92 results
Keyword Imfinzi Remove keyword
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Summary of opinion: Imfinzi
durvalumab, opinion date: 12/10/2023, Positive, Last updated: 13/10/2023Imfinzi: Pending EC decision … opinion1 (post authorisation) Imfinzi durvalumab On 12 October … for the medicinal product Imfinzi. The marketing authorisation … -
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Opinion/decision on a Paediatric investigation plan (PIP): Imfinzi, durvalumab
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Oncology
PIP number: EMEA-002028-PIP01-16-M03, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Concentrate for solution for infusion
Decision date: 09/09/2022, Last updated: 18/09/2023, Compliance check: XInvented name Imfinzi Active substance durvalumab … investigation plan for durvalumab (Imfinzi), (EMEA-002028-PIP01-16-M03 … investigation plan for durvalumab (Imfinzi), (EMEA-002028-PIP01-16-M03 … -
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Human medicine European public assessment report (EPAR): Imfinzi (updated)
durvalumab, Carcinoma, Non-Small-Cell Lung
Date of authorisation: 21/09/2018,
, Revision: 18, Authorised, Last updated: 20/11/2023
Imfinzi Cancer Neoplasms Lung … thorised durvalumab Overview Imfinzi is a medicine used to treat … medicines to treat cancer). Imfinzi is used on its own and only … -
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News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 9-12 October 2023
CHMP, Last updated: 13/10/2023Imfinzi, … -
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News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 20-23 July 2020
CHMP, Last updated: 24/07/2020Imfinzi … -
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News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 12-15 December 2022
CHMP, Last updated: 16/12/2022 -
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News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 23-26 July 2018
CHMP, Last updated: 27/07/2018Imfinzi … -
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News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 7-10 November 2022
CHMP, Last updated: 11/11/2022Imfinzi … -
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Human medicine European public assessment report (EPAR): Lytgobi
Futibatinib, Cholangiocarcinoma
Date of authorisation: 04/07/2023,, 
, Revision: 1, Authorised, Last updated: 19/10/2023
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Human medicine European public assessment report (EPAR): Evusheld (updated)
tixagevimab, cilgavimab, COVID-19 virus infection
Date of authorisation: 25/03/2022,, Revision: 5, Authorised, Last updated: 22/11/2023
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Human medicine European public assessment report (EPAR): Tremelimumab AstraZeneca
Tremelimumab, Carcinoma, Non-Small-Cell Lung
Date of authorisation: 20/02/2023,, Revision: 1, Authorised, Last updated: 11/09/2023
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Human medicine European public assessment report (EPAR): Imjudo
Tremelimumab, Carcinoma, Hepatocellular
Date of authorisation: 20/02/2023,, Revision: 2, Authorised, Last updated: 22/09/2023
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Human medicine European public assessment report (EPAR): Libtayo
Cemiplimab, Carcinoma, Squamous Cell
Date of authorisation: 28/06/2019,, Revision: 15, Authorised, Last updated: 18/07/2023
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Human medicine European public assessment report (EPAR): Jemperli
dostarlimab, Endometrial Neoplasms
Date of authorisation: 21/04/2021,, , Revision: 6, Authorised, Last updated: 19/12/2022
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PRAC recommendations on safety signals (updated)
Last updated: 20/11/2023 -
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Pharmacovigilance Risk Assessment Committee (PRAC): 27-30 November 2023 (updated)
European Medicines Agency, Amsterdam, the Netherlands, from 27/11/2023 to 30/11/2023, Last updated: 27/11/2023 -
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PRAC: Agendas, minutes and highlights (updated)
Last updated: 27/11/2023 -
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CHMP: Agendas, minutes and highlights (updated)
Last updated: 10/11/2023 -
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Committee for Medicinal Products for Human Use (CHMP): 17-20 July 2023
European Medicines Agency, Amsterdam, the Netherlands, from 17/07/2023 to 20/07/2023, Last updated: 06/10/2023 -
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Pharmacovigilance Risk Assessment Committee (PRAC): 28-31 August 2023
European Medicines Agency, Amsterdam, the Netherlands, from 28/08/2023 to 31/08/2023, Last updated: 27/10/2023 -
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Committee for Medicinal Products for Human Use (CHMP): 11-14 September 2023
European Medicines Agency, Amsterdam, the Netherlands, from 11/09/2023 to 14/09/2023, Last updated: 14/09/2023 -
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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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Pharmacovigilance Risk Assessment Committee (PRAC): 24-27 October 2022
European Medicines Agency, Amsterdam, the Netherlands, from 24/10/2022 to 27/10/2022, Last updated: 31/03/2023 -
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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: 22/06/2023