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Summary of opinion: Keytruda (new)
pembrolizumab, opinion date: 22/04/2022, Positive, Last updated: 22/04/2022Keytruda: Pending EC decision … opinion1 (post authorisation) Keytruda pembrolizumab On 22 April … for the medicinal product Keytruda. The marketing authorisation … -
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Summary of opinion: Keytruda (new)
pembrolizumab, opinion date: 19/05/2022, Positive, Last updated: 20/05/2022Keytruda: Pending EC decision … opinion1 (post authorisation) Keytruda pembrolizumab On 19 May … for the medicinal product Keytruda. The marketing authorisation … -
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Withdrawn application: Keytruda
pembrolizumab, date of withdrawal: 10/12/2019, Post-authorisation, Last updated: 19/03/2020Keytruda: Withdrawn application … Keytruda Keytruda pembrolizumab Pembrolizumab … -
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Withdrawn application: Keytruda
pembrolizumab, date of withdrawal: 11/10/2017, Post-authorisation, Last updated: 28/11/2017Keytruda: Withdrawn application … Keytruda ext of ind withdrawal Q&A … marketing authorisation for Keytruda (pembrolizumab) On 11 … -
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Opinion/decision on a Paediatric investigation plan (PIP): Keytruda, Pembrolizumab
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Oncology
PIP number: EMEA-001474-PIP02-16-M02, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Concentrate for solution for infusion, Powder for concentrate for solution for infusion
Decision date: 30/01/2018, Last updated: 19/04/2018, Compliance check: XInvented name Keytruda Active substance Pembrolizumab … plan for pembrolizumab (Keytruda), (EMEA-001474-PIP02-16-M02 … plan for pembrolizumab (Keytruda), (EMEA-001474-PIP02-16-M02 … -
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Human medicine European public assessment report (EPAR): Keytruda (updated)
Pembrolizumab, Melanoma; Hodgkin Disease; Carcinoma, Renal Cell; Carcinoma, Non-Small-Cell Lung; Carcinoma, Transitional Cell; Squamous Cell Carcinoma of Head and Neck; Urologic Neoplasms; Endometrial Neoplasms
Date of authorisation: 17/07/2015,
, Revision: 44, Authorised, Last updated: 17/05/2022
Keytruda Cancer Neoplasms Neuroectodermal … rised pembrolizumab Overview Keytruda is a cancer medicine used … carcinoma (a cancer of the womb) Keytruda is mainly used in adults … -
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Opinion/decision on a Paediatric investigation plan (PIP): Keytruda, Anti-PD1 humanized monoclonal antibody of the IgG4/kappa class (MK-3475) (pembrolizumab)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Oncology
PIP number: EMEA-001474-PIP01-13-M01, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Powder for concentrate for solution for infusion, Concentrate for solution for infusion
Decision date: 16/02/2018, Last updated: 21/09/2021, Compliance check: V, 01/02/2019Invented name Keytruda Active substance Anti-PD1 … plan for pembrolizumab (KEYTRUDA), (EMEA-001474-PIP01-13-M01 … plan for pembrolizumab (KEYTRUDA), (EMEA-001474-PIP01-13-M01 … -
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Press release: EMA restricts use of Keytruda and Tecentriq in bladder cancer
CHMP, Last updated: 01/06/2018EMA restricts use of Keytruda and Tecentriq in bladder … show reduced survival with Keytruda (pembrolizumab) and Tecentriq … PD-L1. The data indicate that Keytruda and Tecentriq may not work … -
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Press release: New treatment option recommended for patients with advanced melanoma
CHMP, Last updated: 22/05/2015Keytruda extends range of treatment … with advanced melanoma Keytruda extends range of treatment … marketing authorisation for Keytruda (pembrolizumab). It is recommended … -
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News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 25-29 January 2021
CHMP, Last updated: 01/02/2021Keytruda … -
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News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 20-23 March 2017
CHMP, Last updated: 24/03/2017Keytruda … -
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News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 28-31 May 2018
CHMP, Last updated: 01/06/2018Outcome of review on Keytruda and Tecentriq … -
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News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 22-25 July 2019
CHMP, Last updated: 26/07/2019Empliciti, Keytruda, Lonsurf, Lucentis, Soliris … -
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News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 6-9 November 2017
CHMP, Last updated: 10/11/2017Keytruda … -
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News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 17-20 July 2017
CHMP, Last updated: 21/07/2017Keytruda … -
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News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 20-23 June 2016
CHMP, Last updated: 24/06/2016Keytruda … -
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News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 18-21 May 2015
CHMP, Last updated: 22/05/2015Keytruda … -
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News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 27-30 January 2020
CHMP, Last updated: 31/01/2020Keytruda … -
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News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 7-10 December 2020
CHMP, Last updated: 11/12/2020Keytruda … -
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National expert: Nuno Sousa, National Authority of Medicines and Health Products, I.P.
- Declaration of interests - 85.79 KB | PDF
- Curriculum Vitae - 16.82 KB | PDF
06/2018-06/2018 Merck Sharp & Dohme Keytruda(R) Bladder Cancer 2.3 Strategic … -
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News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 15-18 October 2018
CHMP, Last updated: 19/10/2018Keytruda … -
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News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 11-14 October 2021
CHMP, Last updated: 15/10/2021Keytruda … -
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News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 19-22 April 2022 (new)
CHMP, Last updated: 22/04/2022Keytruda … -
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News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 23-26 July 2018
CHMP, Last updated: 27/07/2018Keytruda … -
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News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 12-15 December 2016
CHMP, Last updated: 16/12/2016Keytruda …