| Selumetinib | US FDA | — | KOSELUGO is indicated for the treatment of adult and pediatric patients 1 year of age and older with neurofibromatosis type 1 (NF1) who have symptomatic, inoperable plexiform neurofibromas (PN) [see Dosage and Administration (2) ]. KOSELUGO is a kinase inhibitor indicated for the treatment of adult and pediatric patients 1 year of age and older with neurofibromatosis type 1 (NF1) who have symptomatic, inoperable plexiform neurofibromas (PN). ( 1 ) | approved | Apr 10, 2020 | openfda |
| Sorafenib | CA Health Canada | — | Marketed in Canada as NEXAVAR (DIN 02284227) under ATC L01EX02 SORAFENIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph. | approvedsource: Marketed | Jul 31, 2006 | health-canada-dpd |
| Sorafenib | CA Health Canada | — | Marketed in Canada as APO-SORAFENIB (DIN 02490641) under ATC L01EX02 SORAFENIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph. | approved | — | health-canada-dpd |
| Sorafenib | EU EMA | — | Hepatocellular carcinomaSorafenib Accord is indicated for the treatment of hepatocellular carcinoma (see section 5.1). Renal cell carcinomaSorafenib Accord is indicated for the treatment of patients with advanced renal cell carcinoma who have failed prior interferon-alpha or interleukin-2 based therapy or are considered unsuitable for such therapy. | approved | Nov 9, 2022 | ema |
| Sorafenib | EU EMA | — | Hepatocellular carcinoma Nexavar is indicated for the treatment of hepatocellular carcinoma. Renal cell carcinoma Nexavar is indicated for the treatment of patients with advanced renal cell carcinoma who have failed prior interferon-alpha or interleukin-2 based therapy or are considered unsuitable for such therapy. Differentiated thyroid carcinoma Nexavar is indicated for the treatment of patients with progressive, locally advanced or metastatic, differentiated (papillary/follicular/Hürthle cell) thyroid carcinoma, refractory to radioactive iodine. | approved | Jul 19, 2006 | ema |
| Sorafenib | US FDA | — | Efficacy supplement 2017-12-22 (see label) | approved | Dec 22, 2017 | openfda |
| Sorafenib | US FDA | — | Efficacy supplement 2013-11-22 (see label) | approved | Nov 22, 2013 | openfda |
| Sorafenib | US FDA | — | Efficacy supplement 2007-11-16 (see label) | approved | Nov 16, 2007 | openfda |
| Sorafenib | US FDA | — | Efficacy supplement 2007-11-16 (see label) | approved | Nov 16, 2007 | openfda |
| Sorafenib | US FDA | — | Efficacy supplement 2007-11-16 (see label) | approved | Nov 16, 2007 | openfda |
| Sorafenib | US FDA | — | Efficacy supplement 2007-11-16 (see label) | approved | Nov 16, 2007 | openfda |
| Sorafenib | US FDA | Hepatocellular Carcinoma | NEXAVAR is a kinase inhibitor indicated for the treatment of • Unresectable hepatocellular carcinoma | approved | Dec 1, 2005 | openfda |
| Sorafenib | US FDA | Differentiated Thyroid Gland Carcinoma | Locally recurrent or metastatic, progressive, differentiated thyroid carcinoma (DTC) refractory to radioactive iodine treatment | approved | Dec 1, 2005 | openfda |
| Sorafenib | US FDA | Renal Cell Carcinoma | Advanced renal cell carcinoma | approved | Dec 1, 2005 | openfda |
| Sunitinib | CA Health Canada | — | Marketed in Canada as NAT-SUNITINIB (DIN 02539284) under ATC L01EX01 SUNITINIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph. | approvedsource: Marketed | Sep 30, 2025 | health-canada-dpd |
| Sunitinib | CA Health Canada | — | Marketed in Canada as NAT-SUNITINIB (DIN 02552892) under ATC L01EX01 SUNITINIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph. | approvedsource: Marketed | Sep 30, 2025 | health-canada-dpd |
| Sunitinib | CA Health Canada | — | Marketed in Canada as NAT-SUNITINIB (DIN 02552906) under ATC L01EX01 SUNITINIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph. | approvedsource: Marketed | Sep 30, 2025 | health-canada-dpd |
| Sunitinib | CA Health Canada | — | Marketed in Canada as AURO-SUNITINIB (DIN 02532190) under ATC L01EX01 SUNITINIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph. | approvedsource: Marketed | Sep 18, 2023 | health-canada-dpd |
| Sunitinib | CA Health Canada | — | Marketed in Canada as TEVA-SUNITINIB (DIN 02526204) under ATC L01EX01 SUNITINIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph. | approvedsource: Marketed | Sep 11, 2023 | health-canada-dpd |
| Sunitinib | CA Health Canada | — | Marketed in Canada as TEVA-SUNITINIB (DIN 02526220) under ATC L01EX01 SUNITINIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph. | approvedsource: Marketed | Sep 11, 2023 | health-canada-dpd |
| Sunitinib | CA Health Canada | — | Marketed in Canada as TEVA-SUNITINIB (DIN 02526212) under ATC L01EX01 SUNITINIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph. | approvedsource: Marketed | Sep 11, 2023 | health-canada-dpd |
| Sunitinib | CA Health Canada | — | Marketed in Canada as AURO-SUNITINIB (DIN 02532204) under ATC L01EX01 SUNITINIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph. | approvedsource: Marketed | Jul 21, 2023 | health-canada-dpd |
| Sunitinib | CA Health Canada | — | Marketed in Canada as AURO-SUNITINIB (DIN 02532220) under ATC L01EX01 SUNITINIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph. | approvedsource: Marketed | Jul 21, 2023 | health-canada-dpd |
| Sunitinib | CA Health Canada | — | Marketed in Canada as SANDOZ SUNITINIB (DIN 02532867) under ATC L01EX01 SUNITINIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph. | approvedsource: Marketed | May 24, 2023 | health-canada-dpd |
| Sunitinib | CA Health Canada | — | Marketed in Canada as SANDOZ SUNITINIB (DIN 02532840) under ATC L01EX01 SUNITINIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph. | approvedsource: Marketed | May 24, 2023 | health-canada-dpd |
| Sunitinib | CA Health Canada | — | Marketed in Canada as SANDOZ SUNITINIB (DIN 02532883) under ATC L01EX01 SUNITINIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph. | approvedsource: Marketed | May 24, 2023 | health-canada-dpd |
| Sunitinib | CA Health Canada | — | Marketed in Canada as TARO-SUNITINIB (DIN 02524058) under ATC L01EX01 SUNITINIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph. | approvedsource: Marketed | Jan 17, 2023 | health-canada-dpd |
| Sunitinib | CA Health Canada | — | Marketed in Canada as TARO-SUNITINIB (DIN 02524066) under ATC L01EX01 SUNITINIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph. | approvedsource: Marketed | Sep 20, 2022 | health-canada-dpd |
| Sunitinib | CA Health Canada | — | Marketed in Canada as TARO-SUNITINIB (DIN 02524082) under ATC L01EX01 SUNITINIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph. | approvedsource: Marketed | Sep 20, 2022 | health-canada-dpd |
| Sunitinib | CA Health Canada | — | Marketed in Canada as SUTENT (DIN 02280795) under ATC L01EX01 SUNITINIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph. | approvedsource: Marketed | Jun 22, 2006 | health-canada-dpd |
| Sunitinib | CA Health Canada | — | Marketed in Canada as SUTENT (DIN 02280817) under ATC L01EX01 SUNITINIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph. | approvedsource: Marketed | Jun 22, 2006 | health-canada-dpd |
| Sunitinib | CA Health Canada | — | Marketed in Canada as SUTENT (DIN 02280809) under ATC L01EX01 SUNITINIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph. | approvedsource: Marketed | Jun 22, 2006 | health-canada-dpd |
| Sunitinib | CA Health Canada | — | Marketed in Canada as AURO-SUNITINIB (DIN 02532212) under ATC L01EX01 SUNITINIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph. | approved | — | health-canada-dpd |
| Sunitinib | CA Health Canada | — | Marketed in Canada as TARO-SUNITINIB (DIN 02524074) under ATC L01EX01 SUNITINIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph. | approved | — | health-canada-dpd |
| Sunitinib | CA Health Canada | — | Marketed in Canada as SANDOZ SUNITINIB (DIN 02532875) under ATC L01EX01 SUNITINIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph. | approved | — | health-canada-dpd |
| Sunitinib | CA Health Canada | — | Marketed in Canada as EUGIA-SUNITINIB (DIN 02548062) under ATC L01EX01 SUNITINIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph. | approved | — | health-canada-dpd |
| Sunitinib | CA Health Canada | — | Marketed in Canada as SUTENT (DIN 02328607) under ATC L01EX01 SUNITINIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph. | withdrawnsource: Cancelled Pre Marketsince Mar 31, 2025 | — | health-canada-dpd |
| Sunitinib | CA Health Canada | — | Marketed in Canada as EUGIA-SUNITINIB (DIN 02548038) under ATC L01EX01 SUNITINIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph. | approved | — | health-canada-dpd |
| Sunitinib | CA Health Canada | — | Marketed in Canada as EUGIA-SUNITINIB (DIN 02548046) under ATC L01EX01 SUNITINIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph. | approved | — | health-canada-dpd |
| Sunitinib | CA Health Canada | — | Marketed in Canada as EUGIA-SUNITINIB (DIN 02548054) under ATC L01EX01 SUNITINIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph. | approved | — | health-canada-dpd |
| Sunitinib | EU EMA | — | Gastrointestinal stromal tumour (GIST) Sunitinib Accord is indicated for the treatment of unresectable and/or metastatic malignant gastrointestinal stromal tumour (GIST) in adults after failure of imatinib treatment due to resistance or intolerance. Metastatic renal cell carcinoma (MRCC) Sunitinib Accord is indicated for the treatment of advanced/metastatic renal cell carcinoma (MRCC) in adults. Pancreatic neuroendocrine tumours (pNET) Sunitinib Accord is indicated for the treatment of unresectable or metastatic, well-differentiated pancreatic neuroendocrine tumours (pNET) with disease progression in adults. | approved | Feb 11, 2021 | ema |
| Sunitinib | EU EMA | — | Gastrointestinal stromal tumour (GIST) Sutent is indicated for the treatment of unresectable and/or metastatic malignant gastrointestinal stromal tumour (GIST) in adults after failure of imatinib mesilate treatment due to resistance or intolerance. Metastatic renal cell carcinoma (MRCC) Sutent is indicated for the treatment of advanced/metastatic renal cell carcinoma (MRCC) in adults. Pancreatic neuroendocrine tumours (pNET) Sutent is indicated for the treatment of unresectable or metastatic, well-differentiated pancreatic neuroendocrine tumours with disease progression in adults. Experience with Sutent as first-line treatment is limited (see section 5.1). | approved | Jul 19, 2006 | ema |
| Sunitinib | US FDA | — | Efficacy supplement 2021-08-30 (see label) | approved | Aug 30, 2021 | openfda |
| Sunitinib | US FDA | — | Efficacy supplement 2019-05-07 (see label) | approved | May 7, 2019 | openfda |
| Sunitinib | US FDA | — | Efficacy supplement 2017-11-16 (see label) | approved | Nov 16, 2017 | openfda |
| Sunitinib | US FDA | — | Efficacy supplement 2011-05-20 (see label) | approved | May 20, 2011 | openfda |
| Sunitinib | US FDA | — | Efficacy supplement 2010-07-01 (see label) | approved | Jul 1, 2010 | openfda |
| Sunitinib | US FDA | — | Efficacy supplement 2007-02-02 (see label) | approved | Feb 2, 2007 | openfda |
| Sunitinib | US FDA | — | Efficacy supplement 2007-02-02 (see label) | approved | Feb 2, 2007 | openfda |
| Sunitinib | US FDA | — | Efficacy supplement 2007-02-02 (see label) | approved | Feb 2, 2007 | openfda |