38 results
Keyword Besponsa Remove keyword
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Orphan designation: inotuzumab ozogamicin for: Treatment of B-cell acute lymphoblastic leukaemia
Date of designation: 07/06/2013, Positive, Last updated: 25/06/2013been authorised in the EU as Besponsa since 29 June 2017. The sponsorship … Besponsa Besponsa inotuzumab ozogamicin inotuzumab … designation EU/3/13/1127 for Besponsa (inotuzumab ozogamicin … -
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Opinion/decision on a Paediatric investigation plan (PIP): Besponsa, inotuzumab ozogamicin
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Haematology-Hemostaseology
PIP number: EMEA-001429-PIP01-13-M03, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Powder for concentrate for solution for infusion
Decision date: 10/02/2020, Last updated: 12/06/2020, Compliance check: XInvented name Besponsa Active substance inotuzumab … Besponsa Besponsa inotuzumab ozogamicin inotuzumab … -
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Human medicine European public assessment report (EPAR): Besponsa
inotuzumab ozogamicin, Precursor Cell Lymphoblastic Leukemia-Lymphoma
Date of authorisation: 28/06/2017,
, Revision: 9, Authorised, Last updated: 16/03/2022
Besponsa Leukemia, Lymphoid Leukemia Lymphoproliferative … Besponsa … summary for the public Besponsa inotuzumab ozogamicin This … -
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News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 18-21 April 2017
CHMP, Last updated: 21/04/2017Besponsa … -
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Human medicine European public assessment report (EPAR): Tecartus (updated)
Autologous peripheral blood T cells CD4 and CD8 selected and CD3 and CD28 activated transduced with retroviral vector expressing anti-CD19 CD28/CD3-zeta chimeric antigen receptor and cultured (brexucabtagene autoleucel), Lymphoma, Mantle-Cell
Date of authorisation: 14/12/2020,
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, Revision: 4, Authorised, Last updated: 30/01/2023
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Human medicine European public assessment report (EPAR): Dasatinib Accord (updated)
dasatinib, Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Date of authorisation: 24/03/2022,
, Revision: 1, Authorised, Last updated: 20/01/2023
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Human medicine European public assessment report (EPAR): Dasatinib Accordpharma
dasatinib, Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Date of authorisation: 24/03/2022,, Revision: 1, Authorised, Last updated: 24/10/2022
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Human medicine European public assessment report (EPAR): Blincyto
blinatumomab, Precursor Cell Lymphoblastic Leukemia-Lymphoma
Date of authorisation: 23/11/2015,, , Revision: 15, Authorised, Last updated: 22/09/2022
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Human medicine European public assessment report (EPAR): Carmustine Obvius
carmustine, Hodgkin Disease; Lymphoma, Non-Hodgkin
Date of authorisation: 18/07/2018,, Revision: 7, Authorised, Last updated: 20/09/2022
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Human medicine European public assessment report (EPAR): Imatinib Koanaa
imatinib mesilate, Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Myelodysplastic-Myeloproliferative Diseases; Hypereosinophilic Syndrome; Dermatofibrosarcoma; Gastrointestinal Stromal Tumors
Date of authorisation: 22/09/2021,, Authorised, Last updated: 01/10/2021
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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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COMP: Agendas, minutes and meeting reports (updated)
Last updated: 12/01/2023 -
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Pharmacovigilance Risk Assessment Committee (PRAC): 4-7 July 2022
European Medicines Agency, Amsterdam, the Netherlands, from 04/07/2022 to 07/07/2022, Last updated: 04/07/2022 -
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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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PRAC: Agendas, minutes and highlights (updated)
Last updated: 18/01/2023 -
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Committee for Orphan Medicinal Products (COMP): 10-12May 2017
European Medicines Agency, London, UK, from 10/05/2017 to 12/05/2017, Last updated: 19/06/2014time of CHMP opinion • Besponsa (inotuzumab ozogamicin) for … -
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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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Download medicine data
Last updated: 02/12/2021 -
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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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Committee for Medicinal Products for Human Use (CHMP): 17-20 May 2021
European Medicines Agency, Amsterdam, the Netherlands, from 17/05/2021 to 20/05/2021, Last updated: 07/12/2021 -
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Committee for Medicinal Products for Human Use (CHMP): 22-25 March 2021
European Medicines Agency, Amsterdam, the Netherlands, from 22/03/2021 to 25/03/2021, Last updated: 07/12/2021 -
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CHMP: Agendas, minutes and highlights (updated)
Last updated: 27/01/2023 -
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News: EMA 2017 annual report published
Last updated: 02/05/2018 -
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News: Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 4-7 July 2022
PRAC, Last updated: 08/07/2022 -
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Pharmacovigilance Risk Assessment Committee (PRAC): 9-12 July 2018
European Medicines Agency, London, UK, from 09/07/2018 to 12/07/2018, Last updated: 13/03/2014