53 results
Keyword Erleada Remove keyword
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Human medicine European public assessment report (EPAR): Erleada
apalutamide, Prostatic Neoplasms
Date of authorisation: 14/01/2019,
, Revision: 9, Authorised, Last updated: 20/03/2023
Erleada Cancer Neoplasms Genital … horised apalutamide Overview Erleada is a cancer medicine used … levels (hormone sensitive). Erleada is used in combination with … -
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News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 9-12 December 2019
CHMP, Last updated: 13/12/2019Erleada … -
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News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 12-15 November 2018
CHMP, Last updated: 16/11/2018Erleada … -
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Human medicine European public assessment report (EPAR): Orgovyx
relugolix, Prostatic Neoplasms
Date of authorisation: 29/04/2022,, Revision: 5, Authorised, Last updated: 31/03/2023
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Human medicine European public assessment report (EPAR): Xtandi
enzalutamide, Prostatic Neoplasms
Date of authorisation: 21/06/2013,
Date of refusal: 26/04/2013, Revision: 21, Authorised, Last updated: 17/06/2022 -
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Human medicine European public assessment report (EPAR): Norvir
ritonavir, HIV Infections
Date of authorisation: 25/08/1996, Revision: 68, Authorised, Last updated: 18/10/2022 -
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Human medicine European public assessment report (EPAR): Kaletra
lopinavir, ritonavir, HIV Infections
Date of authorisation: 19/03/2001, Revision: 60, Authorised, Last updated: 29/11/2022 -
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Opinion on medicine for use outside EU: Aluvia
lopinavir, ritonavir, HIV Infections, ATC code: J05AR10 Opinion number: H-W-764, Positive opinion Opinion date: 21/09/2006, Last updated: 15/12/2022 -
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Committee for Medicinal Products for Human Use (CHMP): 27-30 March 2023 (updated)
European Medicines Agency, Amsterdam, the Netherlands, from 27/03/2023 to 30/03/2023, Last updated: 22/05/2023 -
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List of medicines under additional monitoring (updated)
Last updated: 30/05/2023 -
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Committee for Medicinal Products for Human Use (CHMP): 24-26 April 2023
European Medicines Agency, Amsterdam, the Netherlands, from 24/04/2023 to 26/04/2023, Last updated: 24/04/2023 -
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Exemptions to labelling and package-leaflet obligations
Last updated: 19/04/2023 -
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Pharmacovigilance Risk Assessment Committee (PRAC): 11-14 April 2023
European Medicines Agency, Amsterdam, the Netherlands, from 11/04/2023 to 14/04/2023, Last updated: 11/04/20234.1.2. Apalutamide – ERLEADA (CAP … -
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CHMP: Agendas, minutes and highlights (updated)
Last updated: 06/06/2023 -
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PRAC: Agendas, minutes and highlights (updated)
Last updated: 07/06/2023 -
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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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Committee for Medicinal Products for Human Use (CHMP): 22-25 May 2023 (updated)
European Medicines Agency, Amsterdam, the Netherlands, from 22/05/2023 to 25/05/2023, Last updated: 22/05/2023 -
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Pharmacovigilance Risk Assessment Committee (PRAC): 7-10 February 2022
European Medicines Agency, Amsterdam, the Netherlands, from 07/02/2022 to 10/02/2022, Last updated: 07/11/2022 -
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Pharmacovigilance Risk Assessment Committee (PRAC): 29 November-2 December 2021
European Medicines Agency, Amsterdam, the Netherlands, from 29/11/2021 to 02/12/2021, Last updated: 04/10/2022 -
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Committee for Medicinal Products for Human Use (CHMP): 11-14 October 2021
European Medicines Agency, Amsterdam, the Netherlands, from 11/10/2021 to 14/10/2021, Last updated: 20/01/2022 -
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Pharmacovigilance Risk Assessment Committee (PRAC): 26-29 September 2022
European Medicines Agency, Amsterdam, the Netherlands, from 26/09/2022 to 29/09/2022, Last updated: 04/07/2022 -
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Committee for Medicinal Products for Human Use (CHMP): 10-13 October 2022
European Medicines Agency, Amsterdam, the Netherlands, from 10/10/2022 to 13/10/2022, Last updated: 23/11/2022 -
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Committee for Medicinal Products for Human Use (CHMP): 17-20 May 2021
European Medicines Agency, Amsterdam, the Netherlands, from 17/05/2021 to 20/05/2021, Last updated: 07/12/2021 -
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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 2021
Virtual meeting, from 11/01/2021 to 14/01/2021, Last updated: 27/02/2018