170 results
Keyword Atezolizumab Remove keyword
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Direct healthcare professional communication (DHPC): Tecentriq (atezolizumab): Risk of Severe Cutaneous Adverse Reactions (SCARs)
Active substance: atezolizumab, DHPC type: Adverse event, Last updated: 25/03/2021Tecentriq (atezolizumab): Risk of Severe Cutaneous … Tecentriq (atezolizumab): Risk of Severe Cutaneous … DHPC) TECENTRIQ® (atezolizumab): Risk of Severe Cutaneous … -
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Human medicine European public assessment report (EPAR): Tecentriq (updated)
atezolizumab, Carcinoma, Transitional Cell; Carcinoma, Non-Small-Cell Lung; Urologic Neoplasms; Breast Neoplasms; Small Cell Lung Carcinoma
Date of authorisation: 20/09/2017, Revision: 21, Authorised, Last updated: 07/03/2023atezolizumab … EMEA/H/C/004143 Tecentriq (atezolizumab) An overview of Tecentriq … contains the active substance atezolizumab. How is Tecentriq used … -
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Opinion/decision on a Paediatric investigation plan (PIP): Tecentriq, atezolizumab
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Oncology
PIP number: EMEA-001638-PIP01-14-M02, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Concentrate for solution for infusion
Decision date: 12/06/2019, Last updated: 21/09/2021, Compliance check: V, 20/09/2019Tecentriq Active substance atezolizumab Therapeutic area Oncology … Tecentriq Tecentriq atezolizumab atezolizumab atezolizumab … -
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Opinion/decision on a Paediatric investigation plan (PIP): Tecentriq, atezolizumab
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Oncology
PIP number: EMEA-001638-PIP02-21, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Solution for injection
Decision date: 08/09/2021, Last updated: 09/01/2023, Compliance check: XTecentriq Active substance atezolizumab Therapeutic area Oncology … product specific waiver for atezolizumab (Tecentriq), (EMEA-001638-PIP02-21 … product specific waiver for atezolizumab (Tecentriq), (EMEA-001638-PIP02-21 … -
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Withdrawn application: Tecentriq
atezolizumab, date of withdrawal: 08/01/2021, Post-authorisation, Last updated: 01/02/2021authorisation for Tecentriq (atezolizumab) Roche Registration GmbH … contains the active substance atezolizumab and is given as an infusion … authorisation for Tecentriq (atezolizumab) EMA/47544/2021 Page … -
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Withdrawn application: Tecentriq
atezolizumab, date of withdrawal: 23/06/2021, Post-authorisation, Last updated: 23/07/2021authorisation for Tecentriq (atezolizumab) Roche Registration GmbH … contains the active substance atezolizumab and is given as an infusion … authorisation for Tecentriq (atezolizumab) EMA/409715/2021 Page … -
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Withdrawn application: Tecentriq
atezolizumab, date of withdrawal: 22/10/2018, Post-authorisation, Last updated: 16/11/2018Tecentriq Tecentriq atezolizumab atezolizumab … -
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News: EMA reminds physicians to use Tecentriq with nab-paclitaxel for treating breast cancer
CHMP, Last updated: 21/05/2021product information, Tecentriq (atezolizumab) should continue to be used … physicians to use Tecentriq (atezolizumab) only in combination with … contains the active substance atezolizumab. … -
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National expert: Kaisa Sunela, Finnish Medicines Agency (updated)
- Declaration of interests - 88.7 KB | PDF
- Curriculum Vitae - 23.55 KB | PDF
Roche polatuzumab vedotin, atezolizumab, other mABs in pipe line lymphoma … patient cases concerning atezolizumab, making diet guidance to cancer … -
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Joint Biologics Working Party / Quality Working Party workshop with stakeholders in relation to prior knowledge and its use in regulatory applications
European Medicines Agency, London, UK, 23/11/2017, Last updated: 04/04/2018Presentation - Case study 1 - Atezolizumab: Accelerated development … EBE, Biogen Case Study 1: Atezolizumab: A Case Study of Accelerated … -
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National expert: Kevin Punie, Federal Agency for Medicines and Health Products (updated)
- Declaration of interests - 87.31 KB | PDF
- Curriculum Vitae - 37.86 KB | PDF
06/2019-(current) Hoffmann-La Roche Atezolizumab Breast Cancer 06/2019-(current … 01/2019-(current) Hoffmann-La Roche Atezolizumab Breast Cancer 01/2019-(current … -
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National expert: Philipp Harter, European Medicines Agency (updated)
- Declaration of interests - 84.81 KB | PDF
- Curriculum Vitae - 17.39 KB | PDF
01/2019-08/2020 Roche Bevacizumab, Atezolizumab Ovarian Cancer 01/2019-11/2022 … trials: - AGO OVAR 2.29: Atezolizumab in Ovarian Cancer - AGO-OVAR … -
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National expert: Alexandra Leary, European Medicines Agency (updated)
- Declaration of interests - 85.56 KB | PDF
- Curriculum Vitae - 17.33 KB | PDF
ovarian 01/2019-(current) roche atezolizumab relapsed ovarian cancer … cancers 01/2019-(current) roche atezolizumab cervical cancer 09/2022-(current … -
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National expert: Nuno Sousa, National Authority Of Medicines And Health Products (updated)
- Declaration of interests - 85.13 KB | PDF
- Curriculum Vitae - 16.82 KB | PDF
Cancer 08/2017-(current) Roche Atezolizumab Metastatic Bladder Cancer … Cancer 02/2021-(current) Roche Atezolizumab with or without tiragolumab Esophageal … -
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National expert: Maria Vidal Losada, European Medicines Agency (updated)
- Declaration of interests - 80.36 KB | PDF
- Curriculum Vitae - 41.76 KB | PDF
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News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 12-15 November 2018
CHMP, Last updated: 16/11/2018atezolizumab) to treat kidney cancer was … -
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News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 17-20 July 2017
CHMP, Last updated: 21/07/2017atezolizumab) received a positive opinion … -
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News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 19-22 July 2021
CHMP, Last updated: 23/07/2021atezolizumab … -
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Press release: EMA restricts use of Keytruda and Tecentriq in bladder cancer
CHMP, Last updated: 01/06/2018pembrolizumab) and Tecentriq (atezolizumab) when used as first-line … pembrolizumab) and Tecentriq (atezolizumab) when used as first-line … -
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Human medicine European public assessment report (EPAR): Imjudo (updated)
Tremelimumab, Carcinoma, Hepatocellular
Date of authorisation: 15/12/2022,
, Authorised, Last updated: 02/03/2023
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News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 14-17 September 2020
CHMP, Last updated: 18/09/2020Tecentriq INN atezolizumab Marketing-authorisation applicant … -
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Human medicine European public assessment report (EPAR): Rybrevant
amivantamab, Carcinoma, Non-Small-Cell Lung
Date of authorisation: 09/12/2021,, 
, Revision: 2, Authorised, Last updated: 30/01/2023
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Human medicine European public assessment report (EPAR): Retsevmo
Selpercatinib, Carcinoma, Non-Small-Cell Lung; Thyroid Neoplasms
Date of authorisation: 11/02/2021,, , Revision: 5, Authorised, Last updated: 20/12/2022
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Human medicine European public assessment report (EPAR): Lumykras
sotorasib, Carcinoma, Non-Small-Cell Lung
Date of authorisation: 06/01/2022,, , Revision: 1, Authorised, Last updated: 29/11/2022
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Human medicine European public assessment report (EPAR): Yescarta
axicabtagene ciloleucel, Lymphoma, Follicular; Lymphoma, Large B-Cell, Diffuse
Date of authorisation: 23/08/2018,, 
, Revision: 11, Authorised, Last updated: 30/01/2023