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

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
- Conditions were met on March 12, 2025

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

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

Amtagvi

Company name: Iovance Biotherapeutics Inc.
Active ingredient: lifileucel
Date of issuance of NOC/c: August 15, 2025
Control number: 293019

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

Braftovi

Company name: Pfizer Canada ULC
Active ingredient: encorafenib
Date of issuance of NOC/c: July 25, 2025
Control number: 292474
- Conditions were met on June 24, 2026

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

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

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

Enhertu

Company name: Astrazeneca Canada Inc.
Active ingredient: trastuzumab deruxtecan
Date of issuance of NOC/c: July 3, 2025
Control number: 288114

Enhertu

Company name: Astrazeneca Canada Inc.
Active ingredient: trastuzumab deruxtecan
Date of issuance of NOC/c: January 17, 2025
Control number: 285834

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

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

Eylea

Company name: Bayer Inc.
Active ingredient: aflibercept
Date of issuance of NOC/c: May 2, 2025
Control number: 278211

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

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

Gavreto

Company name: Hoffmann-La Roche Limited
Active ingredient: pralsetinib
Date of issuance of NOC/c: June 30, 2021
Control number: 243731
- Discontinued by company on February 26, 2025

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

Hyrnuo

Company name: Bayer Inc.
Active ingredient: sevabertinib
Date of issuance of NOC/c: January 29, 2026
Control number: 297051

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

Imfinzi

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

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

Iqirvo

Company name: Ipsen Biopharmaceuticals Canada Inc.
Active ingredient: elafibranor
Date of issuance of NOC/c: April 25, 2025
Control number: 287772

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

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

Jaypirca

Company name: Eli Lilly Canada Inc.
Active ingredient: pirtobrutinib
Date of issuance of NOC/c: October 17, 2025
Control number: 293854

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

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

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

Kymriah

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

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

Leqembi

Company name: Eisai Limited
Active ingredient: lecanemab
Date of issuance of NOC/c: October 24, 2025
Control number: 273840

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

Lunsumio

Company name: Hoffmann-La Roche Limited
Active ingredient: mosunetuzumab
Date of issuance of NOC/c: February 6, 2026
Control number: 298079

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

Lyvdelzi

Company name: Gilead Sciences Canada Inc.
Active ingredient: Seladelpar lysine
Date of issuance of NOC/c: October 16, 2025
Control number: 294551

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

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

Ocrevus

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

Ojemda

Company name: Ipsen Biopharmaceuticals Canada Inc.
Active ingredient: tovorafenib
Date of issuance of NOC/c: July 13, 2026
Control number: 301603

Ondexxya

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

Opdivo

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

Opdivo

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

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

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

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

Q

Qalsody

Company name: Biogen Canada Inc.
Active ingredient: Tofersen
Date of issuance of NOC/c: February 28, 2025
Control number: 283158

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

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: Eli Lilly Canada Inc.
Active ingredient: selpercatinib
Date of issuance of NOC/c: June 15, 2021
Control number: 243748
- The product has been transferred from Loxo Oncology Inc. to Eli Lilly Canada Inc. on November 6, 2025

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

Rybrevant

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

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
- Conditions were met on June 28, 2023

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 mesylate
Date of issuance of NOC/c: April 23, 2025
Control number: 288417

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

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

Tepadina

Company name: Adienne SA
Active ingredient: thiotepa
Date of issuance of NOC/c: March 29, 2017
Control number: 168816
- Conditions were met on February 17, 2026

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
- Conditions were met on March 5, 2024

Thiotepa For Injection, BP

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

Thiotepa for Injection USP

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

Truseltiq

Company name: QED Therapeutics, Inc.
Active ingredient: infigratinib
Date of issuance of NOC/c: September 27, 2021
Control number: 246904
- Discontinued by company on January 23, 2023

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

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

Voxzogo

Company name: BioMarin International Limited
Active ingredient: vosoritide
Date of issuance of NOC/c: January 21, 2026
Control number: 290788

W

Wegovy

Company name: Novo Nordisk Canada Inc.
Active ingredient: Semaglutide
Date of issuance of NOC/c: December 11, 2025
Control number: 296143

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

Z

Zepzelca

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

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

Ziihera

Company name: Jazz Pharmaceuticals Ireland Limited
Active ingredient: zanidatamab
Date of issuance of NOC/c: January 15, 2026
Control number: 296499

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
- The conditions were met on December 10, 2025

Zynlonta

Company name: Swedish Orphan Biovitrum AB (Publ)
Active ingredient: loncastuximab tesirine
Date of issuance of NOC/c: March 11, 2025
Control number: 284436

Page details

2026-08-18

Notice of Compliance with conditions (NOC/c)

A

Abecma

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