38 results
Keyword Tucatinib Remove keyword
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Human medicine European public assessment report (EPAR): Tukysa (updated)
Tucatinib, Breast Neoplasms; Neoplasm Metastasis
Date of authorisation: 11/02/2021,
, Revision: 4, Authorised, Last updated: 29/03/2023
Authorised tucatinib Overview Tukysa is a cancer … active substance in Tukysa is tucatinib. How is Tukysa used? Tukysa … active substance in Tukysa, tucatinib, is a type of cancer medicine … -
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Opinion/decision on a Paediatric investigation plan (PIP): Tucatinib
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Oncology
PIP number: EMEA-002242-PIP01-17, Route(s) of administration: Oral use, Pharmaceutical form(s): Tablet
Decision date: 31/01/2018, Last updated: 18/04/2018, Compliance check: XActive substance Tucatinib Therapeutic area Oncology … product specific waiver for tucatinib (EMEA-002242-PIP01-17 … product specific waiver for tucatinib (EMEA-002242-PIP01-17) in … -
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News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 7-10 December 2020
CHMP, Last updated: 11/12/2020tucatinib) received a positive opinion … -
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Human medicine European public assessment report (EPAR): Enhertu
trastuzumab deruxtecan, Breast Neoplasms
Date of authorisation: 18/01/2021,, 
, Revision: 10, Authorised, Last updated: 16/02/2023
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Human medicine European public assessment report (EPAR): Quviviq (updated)
daridorexant hydrochloride, Sleep Initiation and Maintenance Disorders
Date of authorisation: 29/04/2022,, Revision: 4, Authorised, Last updated: 17/03/2023
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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: 27/03/2023 -
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PDCO: Agendas, minutes and reports (updated)
Last updated: 29/03/2023 -
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Pharmacovigilance Risk Assessment Committee (PRAC): 25-28 October 2021
European Medicines Agency, Amsterdam, the Netherlands, from 25/10/2021 to 28/10/2021, Last updated: 02/08/2022 -
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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 (updated)
Last updated: 27/03/2023 -
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PRAC: Agendas, minutes and highlights (updated)
Last updated: 17/03/2023 -
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Newsletters (updated)
Last updated: 27/03/2023 -
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Paediatric Committee (PDCO): 12-15 December 2017
European Medicines Agency, London, UK, from 12/12/2017 to 15/12/2017, Last updated: 03/07/201412 2.1.12. Tucatinib - EMEA-002242-PIP01-17 … -
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Paediatric Committee (PDCO): 7-10 November 2017
European Medicines Agency, London, UK, from 07/11/2017 to 10/11/2017, Last updated: 03/07/2014 -
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Paediatric Committee (PDCO): 18-21 January 2022
Virtual meeting, from 18/01/2022 to 21/01/2022, Last updated: 24/03/2021 -
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Committee for Medicinal Products for Human Use (CHMP): 12-15 October 2020
Virtual meeting, from 12/10/2020 to 15/10/2020, Last updated: 16/10/2020 -
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Pharmacovigilance Risk Assessment Committee (PRAC): 28 September-1 October 2020
Virtual meeting, from 28/09/2020 to 01/10/2020, Last updated: 29/09/2020 -
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Pharmacovigilance Risk Assessment Committee (PRAC): 13-16 March 2023
European Medicines Agency, Amsterdam, the Netherlands, from 13/03/2023 to 16/03/2023, Last updated: 18/08/2021 -
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News: Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 13 - 16 March 2023 (new)
PRAC, Last updated: 17/03/2023 -
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PDCO: meeting archive 2015-2017
Last updated: 19/04/202210 2.1.12. Tucatinib - EMEA-002242-PIP01-17 …
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Paediatric Committee (PDCO): 14-17 December 2021
Virtual meeting, from 14/12/2021 to 17/12/2021, Last updated: 27/01/2021 -
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Committee for Medicinal Products for Human Use (CHMP): 7-10 December 2020
Virtual meeting, from 07/12/2020 to 10/12/2020, Last updated: 04/11/2019 -
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Committee for Medicinal Products for Human Use (CHMP): 23-26 January 2023
European Medicines Agency, Amsterdam, the Netherlands, from 23/01/2023 to 26/01/2023, Last updated: 29/11/2022 -
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Committee for Medicinal Products for Human Use (CHMP): 27-30 March 2023 (new)
European Medicines Agency, Amsterdam, the Netherlands, from 27/03/2023 to 30/03/2023, Last updated: 27/03/2023