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Human medicine European public assessment report (EPAR): Docetaxel Mylan
docetaxel, anhydrous, Head and Neck Neoplasms, Carcinoma, Non-Small-Cell Lung, Adenocarcinoma, Prostatic Neoplasms, Breast Neoplasms
Date of authorisation: 31/01/2012,
, Revision: 6, Withdrawn, Last updated: 12/03/2015
Docetaxel Mylan Head and Neck Neoplasms Carcinoma … Docetaxel Mylan … Rev. 1 Public statement Docetaxel Mylan Cessation of validity … -
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Human medicine European public assessment report (EPAR): Docetaxel Teva
docetaxel, Head and Neck Neoplasms, Carcinoma, Non-Small-Cell Lung, Adenocarcinoma, Prostatic Neoplasms, Stomach Neoplasms, Breast Neoplasms
Date of authorisation: 26/01/2010,, Revision: 18, Authorised, Last updated: 23/11/2020
Docetaxel Teva Head and Neck Neoplasms Carcinoma … Docetaxel Teva … Pack size EU/1/09/611/001 Docetaxel TEVA 20 mg /0.72 ml Concentrate … -
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Human medicine European public assessment report (EPAR): Docetaxel Kabi
docetaxel, Head and Neck Neoplasms, Carcinoma, Non-Small-Cell Lung, Adenocarcinoma, Prostatic Neoplasms, Breast Neoplasms
Date of authorisation: 22/05/2012,, Revision: 14, Authorised, Last updated: 28/10/2020
Docetaxel Kabi Head and Neck Neoplasms Carcinoma … Docetaxel Kabi … initial authorisation) Docetaxel Kabi docetaxel On 15 March 2012 the Committee … -
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Human medicine European public assessment report (EPAR): Docetaxel Accord
docetaxel, Head and Neck Neoplasms, Carcinoma, Non-Small-Cell Lung, Adenocarcinoma, Prostatic Neoplasms, Breast Neoplasms
Date of authorisation: 22/05/2012,, Revision: 14, Authorised, Last updated: 28/10/2020
Docetaxel Accord Head and Neck Neoplasms Carcinoma … Docetaxel Accord … Package size EU/1/12/769/001 Docetaxel Accord 20 mg/1 ml Concentrate … -
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Withdrawn application: Docetaxel Mylan
docetaxel, date of withdrawal: 08/03/2010, Initial authorisation, Last updated: 26/03/2010Docetaxel Mylan: Withdrawn application … authorisation application for Docetaxel Mylan docetaxel) On 8 March 2010, Mylan … marketing authorisation for Docetaxel Mylan intended to be used … -
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Human medicine European public assessment report (EPAR): Docetaxel Teva Pharma
docetaxel, Carcinoma, Non-Small-Cell Lung, Breast Neoplasms, Prostatic Neoplasms
Date of authorisation: 21/01/2011,, Revision: 6, Withdrawn, Last updated: 21/01/2014
Docetaxel Teva Pharma Carcinoma, Non-Small-Cell … Docetaxel Teva Pharma … Public statement on Docetaxel Teva Pharma 7 Westferry … -
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Withdrawn application: Docetaxel SUN
docetaxel, date of withdrawal: 06/06/2016, Initial authorisation, Last updated: 29/09/2016Docetaxel SUN: Withdrawn application … authorisation application for Docetaxel Sun docetaxel) On 6 June 2016, Sun … marketing authorisation for Docetaxel Sun, for the treatment of … -
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Human medicine European public assessment report (EPAR): Taxespira (previously Docetaxel Hospira UK Limited )
docetaxel trihydrate, Stomach Neoplasms, Prostatic Neoplasms, Breast Neoplasms, Head and Neck Neoplasms, Carcinoma, Non-Small-Cell Lung
Date of authorisation: 28/08/2015,, Revision: 8, Withdrawn, Last updated: 15/10/2019
Taxespira (previously Docetaxel Hospira UK Limited ) Stomach … Taxespira (previously Docetaxel Hospira UK Limited … Taxespira (previously Docetaxel Hospira UK Limited docetaxel docetaxel trihydrate … -
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Human medicine European public assessment report (EPAR): Docefrez
docetaxel, Stomach Neoplasms, Adenoma, Breast Neoplasms, Carcinoma, Non-Small-Cell Lung, Prostatic Neoplasms
Date of authorisation: 10/05/2010,, Revision: 1, Withdrawn, Last updated: 14/06/2012
docetaxel … Docefrez, INN-docetaxel 7 Westferry Circus … statement on Docefrez (Docetaxel) Withdrawal of the marketing … -
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Human medicine European public assessment report (EPAR): Zytiga
abiraterone acetate, Prostatic Neoplasms
Date of authorisation: 05/09/2011,
, Revision: 23, Authorised, Last updated: 21/12/2020
and chemotherapy containing docetaxel have not worked or no longer … treatment and chemotherapy with docetaxel, the main measure of effectiveness … and chemotherapy containing docetaxel have not worked or no longer … -
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Human medicine European public assessment report (EPAR): Cabazitaxel Accord
cabazitaxel, Prostatic Neoplasms, Castration-Resistant
Date of authorisation: 28/08/2020,
, , Authorised, Last updated: 28/10/2020
previously been treated with docetaxel (another cancer medicine … -
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Human medicine European public assessment report (EPAR): Capecitabine Medac
capecitabine, Colorectal Neoplasms
Date of authorisation: 19/11/2012,
, , Revision: 10, Authorised, Last updated: 05/08/2020
Capecitabine medac is used with docetaxel (another cancer medicine … -
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Human medicine European public assessment report (EPAR): Capecitabine Accord
capecitabine, Colonic Neoplasms, Breast Neoplasms, Colorectal Neoplasms, Stomach Neoplasms
Date of authorisation: 20/04/2012,, , Revision: 12, Authorised, Last updated: 03/08/2020
Capecitabine Accord is used with docetaxel (another cancer medicine … -
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Human medicine European public assessment report (EPAR): Ecansya (previously Capecitabine Krka)
capecitabine, Colonic Neoplasms, Breast Neoplasms, Colorectal Neoplasms, Stomach Neoplasms
Date of authorisation: 20/04/2012,, , Revision: 12, Authorised, Last updated: 31/07/2020
body). Ecansya is used with docetaxel (another cancer medicine … -
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Human medicine European public assessment report (EPAR): Capecitabine Teva
capecitabine, Colonic Neoplasms, Breast Neoplasms, Colorectal Neoplasms, Stomach Neoplasms
Date of authorisation: 20/04/2012,, , Revision: 13, Authorised, Last updated: 29/07/2020
Capecitabine Teva is used with docetaxel (another cancer medicine … -
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Human medicine European public assessment report (EPAR): Capecitabine SUN
capecitabine, Stomach Neoplasms, Breast Neoplasms, Colonic Neoplasms, Colorectal Neoplasms
Date of authorisation: 21/06/2013,, Revision: 3, Withdrawn, Last updated: 22/12/2016
Capecitabine in combination with docetaxel is indicated for the treatment … regimen. - in combination with docetaxel for the treatment of patients … -
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Human medicine European public assessment report (EPAR): Pemetrexed Fresenius Kabi
pemetrexed, Carcinoma, Non-Small-Cell Lung, Mesothelioma
Date of authorisation: 22/07/2016,, Revision: 9, Authorised, Last updated: 09/12/2020
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Human medicine European public assessment report (EPAR): Imatinib Actavis
imatinib, Leukemia, Myelogenous, Chronic, BCR-ABL Positive, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Myelodysplastic-Myeloproliferative Diseases, Hypereosinophilic Syndrome, Dermatofibrosarcoma
Date of authorisation: 17/04/2013,, Revision: 12, Authorised, Last updated: 10/09/2020
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Human medicine European public assessment report (EPAR): Caprelsa
Vandetanib, Thyroid Neoplasms
Date of authorisation: 16/02/2012,, 
, Revision: 18, Authorised, Last updated: 07/12/2020
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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: 12, Authorised, Last updated: 16/10/2020
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Human medicine European public assessment report (EPAR): Sylvant
siltuximab, Giant Lymph Node Hyperplasia
Date of authorisation: 22/05/2014,, 
, Revision: 10, Authorised, Last updated: 08/10/2019
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Human medicine European public assessment report (EPAR): Cabometyx
cabozantinib (s)-malate, Carcinoma, Renal Cell
Date of authorisation: 09/09/2016,, , Revision: 9, Authorised, Last updated: 11/11/2020
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Human medicine European public assessment report (EPAR): Ketoconazole HRA
Ketoconazole, Cushing Syndrome
Date of authorisation: 18/11/2014,, , , Revision: 10, Authorised, Last updated: 10/01/2020
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Opinion/decision on a Paediatric investigation plan (PIP): Vargatef, nintedanib
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Oncology
PIP number: EMEA-001006-PIP03-16, Route(s) of administration: Oral use, Pharmaceutical form(s): Capsule, soft
Decision date: 05/05/2017, Last updated: 03/07/2017, Compliance check: Xindicated in combination with docetaxel for the treatment of adult …