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Keyword Jevtana Remove keyword
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Human medicine European public assessment report (EPAR): Jevtana
cabazitaxel, Prostatic Neoplasms
Date of authorisation: 17/03/2011, Revision: 20, Authorised, Last updated: 14/12/2021Jevtana Genital Neoplasms, Male Urogenital … Jevtana … Jevtana, INN-cabazitaxel 30 … -
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Direct healthcare professional communication (DHPC): Cabazitaxel Accord 20 mg/mL concentrate for solution for infusion: Risk of medication errors and mix-up with Jevtana (60 mg/1.5 mL) concentrate and solvent for solution for infusion
Active substance: cabazitaxel, DHPC type: Medication error, Last updated: 28/10/2020medication errors and mix-up with Jevtana (60 mg/1.5 mL) concentrate … medication errors and mix-up with Jevtana (60 mg/1.5 mL) concentrate … -
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Human medicine European public assessment report (EPAR): Cabazitaxel Accord
cabazitaxel, Prostatic Neoplasms, Castration-Resistant
Date of authorisation: 28/08/2020,
, Revision: 2, Authorised, Last updated: 08/04/2022
for Cabazitaxel Accord is Jevtana. Expand section Collapse section … with the reference medicine, Jevtana, and do not need to be repeated … and to be bioequivalent to Jevtana. Therefore, the Agency’s … -
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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: 24/07/2019reference to two medicines, Jevtana (containing cabazitaxel … as the reference medicine, Jevtana. Cabazitaxel belongs to the … demonstrate that it is similar to Jevtana. There was no need for ‘bioequivalence’ … -
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National expert: Pierre Demolis, National Agency For The Safety Of Medicine And Health Products (updated)
- Declaration of interests - 79.81 KB | PDF
- Curriculum Vitae - 21.68 KB | PDF
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National expert: Hugues Malonne, Federal Agency for Medicines and Health Products (updated)
- Declaration of interests - 81.15 KB | PDF
- Curriculum Vitae - 35.02 KB | PDF
09/2016-12/2016 Sanofi Omnivit - Jevtana - Praluent multivitamins … -
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Press release: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 17-20 January 2011
CHMP, Last updated: 21/01/2011Jevtana … review time of 180 days. • Jevtana (cabazitaxel), from Sanofi-aventis … docetaxel-containing regimen. The review for Jevtana began on 26 May 2010 with … -
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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, Withdrawn, Last updated: 20/05/2022 -
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Scientific publications (updated)
Last updated: 16/09/2022 -
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Pharmacovigilance Risk Assessment Committee (PRAC): 6-9 July 2020
European Medicines Agency, Amsterdam, the Netherlands, from 06/07/2020 to 09/07/2020, Last updated: 10/12/2020 -
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Download medicine data
Last updated: 02/12/2021 -
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Pharmacovigilance Risk Assessment Committee (PRAC): 6-9 January 2014
European Medicines Agency, London, UK, from 06/01/2014 to 09/01/2014, Last updated: 13/08/2013 -
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Pharmacovigilance Risk Assessment Committee (PRAC): 8-11 July 2013
European Medicines Agency, London, UK, from 08/07/2013 to 11/07/2013, Last updated: 02/07/2012 -
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Pharmacovigilance Risk Assessment Committee (PRAC): 2-5 December 2013
European Medicines Agency, London, UK, from 02/12/2013 to 05/12/2013, Last updated: 02/07/2012 -
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Pharmacovigilance Risk Assessment Committee (PRAC): 7-10 October 2013
European Medicines Agency, London, UK, from 07/10/2013 to 10/10/2013, Last updated: 02/07/2012of the PRAC Minutes) * Jevtana - correction on page 18 7 … -
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Pharmacovigilance Risk Assessment Committee (PRAC): 7-10 January 2013
European Medicines Agency, London, UK, from 07/01/2013 to 10/01/2013, Last updated: 02/06/2012 -
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Committee for Medicinal Products for Human Use (CHMP): 22-25 February 2021
European Medicines Agency, Amsterdam, the Netherlands, from 22/02/2021 to 25/02/2021, Last updated: 07/12/2021 -
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Pharmacovigilance Risk Assessment Committee (PRAC): 11-14 January 2016
European Medicines Agency, London, UK, from 11/01/2016 to 14/01/2016, Last updated: 13/03/2014 -
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Pharmacovigilance Risk Assessment Committee (PRAC): 7-10 July 2014
European Medicines Agency, London, UK, from 07/07/2014 to 10/07/2014, Last updated: 13/08/2013 -
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Pharmacovigilance Risk Assessment Committee (PRAC): 28 September-1 October 2020
Virtual meeting, from 28/09/2020 to 01/10/2020, Last updated: 29/09/2020 -
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Pharmacovigilance Risk Assessment Committee (PRAC): 9-12 January 2017
European Medicines Agency, London, UK, from 09/01/2017 to 12/01/2017, Last updated: 13/03/2014 -
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Pharmacovigilance Risk Assessment Committee (PRAC): 6-9 January 2015
European Medicines Agency, London, UK, from 06/01/2015 to 09/01/2015, Last updated: 13/03/2014 -
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PRAC: Agendas, minutes and highlights
Last updated: 02/09/2022 -
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Pharmacovigilance Risk Assessment Committee (PRAC): 7-10 April 2015
European Medicines Agency, London, UK, from 07/04/2015 to 10/04/2015, Last updated: 20/05/2015 -
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Pharmacovigilance Risk Assessment Committee (PRAC): 7-10 September 2015
European Medicines Agency, London, UK, from 07/09/2015 to 10/09/2015, Last updated: 13/03/2014