47 results
Keyword Cotellic Remove keyword
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Opinion/decision on a Paediatric investigation plan (PIP): Cotellic, Cobimetinib (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Oncology
PIP number: EMEA-001425-PIP01-13-M05, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet, Age-appropriate oral formulation
Decision date: 17/03/2021, Last updated: 10/03/2023, Compliance check: V, 25/06/2021Key facts Cotellic Cobimetinib OncologyP/0119/2021EMEA-001425-PIP01-13-M05 … investigation plan for cobimetinib (Cotellic) (EMEA-001425-PIP01-13-M05 … 26/11/2021 EMA/93313/2021 Generic Cotellic: EPAR Topics: Paediatrics … -
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Human medicine European public assessment report (EPAR): Cotellic (updated)
cobimetinib hemifumarate, Melanoma
Date of authorisation: 20/11/2015, Revision: 14, Authorised, Last updated: 06/03/2023Cotellic Neuroendocrine Tumors Neuroectodermal … Cotellic … Cotellic, INN-cobimetinib … -
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News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 21-24 September 2015
CHMP, Last updated: 25/09/2015Cotellic … -
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Human medicine European public assessment report (EPAR): Yervoy
Ipilimumab, Melanoma; Carcinoma, Renal Cell; Carcinoma, Non-Small-Cell Lung; Mesothelioma, Malignant; Colorectal Neoplasms
Date of authorisation: 13/07/2011, Revision: 50, Authorised, Last updated: 07/12/2022 -
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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: 51, Authorised, Last updated: 07/12/2022 -
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Withdrawn application: Balimek
binimetinib, date of withdrawal: 04/01/2018, Initial authorisation, Last updated: 27/03/2018 -
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PRAC: Agendas, minutes and highlights (updated)
Last updated: 17/03/2023 -
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Pharmacovigilance Risk Assessment Committee (PRAC): 29 August - 1 September 2022
European Medicines Agency, Amsterdam, the Netherlands, from 29/08/2022 to 01/09/2022, Last updated: 02/09/2022 -
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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): 16-19 May 2022
European Medicines Agency, Amsterdam, the Netherlands, from 16/05/2022 to 19/05/2022, Last updated: 12/08/2022 -
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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 -
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CHMP: Agendas, minutes and highlights
Last updated: 08/02/2023 -
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Pharmacovigilance Risk Assessment Committee (PRAC): 6-9 March 2017
European Medicines Agency, London, UK, from 06/03/2017 to 09/03/2017, Last updated: 06/03/2017 -
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Pharmacovigilance Risk Assessment Committee (PRAC): 3-6 July 2017
European Medicines Agency, London, UK, from 03/07/2017 to 06/07/2017, Last updated: 13/03/2014 -
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Committee for Medicinal Products for Human Use (CHMP): 11-14 September 2017
European Medicines Agency, London, UK, from 11/09/2017 to 14/09/2017, Last updated: 06/01/2014 -
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Pharmacovigilance Risk Assessment Committee (PRAC): 5-8 February 2018
European Medicines Agency, London, UK, from 05/02/2018 to 08/02/2018, Last updated: 13/03/2014 -
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Download medicine data
Last updated: 02/12/2021 -
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Pharmacovigilance Risk Assessment Committee (PRAC): 5-8 March 2018
European Medicines Agency, London, UK, from 05/03/2018 to 08/03/2018, Last updated: 05/03/2018 -
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Pharmacovigilance Risk Assessment Committee (PRAC): 8-11 March 2021
European Medicines Agency, Amsterdam, the Netherlands, from 08/03/2021 to 11/03/2021, Last updated: 27/02/2018 -
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Pharmacovigilance Risk Assessment Committee (PRAC): 8-11 February 2016
European Medicines Agency, London, UK, from 08/02/2016 to 11/02/2016, Last updated: 13/03/2014 -
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Pharmacovigilance Risk Assessment Committee (PRAC): 10-13 May 2016
European Medicines Agency, London, UK, from 10/05/2016 to 13/05/2016, Last updated: 13/03/2014 -
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Pharmacovigilance Risk Assessment Committee (PRAC): 3-6 September 2018
European Medicines Agency, London, UK, from 03/09/2018 to 06/09/2018, Last updated: 13/03/2014 -
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Committee for Medicinal Products for Human Use (CHMP): 21-24 September 2015
European Medicines Agency, London, UK, from 21/09/2015 to 24/09/2015, Last updated: 03/01/201412 3.1.4. Cotellic - cobimetinib - EMEA/H/C/003960 … -
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Pharmacovigilance Risk Assessment Committee (PRAC): 25-29 September 2017
European Medicines Agency, London, UK, from 25/09/2017 to 29/09/2017, Last updated: 06/09/2017 -
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Opinions and letters of support on the qualification of novel methodologies for medicine development (updated)
Last updated: 01/03/2023