| Afatinib | CA Health Canada | — | Marketed in Canada as MAR-AFATINIB (DIN 02517019) under ATC L01EB03 AFATINIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph. | approvedsource: Marketed | Jan 31, 2025 | health-canada-dpd |
| Afatinib | CA Health Canada | — | Marketed in Canada as MAR-AFATINIB (DIN 02517027) under ATC L01EB03 AFATINIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph. | approvedsource: Marketed | Jan 31, 2025 | health-canada-dpd |
| Afatinib | CA Health Canada | — | Marketed in Canada as MAR-AFATINIB (DIN 02517035) under ATC L01EB03 AFATINIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph. | approvedsource: Marketed | Jan 31, 2025 | health-canada-dpd |
| Afatinib | CA Health Canada | — | Marketed in Canada as SANDOZ AFATINIB (DIN 02512793) under ATC L01EB03 AFATINIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph. | approvedsource: Marketed | Oct 28, 2024 | health-canada-dpd |
| Afatinib | CA Health Canada | — | Marketed in Canada as SANDOZ AFATINIB (DIN 02512777) under ATC L01EB03 AFATINIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph. | approvedsource: Marketed | Oct 28, 2024 | health-canada-dpd |
| Afatinib | CA Health Canada | — | Marketed in Canada as SANDOZ AFATINIB (DIN 02512785) under ATC L01EB03 AFATINIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph. | approvedsource: Marketed | Oct 28, 2024 | health-canada-dpd |
| Afatinib | CA Health Canada | — | Marketed in Canada as GIOTRIF (DIN 02415674) under ATC L01EB03 AFATINIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph. | approvedsource: Marketed | Jan 17, 2014 | health-canada-dpd |
| Afatinib | CA Health Canada | — | Marketed in Canada as GIOTRIF (DIN 02415666) under ATC L01EB03 AFATINIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph. | approvedsource: Marketed | Jan 17, 2014 | health-canada-dpd |
| Afatinib | CA Health Canada | — | Marketed in Canada as GIOTRIF (DIN 02415682) under ATC L01EB03 AFATINIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph. | approvedsource: Marketed | Jan 17, 2014 | health-canada-dpd |
| Afatinib | CA Health Canada | — | Marketed in Canada as TEVA-AFATINIB (DIN 02514605) under ATC L01EB03 AFATINIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph. | withdrawnsource: Cancelled Pre Marketsince Apr 9, 2025 | — | health-canada-dpd |
| Afatinib | CA Health Canada | — | Marketed in Canada as TEVA-AFATINIB (DIN 02514613) under ATC L01EB03 AFATINIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph. | withdrawnsource: Cancelled Pre Marketsince Apr 9, 2025 | — | health-canada-dpd |
| Afatinib | CA Health Canada | — | Marketed in Canada as TEVA-AFATINIB (DIN 02514591) under ATC L01EB03 AFATINIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph. | withdrawnsource: Cancelled Pre Marketsince Apr 9, 2025 | — | health-canada-dpd |
| Afatinib | EU EMA | Lung Non-Small Cell Carcinoma | Giotrif as monotherapy is indicated for the treatment of Epidermal Growth Factor Receptor (EGFR) TKI-naïve adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with activating EGFR mutation(s); locally advanced or metastatic NSCLC of squamous histology progressing on or after platinum-based chemotherapy. | approved | Sep 25, 2013 | ema |
| Afatinib | US FDA | — | Efficacy supplement 2022-04-07 (see label) | approved | Apr 7, 2022 | openfda |
| Afatinib | US FDA | — | Efficacy supplement 2018-01-12 (see label) | approved | Jan 12, 2018 | openfda |
| Afatinib | US FDA | — | Efficacy supplement 2016-04-15 (see label) | approved | Apr 15, 2016 | openfda |
| Afatinib | US FDA | — | Efficacy supplement 2015-11-09 (see label) | approved | Nov 9, 2015 | openfda |
| Afatinib | US FDA | — | Limitations of Use : Safety and efficacy of GILOTRIF were not established in patients whose tumors have resistant EGFR mutations | approved | Jul 12, 2013 | openfda |
| Afatinib | US FDA | Lung Non-Small Cell Carcinoma | Treatment of patients with metastatic, squamous NSCLC progressing after platinum-based chemotherapy | approved | Jul 12, 2013 | openfda |
| Afatinib | US FDA | Lung Non-Small Cell Carcinoma | First-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have non-resistant epidermal growth factor receptor (EGFR) mutations as detected by an FDA-approved test | approved | Jul 12, 2013 | openfda |
| Amivantamab | CA Health Canada | — | Marketed in Canada as RYBREVANT SC (DIN 02569167) under ATC L01FX18 AMIVANTAMAB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph. | approvedsource: Marketed | Jul 24, 2026 | health-canada-dpd |
| Amivantamab | CA Health Canada | — | Marketed in Canada as RYBREVANT SC (DIN 02569175) under ATC L01FX18 AMIVANTAMAB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph. | approvedsource: Marketed | Jul 24, 2026 | health-canada-dpd |
| Amivantamab | CA Health Canada | — | Marketed in Canada as RYBREVANT SC (DIN 02569140) under ATC L01FX18 AMIVANTAMAB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph. | approvedsource: Marketed | Jul 24, 2026 | health-canada-dpd |
| Amivantamab | CA Health Canada | — | Marketed in Canada as RYBREVANT SC (DIN 02569159) under ATC L01FX18 AMIVANTAMAB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph. | approvedsource: Marketed | Jul 24, 2026 | health-canada-dpd |
| Amivantamab | CA Health Canada | — | Marketed in Canada as RYBREVANT (DIN 02526182) under ATC L01FX18 AMIVANTAMAB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph. | approvedsource: Marketed | Apr 26, 2022 | health-canada-dpd |
| Amivantamab | EU EMA | Lung Non-Small Cell Carcinoma | Rybrevant is indicated: in combination with lazertinib for the first line treatment of adult patients with advanced non small cell lung cancer (NSCLC) with EGFR Exon 19 deletions or Exon 21 L858R substitution mutations. in combination with carboplatin and pemetrexed for the treatment of adult patients with advanced NSCLC with EGFR Exon 19 deletions or Exon 21 L858R substitution mutations after failure of prior therapy including an EGFR tyrosine kinase inhibitor (TKI). in combination with carboplatin and pemetrexed for the first line treatment of adult patients with advanced NSCLC with activating EGFR Exon 20 insertion mutations. as monotherapy for treatment of adult patients with advanced NSCLC with activating EGFR Exon 20 insertion mutations, after failure of platinum based therapy. | approved | Dec 9, 2021 | ema |
| Amivantamab | US FDA | — | Efficacy supplement 2025-08-14 (see label) | approved | Aug 14, 2025 | openfda |
| Amivantamab | US FDA | — | Efficacy supplement 2024-09-19 (see label) | approved | Sep 19, 2024 | openfda |
| Amivantamab | US FDA | — | Efficacy supplement 2024-08-19 (see label) | approved | Aug 19, 2024 | openfda |
| Amivantamab | US FDA | — | Efficacy supplement 2024-03-01 (see label) | approved | Mar 1, 2024 | openfda |
| Amivantamab | US FDA | — | Efficacy supplement 2022-11-04 (see label) | approved | Nov 4, 2022 | openfda |
| Amivantamab | US FDA | Lung Non-Small Cell Carcinoma | First-Line Treatment of NSCLC with EGFR Exon 19 Deletions or Exon 21 L858R Substitution Mutations RYBREVANT, in combination with lazertinib, is indicated for the first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R substitution mutations, as detected by an FDA-approved test [see Dosage and Administration (2.2) ] . | approved | May 21, 2021 | openfda |
| Amivantamab | US FDA | Lung Non-Small Cell Carcinoma | Previously Treated NSCLC with EGFR Exon 20 Insertion Mutations RYBREVANT is indicated as a single agent for the treatment of adult patients with locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutations, as detected by an FDA-approved test [see Dosage and Administration (2.2) ] , whose disease has progressed on or after platinum-based chemotherapy. | approved | May 21, 2021 | openfda |
| Amivantamab | US FDA | Lung Non-Small Cell Carcinoma | First-Line Treatment of NSCLC with EGFR Exon 20 Insertion Mutations RYBREVANT, in combination with carboplatin and pemetrexed, is indicated for the first-line treatment of adult patients with locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutations, as detected by an FDA-approved test [see Dosage and Administration (2.2) ] . | approved | May 21, 2021 | openfda |
| Amivantamab | US FDA | Lung Non-Small Cell Carcinoma | Previously Treated NSCLC with EGFR Exon 19 Deletions or Exon 21 L858R Substitution Mutations RYBREVANT, in combination with carboplatin and pemetrexed, is indicated for the treatment of adult patients with locally advanced or metastatic NSCLC with EGFR exon 19 deletions or exon 21 L858R substitution mutations, whose disease has progressed on or after treatment with an EGFR tyrosine kinase inhibitor [see Dosage and Administration (2.2) ] . | approved | May 21, 2021 | 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 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 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 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 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 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 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 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 |