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Human medicine European public assessment report (EPAR): Azilect
rasagiline, Parkinson Disease
Date of authorisation: 21/02/2005, Revision: 23, Authorised, Last updated: 18/08/2023Azilect Nervous System Diseases Central … Azilect … AZILECT, INN-rasagiline mesilate … -
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Human medicine European public assessment report (EPAR): Rasagiline Mylan
rasagiline tartrate, Parkinson Disease
Date of authorisation: 04/04/2016,, Revision: 7, Authorised, Last updated: 23/02/2023
European Union (EU) called Azilect. Rasagiline Mylan contains … to the reference medicine, Azilect. Two medicines are bioequivalent … and to be bioequivalent to Azilect. Therefore, the Committee … -
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Human medicine European public assessment report (EPAR): Rasagiline ratiopharm
rasagiline, Parkinson Disease
Date of authorisation: 12/01/2015, Revision: 8, Authorised, Last updated: 05/11/2021This medicine is the same as Azilect, which is already authorised … EU). The company that makes Azilect has agreed that its scientific … This medicine is the same as Azilect, which is already authorised … -
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Press release: European Medicines Agency: Committee for Medicinal Products for Human Use 15-18 November 2004
Last updated: 18/11/2004Azilect … authorisation applications for: Azilect (rasagiline), from Teva Pharma … -
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Human medicine European public assessment report (EPAR): Nouryant
Istradefylline, Parkinson Disease
Date of refusal: 06/01/2022, Refused, Last updated: 19/01/2022 -
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Committee for Medicinal Products for Human Use (CHMP): 7-10 November 2022
European Medicines Agency, Amsterdam, the Netherlands, from 07/11/2022 to 10/11/2022, Last updated: 10/01/2023 -
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CHMP: Agendas, minutes and highlights (updated)
Last updated: 11/09/2023 -
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Committee for Medicinal Products for Human Use (CHMP): 19-22 April 2021
European Medicines Agency, Amsterdam, the Netherlands, from 19/04/2021 to 22/04/2021, Last updated: 07/12/2021 -
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Committee for Medicinal Products for Human Use (CHMP): 22-25 March 2021
European Medicines Agency, Amsterdam, the Netherlands, from 22/03/2021 to 25/03/2021, Last updated: 07/12/2021 -
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PRAC: Agendas, minutes and highlights (updated)
Last updated: 25/09/2023 -
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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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Committee for Medicinal Products for Human Use (CHMP): 14-17 September 2020
Virtual meeting, from 14/09/2020 to 17/09/2020, Last updated: 10/03/2021 -
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Committee for Medicinal Products for Human Use (CHMP): 25-29 January 2021
Virtual meeting, from 25/01/2021 to 29/01/2021, Last updated: 04/03/2021 -
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Pharmacovigilance Risk Assessment Committee (PRAC): 2-5 September 2013
European Medicines Agency, London, UK, from 02/09/2013 to 05/09/2013, Last updated: 02/07/2012 -
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Pharmacovigilance Risk Assessment Committee (PRAC): 31 August-3 September 2020
Virtual meeting, from 31/08/2020 to 03/09/2020, Last updated: 27/02/2018 -
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Committee for Medicinal Products for Human Use (CHMP): 7-10 November 2016
European Medicines Agency, London, UK, from 07/11/2016 to 10/11/2016, Last updated: 06/01/2014 -
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Committee for Medicinal Products for Human Use (CHMP): 19-22 February 2018
European Medicines Agency, London, UK, from 19/02/2018 to 22/02/2018, Last updated: 06/04/2018 -
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Pharmacovigilance Risk Assessment Committee (PRAC): 8-11 March 2021
European Medicines Agency, Amsterdam, the Netherlands, from 08/03/2021 to 11/03/2021, Last updated: 27/02/2018 -
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Pharmacovigilance Risk Assessment Committee (PRAC): 6-9 April 2021
European Medicines Agency, Amsterdam, the Netherlands, from 06/04/2021 to 09/04/2021, Last updated: 27/02/2018 -
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Committee for Medicinal Products for Human Use (CHMP): 11-14 September 2017
European Medicines Agency, London, UK, from 11/09/2017 to 14/09/2017, Last updated: 06/01/2014 -
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Committee for Medicinal Products for Human Use (CHMP): 23-26 April 2018
European Medicines Agency, London, UK, from 23/04/2018 to 26/04/2018, Last updated: 08/06/2018 -
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Download medicine data
Last updated: 02/12/2021 -
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Committee for Medicinal Products for Human Use (CHMP): 20-23 February 2017
European Medicines Agency, London, UK, from 20/02/2017 to 23/02/2017, Last updated: 06/01/2014 -
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Committee for Medicinal Products for Human Use (CHMP): 17-20 July 2017
European Medicines Agency, London, UK, from 17/07/2017 to 20/07/2017, Last updated: 06/01/2014 -
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Pharmacovigilance Risk Assessment Committee (PRAC): 29 August-1 September 2017
European Medicines Agency, London, UK, from 29/08/2017 to 01/09/2017, Last updated: 13/03/2014