26 results
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Human medicine European public assessment report (EPAR): Vargatef
nintedanib, Carcinoma, Non-Small-Cell Lung
Date of authorisation: 21/11/2014,
, Revision: 10, Authorised, Last updated: 11/04/2019
chemotherapy medicine called docetaxel in patients who have already … given on the same day as docetaxel and because docetaxel is given on day 1 of a 21-day … given on days 2 to 21 with docetaxel being given on day 1. Treatment … -
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Human medicine European public assessment report (EPAR): Ogivri
trastuzumab, Stomach Neoplasms, Breast Neoplasms
Date of authorisation: 12/12/2018,, 
, Revision: 2, Authorised, Last updated: 05/08/2019
medicines: with paclitaxel or docetaxel, or with another type of medicine … -
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Human medicine European public assessment report (EPAR): Cyramza (updated)
Ramucirumab, Stomach Neoplasms
Date of authorisation: 19/12/2014,, Revision: 8, Authorised, Last updated: 03/10/2019
used in combination with docetaxel in patients whose disease … given in combination with docetaxel, the recommended dose is 10 … being given the infusion of docetaxel. Treatment should continue … -
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Human medicine European public assessment report (EPAR): Herzuma
trastuzumab, Stomach Neoplasms, Breast Neoplasms
Date of authorisation: 08/02/2018,, , Revision: 6, Authorised, Last updated: 14/08/2019
medicines: with paclitaxel or docetaxel, or with another class of … medicines: with paclitaxel or docetaxel, or with another class of … -
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Human medicine European public assessment report (EPAR): Kanjinti
trastuzumab, Stomach Neoplasms, Breast Neoplasms
Date of authorisation: 16/05/2018,, , Revision: 5, Authorised, Last updated: 05/08/2019
medicines: with paclitaxel or docetaxel, or with another class of … medicines: with paclitaxel or docetaxel, or with another class of … -
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Human medicine European public assessment report (EPAR): Tecentriq
atezolizumab, Carcinoma, Transitional Cell, Carcinoma, Non-Small-Cell Lung
Date of authorisation: 20/09/2017,, Revision: 5, Authorised, Last updated: 17/06/2019
Tecentriq is more effective than docetaxel (another cancer medicine … average while those given docetaxel lived for 10 months. In a … 10 months for patients on docetaxel. In a main study of 1,202 … -
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Human medicine European public assessment report (EPAR): Ontruzant (updated)
trastuzumab, Stomach Neoplasms, Breast Neoplasms
Date of authorisation: 15/11/2017,, , Revision: 4, Authorised, Last updated: 07/10/2019
medicines: with paclitaxel or docetaxel, or with another class of … medicines: with paclitaxel or docetaxel, or with another class of … -
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Human medicine European public assessment report (EPAR): Trazimera (updated)
trastuzumab, Stomach Neoplasms, Breast Neoplasms
Date of authorisation: 26/07/2018,, , Revision: 3, Authorised, Last updated: 07/10/2019
medicines: with paclitaxel or docetaxel, or with another class of … medicines: with paclitaxel or docetaxel, or with another class of … -
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Human medicine European public assessment report (EPAR): Opdivo (updated)
nivolumab, Melanoma, Hodgkin Disease, Carcinoma, Renal Cell, Carcinoma, Non-Small-Cell Lung
Date of authorisation: 19/06/2015,, Revision: 27, Authorised, Last updated: 11/10/2019
compared with 9.4 months with docetaxel. For squamous NSCLC, a study … months in patients given docetaxel. Supportive information was … -
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Human medicine European public assessment report (EPAR): Keytruda
Pembrolizumab, Melanoma, Hodgkin Disease, Carcinoma, Non-Small-Cell Lung
Date of authorisation: 17/07/2015,, Revision: 21, Authorised, Last updated: 11/09/2019
another cancer medicine called docetaxel (around 8 months) and the … -
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Human medicine European public assessment report (EPAR): Sylvant (updated)
siltuximab, EUSA Pharma (Netherlands) BV
Date of authorisation: 22/05/2014,, 
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, Revision: 10, Authorised, Last updated: 08/10/2019
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Human medicine European public assessment report (EPAR): Zykadia
ceritinib, Carcinoma, Non-Small-Cell Lung
Date of authorisation: 06/05/2015,, Revision: 12, Authorised, Last updated: 26/08/2019
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Human medicine European public assessment report (EPAR): Akynzeo
netupitant, palonosetron hydrochloride, Vomiting, Cancer, Nausea
Date of authorisation: 27/05/2015,, Revision: 5, Authorised, Last updated: 10/07/2019
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Human medicine European public assessment report (EPAR): Ketoconazole HRA
Ketoconazole, Cushing Syndrome
Date of authorisation: 18/11/2014,, , , Revision: 9, Authorised, Last updated: 18/09/2019
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Human medicine European public assessment report (EPAR): Zejula
niraparib tosylate monohydrate, Fallopian Tube Neoplasms, Peritoneal Neoplasms, Ovarian Neoplasms
Date of authorisation: 16/11/2017,, , Revision: 5, Authorised, Last updated: 26/06/2019
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Human medicine European public assessment report (EPAR): Xofigo
radium Ra223 dichloride, Prostatic Neoplasms
Date of authorisation: 13/11/2013,
, , Revision: 10, Authorised, Last updated: 11/10/2018
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Human medicine European public assessment report (EPAR): Cabometyx (updated)
cabozantinib s-malate, Carcinoma, Renal Cell
Date of authorisation: 09/09/2016,, , Revision: 5, Authorised, Last updated: 16/10/2019
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Human medicine European public assessment report (EPAR): Caprelsa
Vandetanib, Thyroid Neoplasms
Date of authorisation: 16/02/2012,, 
, Revision: 15, Authorised, Last updated: 10/04/2019
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Human medicine European public assessment report (EPAR): Farydak
panobinostat lactate anhydrous, Multiple Myeloma
Date of authorisation: 28/08/2015,, , Revision: 6, Authorised, Last updated: 05/06/2019
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Human medicine European public assessment report (EPAR): Yescarta
axicabtagene ciloleucel, Lymphoma, Follicular, Lymphoma, Large B-Cell, Diffuse
Date of authorisation: 23/08/2018,, , Revision: 2, Authorised, Last updated: 27/05/2019
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Human medicine European public assessment report (EPAR): Lynparza
Olaparib, Ovarian Neoplasms
Date of authorisation: 16/12/2014,, Revision: 7, Authorised, Last updated: 02/08/2019
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Human medicine European public assessment report (EPAR): Ristempa
pegfilgrastim, Neutropenia
Date of authorisation: 13/04/2015,, Revision: 3, Withdrawn, Last updated: 07/03/2018
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Human medicine European public assessment report (EPAR): Provenge
autologous peripheral-blood mononuclear cells including a minimum of 50 million autologous CD54+ cells activated with prostatic acid phosphatase granulocyte-macrophage colony-stimulating factor, Prostatic Neoplasms
Date of authorisation: 06/09/2013,, Revision: 1, Withdrawn, Last updated: 19/05/2015
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Human medicine European public assessment report (EPAR): Tagrisso
osimertinib mesylate, Carcinoma, Non-Small-Cell Lung
Date of authorisation: 01/02/2016,, , Revision: 8, Authorised, Last updated: 30/11/2018
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Human medicine European public assessment report (EPAR): Alecensa
alectinib hydrochloride, Carcinoma, Non-Small-Cell Lung
Date of authorisation: 16/02/2017,, Revision: 7, Authorised, Last updated: 14/09/2018