| 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 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 |
| 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 |
| 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 | — | Erlotinib tablets are not recommended for use in combination with platinum-based chemotherapy. | 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 | Aug 28, 2015 | 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 | Aug 28, 2015 | openfda |
| 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 | Aug 28, 2015 | openfda |
| Erlotinib | US FDA | — | Erlotinib tablets are not recommended for use in combination with platinum-based chemotherapy. | approved | Aug 28, 2015 | openfda |
| Gefitinib | CA Health Canada | — | Marketed in Canada as JAMP GEFITINIB (DIN 02500663) under ATC L01EB01 GEFITINIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph. | approvedsource: Marketed | Dec 23, 2020 | health-canada-dpd |
| Gefitinib | CA Health Canada | — | Marketed in Canada as NAT-GEFITINIB (DIN 02491796) under ATC L01EB01 GEFITINIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph. | withdrawnsource: Dormantsince Mar 1, 2026 | Nov 13, 2019 | health-canada-dpd |
| Gefitinib | CA Health Canada | — | Marketed in Canada as SANDOZ GEFITINIB (DIN 02487748) under ATC L01EB01 GEFITINIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph. | withdrawnsource: Cancelled Post Marketsince Jul 31, 2026 | Jun 26, 2019 | health-canada-dpd |
| Gefitinib | CA Health Canada | — | Marketed in Canada as APO-GEFITINIB (DIN 02468050) under ATC L01EB01 GEFITINIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph. | approvedsource: Marketed | Oct 18, 2017 | health-canada-dpd |
| Gefitinib | CA Health Canada | — | Marketed in Canada as IRESSA (DIN 02248676) under ATC L01EB01 GEFITINIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph. | approvedsource: Marketed | Dec 17, 2003 | health-canada-dpd |
| Gefitinib | CA Health Canada | — | Marketed in Canada as AURO-GEFITINIB (DIN 02533685) under ATC L01EB01 GEFITINIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph. | approved | — | health-canada-dpd |
| Gefitinib | CA Health Canada | — | Marketed in Canada as EUGIA-GEFITINIB (DIN 02547546) under ATC L01EB01 GEFITINIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph. | approved | — | health-canada-dpd |
| Gefitinib | EU EMA | Lung Non-Small Cell Carcinoma | Gefitinib Mylan is indicated as monotherapy for the treatment of adult patients with locally advanced or metastatic non small cell lung cancer (NSCLC) with activating mutations of EGFR TK. | withdrawnsince Sep 27, 2024 | Sep 27, 2018 | ema |
| Gefitinib | EU EMA | Lung Non-Small Cell Carcinoma | Iressa is indicated for the treatment of adult patients with locally advanced or metastatic non-small-cell lung cancer with activating mutations of epidermal-growth-factor-receptor tyrosine kinase. | approved | Jun 24, 2009 | ema |
| Gefitinib | US FDA | Lung Non-Small Cell Carcinoma | IRESSA is indicated for the first-line 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 [see Clinical Studies (14) ] . Limitation of Use: Safety and efficacy of IRESSA have not been established in patients with metastatic NSCLC whose tumors have EGFR mutations other than exon 19 deletions or exon 21 (L858R) substitution mutations [see Clinical Studies (14) ] . IRESSA is a tyrosine kinase inhibitor indicated for the first-line 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. (1) Limitation of Use: Safety and efficacy of IRESSA have not been established in patients whose tumors have EGFR mutations other than exon 19 deletions or exon 21 (L858R) substitution mutations. (1) | approved | Jul 13, 2015 | openfda |
| Melphalan | CA Health Canada | — | Marketed in Canada as TARO-MELPHALAN (DIN 02480026) under ATC L01AA03 MELPHALAN. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph. | approvedsource: Marketed | Jan 25, 2021 | health-canada-dpd |
| Melphalan | CA Health Canada | — | Marketed in Canada as MELPHALAN FOR INJECTION (DIN 02468921) under ATC L01AA03 MELPHALAN. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph. | withdrawnsource: Dormantsince Apr 13, 2023 | Nov 20, 2018 | health-canada-dpd |
| Melphalan | CA Health Canada | — | Marketed in Canada as MELPHALAN FOR INJECTION (DIN 02473348) under ATC L01AA03 MELPHALAN. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph. | approvedsource: Marketed | Jun 18, 2018 | health-canada-dpd |
| Melphalan | CA Health Canada | — | Marketed in Canada as ALKERAN (DIN 02087286) under ATC L01AA03 MELPHALAN. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph. | approvedsource: Marketed | Dec 31, 1995 | health-canada-dpd |
| Melphalan | CA Health Canada | — | Marketed in Canada as ALKERAN (DIN 00004715) under ATC L01AA03 MELPHALAN. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph. | approvedsource: Marketed | Dec 31, 1964 | health-canada-dpd |
| Melphalan | CA Health Canada | — | Marketed in Canada as MELPHALAN FOR INJECTION (DIN 02537389) under ATC L01AA03 MELPHALAN. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph. | approved | — | health-canada-dpd |
| Melphalan | CA Health Canada | — | Marketed in Canada as MELPHALAN FOR INJECTION (DIN 02526077) under ATC L01AA03 MELPHALAN. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph. | withdrawnsource: Cancelled Pre Marketsince Jul 29, 2026 | — | health-canada-dpd |
| Melphalan | CA Health Canada | — | Marketed in Canada as MELPHALAN FOR INJECTION (DIN 02508214) under ATC L01AA03 MELPHALAN. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph. | approved | — | health-canada-dpd |
| Melphalan | EU EMA | — | High-dose of Phelinun used alone or in combination with other cytotoxic medicinal products and/or total body irradiation is indicated in the treatment of: multiple myeloma, malignant lymphoma (Hodgkin, non-Hodgkin lymphoma), acute lymphoblastic and myeloblastic leukemia, childhood neuroblastoma, ovarian cancer, mammary adenocarcinoma. Phelinun in combination with other cytotoxic medicinal products is indicated as reduced intensity conditioning (RIC) treatment prior to allogeneic haematopoietic stem cell transplantation (allo-HSCT) in malignant haematological diseases in adults. Phelinun in combination with other cytotoxic medicinal products is indicated as conditioning regimen prior to allogeneic haematopoietic stem cell transplantation in haematological diseases in the paediatric population as: Myeloablative conditioning (MAC) treatment in case of malignant haematological diseases RIC treatment in case of non-malignant haematological diseases. | approved | Nov 16, 2020 | ema |
| Melphalan | US FDA | Multiple Myeloma | Multiple Myeloma-Palliative Treatment IVRA is indicated for the palliative treatment of patients with multiple myeloma for whom oral therapy is not appropriate. IVRA is an alkylating drug indicated for palliative treatment of patients with multiple myeloma for whom oral therapy is not appropriate. ( 1 ) | approved | Aug 18, 2023 | openfda |
| Melphalan | US FDA | Multiple Myeloma | Evomela is an alkylating drug indicated for use as a high-dose conditioning treatment prior to hematopoietic progenitor (stem) cell transplantation in patients with multiple myeloma. | approved | Mar 10, 2016 | openfda |
| Melphalan | US FDA | Multiple Myeloma | Evomela is an alkylating drug indicated for use as a high-dose conditioning treatment prior to hematopoietic progenitor (stem) cell transplantation in patients with multiple myeloma. | approved | Mar 10, 2016 | openfda |
| Melphalan | US FDA | Multiple Myeloma | Melphalan Hydrochloride for Injection is indicated for the palliative treatment of patients with multiple myeloma for whom oral therapy is not appropriate. | approved | Jun 9, 2009 | openfda |
| Panitumumab | CA Health Canada | — | Marketed in Canada as VECTIBIX (DIN 02308509) under ATC L01FE02 PANITUMUMAB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph. | approvedsource: Marketed | Jan 3, 2017 | health-canada-dpd |
| Panitumumab | CA Health Canada | — | Marketed in Canada as VECTIBIX (DIN 02308487) under ATC L01FE02 PANITUMUMAB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph. | approvedsource: Marketed | May 27, 2008 | health-canada-dpd |
| Panitumumab | CA Health Canada | — | Marketed in Canada as VECTIBIX (DIN 02308495) under ATC L01FE02 PANITUMUMAB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph. | approved | — | health-canada-dpd |
| Panitumumab | EU EMA | Malignant Colorectal Neoplasm | Vectibix is indicated for the treatment of adult patients with wild-type RAS metastatic colorectal cancer (mCRC): in first-line in combination with Folfox or Folfiri. in second-line in combination with Folfiri for patients who have received first-line fluoropyrimidine-based chemotherapy (excluding irinotecan). as monotherapy after failure of fluoropyrimidine-, oxaliplatin-, and irinotecan-containing chemotherapy regimens. | approved | Dec 3, 2007 | ema |
| Panitumumab | US FDA | — | Efficacy supplement 2025-01-16 (see label) | approved | Jan 16, 2025 | openfda |
| Panitumumab | US FDA | — | Efficacy supplement 2017-06-29 (see label) | approved | Jun 29, 2017 | openfda |
| Panitumumab | US FDA | — | Efficacy supplement 2014-05-23 (see label) | approved | May 23, 2014 | openfda |
| Panitumumab | US FDA | — | Efficacy supplement 2014-05-23 (see label) | approved | May 23, 2014 | openfda |
| Panitumumab | US FDA | — | Efficacy supplement 2008-06-23 (see label) | approved | Jun 23, 2008 | openfda |