67 results
Keyword Entrectinib Remove keyword
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Human medicine European public assessment report (EPAR): Rozlytrek
Entrectinib, Cancer; Carcinoma, Non-Small-Cell Lung
Date of authorisation: 31/07/2020,
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, Revision: 5, Authorised, Last updated: 29/11/2022
entrectinib … capsule contains 100 mg of entrectinib. Excipients with known … capsule contains 200 mg of entrectinib. Excipients with known … -
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Opinion/decision on a Paediatric investigation plan (PIP): Rozlytrek, Entrectinib
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Oncology
PIP number: EMEA-002096-PIP01-16-M03, Route(s) of administration: Oral use, Gastric use, Pharmaceutical form(s): Capsule, hard, Coated granules
Decision date: 08/09/2021, Last updated: 12/01/2023, Compliance check: XKey facts Rozlytrek Entrectinib OncologyP/0351/2021EMEA-002096-PIP01-16-M03 … paediatric investigation plan for entrectinib (Rozlytrek), (EMEA-002096-PIP01-16-M03 … paediatric investigation plan for entrectinib (Rozlytrek), (EMEA-002096-PIP01-16-M03 … -
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Orphan designation: N-[5-(3,5-difluorobenzyl)-1H-indazol-3-yl]-4-(4 methylpiperazin-1-yl)-2-(tetrahydro-2H-pyran-4-ylamino) benzamide (entrectinib) for: Treatment of neuroblastoma
Date of designation: 11/11/2015, Withdrawn, Last updated: 21/02/2019methylpiperazin-1-yl)-2-(tetrahydro-2H-pyran-4-ylamino) benzamide (entrectinib … methylpiperazin-1-yl)-2-(tetrahydro-2H-pyran-4-ylamino) benzamide (entrectinib … -
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News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 25-28 May 2020
CHMP, Last updated: 29/05/2020entrectinib), for the treatment of patients … -
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National expert: Cristina Migali, Italian Medicines Agency (updated)
- Declaration of interests - 79.78 KB | PDF
- Curriculum Vitae - 19.87 KB | PDF
European Medicines Agency review of entrectinib for the treatment of adult … -
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National expert: Tom Meyerson Goldschmidt, Medical Products Agency (updated)
- Declaration of interests - 80.63 KB | PDF
- Curriculum Vitae - 23.52 KB | PDF
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National expert: Fausto Roila, European Medicines Agency (updated)
- Declaration of interests - 86.05 KB | PDF
- Curriculum Vitae - 18.02 KB | PDF
Cobimetinib (RO5514041) Entrectinib (RO7102122) Erlotinib (RO508231 … -
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Human medicine European public assessment report (EPAR): Imjudo (updated)
Tremelimumab, Carcinoma, Hepatocellular
Date of authorisation: 15/12/2022,, Authorised, Last updated: 02/03/2023
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Human medicine European public assessment report (EPAR): Cabometyx
cabozantinib (s)-malate, Carcinoma, Renal Cell; Carcinomas, Hepatocellular
Date of authorisation: 09/09/2016,
, Revision: 15, Authorised, Last updated: 05/12/2022
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Human medicine European public assessment report (EPAR): Teysuno
tegafur, gimeracil, oteracil, Stomach Neoplasms
Date of authorisation: 14/03/2011, Revision: 21, Authorised, Last updated: 04/04/2022 -
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Withdrawn application: Sitoiganap
autologous glioma tumor cell lysates (inactivated), allogeneic glioma tumor cell lysates (inactivated), allogeneic glioma tumor cells (inactivated), autologous glioma tumor cells (inactivated), date of withdrawal: 02/05/2022, Initial authorisation, Last updated: 17/06/2022 -
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Paediatric Committee (PDCO): 21-24 February 2023
Virtual meeting, from 21/02/2023 to 24/02/2023, Last updated: 22/02/2023 -
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PRIME: priority medicines (updated)
Last updated: 01/03/2023 -
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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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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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PRAC: Agendas, minutes and highlights (updated)
Last updated: 17/03/2023 -
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Committee for Medicinal Products for Human Use (CHMP): 20-23 February 2023
European Medicines Agency, Amsterdam, the Netherlands, from 20/02/2023 to 23/02/2023, Last updated: 20/02/2023 -
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List of medicines under additional monitoring
Last updated: 22/02/2023 -
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PDCO: Agendas, minutes and reports
Last updated: 21/02/2023 -
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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: 04/07/2022 -
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Paediatric Committee (PDCO): 20-23 July 2021
Virtual meeting, from 20/07/2021 to 23/07/2021, Last updated: 21/02/2022 -
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Committee for Medicinal Products for Human Use (CHMP): 19-22 April 2022
European Medicines Agency, Amsterdam, the Netherlands, from 19/04/2022 to 22/04/2022, Last updated: 12/08/2022 -
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Pharmacovigilance Risk Assessment Committee (PRAC): 5-8 July 2021
European Medicines Agency, Amsterdam, the Netherlands, from 05/07/2021 to 08/07/2021, Last updated: 10/05/2022 -
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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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CHMP: Agendas, minutes and highlights
Last updated: 08/02/2023