| Cetuximab | CA Health Canada | — | Marketed in Canada as ERBITUX (DIN 02271249) under ATC L01FE01 CETUXIMAB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph. | approvedsource: Marketed | Oct 28, 2008 | health-canada-dpd |
| Cetuximab | EU EMA | — | Erbitux is indicated for the treatment of patients with epidermal growth factor receptor (EGFR)-expressing, RAS wild-type metastatic colorectal cancer: in combination with irinotecan-based chemotherapy; in first-line in combination with FOLFOX; as a single agent in patients who have failed oxaliplatin- and irinotecan-based therapy and who are intolerant to irinotecan. For details, see section 5.1. Erbitux is indicated for the treatment of adult patients with BRAF V600E mutant metastatic colorectal cancer: in combination with encorafenib and FOLFOX for the first line treatment; in combination with encorafenib in patients who have received prior systemic therapy. For details, see section 5.1, for biomarker-based patient selection, see section 4.2. Erbitux is indicated for the treatment of patients with squamous cell cancer of the head and neck: in combination with radiation therapy for locally advanced disease; in combination with platinum-based chemotherapy for recurrent and/or metastatic disease. | approved | Jun 29, 2004 | ema |
| Cetuximab | US FDA | — | Efficacy supplement 2021-09-24 (see label) | approved | Sep 24, 2021 | openfda |
| Cetuximab | US FDA | — | Efficacy supplement 2021-04-06 (see label) | approved | Apr 6, 2021 | openfda |
| Cetuximab | US FDA | — | Efficacy supplement 2021-04-06 (see label) | approved | Apr 6, 2021 | openfda |
| Cetuximab | US FDA | — | Efficacy supplement 2012-07-06 (see label) | approved | Jul 6, 2012 | openfda |
| Cetuximab | US FDA | — | Efficacy supplement 2011-11-07 (see label) | approved | Nov 7, 2011 | openfda |
| Cetuximab | US FDA | — | Efficacy supplement 2007-10-02 (see label) | approved | Oct 2, 2007 | openfda |
| Cetuximab | US FDA | — | Efficacy supplement 2006-03-01 (see label) | approved | Mar 1, 2006 | openfda |
| Cetuximab | US FDA | — | Efficacy supplement 2006-03-01 (see label) | approved | Mar 1, 2006 | openfda |
| Cetuximab | US FDA | Head and Neck Squamous Cell Carcinoma | Head and Neck Cancer Locally or regionally advanced squamous cell carcinoma of the head and neck in combination with radiation therapy. | approved | Feb 12, 2004 | openfda |
| Cetuximab | US FDA | Malignant Colorectal Neoplasm | Limitations of Use: ERBITUX is not indicated for treatment of Ras-mutant colorectal cancer or when the results of the Ras mutation tests are unknown. ( 5.7 ) BRAF V600E Mutation-Positive Metastatic Colorectal Cancer (CRC) in combination with encorafenib, for the treatment of adult patients with metastatic colorectal cancer (CRC) with a BRAF V600E mutation, as detected by an FDA-approved test, after prior therapy. | approved | Feb 12, 2004 | openfda |
| Cetuximab | US FDA | Head and Neck Squamous Cell Carcinoma | Recurrent or metastatic squamous cell carcinoma of the head and neck progressing after platinum-based therapy. | approved | Feb 12, 2004 | openfda |
| Cetuximab | US FDA | Malignant Colorectal Neoplasm | Colorectal Cancer K-Ras wild-type, EGFR-expressing, metastatic colorectal cancer as determined by an FDA-approved test in combination with FOLFIRI for first-line treatment, in combination with irinotecan in patients who are refractory to irinotecan-based chemotherapy, as a single-agent in patients who have failed oxaliplatin- and irinotecan-based chemotherapy or who are intolerant to irinotecan. | approved | Feb 12, 2004 | openfda |
| Cetuximab | US FDA | Head and Neck Squamous Cell Carcinoma | Recurrent locoregional disease or metastatic squamous cell carcinoma of the head and neck in combination with platinum-based therapy with fluorouracil. | approved | Feb 12, 2004 | openfda |
| Crizotinib | CA Health Canada | — | Marketed in Canada as XALKORI (DIN 02384256) under ATC L01ED01 CRIZOTINIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph. | approvedsource: Marketed | May 10, 2012 | health-canada-dpd |
| Crizotinib | CA Health Canada | — | Marketed in Canada as XALKORI (DIN 02384264) under ATC L01ED01 CRIZOTINIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph. | approvedsource: Marketed | May 10, 2012 | health-canada-dpd |
| Crizotinib | EU EMA | — | Xalkori as monotherapy is indicated for: The first line treatment of adults with anaplastic lymphoma kinase (ALK) positive advanced non small cell lung cancer (NSCLC) The treatment of adults with previously treated anaplastic lymphoma kinase (ALK) positive advanced non small cell lung cancer (NSCLC) The treatment of adults with ROS1 positive advanced non small cell lung cancer (NSCLC) The treatment of paediatric patients (age 1 to <18 years) with relapsed or refractory systemic anaplastic lymphoma kinase (ALK) positive anaplastic large cell lymphoma (ALCL) The treatment of paediatric patients (age 1 to <18 years) with recurrent or refractory anaplastic lymphoma kinase (ALK) positive unresectable inflammatory myofibroblastic tumour (IMT) | approved | Oct 23, 2012 | ema |
| Crizotinib | US FDA | Anaplastic Large Cell Lymphoma | o Limitations of Use: The safety and efficacy of XALKORI have not been established in older adults with relapsed or refractory, systemic ALK-positive ALCL. • adult and pediatric patients 1 year of age and older with unresectable, recurrent, or refractory inflammatory myofibroblastic tumor (IMT) that is ALK-positive. | approved | Sep 7, 2023 | openfda |
| Crizotinib | US FDA | — | XALKORI is a kinase inhibitor indicated for the treatment of • adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors are anaplastic lymphoma kinase (ALK) or ROS1-positive as detected by an FDA-approved test. | approved | Sep 7, 2023 | openfda |
| Crizotinib | US FDA | — | Efficacy supplement 2023-09-07 (see label) | approved | Sep 7, 2023 | openfda |
| Crizotinib | US FDA | Anaplastic Large Cell Lymphoma | pediatric patients 1 year of age and older and young adults with relapsed or refractory, systemic anaplastic large cell lymphoma (ALCL) that is ALK-positive. | approved | Sep 7, 2023 | openfda |
| Crizotinib | US FDA | — | Efficacy supplement 2022-07-14 (see label) | approved | Jul 14, 2022 | openfda |
| Crizotinib | US FDA | — | Efficacy supplement 2021-01-14 (see label) | approved | Jan 14, 2021 | openfda |
| Crizotinib | US FDA | — | Efficacy supplement 2018-11-30 (see label) | approved | Nov 30, 2018 | openfda |
| Crizotinib | US FDA | — | Efficacy supplement 2017-04-28 (see label) | approved | Apr 28, 2017 | openfda |
| Crizotinib | US FDA | — | Efficacy supplement 2016-03-11 (see label) | approved | Mar 11, 2016 | openfda |
| Crizotinib | US FDA | — | Efficacy supplement 2015-09-14 (see label) | approved | Sep 14, 2015 | openfda |
| Crizotinib | US FDA | — | Efficacy supplement 2013-11-20 (see label) | approved | Nov 20, 2013 | openfda |
| Crizotinib | US FDA | — | XALKORI is a kinase inhibitor indicated for the treatment of • adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors are anaplastic lymphoma kinase (ALK) or ROS1-positive as detected by an FDA-approved test. | approved | Aug 26, 2011 | openfda |
| Crizotinib | US FDA | Anaplastic Large Cell Lymphoma | o Limitations of Use: The safety and efficacy of XALKORI have not been established in older adults with relapsed or refractory, systemic ALK-positive ALCL. • adult and pediatric patients 1 year of age and older with unresectable, recurrent, or refractory inflammatory myofibroblastic tumor (IMT) that is ALK-positive. | approved | Aug 26, 2011 | openfda |
| Crizotinib | US FDA | Anaplastic Large Cell Lymphoma | pediatric patients 1 year of age and older and young adults with relapsed or refractory, systemic anaplastic large cell lymphoma (ALCL) that is ALK-positive. | approved | Aug 26, 2011 | openfda |
| Erlotinib | CA Health Canada | — | Marketed in Canada as NAT-ERLOTINIB (DIN 02483920) under ATC L01EB02 ERLOTINIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph. | withdrawnsource: Dormantsince Oct 1, 2021 | May 8, 2019 | health-canada-dpd |
| Erlotinib | CA Health Canada | — | Marketed in Canada as NAT-ERLOTINIB (DIN 02483939) under ATC L01EB02 ERLOTINIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph. | withdrawnsource: Dormantsince Dec 1, 2021 | May 8, 2019 | health-canada-dpd |
| Erlotinib | CA Health Canada | — | Marketed in Canada as NAT-ERLOTINIB (DIN 02483912) under ATC L01EB02 ERLOTINIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph. | withdrawnsource: Dormantsince May 1, 2021 | May 8, 2019 | health-canada-dpd |
| Erlotinib | CA Health Canada | — | Marketed in Canada as APO-ERLOTINIB (DIN 02461870) under ATC L01EB02 ERLOTINIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph. | approvedsource: Marketed | Aug 22, 2017 | health-canada-dpd |
| Erlotinib | CA Health Canada | — | Marketed in Canada as APO-ERLOTINIB (DIN 02461862) under ATC L01EB02 ERLOTINIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph. | approvedsource: Marketed | Aug 22, 2017 | health-canada-dpd |
| Erlotinib | CA Health Canada | — | Marketed in Canada as APO-ERLOTINIB (DIN 02461889) under ATC L01EB02 ERLOTINIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph. | approvedsource: Marketed | Aug 22, 2017 | health-canada-dpd |
| Erlotinib | CA Health Canada | — | Marketed in Canada as PMS-ERLOTINIB (DIN 02454394) under ATC L01EB02 ERLOTINIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph. | approvedsource: Marketed | Jul 28, 2016 | health-canada-dpd |
| Erlotinib | CA Health Canada | — | Marketed in Canada as PMS-ERLOTINIB (DIN 02454386) under ATC L01EB02 ERLOTINIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph. | withdrawnsource: Dormantsince Jul 31, 2025 | Jul 28, 2016 | health-canada-dpd |
| Erlotinib | CA Health Canada | — | Marketed in Canada as TEVA-ERLOTINIB (DIN 02377691) under ATC L01EB02 ERLOTINIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph. | approvedsource: Marketed | Dec 8, 2014 | health-canada-dpd |
| Erlotinib | CA Health Canada | — | Marketed in Canada as TEVA-ERLOTINIB (DIN 02377705) under ATC L01EB02 ERLOTINIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph. | approvedsource: Marketed | Dec 8, 2014 | health-canada-dpd |
| Erlotinib | CA Health Canada | — | Marketed in Canada as TEVA-ERLOTINIB (DIN 02377713) under ATC L01EB02 ERLOTINIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph. | approvedsource: Marketed | Dec 8, 2014 | health-canada-dpd |
| Erlotinib | CA Health Canada | — | Marketed in Canada as TARCEVA (DIN 02269007) under ATC L01EB02 ERLOTINIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph. | withdrawnsource: Cancelled Post Marketsince Oct 1, 2024 | Jan 5, 2007 | health-canada-dpd |
| Erlotinib | CA Health Canada | — | Marketed in Canada as TARCEVA (DIN 02269023) under ATC L01EB02 ERLOTINIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph. | withdrawnsource: Cancelled Post Marketsince Oct 1, 2024 | Jul 19, 2005 | health-canada-dpd |
| Erlotinib | CA Health Canada | — | Marketed in Canada as TARCEVA (DIN 02269015) under ATC L01EB02 ERLOTINIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph. | withdrawnsource: Cancelled Post Marketsince Oct 1, 2024 | Jul 19, 2005 | health-canada-dpd |
| Erlotinib | EU EMA | — | Non-small cell lung cancer (NSCLC) Tarceva is also indicated for switch maintenance treatment in patients with locally advanced or metastatic non-small cell lung cancer with EGFR activating mutations and stable disease after first-line chemotherapy. Tarceva is also indicated for the treatment of patients with locally advanced or metastatic non-small cell lung cancer after failure of at least one prior chemotherapy regimen. In patients with tumours without EGFR activating mutations, Tarceva is indicated when other treatment options are not considered suitable. When prescribing Tarceva, factors associated with prolonged survival should be taken into account. No survival benefit or other clinically relevant effects of the treatment have been demonstrated in patients with Epidermal Growth Factor Receptor (EGFR)-IHC - negative tumours. Pancreatic cancer Tarceva in combination with gemcitabine is indicated for the treatment of patients with metastatic pancreatic cancer. When prescribing Tarceva, factors associated with prolonged survival should be taken into account. | approved | Sep 19, 2005 | ema |
| Erlotinib | US FDA | Lung Non-Small Cell Carcinoma | Limitations of Use: Safety and efficacy of erlotinib tablets have not been established in patients with NSCLC whose tumors have other EGFR mutations. | approved | Nov 9, 2020 | openfda |
| Erlotinib | US FDA | Malignant Pancreatic Neoplasm | First-line treatment of patients with locally advanced, unresectable or metastatic pancreatic cancer, in combination with gemcitabine. | approved | Nov 9, 2020 | openfda |
| Erlotinib | US FDA | Lung Non-Small Cell Carcinoma | The treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations as detected by an FDA-approved test receiving first-line, maintenance, or second or greater line treatment after progression following at least one prior chemotherapy regimen. | approved | Nov 9, 2020 | openfda |