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Human medicine European public assessment report (EPAR): Nubeqa (updated)
darolutamide, Prostatic Neoplasms, Castration-Resistant
Date of authorisation: 27/03/2020,, Revision: 4, Authorised, Last updated: 20/03/2023
Nubeqa Cancer Neoplasms Genital … orised darolutamide Overview Nubeqa is a medicine used to treat … lower male sex hormones). Nubeqa contains the The substance … -
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News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 23-26 January 2023
CHMP, Last updated: 27/01/2023Union (EU): Byfavo, Dupixent, Nubeqa, Reblozyl, Trecondi, Trulicity … -
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News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 27-30 January 2020
CHMP, Last updated: 31/01/2020Nubeqa … -
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National expert: John Aspegren, Finnish Medicines Agency (updated)
- Declaration of interests - 80.35 KB | PDF
- Curriculum Vitae - 20.05 KB | PDF
product responsibility Nubeqa Prostate cancer 2.2 Consultancy … -
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Pharmacovigilance Risk Assessment Committee (PRAC): 28 November - 1 December 2022
European Medicines Agency, Amsterdam, the Netherlands, from 28/11/2022 to 01/12/2022, Last updated: 29/11/2022 -
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List of medicines under additional monitoring (updated)
Last updated: 22/02/2023 -
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PRAC: Agendas, minutes and highlights (updated)
Last updated: 17/03/2023 -
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Pharmacovigilance Risk Assessment Committee (PRAC): 7-10 March 2022
European Medicines Agency, Amsterdam, the Netherlands, from 07/03/2022 to 10/03/2022, Last updated: 22/11/2022 -
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Pharmacovigilance Risk Assessment Committee (PRAC): 29 August - 1 September 2022
European Medicines Agency, Amsterdam, the Netherlands, from 29/08/2022 to 01/09/2022, Last updated: 02/09/2022 -
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Pharmacovigilance Risk Assessment Committee (PRAC): 4-7 July 2022
European Medicines Agency, Amsterdam, the Netherlands, from 04/07/2022 to 07/07/2022, Last updated: 04/07/2022 -
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Committee for Medicinal Products for Human Use (CHMP): 20-23 June 2022
European Medicines Agency, Amsterdam, the Netherlands, from 20/06/2022 to 23/06/2022, Last updated: 18/08/2022 -
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Pharmacovigilance Risk Assessment Committee (PRAC): 7-10 June 2022
European Medicines Agency, Amsterdam, the Netherlands, from 07/06/2022 to 10/06/2022, Last updated: 07/06/2022 -
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CHMP: Agendas, minutes and highlights
Last updated: 08/02/2023 -
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Pharmacovigilance Risk Assessment Committee (PRAC): 8-11 February 2021
European Medicines Agency, Amsterdam, the Netherlands, from 08/02/2021 to 11/02/2021, Last updated: 08/02/2021 -
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Committee for Medicinal Products for Human Use (CHMP): 19-22 April 2022
European Medicines Agency, Amsterdam, the Netherlands, from 19/04/2022 to 22/04/2022, Last updated: 12/08/2022 -
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Newsletters (updated)
Last updated: 09/03/2023 -
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News: Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 30 August – 2 September 2021
PRAC, Last updated: 17/09/2021 -
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News: Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 29 August – 1 September 2022
PRAC, Last updated: 02/09/2022 -
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News: Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 28 November - 1 December 2022
PRAC, Last updated: 02/12/2022 -
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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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Pharmacovigilance Risk Assessment Committee (PRAC): 30 August-2 September 2021
European Medicines Agency, Amsterdam, the Netherlands, from 30/08/2021 to 02/09/2021, Last updated: 27/02/2018 -
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Download medicine data
Last updated: 02/12/2021 -
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News: Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 9 - 12 January 2023
PRAC, Last updated: 13/01/2023 -
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Pharmacovigilance Risk Assessment Committee (PRAC): 9-12 January 2023
European Medicines Agency, Amsterdam, the Netherlands, from 09/01/2023 to 12/01/2023, Last updated: 18/08/2021 -
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Committee for Medicinal Products for Human Use (CHMP): 12-15 December 2022
European Medicines Agency, Amsterdam, the Netherlands, from 12/12/2022 to 15/12/2022, Last updated: 06/04/2021