53 results
Keyword Glasdegib Remove keyword
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Orphan designation: Glasdegib maleate for: Treatment of acute myeloid leukaemia
Date of designation: 16/10/2017, Positive, Last updated: 09/01/2018Glasdegib maleate … opinion on orphan designation Glasdegib maleate for the treatment … Limited, United Kingdom, for glasdegib maleate for the treatment … -
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Human medicine European public assessment report (EPAR): Daurismo
Glasdegib maleate, Leukemia, Myeloid, Acute
Date of authorisation: 26/06/2020,
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, Revision: 4, Authorised, Last updated: 07/07/2021
glasdegib … EMEA/H/C/004878 Daurismo (glasdegib) An overview of Daurismo … substance in Daurismo is glasdegib. Acute myeloid leukaemia … -
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Opinion/decision on a Paediatric investigation plan (PIP): Glasdegib
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Oncology
PIP number: EMEA-002199-PIP01-17, Route(s) of administration: Oral use, Pharmaceutical form(s): Tablet
Decision date: 15/08/2018, Last updated: 28/01/2019, Compliance check: XActive substance Glasdegib Therapeutic area Oncology … -
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Human medicine European public assessment report (EPAR): Vfend (updated)
voriconazole, Candidiasis; Mycoses; Aspergillosis
Date of authorisation: 19/03/2002, Revision: 55, Authorised, Last updated: 09/11/2023 -
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Human medicine European public assessment report (EPAR): Vanflyta (updated)
Quizartinib dihydrochloride, Leukemia, Myeloid
Date of authorisation: 06/11/2023,, Authorised, Last updated: 21/11/2023
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Human medicine European public assessment report (EPAR): Tibsovo
Ivosidenib, Leukemia, Myeloid, Acute; Cholangiocarcinoma
Date of authorisation: 04/05/2023,, , Authorised, Last updated: 12/05/2023
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News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 28-30 April 2020
CHMP, Last updated: 30/04/2020glasdegib) for the treatment of acute … -
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Human medicine European public assessment report (EPAR): Venclyxto (updated)
Venetoclax, Leukemia, Lymphocytic, Chronic, B-Cell
Date of authorisation: 04/12/2016,, Revision: 16, Authorised, Last updated: 31/10/2023
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Human medicine European public assessment report (EPAR): Voriconazole Hikma (previously Voriconazole Hospira)
voriconazole, Bacterial Infections and Mycoses; Aspergillosis; Candidiasis
Date of authorisation: 27/05/2015,
, Revision: 12, Authorised, Last updated: 16/06/2023
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Human medicine European public assessment report (EPAR): Voriconazole Accord
voriconazole, Aspergillosis; Candidiasis; Mycoses
Date of authorisation: 16/05/2013,, Revision: 17, Authorised, Last updated: 14/06/2023
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Human medicine European public assessment report (EPAR): Onureg
azacitidine, Leukemia, Myeloid, Acute
Date of authorisation: 17/06/2021, Revision: 1, Authorised, Last updated: 06/09/2021 -
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Withdrawn application: Tidhesco
ivosidenib, date of withdrawal: 27/03/2023, Initial authorisation, Last updated: 21/06/2023 -
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List of medicines under additional monitoring (updated)
Last updated: 29/11/2023 -
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Pharmacovigilance Risk Assessment Committee (PRAC): 5-8 June 2023
European Medicines Agency, Amsterdam, the Netherlands, from 05/06/2023 to 08/06/2023, Last updated: 04/09/2023 -
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PRAC: Agendas, minutes and highlights (updated)
Last updated: 27/11/2023 -
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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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COMP: Agendas, minutes and meeting reports (updated)
Last updated: 07/11/2023 -
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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: 31/03/2022 -
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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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Paediatric Committee (PDCO): 29 May – 1 June 2018
European Medicines Agency, London, UK, from 29/05/2018 to 01/06/2018, Last updated: 25/07/2018 -
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Paediatric Committee (PDCO): 10-13 October 2017
European Medicines Agency, London, UK, from 10/10/2017 to 13/10/2017, Last updated: 03/07/2014 -
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CHMP: Agendas, minutes and highlights (updated)
Last updated: 10/11/2023 -
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Paediatric Committee (PDCO): 26-29 June 2018
European Medicines Agency, London, UK, from 26/06/2018 to 29/06/2018, Last updated: 18/07/2014EMEA-002133-PIP01-17......................................................................... 11 2.1.7. Glasdegib - Orphan - EMEA-002199-PIP01-17 … -
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Paediatric Committee (PDCO): 12-15 September 2017
European Medicines Agency, London, UK, from 12/09/2017 to 15/09/2017, Last updated: 03/07/2014 -
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Committee for Orphan Medicinal Products (COMP): 5-7 September 2017
European Medicines Agency, London, UK, from 05/09/2017 to 07/09/2017, Last updated: 19/06/2014