39 results
Keyword Verzenios Remove keyword
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Opinion/decision on a Paediatric investigation plan (PIP): Verzenios, abemaciclib
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Oncology
PIP number: EMEA-002342-PIP02-18-M01, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet, Age-appropriate oral solid dosage form
Decision date: 29/10/2021, Last updated: 13/02/2023, Compliance check: XInvented name Verzenios Active substance abemaciclib … investigation plan for abemaciclib (Verzenios), (EMEA-002342-PIP02-18-M01 … investigation plan for abemaciclib (Verzenios), (EMEA-002342-PIP02-18-M01 … -
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Opinion/decision on a Paediatric investigation plan (PIP): Verzenios, abemaciclib
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Oncology
PIP number: EMEA-002342-PIP01-18-M02, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet
Decision date: 29/10/2021, Last updated: 13/02/2023, Compliance check: XInvented name Verzenios Active substance abemaciclib … investigation plan for abemaciclib (Verzenios), (EMEA-002342-PIP01-18-M02 … investigation plan for abemaciclib (Verzenios), (EMEA-002342-PIP01-18-M02 … -
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Opinion/decision on a Paediatric investigation plan (PIP): Verzenios, abemaciclib
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Oncology
PIP number: EMEA-002342-PIP03-18, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet
Decision date: 12/06/2019, Last updated: 07/11/2019, Compliance check: XInvented name Verzenios Active substance abemaciclib … Verzenios Verzenios abemaciclib abemaciclib ab … -
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Human medicine European public assessment report (EPAR): Verzenios
abemaciclib, Breast Neoplasms
Date of authorisation: 26/09/2018,
, Revision: 9, Authorised, Last updated: 22/02/2023
Verzenios Neoplasms Cancer Skin … Verzenios … EMA/191270/2022 EMEA/H/C/004302 Verzenios (abemaciclib) An overview … -
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News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 21-24 February 2022
CHMP, Last updated: 25/02/2022Verzenios … -
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News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 23-26 July 2018
CHMP, Last updated: 27/07/2018Verzenios … -
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List of medicines under additional monitoring
Last updated: 22/02/2023 -
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Pharmacovigilance Risk Assessment Committee (PRAC): 2-5 May 2022
European Medicines Agency, Amsterdam, the Netherlands, from 02/05/2022 to 05/05/2022, Last updated: 06/02/2023 -
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CHMP: Agendas, minutes and highlights
Last updated: 08/02/2023 -
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PRAC: Agendas, minutes and highlights (updated)
Last updated: 17/03/2023 -
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Committee for Medicinal Products for Human Use (CHMP): 24-27 January 2022
European Medicines Agency, Amsterdam, the Netherlands, from 24/01/2022 to 27/01/2022, Last updated: 16/03/2022 -
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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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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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Committee for Medicinal Products for Human Use (CHMP): 21-24 June 2021
European Medicines Agency, Amsterdam, the Netherlands, from 21/06/2021 to 24/06/2021, Last updated: 07/12/2021 -
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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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Pharmacovigilance Risk Assessment Committee (PRAC): 7-10 June 2021
European Medicines Agency, Amsterdam, the Netherlands, from 07/06/2021 to 10/06/2021, Last updated: 07/06/2021 -
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Pharmacovigilance Risk Assessment Committee (PRAC): 26-29 October 2020
Virtual meeting, from 26/10/2020 to 29/10/2020, Last updated: 08/01/2021 -
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Pharmacovigilance Risk Assessment Committee (PRAC): 3-6 May 2021
European Medicines Agency, Amsterdam, the Netherlands, from 03/05/2021 to 06/05/2021, Last updated: 27/02/2018 -
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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 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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Download medicine data
Last updated: 02/12/2021 -
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Newsletters (updated)
Last updated: 09/03/2023 -
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Committee for Medicinal Products for Human Use (CHMP): 21-24 February 2022
European Medicines Agency, Amsterdam, the Netherlands, from 21/02/2022 to 24/02/2022, Last updated: 06/04/2021 -
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News: Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 8-11 February 2021
PRAC, Last updated: 12/02/2021 -
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News: Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 3-6 May 2021
PRAC, Last updated: 07/05/2021