39 results
Keyword Braftovi Remove keyword
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Opinion/decision on a Paediatric investigation plan (PIP): Braftovi, Encorafenib
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Oncology
PIP number: EMEA-001588-PIP03-18, Route(s) of administration: Oral use, Pharmaceutical form(s): Capsule, hard
Decision date: 29/01/2019, Last updated: 11/04/2019, Compliance check: XInvented name Braftovi Active substance Encorafenib … Braftovi Braftovi encorafenib Encorafenib En … -
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Human medicine European public assessment report (EPAR): Braftovi
Encorafenib, Melanoma; Colorectal Neoplasms
Date of authorisation: 19/09/2018,
, Revision: 10, Authorised, Last updated: 05/08/2022
Braftovi Cancer Nevi and Melanomas Neuroendocrine … Braftovi … initial authorisation) Braftovi encorafenib On 26 July … -
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Human medicine European public assessment report (EPAR): Mektovi
binimetinib, Melanoma
Date of authorisation: 20/09/2018,, Revision: 6, Authorised, Last updated: 26/01/2022
another medicine, encorafenib (Braftovi), and is only for patients … -
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News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 28-30 April 2020
CHMP, Last updated: 30/04/2020Braftovi … -
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News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 23-26 July 2018
CHMP, Last updated: 27/07/2018Braftovi … -
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Human medicine European public assessment report (EPAR): Norvir
ritonavir, HIV Infections
Date of authorisation: 25/08/1996, Revision: 68, Authorised, Last updated: 18/10/2022 -
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Human medicine European public assessment report (EPAR): Kaletra
lopinavir, ritonavir, HIV Infections
Date of authorisation: 19/03/2001, Revision: 60, Authorised, Last updated: 29/11/2022 -
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Opinion on medicine for use outside EU: Aluvia
lopinavir, ritonavir, HIV Infections, ATC code: J05AR10 Opinion number: H-W-764, Positive opinion Opinion date: 21/09/2006, Last updated: 15/12/2022 -
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List of medicines under additional monitoring (updated)
Last updated: 30/05/2023 -
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Pharmacovigilance Risk Assessment Committee (PRAC): 6-9 February 2023 (updated)
European Medicines Agency, Amsterdam, the Netherlands, from 06/02/2023 to 09/02/2023, Last updated: 17/05/2023 -
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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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Committee for Medicinal Products for Human Use (CHMP): 20-23 February 2023
European Medicines Agency, Amsterdam, the Netherlands, from 20/02/2023 to 23/02/2023, Last updated: 24/04/2023 -
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Pharmacovigilance Risk Assessment Committee (PRAC): 10-13 January 2022
European Medicines Agency, Amsterdam, the Netherlands, from 10/01/2022 to 13/01/2022, Last updated: 07/10/2022 -
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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: 07/06/2023 -
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Pharmacovigilance Risk Assessment Committee (PRAC): 5-8 July 2021
European Medicines Agency, Amsterdam, the Netherlands, from 05/07/2021 to 08/07/2021, Last updated: 10/05/2022 -
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Pharmacovigilance Risk Assessment Committee (PRAC): 6-9 July 2020
European Medicines Agency, Amsterdam, the Netherlands, from 06/07/2020 to 09/07/2020, Last updated: 10/12/2020 -
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CHMP: Agendas, minutes and highlights (updated)
Last updated: 06/06/2023 -
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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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Committee for Medicinal Products for Human Use (CHMP): 20-23 June 2022
European Medicines Agency, Amsterdam, the Netherlands, from 20/06/2022 to 23/06/2022, Last updated: 18/08/2022 -
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Pharmacovigilance Risk Assessment Committee (PRAC): 11-14 January 2021
Virtual meeting, from 11/01/2021 to 14/01/2021, Last updated: 27/02/2018 -
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Committee for Medicinal Products for Human Use (CHMP): 11-14 October 2021
European Medicines Agency, Amsterdam, the Netherlands, from 11/10/2021 to 14/10/2021, Last updated: 20/01/2022 -
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Download medicine data
Last updated: 02/12/2021 -
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News: Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 11-14 April 2023
PRAC, Last updated: 14/04/2023 -
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News: Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 6 - 9 February 2023
PRAC, Last updated: 10/02/2023