104 results
Keyword Bosulif Remove keyword
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Opinion/decision on a Paediatric investigation plan (PIP): Bosulif, Bosutinib (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Oncology
PIP number: EMEA-000727-PIP01-09-M05, Route(s) of administration: Oral use, Pharmaceutical form(s): Capsule, hard, Film-coated tablet
Decision date: 08/09/2021, Last updated: 12/01/2023, Compliance check: XKey facts Bosulif Bosutinib OncologyP/0368/2021EMEA-000727-PIP01-09-M05 … investigation plan for bosutinib (Bosulif), (000727-PIP01-09-M05) PDF … EMA/PDCO/242956/2021 Generic Bosulif: EPAR Topics: Medicines … -
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Human medicine European public assessment report (EPAR): Bosulif
bosutinib (as monohydrate), Leukemia, Myeloid
Date of authorisation: 27/03/2013, Revision: 23, Authorised, Last updated: 09/06/2022Bosulif Leukemia Cancer Neoplasms Leukemia … Bosulif … EMA/318082/2022 EMEA/H/C/002373 Bosulif (bosutinib) An overview of Bosulif and why it is authorised … -
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Orphan designation: Bosutinib for: Treatment of chronic myeloid leukaemia
Date of designation: 04/08/2010, Withdrawn, Last updated: 07/05/2018been authorised in the EU as Bosulif since 27 March 2013. Please … designation. Update: Bosutinib (Bosulif) has been authorised in the … the orphan designation of Bosulif at the time of the granting … -
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News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 19-22 February 2018
CHMP, Last updated: 23/02/2018Bosulif … -
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News: European Medicines Agency recommends approval of 44 medicines for human use and six medicines for veterinary use in first half 2013
Last updated: 31/07/2013include two anticancer agents (Bosulif and Iclusig), a smallpox … -
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News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 14-17 January 2013
CHMP, Last updated: 18/01/2013Bosulif International non-proprietary … application/pdf Summary of opinion for Bosulif … -
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Human medicine European public assessment report (EPAR): Imatinib Actavis
imatinib, Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Myelodysplastic-Myeloproliferative Diseases; Hypereosinophilic Syndrome; Dermatofibrosarcoma
Date of authorisation: 17/04/2013,
, Revision: 13, Withdrawn, Last updated: 05/07/2022
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Human medicine European public assessment report (EPAR): Tasigna
nilotinib, Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Date of authorisation: 19/11/2007, Revision: 42, Authorised, Last updated: 26/10/2022 -
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Human medicine European public assessment report (EPAR): Scemblix
asciminib hydrochloride, Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Date of authorisation: 25/08/2022,
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, Revision: 1, Authorised, Last updated: 15/12/2022
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News: EMA recommends 81 medicines for marketing authorisation in 2013
Last updated: 20/01/2014include anticancer agents (Bosulif, Erivedge and Cometriq … -
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Pharmacovigilance Risk Assessment Committee (PRAC): 29 November-2 December 2021
European Medicines Agency, Amsterdam, the Netherlands, from 29/11/2021 to 02/12/2021, Last updated: 04/10/2022 -
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PRAC: Agendas, minutes and highlights (updated)
Last updated: 18/01/2023 -
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COMP: Agendas, minutes and meeting reports (updated)
Last updated: 01/02/2023 -
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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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CHMP: Agendas, minutes and highlights (updated)
Last updated: 27/01/2023 -
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Pharmacovigilance Risk Assessment Committee (PRAC): 26-29 September 2022
European Medicines Agency, Amsterdam, the Netherlands, from 26/09/2022 to 29/09/2022, Last updated: 04/07/2022 -
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Committee for Medicinal Products for Human Use (CHMP): 24-27 January 2022
European Medicines Agency, Amsterdam, the Netherlands, from 24/01/2022 to 27/01/2022, Last updated: 16/03/2022 -
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Pharmacovigilance Risk Assessment Committee (PRAC): 28 September-1 October 2020
Virtual meeting, from 28/09/2020 to 01/10/2020, Last updated: 29/09/2020 -
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PRAC recommendations on safety signals (updated)
Last updated: 05/01/2023 -
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News: Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 30 August – 2 September 2021
PRAC, Last updated: 17/09/2021 -
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Pharmacovigilance Risk Assessment Committee (PRAC): 7-10 September 2015
European Medicines Agency, London, UK, from 07/09/2015 to 10/09/2015, Last updated: 13/03/2014 -
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Download medicine data
Last updated: 02/12/2021 -
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Committee for Orphan Medicinal Products (COMP): 30-31 October 2017
European Medicines Agency, London, UK, from 30/10/2017 to 31/10/2017, Last updated: 19/06/2014 -
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Committee for Orphan Medicinal Products (COMP): 13-15 March 2018
European Medicines Agency, London, UK, from 13/03/2018 to 15/03/2018, Last updated: 19/06/2014 -
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Committee for Orphan Medicinal Products (COMP): 5-6 February 2013
European Medicines Agency, London, UK, from 05/02/2013 to 06/02/2013, Last updated: 08/05/2012