66 results
Keyword Bavencio Remove keyword
-
List item
Opinion/decision on a Paediatric investigation plan (PIP): Bavencio, avelumab
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Oncology
PIP number: EMEA-001849-PIP02-15-M04, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Concentrate for solution for infusion
Decision date: 31/12/2021, Last updated: 27/03/2023, Compliance check: XInvented name Bavencio Active substance avelumab … investigation plan for avelumab (Bavencio), (EMEA-001849-PIP02-15-M04 … investigation plan for avelumab (Bavencio), (EMEA-001849-PIP02-15-M04 … -
List item
Human medicine European public assessment report (EPAR): Bavencio
avelumab, Neuroendocrine Tumors
Date of authorisation: 18/09/2017,
, Revision: 15, Authorised, Last updated: 24/03/2023
Bavencio Cancer Neoplasms Neuroectodermal … Bavencio … EMA/584705/2022 EMEA/H/C/004338 Bavencio (avelumab) An overview of Bavencio and why it is authorised … -
List item
Orphan designation: Recombinant human monoclonal IgG1 antibody against programmed death ligand-1 (avelumab) for: Treatment of Merkel cell carcinoma
Date of designation: 14/12/2015, Withdrawn, Last updated: 15/10/2019been authorised in the EU as Bavencio since 18 September 2017 … of marketing authorisation Bavencio (avelumab) for the treatment … marketing authorisation Bavencio (avelumab) for the treatment … -
List item
News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 16-19 September 2019
CHMP, Last updated: 20/09/2019Bavencio, Benlysta, Docetaxel Zentiva … -
List item
News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 7-10 December 2020
CHMP, Last updated: 11/12/2020Bavencio … -
List item
News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 17-20 July 2017
CHMP, Last updated: 21/07/2017Bavencio … -
List item
National expert: Fausto Roila, European Medicines Agency (updated)
- Declaration of interests - 45.52 KB | PDF
- Curriculum Vitae - 54.19 KB | PDF
metast Past 01-03- 2019 01-10- 2019 Pfizer AVELUMAB (BAVENCIO) IN COMBINATION WITH Patient … -
List item
Human medicine European public assessment report (EPAR): Cabometyx
cabozantinib (s)-malate, Carcinoma, Renal Cell; Carcinomas, Hepatocellular
Date of authorisation: 09/09/2016,
, Revision: 16, Authorised, Last updated: 05/04/2023
-
List item
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
-
List item
Human medicine European public assessment report (EPAR): Opdivo
nivolumab, Melanoma; Hodgkin Disease; Carcinoma, Renal Cell; Carcinoma, Non-Small-Cell Lung; Carcinoma, Transitional Cell; Squamous Cell Carcinoma of Head and Neck; Urologic Neoplasms; Mesothelioma; Colorectal Neoplasms
Date of authorisation: 19/06/2015, Revision: 52, Authorised, Last updated: 28/03/2023 -
List item
PRAC: Agendas, minutes and highlights (updated)
Last updated: 07/06/2023 -
List item
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 -
List item
Pharmacovigilance Risk Assessment Committee (PRAC): 2-5 May 2022
European Medicines Agency, Amsterdam, the Netherlands, from 02/05/2022 to 05/05/2022, Last updated: 06/02/2023 -
List item
List of medicines under additional monitoring (updated)
Last updated: 30/05/2023 -
List item
PRAC recommendations on safety signals (updated)
Last updated: 05/06/2023 -
List item
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 -
List item
CHMP: Agendas, minutes and highlights (updated)
Last updated: 06/06/2023 -
List item
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 -
List item
Pharmacovigilance Risk Assessment Committee (PRAC): 26-29 October 2020
Virtual meeting, from 26/10/2020 to 29/10/2020, Last updated: 08/01/2021TECENTRIQ (CAP); avelumab – BAVENCIO (CAP); cemiplimab – LIBTAYO … -
List item
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 -
List item
Committee for Medicinal Products for Human Use (CHMP): 16-19 August 2022
Written procedure, from 16/08/2022 to 19/08/2022, Last updated: 04/10/2022 -
List item
Committee for Medicinal Products for Human Use (CHMP): 14-17 September 2020
Virtual meeting, from 14/09/2020 to 17/09/2020, Last updated: 10/03/2021 -
List item
Pharmacovigilance Risk Assessment Committee (PRAC): 3-6 May 2021
European Medicines Agency, Amsterdam, the Netherlands, from 03/05/2021 to 06/05/2021, Last updated: 27/02/2018 -
List item
Pharmacovigilance Risk Assessment Committee (PRAC): 14-17 May 2018
European Medicines Agency, London, UK, from 14/05/2018 to 17/05/2018, Last updated: 14/05/2018 -
List item
Pharmacovigilance Risk Assessment Committee (PRAC): 6-9 July 2020
European Medicines Agency, Amsterdam, the Netherlands, from 06/07/2020 to 09/07/2020, Last updated: 10/12/2020