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

• Abecma: Qualifying notice

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

• Akeega: Qualifying notice

Albrioza

• Company name: Amylyx Pharmaceuticals Inc.
• Active ingredient: Sodium Phenylbutyrate, Ursodoxicoltaurine
• Date of issuance of NOC/c: June 10, 2022.
• Control number: 253502
  • Discontinued by company on September 23, 2024.

Related documentation

• Dear health care professional letter – Withdrawal of Albrioza

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
  • Conditions were met on September 25, 2024.

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
  • Conditions were met on August 6, 2024.

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
  • French Qualifying Notice revised to correct the indication on October 5, 2023.

Related documentation

• Carvykti: Qualifying notice

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 on 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

• Columvi: Qualifying notice

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.

Elrexfio

• Company name: Pfizer Canada ULC.
• Active ingredient: elranatamab
• Date of issuance of NOC/c: December 6, 2023.
• Control number: 273519

Related documentation

• Elrexfio: Qualifying notice

Enhertu

• Company name: Astrazeneca Canada Inc.
• Active ingredient: Trastuzumab Deruxtecan
• Date of issuance of NOC/c: April 15, 2021.
• Control number: 242104
  • Conditions were met on July 9, 2024.

Epkinly

• Company name: Abbvie Corporation
• Active ingredient: Epcoritamab
• Date of issuance of NOC/c: October 13, 2023.
• Control number: 271331

Related documentation

• Epkinly: Qualifying notice

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

• Folotyn: Qualifying notice
• Folotyn: Qualifying notice amendment

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

• Gardasil 9: Qualifying notice

Gavreto

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

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.
• 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]
• Date of issuance of NOC/c: January 19, 2007.
• Control number: 089393
  • 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.
  • Conditions were met on February 20, 2024.

I

Ibrance

• Company name: Pfizer Canada Inc.
• Active ingredient: palbociclib
• Date of issuance of NOC/c: March 16, 2016.
• Control number: 182048
  • 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.
• Control number: 165121
  • Conditions were met on October 3, 2022

Idhifa

• Company name: Celgene Inc.
• Active ingredient: enasidenib mesylate
• Date of issuance of NOC/c: February 6, 2019.
• Control number: 217033
  • Discontinued by company on June 30, 2023

Imbruvica

• Company name: Janssen Inc
• Active ingredient: ibrutinib
• Date of issuance of NOC/c: July 28, 2015.
• Control number: 179136
  • Conditions were met on September 12, 2017.

Imdelltra

• Company name: Amgen Canada Inc.
• Active ingredient: Tarlatamab
• Date of issuance of NOC/c: September 11, 2024.
• Control number: 281963

Related documentation

• Imdelltra: Qualifying notice

Imfinzi

• Company name: AstraZeneca Canada Inc.
• Active ingredient: durvalumab
• Date of issuance of NOC/c: November 03, 2017.
• Control number: 202953

Related documentation

• Imfinzi: Qualifying notice
• Imfinzi: Qualifying notice amendment

Imfinzi

• Company name: AstraZeneca Canada Inc.
• Active ingredient: durvalumab
• Date of issuance of NOC/c: May 4, 2018.
• Control number: 208834
  • 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.
• Control number: 081219
  • 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.
• Control number: 113408
  • Conditions were met on March 4, 2009.

Istodax

• Company name: Bristol-Myers Squibb Canada
• Active ingredient: romidepsin
• Date of issuance of NOC/c: October 16, 2013.
• Control number: 152293
  • The product has been transferred from Celgene Inc. to Bristol-Myers Squibb Canada on February 27, 2024.
  • Indication for the treatment of patients with relapsed/refractory peripheral T-cell lymphoma (PTCL) who are not eligible for transplant and have received at least one prior systemic therapy has been placed under a Restricted Access Program as of March 14, 2023 because the confirmatory study did not support this use.

Related documentation

• Dear Health Care Professional Letter - Approval of Istodax with conditions

J

Jadenu

• Company name: Novartis Pharmaceuticals Canada Inc.
• Active ingredient: deferasirox
• Date of issuance of NOC/c: February 24, 2016.
• Control number: 179088
  • Conditions were met on January 10, 2017.

Jemperli

• Company name: GlaxoSmithKline Inc.
• Active ingredient: dostarlimab
• Date of issuance of NOC/c: December 23, 2021.
• Control number: 251105
  • Conditions were met on July 23, 2024.

K

Kanuma

• Company name: Alexion Pharma GmbH
• Active ingredient: sebelipase alfa
• Date of issuance of NOC/c: December 15, 2017.
• Control number: 204085
  • 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.
• Control number: 246373
  • 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.
• Control number: 239505

Related documentation

• Keytruda: Qualifying notice

Keytruda

• Company name: Merck Canada Inc.
• Active ingredient: pembrolizumab
• Date of issuance of NOC/c: September 8, 2017.
• Control number: 201200
  • 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.
• Control number: 236910

Related documentation

• Keytruda: Qualifying notice

Keytruda

• Company name: Merck Canada Inc.
• Active ingredient: pembrolizumab
• Date of issuance of NOC/c: September 20, 2019.
• Control number: 228721
  • 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.
• Control number: 209011
  • Conditions were met on August 16, 2024.

Keytruda

• Company name: Merck Canada Inc.
• Active ingredient: pembrolizumab
• Date of issuance of NOC/c: April 18, 2019.
• Control number: 218779
  • Conditions were met on November 30, 2023.

Keytruda

• Company name: Merck Canada Inc.
• Active ingredient: pembrolizumab
• Date of issuance of NOC/c: April 15, 2016.
• Control number: 186275
  • 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.
• Control number: 175884
  • 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.
• Control number: 212388

Related documentation

• Keytruda: Qualifying notice

Kymriah

• Company name: Novartis Pharmaceuticals Canada Inc.
• Active ingredient: tisagenlecleucel
• Date of issuance of NOC/c: December 19, 2022.
• Control number: 263500

Related documentation

• Kymriah: Qualifying notice

L

Lartruvo

• Company name: Eli Lilly Canada Inc.
• Active ingredient: olaratumab
• Date of issuance of NOC/c: November 23, 2017.
• Control number: 203478
  • Discontinued by company on October 8, 2020.

Lenvima

• Company name: Eisai Limited
• Active ingredient: lenvatinib mesylate
• Date of issuance of NOC/c: September 20, 2019.
• Control number: 228723
  • Conditions were met on July 21, 2023.

Libtayo

• Company name: Sanofi-Aventis Canada Inc.
• Active ingredient: cemiplimab
• Date of issuance of NOC/c: April 10, 2019.
• Control number: 218718
  • 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.
• Control number: 215733
  • Conditions were met on May 20, 2022.

Lucentis

• Company name: Novartis Pharmaceuticals Canada Inc.
• Active ingredient: ranibizumab
• Date of issuance of NOC/c: November 19, 2021.
• Control number: 233361
  • Conditions were met on May 27, 2024.

Lumakras

• Company name: Amgen Canada Inc.
• Active ingredient: sotorasib
• Date of issuance of NOC/c: September 10, 2021.
• Control number: 248435

Related documentation

• Lumakras: Qualifying notice

Lynparza

• Company name: AstraZeneca Canada Inc.
• Active ingredient: olaparib
• Date of issuance of NOC/c: April 29, 2016.
• Control number: 182823
  • 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.
• Control number: 205344
  • Conditions were met on October 24, 2023.

Lynparza

• Company name: AstraZeneca Canada Inc.
• Active ingredient: olaparib
• Date of issuance of NOC/c: July 27, 2022.
• Control number: 259417
  • Conditions were met on December 13, 2023.

Lynparza

• Company name: AstraZeneca Canada Inc.
• Active ingredient: olaparib
• Date of issuance of NOC/c: July 11, 2023.
• Control number: 265427
  • Conditions were met on September 27, 2024.

Lyrica

• Company name: Pfizer Canada Inc.
• Active ingredient: pregabalin
• Date of issuance of NOC/c: November 9, 2007.
• Control number: 103320
  • 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.
• Control number: 122975
  • 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.
• Control number: 183167
  • 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.
• Control number: 137643
  • Conditions were removed on December 21, 2011 as per the updates to the Product Monograph of the Canadian Reference Product: Ebixa.

Minjuvi

• Company name: Incyte Corporation
• Active ingredient: tafasitamab
• Date of issuance of NOC/c: August 19, 2021
• Control number: 247025

Related documentation

• Minjuvi: Qualifying notice

Mylan-Imatinib

• Company name: Mylan Pharmaceuticals ULC
• Active ingredient: imatinib mesylate
• Date of issuance of NOC/c: July 7, 2014.
• Control number: 157365
  • Discontinued by company on April 25, 2016.

Mylan-Letrozole

• Company name: Mylan Pharmaceuticals ULC
• Active ingredient: letrozole
• Date of issuance of NOC/c: April 28, 2010.
• Control number: 123133
  • 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.
• Control number: 111760
  • Discontinued by company on August 1, 2012.

Nexavar

• Company name: Bayer Inc.
• Active ingredient: sorafenib
• Date of issuance of NOC/c: July 28, 2006.
• Control number: 102070
  • Conditions were met on June 12, 2009.

NiaStase

• Company name: Novo Nordisk Canada Inc.
• Active ingredient: eptacog alfa
• Date of issuance of NOC/c: February 12, 1999.
• Control number: 057147
  • 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.
• Control number: 124459
  • Conditions were met on June 22, 2011.
  • May 8, 2013: Company name change from Novopharm Limited to Teva Canada Limited, and product name change from Novo-Letrozole to Teva-Letrozole.

O

Ocaliva

• Company name: Intercept Pharmaceuticals Inc
• Active ingredient: obeticholic acid
• Date of issuance of NOC/c: May 24, 2017.
• Control number: 198418

Related documentation

• Ocaliva: Qualifying notice

Ocrevus

• Company name: Hoffmann-La Roche Limited
• Active ingredient: ocrelizumab
• Date of issuance of NOC/c: February 14, 2018.
• Control number: 197969

Related documentation

• Ocrevus: Qualifying notice

Ondexxya

• Company name: AstraZeneca Canada Inc.
• Active ingredient: andexanet alfa
• Date of issuance of NOC/c: June 18, 2023.
• Control number: 266464

Related documentation

• Ondexxya: Qualifying notice

Opdivo

• Company name: Bristol-Myers Squibb Canada
• Active ingredient: nivolumab
• Date of issuance of NOC/c: June 27, 2022.
• Control number: 253652

Related documentation

• Opdivo: Qualifying notice

Opdivo

• Company name: Bristol-Myers Squibb Canada
• Active ingredient: nivolumab
• Date of issuance of NOC/c: February 11, 2021.
• Control number: 239474

Related documentation

• Opdivo: Qualifying notice

Opdivo

• Company name: Bristol-Myers Squibb Canada
• Active ingredient: nivolumab
• Date of issuance of NOC/c: March 23, 2018.
• Control number: 206974
  • 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.
• Control number: 203286

Related documentation

• Opdivo: Qualifying notice
• Opdivo: Qualifying notice amendment

Opdivo

• Company name: Bristol-Myers Squibb Canada
• Active ingredient: nivolumab
• Date of issuance of NOC/c: April 29, 2016.
• Control number: 183397
  • 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.
• Control number: 189307
  • Conditions were met on March 1, 2021.

P

Pemazyre

• Company name: Incyte Corporation
• Active ingredient: pemigatinib
• Date of issuance of NOC/c: September 17, 2021.
• Control number: 242569

Related documentation

• Pemazyre: Qualifying notice

pms-Letrozole

• Company name: Pharmascience Inc.
• Active ingredient: letrozole
• Date of issuance of NOC/c: August 27, 2010.
• Control number: 129198
  • 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.
• Control number: 121144
  • Conditions were removed on September 1, 2011 as per the updates to the Product Monograph of the Canadian Reference Product: Ebixa.

Polivy

• Company name: Hoffman-La Roche Limited
• Active ingredient: polatuzumab vedotin
• Date of issuance of NOC/c: July 9, 2020.
• Control number: 232303
  • 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.
• Control number: 182503
  • 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.
• Control number: 103324
  • Conditions were met on February 22, 2009.

Prochymal

• Company name: Mesoblast International Sarl
• Active ingredient: remestemcel-L
• Date of issuance of NOC/c: May 17, 2012.
• Control number: 150026
  • May 2, 2014: The product has been transferred from Osiris Therapeutics Inc. to Mesoblast International Sarl.

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.
• Control number: 119079
  • Conditions were removed on August 11, 2011 as per the updates to the Product Monograph of the Canadian Reference Product: Ebixa.

Relenza

• Company name: GlaxoSmithKline Inc
• Active ingredient: zanamivir
• Date of issuance of NOC/c: November 2, 1999.
• Control number: 058280
  • Conditions were met on August 26, 2003.
  • February 13, 2003: The product has been transferred from Galaxo Wellcome Inc to GlaxoSmithKline Inc.

Replagal

• Company name: Transkaryotic Therapies, Inc.
• Active ingredient: agalsidase alfa
• Date of issuance of NOC/c: February 6, 2004.
• Control number: 068304
  • 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.
• Control number: 188407

Related documentation

• Replagal: Qualifying notice

Rescriptor

• Company name: Agouron Pharmaceuticals Canada Inc.
• Active ingredient: delavirdine mesylate
• Date of issuance of NOC/c: July 22, 1998.
• Control number: 048824
  • Conditions were met on July 22, 2003.
  • April 25, 2000: The product has been transferred from Pharmacia & Upjohn Inc. to Agouron Pharmaceuticals Canada Inc.

Retevmo

• Company name: Loxo Oncology Inc.
• Active ingredient: selpercatinib
• Date of issuance of NOC/c: June 15, 2021.
• Control number: 243748

Related documentation

• Retevmo: Qualifying notice

Revlimid

• Company name: Celgene
• Active ingredient: lenalidomide
• Date of issuance of NOC/c: January 17, 2008.
• Control number: 111952
  • Conditions were met on June 6, 2013.

Rilutek

• Company name: Sanofi-Aventis Canada Inc.
• Active ingredient: riluzole
• Date of issuance of NOC/c: August 30, 2000.
• Control number: 038188
  • Conditions were met on November 29, 2007.
  • March 21, 2006: The product has been transferred from Aventis Pharma Inc. to Sanofi-Aventis Canada Inc.

Riva-Memantine

• Company name: Laboratoire Riva Inc.
• Active ingredient: memantine hydrochloride
• Date of issuance of NOC/c: May 13, 2010.
• Control number: 135190
  • Conditions were removed on November 27, 2013 as per the updates to the Product Monograph of the Canadian Reference Product: Ebixa..

Rozlytrek

• Company name: Hoffmann-La Roche Limited
• Active ingredient: entrectinib
• Date of issuance of NOC/c: February 10, 2020.
• Control number: 227517

Related documentation

• Rozlytrek: Qualifying notice

Rybrevant

• Company name: Janssen Inc.
• Active ingredient: amivantamab
• Date of issuance of NOC/c: March 30, 2022.
• Control number: 254440

Related documentation

• Rybrevant: Qualifying notice

S

Sandoz Letrozole

• Company name: Sandoz Canada Incorporated
• Active ingredient: letrozole
• Date of issuance of NOC/c: April 7, 2010.
• Control number: 134725
  • 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.
• Control number: 134283
  • Conditions were removed on December 20, 2011 as per the updates to the Product Monograph of the Canadian Reference Product: Ebixa.

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
• Control number: 109461
  • Indication for adjunctive analgesic treatment in adult patients with advanced cancer removed on December 12, 2019 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
• Control number: 091289
  • Indication for the adjunctive treatment for symptomatic relief of neuropathic pain in multiple sclerosis in adults removed on December 12, 2019 because the confirmatory study did not support this use.

Soliris

• Company name: Alexion Pharma International Sarl
• Active ingredient: eculizumab
• Date of issuance of NOC/c: March 1, 2013.
• Control number: 155506
  • Conditions were met on June 30, 2015.
  • May 31, 2013: The product has been transferred from Alexion Pharmaceuticals Inc. to Alexion Pharma International Sarl.

Sprycel

• Company name: Bristol-Myers Squibb Canada
• Active ingredient: dasatinib
• Date of issuance of NOC/c: March 26, 2007.
• Control number: 104993
  • 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.
• Control number: 140047
  • 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.
• Control number: 179340
  • 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.
• Control number: 109337
  • 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.
• Control number: 102788
  • 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.
• Control number: 255972

Related documentation

• Tabrecta: Qualifying notice

Tafinlar

• Company name: Novartis Pharmaceuticals Canada Inc.
• Active ingredient: dabrafenib
• Date of issuance of NOC/c: March 6, 2015.
• Control number: 162438
  • Conditions were met on May 13, 2016.
  • July 31, 2015: The product has been transferred from GlaxoSmithKline Inc. to Novartis Pharmaceuticals Canada Inc.

Tagrisso

• Company name: AstraZeneca Canada Inc.
• Active ingredient: osimertinib
• Date of issuance of NOC/c: July 5 2016.
• Control number: 188171
  • Conditions were met on January 19, 2018.

Talvey

• Company name: Janssen Inc.
• Active ingredient: talquetamab
• Date of issuance of NOC/c: April 30, 2024.
• Control number: 278277

Related documentation

• Talvey: Qualifying notice

Tasigna

• Company name: Novartis Pharmaceuticals Canada Inc.
• Active ingredient: nilotinib hydrochloride monohydrate
• Date of issuance of NOC/c: June 22, 2011.
• Control number: 138440
  • 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.
• Control number: 131169
  • 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.
• Control number: 110305
  • 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.
• Control number: 093830
  • 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.
• Control number: 223911
  • 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.
• Control number: 196843
  • 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.
• Control number: 269369

Related documentation

• Tecvayli: Qualifying notice

Tepadina

• Company name: Adienne SA
• Active ingredient: thiotepa
• Date of issuance of NOC/c: March 29, 2017.
• Control number: 168816

Related documentation

• Tepadina: Qualifying notice

Tepmetko

• Company name: EMD Serono, a Division of EMD Inc., Canada
• Active ingredient: tepotinib
• Date of issuance of NOC/c: May 27, 2021.
• Control number: 242300

Related documentation

• Tepmetko: Qualifying notice

Thiotepa For Injection, BP

• Company name: Hikma Canada Limited
• Active ingredient: thiotepa
• Date of issuance of NOC/c: April 26, 2023.
• Control number: 256254

Related documentation

• Thiotepa For Injection BP: Qualifying notice

Thiotepa for Injection USP

• Company name: Sterimax Inc.
• Active ingredient: thiotepa
• Date of issuance of NOC/c: May 18, 2022.
• Control number: 238038

Related documentation

• Thiotepa for Injection USP: Qualifying notice

Truseltiq

• Company name: QED Therapeutics, Inc.
• Active ingredient: infigratinib
• Date of issuance of NOC/c: September 27, 2021.
• Control number: 246904

Related documentation

• Truseltiq: Qualifying notice

V

Vectibix

• Company name: Amgen Canada Inc.
• Active ingredient: panitumumab
• Date of issuance of NOC/c: April 3, 2008.
• Control number: 105601
  • 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.
• Control number: 240551
  • Conditions were met on May 6, 2024.

Velcade

• Company name: Janssen-Ortho Inc.
• Active ingredient: bortezomib
• Date of issuance of NOC/c: January 27, 2005.
• Control number: 090084
  • Conditions were met on September 11, 2007.

Venclexta

• Company name: AbbVie Corporation
• Active ingredient: venetoclax
• Date of issuance of NOC/c: September 30, 2016.
• Control number: 190761
  • 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
• Control number: 221579

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.
• Control number: 043879
  • 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.
• Control number: 075424
  • Conditions were met on July 20, 2005.

Vitrakvi

• Company name: Bayer Inc.
• Active ingredient: larotrectinib
• Date of issuance of NOC/c: July 10, 2019.
• Control number: 219998

Related documentation

• Vitrakvi: Qualifying notice

X

Xalkori

• Company name: Pfizer Canada Inc.
• Active ingredient: crizotinib
• Date of issuance of NOC/c: April 25, 2012.
• Control number: 145155
  • 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.
• Control number: 094178
  • 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.
• Control number: 256106

Related documentation

• Yescarta: Qualifying notice

Z

Zepzelca

• Company name: Jazz Pharmaceuticals Ireland Limited
• Active ingredient: lurbinectedin
• Date of issuance of NOC/c: September 29, 2021.
• Control number: 247485

Related documentation

• Zepzelca: Qualifying notice

Ziagen

• Company name: Glaxo Wellcome Inc.
• Active ingredient: abacavir sulfate
• Date of issuance of NOC/c: June 4, 1999.
• Control number: 056981
  • Conditions were met on September 10, 2001.

Zydelig

• Company name: Gilead Sciences Canada, Inc.
• Active ingredient: idelalisib
• Date of issuance of NOC/c: March 27, 2015.
• Control number: 172652
  • 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.
• Control number: 175702

Related documentation

• Dear Health Care Professional Letter - Approval of Zykadia with conditions
• Zykadia: Qualifying notice