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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, Revision: 6, Withdrawn, Last updated: 12/03/2015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 Zentiva (previously Docetaxel Winthrop)
docetaxel, Head and Neck Neoplasms, Carcinoma, Non-Small-Cell Lung, Adenocarcinoma, Prostatic Neoplasms, Stomach Neoplasms, Breast Neoplasms
Date of authorisation: 20/04/2007, Revision: 30, Authorised, Last updated: 23/05/2019safety and efficacy of the Docetaxel Winthrop medicinal product … indications are: Breast cancer Docetaxel Winthrop docetaxel) in combination with doxorubicin … positive breast cancer. Docetaxel Winthrop … -
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Summary of opinion: Docetaxel Zentiva (previously Docetaxel Winthrop)
docetaxel, opinion date: 19/09/2019, Positive, Last updated: 20/09/2019Docetaxel Zentiva (previously Docetaxel Winthrop): Pending EC decisio … Docetaxel Zentiva (previously Docetaxel Winthrop Docetaxel Zentiva (previously Docetaxel Winthrop … -
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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Withdrawn application: Docetaxel Zentiva (previously Docetaxel Winthrop)
docetaxel, date of withdrawal: 14/11/2008, Post-authorisation, Last updated: 17/11/2008AUTHORISATION for Taxotere/Docetaxel Winthrop International … non-proprietary name (INN): docetaxel On 24 July 2008, the Committee … medicinal product Taxotere/Docetaxel Winthrop concentrate and … -
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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: 12, Authorised, Last updated: 21/06/2019
summary for the public Docetaxel Accord docetaxel This is a summary of the … assessment report (EPAR) for Docetaxel Accord. It explains how … the conditions of use for Docetaxel Accord. What is … -
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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: 12, Authorised, Last updated: 14/06/2019
summary for the public Docetaxel Kabi docetaxel This is a summary of the … assessment report (EPAR) for Docetaxel Kabi. It explains how the … the conditions of use for Docetaxel Kabi. 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 ) (updated)
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 … Taxespira (previously Docetaxel Hospira UK Limited ) Stomach … Taxespira (previously Docetaxel Hospira UK Limited docetaxel docetaxel trihydrate … -
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Human medicine European public assessment report (EPAR): Taxotere
docetaxel, Head and Neck Neoplasms, Carcinoma, Non-Small-Cell Lung, Adenocarcinoma, Prostatic Neoplasms, Stomach Neoplasms, Breast Neoplasms
Date of authorisation: 27/11/1995, Revision: 44, Authorised, Last updated: 27/03/2019Taxotere, INN-docetaxel 7 Westferry Circus … for the public Taxotere docetaxel This document is a summary … contains the active substance docetaxel. It is available in two forms … -
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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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Opinion/decision on a Paediatric investigation plan (PIP): Taxotere, docetaxel
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), therapeutic area: Oncology, PIP number: Docetaxel, decision date: 16/05/2008, Last updated: 04/06/2008, compliance check: XWord - Decision and Opinon docetaxel 0000029-PIP01-07 to be publi… … Paediatric Investigation Plan for Docetaxel, Taxotere (EMEA-000029-PIP01-07 … Paediatric Investigation Plan for Docetaxel, Taxotere (EMEA-000029-PIP01-07 … -
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Summary of opinion: Taxotere
docetaxel, opinion date: 19/09/2019, Positive, Last updated: 20/09/2019Taxotere Taxotere docetaxel docetaxel … -
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Withdrawn application: Taxotere
docetaxel, date of withdrawal: 14/11/2008, Post-authorisation, Last updated: 17/11/2008AUTHORISATION for Taxotere/Docetaxel Winthrop International … non-proprietary name (INN): docetaxel On 24 July 2008, the Committee … medicinal product Taxotere/Docetaxel Winthrop concentrate and … -
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Referral: Docetaxel Teva Generics
docetaxel, ?> Article 29(4) referrals
Status: European Commission final decision, opinion/position date: 17/02/2011, EC decision date: 07/07/2011,Questions and answers on Docetaxel Teva Generics docetaxel, 20 mg and 80 mg powder and … authorisation of the medicine Docetaxel Teva Generics. The Agency’s … concluded that the benefits of Docetaxel Teva Generics outweigh its … -
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Press release: Mylan S.A.S. withdraws its marketing authorisation application for Docetaxel Mylan (docetaxel)
Last updated: 15/03/2010authorisation cision to withdraw Docetaxel Mylan The medicine was … reference medicinal product for Docetaxel Mylan is Taxotere, which … Notes application for Docetaxel Mylan … -
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Press release: Sanofi-Aventis Pharma S.A. withdraws its application for an extension of indication for Taxotere and Docetaxel Winthrop (docetaxel)
Last updated: 17/11/2008indication for Taxotere and Docetaxel Winthrop docetaxel) The European Medicines … authorised medicines Taxotere (docetaxel) 20 mg/0.5 ml and 80 mg/2 … solution for infusion and Docetaxel Winthrop … -
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Press release: EMA reviewing cancer medicine docetaxel
PRAC, Last updated: 10/03/2017reviewing cancer medicine docetaxel 30 Churchill Place … reviewing cancer medicine docetaxel Preliminary assessment show … investigating the cancer medicine docetaxel following cases of neutropenic … -
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Press release: PRAC concludes there is no evidence of a change in known risk of neutropenic enterocolitis with docetaxel
PRAC, Last updated: 09/06/2017neutropenic enterocolitis with docetaxel 30 Churchill Place … neutropenic enterocolitis with docetaxel Doctors advised to follow … enterocolitis after treatment with docetaxel, a cancer medicine. Neutropenic … -
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Human medicine European public assessment report (EPAR): Cabazitaxel Teva
cabazitaxel, Prostatic Neoplasms
Date of refusal: 11/07/2019, Refused, Last updated: 24/07/2019and Taxotere (containing docetaxel, see below for more details … previously been treated with docetaxel (another cancer medicine … Taxotere, which contains docetaxel. The company claimed that … -
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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 …