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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, Revision: 6, Withdrawn, Last updated: 12/03/2015
Rev. 1 Public statement Docetaxel Mylan Cessation of validity … marketing authorisation of Docetaxel Mylan docetaxel) ceased to be valid in the … S.A.S., had not marketed Docetaxel Mylan in the EU since its … -
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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: 13, Authorised, Last updated: 19/05/2020
initial authorisation) Docetaxel Kabi docetaxel On 15 March 2012 the Committee … for the medicinal product Docetaxel Kabi 20 mg/ml concentrate … The active substance of Docetaxel Kabi is … -
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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: 13, Authorised, Last updated: 08/04/2020
Package size EU/1/12/769/001 Docetaxel Accord 20 mg/1 ml Concentrate … 1 vial EU/1/12/769/002 Docetaxel Accord 80 mg/4 ml Concentrate … 1 vial EU/1/12/769/003 Docetaxel Accord 160 mg/8 ml Concentrate … -
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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: 17, Authorised, Last updated: 05/08/2019
summary for the public Docetaxel Teva docetaxel This is a summary of the … assessment report (EPAR) for Docetaxel Teva. It explains how the … the conditions of use for Docetaxel Teva. What is … -
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Withdrawn application: Docetaxel SUN
docetaxel, date of withdrawal: 06/06/2016, Initial authorisation, Last updated: 29/09/2016authorisation application for Docetaxel Sun docetaxel) On 6 June 2016, Sun … marketing authorisation for Docetaxel Sun, for the treatment of … types of cancer. What is Docetaxel Sun … -
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Withdrawn application: Docetaxel Mylan
docetaxel, date of withdrawal: 08/03/2010, Initial authorisation, Last updated: 26/03/2010authorisation application for Docetaxel Mylan docetaxel) On 8 March 2010, Mylan … marketing authorisation for Docetaxel Mylan intended to be used … neck cancer. What is Docetaxel Mylan … -
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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
Public statement on Docetaxel Teva Pharma 7 Westferry … Public statement on Docetaxel Teva Pharma Cessation of … marketing authorisation for Docetaxel Teva Pharma … -
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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
Docefrez, INN-docetaxel 7 Westferry Circus … statement on Docefrez (Docetaxel) Withdrawal of the marketing … medicinal product Docefrez (docetaxel), which had been approved … -
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Human medicine European public assessment report (EPAR): Zytiga
abiraterone acetate, Prostatic Neoplasms
Date of authorisation: 05/09/2011,
, Revision: 21, Authorised, Last updated: 13/03/2019
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): Capecitabine Medac
capecitabine, Colorectal Neoplasms
Date of authorisation: 19/11/2012,
, , Revision: 9, Authorised, Last updated: 26/11/2019
Capecitabine Medac is used with docetaxel (another anticancer 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: 11, Authorised, Last updated: 13/11/2019
Capecitabine Accord is used with docetaxel (another anticancer medicine … Capecitabine Accord is used with docetaxel (another anticancer 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: 11, Authorised, Last updated: 28/10/2019
body). Ecansya is used with docetaxel (another anticancer medicine … body). Ecansya is used with docetaxel (another anticancer medicine … -
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Human medicine European public assessment report (EPAR): Capecitabine Teva (updated)
capecitabine, Colonic Neoplasms, Breast Neoplasms, Colorectal Neoplasms, Stomach Neoplasms
Date of authorisation: 20/04/2012,, , Revision: 12, Authorised, Last updated: 29/06/2020
Capecitabine Teva is used with docetaxel (another anticancer medicine … Capecitabine Teva is used with docetaxel (another anticancer 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
regimen. - in combination with docetaxel for the treatment of patients … Capecitabine in combination with docetaxel is indicated for the treatment … -
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Human medicine European public assessment report (EPAR): Tagrisso (updated)
osimertinib mesylate, Carcinoma, Non-Small-Cell Lung
Date of authorisation: 01/02/2016,
, , Revision: 10, Authorised, Last updated: 10/06/2020
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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): 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: 08/10/2019
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Human medicine European public assessment report (EPAR): Caprelsa
Vandetanib, Thyroid Neoplasms
Date of authorisation: 16/02/2012,, 
, Revision: 17, Authorised, Last updated: 24/01/2020
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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: 8, Authorised, Last updated: 15/06/2020
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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 …