61 results
Keyword Enhertu Remove keyword
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Opinion/decision on a Paediatric investigation plan (PIP): Enhertu, trastuzumab deruxtecan
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Oncology
PIP number: EMEA-002978-PIP01-21, Route(s) of administration: All routes of administration, Pharmaceutical form(s): All pharmaceutical forms
Decision date: 08/07/2021, Last updated: 19/07/2022, Compliance check: XInvented name Enhertu Active substance trastuzumab … for trastuzumab deruxtecan (Enhertu), (EMEA-002978- PIP01-21 … for trastuzumab deruxtecan (Enhertu), (EMEA-002978- PIP01-21 … -
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Human medicine European public assessment report (EPAR): Enhertu
trastuzumab deruxtecan, Breast Neoplasms
Date of authorisation: 18/01/2021,
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, Revision: 10, Authorised, Last updated: 16/02/2023
Enhertu Breast Diseases Skin Diseases Skin … Enhertu … EMA/950165/2022 EMEA/H/C/005124 Enhertu (trastuzumab deruxtecan … -
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News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 7-10 November 2022
CHMP, Last updated: 11/11/2022Enhertu … -
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News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 7-10 December 2020
CHMP, Last updated: 11/12/2020Enhertu … -
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News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 20-23 June 2022
CHMP, Last updated: 24/06/2022Enhertu … -
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News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 12-15 December 2022
CHMP, Last updated: 16/12/2022Enhertu … -
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Human medicine European public assessment report (EPAR): Kadcyla
trastuzumab emtansine, Breast Neoplasms
Date of authorisation: 15/11/2013, Revision: 15, Authorised, Last updated: 22/03/2023 -
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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): 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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CHMP: Agendas, minutes and highlights (updated)
Last updated: 06/06/2023 -
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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: 03/04/2023 -
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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: 31/03/2023 -
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Committee for Medicinal Products for Human Use (CHMP): 7-10 November 2022
European Medicines Agency, Amsterdam, the Netherlands, from 07/11/2022 to 10/11/2022, Last updated: 10/01/20238 2.3.2. Enhertu - trastuzumab deruxtecan … -
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PRAC: Agendas, minutes and highlights (updated)
Last updated: 07/06/2023 -
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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: 14/04/2023 -
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Pharmacovigilance Risk Assessment Committee (PRAC): 10-13 January 2022
European Medicines Agency, Amsterdam, the Netherlands, from 10/01/2022 to 13/01/2022, Last updated: 07/10/2022 -
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Newsletters (updated)
Last updated: 30/05/2023 -
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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): 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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Committee for Medicinal Products for Human Use (CHMP): 21-24 March 2022
European Medicines Agency, Amsterdam, the Netherlands, from 21/03/2022 to 24/03/2022, Last updated: 12/08/2022 -
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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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PRIME: priority medicines (updated)
Last updated: 06/06/2023 -
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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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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 June 2022
European Medicines Agency, Amsterdam, the Netherlands, from 07/06/2022 to 10/06/2022, Last updated: 31/03/2022