82 results
Keyword Zelboraf Remove keyword
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Opinion/decision on a Paediatric investigation plan (PIP): Zelboraf, vemurafenib
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Oncology
PIP number: EMEA-000978-PIP01-10-M01, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet
Decision date: 12/08/2016, Last updated: 27/10/2016, Compliance check: XInvented name Zelboraf Active substance vemurafenib … investigation plan for vemurafenib (Zelboraf), (EMEA-000978-PIP01-10-M01 … investigation plan for vemurafenib (Zelboraf), (EMEA-000978-PIP01-10-M01 … -
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Human medicine European public assessment report (EPAR): Zelboraf
vemurafenib, Melanoma
Date of authorisation: 17/02/2012, Revision: 23, Authorised, Last updated: 17/03/2023Zelboraf Neuroendocrine Tumors Neuroectodermal … Zelboraf … Zelboraf, INN-vemurafenib 30 … -
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Press release: European Medicines Agency recommends approval of first-in-class treatment for metastatic or unresectable melanoma
CHMP, Last updated: 16/12/2011the pivotal clinical trial, Zelboraf (vemurafenib), the new protein-kinase … potential side effects of Zelboraf. The Committee considered … meeting that the benefits of Zelboraf, particularly the improvements … -
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Press release: European Medicines Agency finalises review of medicines concerned by Roche pharmacovigilance inspection
Last updated: 19/11/2013Viracept, Xeloda, Xenical and Zelboraf. Nationally-authorised medicines … Viracept, Xeloda, Xenical and Zelboraf 3. Nationally-authorised … -
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Press release: European Medicines Agency starts infringement procedure to investigate Roche's alleged non-compliance with pharmacovigilance obligations
Last updated: 23/10/2012Xeloda: EPAR Xenical: EPAR Zelboraf: EPAR Avastin: Paediatric … Paediatric investigation plan Zelboraf: Paediatric investigation … Viracept, Xeloda, Xenical and Zelboraf Nationally authorised … -
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Orphan designation: vemurafenib for: Treatment of Erdheim-Chester disease
Date of designation: 27/02/2017, Positive, Last updated: 31/03/2017submission, vemurafenib (as Zelboraf tablets) was authorised in … submission, vemurafenib (as Zelboraf tablets) was authorised in … -
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National expert: Serena Marchetti, Medicines Evaluation Board (updated)
- Declaration of interests - 40.57 KB | PDF
- Curriculum Vitae - 32.79 KB | PDF
Agency review of vemurafenib (Zelboraf®) for the treatment of adult … -
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News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 12-15 December 2011
CHMP, Last updated: 16/12/2011inactivated) Baxter Innovations GmbH Zelboraf Press release: European Medicines … -
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Human medicine European public assessment report (EPAR): Cotellic
cobimetinib hemifumarate, Melanoma
Date of authorisation: 20/11/2015, Revision: 14, Authorised, Last updated: 06/03/2023 -
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Human medicine European public assessment report (EPAR): Mekinist
trametinib, Melanoma
Date of authorisation: 30/06/2014, Revision: 29, Authorised, Last updated: 27/02/2023 -
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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: 51, Authorised, Last updated: 03/04/2023 -
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Human medicine European public assessment report (EPAR): Invirase
saquinavir, HIV Infections
Date of authorisation: 03/10/1996, Revision: 50, Authorised, Last updated: 13/03/2023 -
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Human medicine European public assessment report (EPAR): Tafinlar
dabrafenib mesilate, Melanoma
Date of authorisation: 26/08/2013, Revision: 28, Authorised, Last updated: 27/02/2023 -
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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: 52, Authorised, Last updated: 28/03/2023 -
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Pharmacovigilance Risk Assessment Committee (PRAC): 11-14 April 2023
European Medicines Agency, Amsterdam, the Netherlands, from 11/04/2023 to 14/04/2023, Last updated: 11/04/2023 -
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Scientific publications (updated)
Last updated: 22/05/2023 -
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Committee for Medicinal Products for Human Use (CHMP): 24-26 April 2023
European Medicines Agency, Amsterdam, the Netherlands, from 24/04/2023 to 26/04/2023, Last updated: 24/04/2023 -
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PRAC: Agendas, minutes and highlights (updated)
Last updated: 17/05/2023 -
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Vemurafenib product-specific bioequivalence guidance
Last updated: 03/03/2017pronounced food effect for Zelboraf, administration with regard …
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PRIME: priority medicines
Last updated: 31/03/2023 -
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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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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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Pharmacovigilance Risk Assessment Committee (PRAC): 4-7 March 2013
European Medicines Agency, London, UK, from 04/03/2013 to 07/03/2013, Last updated: 02/06/2012 -
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Pharmacovigilance Risk Assessment Committee (PRAC): 11-14 January 2016
European Medicines Agency, London, UK, from 11/01/2016 to 14/01/2016, Last updated: 13/03/2014 -
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Pharmacovigilance Risk Assessment Committee (PRAC): 9-12 March 2015
European Medicines Agency, London, UK, from 09/03/2015 to 12/03/2015, Last updated: 13/03/2014