89 results
Keyword Imfinzi Remove keyword
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Summary of opinion: Imfinzi
durvalumab, opinion date: 10/11/2022, Positive, Last updated: 11/11/2022Imfinzi: Pending EC decision … opinion1 (post authorisation) Imfinzi durvalumab On 10 November … 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-M02, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Concentrate for solution for infusion
Decision date: 17/03/2021, Last updated: 05/11/2021, Compliance check: XInvented name Imfinzi Active substance durvalumab … investigation plan for durvalumab (Imfinzi), (EMEA-002028-PIP01-16-M02 … investigation plan for durvalumab (Imfinzi), (EMEA-002028-PIP01-16-M02 … -
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Human medicine European public assessment report (EPAR): Imfinzi
durvalumab, Carcinoma, Non-Small-Cell Lung
Date of authorisation: 21/09/2018,
, Revision: 16, Authorised, Last updated: 02/05/2023
Imfinzi Cancer Neoplasms Lung … Imfinzi … EMA/949093/2022 EMEA/H/C/004771 Imfinzi (durvalumab) An overview of Imfinzi and why it is authorised … -
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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) 7-10 November 2022
CHMP, Last updated: 11/11/2022Imfinzi … -
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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) 20-23 July 2020
CHMP, Last updated: 24/07/2020Imfinzi … -
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List of medicines under additional monitoring (updated)
Last updated: 30/05/2023authorisation (September 2018) Imfinzi - Five years following its …
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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: 2, Authorised, Last updated: 12/05/2023
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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,, Authorised, Last updated: 04/04/2023
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Human medicine European public assessment report (EPAR): Libtayo (updated)
Cemiplimab, Carcinoma, Squamous Cell
Date of authorisation: 28/06/2019,, Revision: 14, Authorised, Last updated: 17/05/2023
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Human medicine European public assessment report (EPAR): Imjudo
Tremelimumab, Carcinoma, Hepatocellular
Date of authorisation: 20/02/2023,, Authorised, Last updated: 02/03/2023
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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: 05/06/2023 -
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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): 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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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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PRAC: Agendas, minutes and highlights (updated)
Last updated: 07/06/2023 -
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Pharmacovigilance Risk Assessment Committee (PRAC): 6-9 February 2023 (updated)
European Medicines Agency, Amsterdam, the Netherlands, from 06/02/2023 to 09/02/2023, Last updated: 17/05/2023 -
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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: 10/01/2023 -
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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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Committee for Medicinal Products for Human Use (CHMP): 10-13 October 2022
European Medicines Agency, Amsterdam, the Netherlands, from 10/10/2022 to 13/10/2022, Last updated: 23/11/2022 -
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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