124 results
Keyword Keytruda Remove keyword
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Withdrawn application: Keytruda
pembrolizumab, date of withdrawal: 10/12/2019, Post-authorisation, Last updated: 19/03/2020Keytruda: Withdrawn application … Keytruda Keytruda pembrolizumab Pembrolizumab … -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Withdrawn application: Keytruda
pembrolizumab, date of withdrawal: 11/10/2017, Post-authorisation, Last updated: 28/11/2017Keytruda: Withdrawn application … Keytruda ext of ind withdrawal Q&A … marketing authorisation for Keytruda (pembrolizumab) On 11 … -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-M01, 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 … investigation plan for pembrolizumab (Keytruda), (EMEA-001474-PIP02-16-M01 … plan for pembrolizumab (Keytruda), (EMEA-001474-PIP02-16-M01 … -
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Human medicine European public assessment report (EPAR): Keytruda (updated)
Pembrolizumab, Melanoma, Hodgkin Disease, Carcinoma, Non-Small-Cell Lung, Carcinoma, Renal Cell, Carcinoma, Transitional Cell, Urologic Neoplasms, Squamous Cell Carcinoma of Head and Neck
Date of authorisation: 17/07/2015,
, Revision: 33, Authorised, Last updated: 29/04/2021
Keytruda Melanoma Hodgkin Disease Carcinoma … Keytruda … report Invented name: Keytruda International non-proprietary … -
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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: 19/04/2018, Compliance check: XInvented 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) 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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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) 14-17 October 2019
CHMP, Last updated: 18/10/2019Keytruda … -
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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) 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) 28-30 April 2020
CHMP, Last updated: 30/04/2020Keytruda … -
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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 … -
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News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 28-31 January 2019
CHMP, Last updated: 01/02/2019Keytruda … -
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National expert: Anne-Berit Erdal, Norwegian Medicines Agency (updated)
- Declaration of interests - 80.75 KB | PDF
- Curriculum Vitae - 17.3 KB | PDF
line 05/2017-08/2019 MSD Keytruda + epacadostat Metastatic … -
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National expert: Hugues Malonne, Federal Agency for Medicines and Health Products (updated)
- Declaration of interests - 81.12 KB | PDF
- Curriculum Vitae - 34.11 KB | PDF
Januvia - Isentress - Keytruda - Noxafil Diabetes (type …