: February 16, 1999.
  • Control number: 042621
    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.
  • Control number: 154851
    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.
  • Control number: 142055
    Conditions were met on September 23, 2016.

Agenerase

  • Company name: GlaxoSmithKline Inc
  • Active ingredient: amprenavir
  • Date of issuance of NOC/c: March 1, 2001.
  • Control number: 058576
    November 21, 2001: The product has been transferred from Glaxo Wellcome Inc to GlaxoSmithKline Inc.
    Conditions were met on July 5, 2004.

Akeega

  • Company name: Janssen Inc.
  • Active ingredient: niraparib, abiraterone acetate
  • Date of issuance of NOC/c: June 12, 2023.
  • Control number: 265223

Related documentation

Albrioza

  • Company name: Amylyx Pharmaceuticals Inc.
  • Active ingredient: Sodium Phenylbutyrate, Ursodoxicoltaurine
  • Date of issuance of NOC/c: June 10, 2022.
  • Control number: 253502

Related documentation

Alecensaro

  • Company name: Hoffman La Roche Limited
  • Active ingredient: alectinib
  • Date of issuance of NOC/c: September 28, 2016.
  • Control number: 189442
    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.
  • Control number: 210369
    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.
  • Control number: 129719
    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.
  • Control number: 076342
    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.
  • Control number: 097618
    Conditions were met on June 6, 2008.

Arzerra

  • Company name: GlaxoSmithKline
  • Active ingredient: ofatumumab
  • Date of issuance of NOC/c: March 9, 2012.
  • Control number: 128188
    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.
  • Control number: 099994
    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.
  • Control number: 130719
    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.
  • Control number: 107746
    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.
  • Control number: 224529

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.
  • Control number: 204052
    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.
  • Control number: 208742

Related documentation

Bavencio

  • Company name: EMD Serono, a Division of EMD Inc., Canada
  • Active ingredient: avelumab
  • Date of issuance of NOC/c: November 6, 2019.
  • Control number: 225974
    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.
  • Control number: 210780
    Conditions were met on August 28, 2023.

Blincyto

  • Company name: Amgen Canada Inc.
  • Active ingredient: blinatumomab
  • Date of issuance of NOC/c: April 28, 2017.
  • Control number: 197615
    Conditions were met on August 28, 2023.

Blincyto

  • Company name: Amgen Canada Inc.
  • Active ingredient: blinatumomab
  • Date of issuance of NOC/c: December 22, 2015.
  • Control number: 181723
    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.
  • Control number: 152211
    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.
  • Control number: 262122

Related documentation

Casodex

  • Company name: Astrazeneca Canada Inc.
  • Active ingredient: bicalutamide
  • Date of issuance of NOC/c: November 25, 2002.
  • Control number: 074234
    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.
  • Control number: 117672
    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.
  • Control number: 120872
    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.
  • Control number: 087158
    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.
  • Control number: 150806
    Conditions removed as of May 26, 2014 due to withdrawal of indication.

Columvi

  • Company name: Hoffmann-La Roche Limited
  • Active ingredient: glofitamab
  • Date of issuance of NOC/c: March 24, 2023.
  • Control number: 265517

Related documentation

CO Memantine

  • Company name: Cobalt Pharmaceuticals Inc.
  • Active ingredient: memantine hydrochloride
  • Date of issuance of NOC/c: November 25, 2009.
  • Control number: 122439
    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.
  • Control number: 172616
    Conditions were met on November 9, 2016.

Darzalex

  • Company name: Janssen Inc.
  • Active ingredient: daratumumab
  • Date of issuance of NOC/c: June 29 2016.
  • Control number: 187648
    Conditions were met October 10, 2018.

Docetaxel for Injection

  • Company name: Hospira Healthcare Corporation
  • Active ingredient: docetaxel
  • Date of issuance of NOC/c: February 25, 2011.
  • Control number: 116151
    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.
  • Control number: 102539
    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.
  • Control number: 085203
    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
  • Control number: 242104

Related documentation

Exjade

  • Company name: Novartis Pharmaceuticals Canada Inc.
  • Active ingredient: deferasirox
  • Date of issuance of NOC/c: October 18, 2006.
  • Control number: 099621
    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.
  • Control number: 100323
    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.
  • Control number: 091486
    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.
  • Control number: 207545

Related documentation

G

Galexos

  • Company name: Janssen Inc.
  • Active ingredient: simeprevir
  • Date of issuance of NOC/c: January 30, 2015.
  • Control number: 176169
    Conditions were met on November 29, 2016.

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.
  • Control number: 251509

Related documentation

Gavreto

  • Company name: Hoffmann-La Roche Limited
  • Active ingredient: pralsetinib
  • Date of issuance of NOC/c: June 30, 2021.
  • Control number: 243731

Related documentation

Gleevec

  • Company name: Novartis Pharmaceuticals Canada Inc.
  • Active ingredient: imatinib mesylate
  • Date of issuance of NOC/c: December 22, 2009.
  • Control number: 127392
    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.
  • Control number: 107659
    Conditions were met February 21, 2013.

Gleevec

  • Company name: Novartis Pharmaceuticals Canada Inc.
  • Active ingredient: imatinib mesylate
  • Date of issuance of NOC/c: October 8, 2003.
  • Control number: 080591
    Conditions were met June 17, 2010.

Gleevec

  • Company name: Novartis Pharmaceuticals Canada Inc.
  • Active ingredient: imatinib mesylate
  • Date of issuance of NOC/c: September 20, 2001.
  • Control number: 070600
    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.

Related documentation

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.
    Discontinued by company on June 30, 2023

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.

Jemperli

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

Related documentation

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.

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.
    Conditions were met on July 20, 2023.

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

Kymriah

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

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.
    Conditions were met on July 21, 2023.

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.
    Conditions were met on August 15, 2023.

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.

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

Lynparza

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

Related documentation

Lynparza

  • Company name: AstraZeneca Canada Inc.
  • Active ingredient: olaparib
  • Date of issuance of NOC/c: July 11, 2023.

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 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.

Related documentation

Ocrevus

  • Company name: Hoffmann-La Roche Limited
  • Active ingredient: ocrelizumab
  • Date of issuance of NOC/c: February 14, 2018.

Related documentation

Ondexxya

  • Company name: AstraZeneca Canada Inc.
  • Active ingredient: Andexanet alfa
  • Date of issuance of NOC/c: June 18, 2023.

Related documentation

Opdivo

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

Related documentation

Opdivo

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

Related documentation

Opdivo

  • Company name: Bristol-Myers Squibb Canada
  • Active ingredient: nivolumab
  • Date of issuance of NOC/c: March 23, 2018.
    Opdivo, indicated as a monotherapy for the treatment of adult patients with advanced (not amenable to curative therapy or local therapeutic measures) or metastatic hepatocellular carcinoma (HCC) who are intolerant to or have progressed on sorafenib therapy, has been withdrawn as of March 22, 2023.

Opdivo

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

Related documentation

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

P

Pemazyre

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

Related documentation

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.

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.

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

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.

Related documentation

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

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.

Related documentation

Rybrevant

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

Related documentation

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.

Related documentation

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.

Tecvayli

  • Company name: Janssen Inc.
  • Active ingredient: teclistamab
  • Date of issuance of NOC/c: July 26, 2023.

Related documentation

Tepadina

  • Company name: Adienne SA
  • Active ingredient: thiotepa
  • Date of issuance of NOC/c: March 29, 2017.

Related documentation

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

Thiotepa For Injection, BP

  • Company name: Hikma Canada Limited
  • Active ingredient: thiotepa
  • Date of issuance of NOC/c: April 26, 2023.

Related documentation

Thiotepa for Injection USP

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

Related documentation

Truseltiq

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

Related documentation

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.

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 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

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

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.

Related documentation

Z

Zepzelca

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

Related documentation

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.

Related documentation

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