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Human medicine European public assessment report (EPAR): Nexavar
sorafenib, Carcinoma, Hepatocellular Carcinoma, Renal Cell
Date of authorisation: 19/07/2006, Revision: 27, AuthorisedNexavar, INN: sorafenib EMA/347706/2014 EMEA/H/C/000690 … for the public Nexavar sorafenib This is a summary of the … contains the active substance sorafenib. It is available as tablets … -
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Human medicine European public assessment report (EPAR): Inlyta
axitinib, Carcinoma, Renal Cell
Date of authorisation: 03/09/2012, Revision: 8, AuthorisedInlyta has been compared with sorafenib (another cancer medicine … Inlyta was more effective than sorafenib in treating advanced renal … months in the patients taking sorafenib. Effects were better for … -
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Human medicine European public assessment report (EPAR): Fotivda
tivozanib hydrochloride monohydrate, Carcinoma, Renal Cell
Date of authorisation: 24/08/2017, Additional monitoring, Revision: 1, Authorisedanother approved medicine sorafenib (9 months). What are the … another approved medicine sorafenib. The most common side effects … tyrosine kinase inhibitors (e.g. sorafenib, sunitinib, pazopanib) and … -
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Human medicine European public assessment report (EPAR): Lenvima (updated)
lenvatinib, Thyroid Neoplasms
Date of authorisation: 28/05/2015, Additional monitoring, Revision: 6, AuthorisedDECISION acronym for the Phase 3 sorafenib trial: “StuDy ofsorafEnib in loCally advanced or metastatIc … acronym for the Phase 3 sorafenib trial: Study of (E7080) LEnvatinib … 2010). To date, one TKI, sorafenib, has been approved in the … -
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Human medicine European public assessment report (EPAR): Stivarga
regorafenib, Colorectal Neoplasms
Date of authorisation: 26/08/2013, Revision: 14, Authorisedwith HCC should have tried sorafenib before starting treatment … worsened after treatment with sorafenib, Stivarga was compared with … with HCC should have tried sorafenib before starting treatment … -
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Human medicine European public assessment report (EPAR): Opdivo
nivolumab, Melanoma Hodgkin Disease Carcinoma, Renal Cell Carcinoma, Non-Small-Cell Lung
Date of authorisation: 19/06/2015, Additional monitoring, Revision: 21, Authorised -
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Human medicine European public assessment report (EPAR): Kisplyx (updated)
lenvatinib, Carcinoma, Renal Cell
Date of authorisation: 25/08/2016, Additional monitoring, Revision: 7, Authorisedsecond-line agents include TKIs: sorafenib, sunitinib, axitinib, and … Authorized Indication Sorafenib Jul 2006 Treatment of patients … -
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Human medicine European public assessment report (EPAR): Votrient
pazopanib, Carcinoma, Renal Cell
Date of authorisation: 14/06/2010, Revision: 20, Authorised -
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Human medicine European public assessment report (EPAR): Afinitor (updated)
everolimus, Carcinoma, Renal Cell Breast Neoplasms Pancreatic Neoplasms
Date of authorisation: 02/08/2009, Revision: 22, AuthorisedVEGF-targeted medicines (sunitinib, sorafenib or both). Patients who took … -
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Human medicine European public assessment report (EPAR): Vargatef
nintedanib, Carcinoma, Non-Small-Cell Lung
Date of authorisation: 21/11/2014, Additional monitoring, Revision: 9, Authorised -
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Human medicine European public assessment report (EPAR): Sutent
sunitinib, Gastrointestinal Stromal Tumors Carcinoma, Renal Cell Neuroendocrine Tumors
Date of authorisation: 19/07/2006, Revision: 33, Authorisedkinase inhibitors such as sorafenib, there remains a large unmet … -
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Human medicine European public assessment report (EPAR): Cabometyx
cabozantinib, Carcinoma, Renal Cell
Date of authorisation: 09/09/2016, Additional monitoring, Revision: 2, Authorised -
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Human medicine European public assessment report (EPAR): Cometriq
cabozantinib, Thyroid Neoplasms
Date of authorisation: 21/03/2014, Additional monitoring, Conditional approval, Revision: 12, Authorised -
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Human medicine European public assessment report (EPAR): Aplidin
plitidepsin, Multiple Myeloma
Date of refusal: 17/07/2018, Refused -
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Human medicine European public assessment report (EPAR): Torisel
temsirolimus, Carcinoma, Renal Cell Lymphoma, Mantle-Cell
Date of authorisation: 19/11/2007, Revision: 28, Authorised -
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Human medicine European public assessment report (EPAR): Zelboraf
vemurafenib, Melanoma
Date of authorisation: 17/02/2012, Revision: 18, Authorised -
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Human medicine European public assessment report (EPAR): Cyramza
ramucirumab, Stomach Neoplasms
Date of authorisation: 19/12/2014, Additional monitoring, Revision: 7, Authorised -
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Human medicine European public assessment report (EPAR): Avastin
bevacizumab, Carcinoma, Non-Small-Cell Lung Breast Neoplasms Ovarian Neoplasms Colorectal Neoplasms Carcinoma, Renal Cell
Date of authorisation: 12/01/2005, Revision: 50, Authorised -
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Human medicine European public assessment report (EPAR): Adempas
riociguat, Hypertension, Pulmonary
Date of authorisation: 27/03/2014, Additional monitoring, Revision: 8, Authorised -
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Human medicine European public assessment report (EPAR): Tyverb
lapatinib, Breast Neoplasms
Date of authorisation: 10/06/2008, Revision: 28, Authorised -
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Human medicine European public assessment report (EPAR): Javlor
vinflunine, Carcinoma, Transitional Cell Urologic Neoplasms
Date of authorisation: 21/09/2009, Revision: 8, Authorised -
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Human medicine European public assessment report (EPAR): Rydapt
midostaurin, Leukemia, Myeloid, Acute Mastocytosis
Date of authorisation: 18/09/2017, Additional monitoring, Revision: 2, Authorised