110 results
Keyword Acalabrutinib Remove keyword
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Opinion/decision on a Paediatric investigation plan (PIP): Calquence, Acalabrutinib
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Oncology
PIP number: EMEA-001796-PIP03-16-M02, Route(s) of administration: Oral use, Pharmaceutical form(s): Capsule, hard, Age-appropriate oral liquid dosage form, Age-appropriate oral solid dosage form, Film-coated tablet
Decision date: 08/10/2021, Last updated: 13/02/2023, Compliance check: XCalquence Active substance Acalabrutinib Therapeutic area Oncology … paediatric investigation plan for acalabrutinib (Calquence), (EMEA-001796-PIP03-16-M02 … paediatric investigation plan for acalabrutinib (Calquence), (EMEA-001796-PIP03-16-M02 … -
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Human medicine European public assessment report (EPAR): Calquence (updated)
Acalabrutinib, Leukemia, Lymphocytic, Chronic, B-Cell
Date of authorisation: 05/11/2020,
, Revision: 4, Authorised, Last updated: 06/03/2023
acalabrutinib … capsule contains 100 mg of acalabrutinib. For the full list of excipients … recommended dose is 100 mg acalabrutinib twice daily (equivalent to … -
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Orphan designation: Acalabrutinib for: Treatment of chronic lymphocytic leukaemia / small lymphocytic lymphoma
Date of designation: 21/03/2016, Withdrawn, Last updated: 11/11/2020Acalabrutinib Overview On 21 March 2016 … BV, the Netherlands, for acalabrutinib for the treatment of chronic … information to show that acalabrutinib might be of significant benefit … -
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Orphan designation: Acalabrutinib for: Treatment of lymphoplasmacytic lymphoma
Date of designation: 21/03/2016, Positive, Last updated: 04/05/2016Acalabrutinib Overview On 21 March 2016 … BV, the Netherlands, for acalabrutinib for the treatment of lymphoplasmacytic … information to show that acalabrutinib might be of significant benefit … -
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Orphan designation: Acalabrutinib for: Treatment of mantle cell lymphoma
Date of designation: 21/03/2016, Positive, Last updated: 04/05/2016Acalabrutinib Overview On 21 March 2016 … BV, the Netherlands, for acalabrutinib for the treatment of mantle … information to show that acalabrutinib might be of significant benefit … -
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National expert: Jeanette Doorduijn, European Medicines Agency (updated)
- Declaration of interests - 80.47 KB | PDF
- Curriculum Vitae - 21.54 KB | PDF
response with single-agent acalabrutinib in patients with relapsed … 19. Kluin-Nelemans, Doorduijn Acalabrutinib in relapsed or refractory … -
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National expert: Julio Delgado Gonzalez, The Spanish Agency Of Medicines And Medical Devices (updated)
- Declaration of interests - 82.01 KB | PDF
- Curriculum Vitae - 18.91 KB | PDF
06/2019-05/2020 AstraZeneca Acalabrutinib Chronic lymphocytic leukemia 2.7 … -
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National expert: Carolina Prieto Fernandez, The Spanish Agency Of Medicines And Medical Devices (updated)
- Declaration of interests - 79.82 KB | PDF
- Curriculum Vitae - 18.64 KB | PDF
Pignatti F. EMA Review of acalabrutinib for the treatment of adult … -
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National expert: Monika Brüggemann, European Medicines Agency (updated)
- Declaration of interests - 81.54 KB | PDF
- Curriculum Vitae - 40.77 KB | PDF
Hallek M. Obinutuzumab, acalabrutinib, and venetoclax, after an … -
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News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 20-23 July 2020
CHMP, Last updated: 24/07/2020acalabrutinib) for the treatment of chronic … -
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Human medicine European public assessment report (EPAR): Brukinsa (updated)
zanubrutinib, Waldenstrom Macroglobulinemia
Date of authorisation: 22/11/2021,, Revision: 5, Authorised, Last updated: 24/03/2023
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Human medicine European public assessment report (EPAR): Tecartus
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): Copiktra
duvelisib, Leukemia, Lymphocytic, Chronic, B-Cell; Lymphoma, Follicular
Date of authorisation: 19/05/2021,, Revision: 2, Authorised, Last updated: 13/07/2022
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COVID-19 treatments: research and development
Last updated: 06/10/2022Immunomodulator Non-clinical phase Acalabrutinib Acerta Pharma BV / AstraZeneca …
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Human medicine European public assessment report (EPAR): Breyanzi
CD19-directed genetically modified autologous cell-based product consisting of purified CD8+ T-cells (CD8+ cells), CD19-directed genetically modified autologous cell-based product consisting of purified CD4+ T cells (CD4+ cells), Lymphoma, Large B-Cell, Diffuse; Lymphoma, Follicular; Mediastinal Neoplasms
Date of authorisation: 04/04/2022,, Authorised, Last updated: 20/05/2022
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Human medicine European public assessment report (EPAR): Imbruvica
Ibrutinib, Lymphoma, Mantle-Cell; Leukemia, Lymphocytic, Chronic, B-Cell
Date of authorisation: 21/10/2014, Revision: 28, Authorised, Last updated: 18/11/2022 -
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National expert: Lucia Lopez-Anglada Fernandez, The Spanish Agency Of Medicines And Medical Devices (updated)
- Declaration of interests - 79.99 KB | PDF
- Curriculum Vitae - 28.16 KB | PDF
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National expert: Christian Gisselbrecht, National Agency For The Safety Of Medicine And Health Products (updated)
- Declaration of interests - 80.94 KB | PDF
- Curriculum Vitae - 39.72 KB | PDF
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Orphan designation: zanubrutinib for: Treatment of marginal zone lymphoma
Date of designation: 20/05/2021, Withdrawn, Last updated: 05/01/2023 -
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Orphan designation: Adeno-associated virus serotype 9 expressing the cDNA for human MECP2 for: Treatment of Rett syndrome
Date of designation: 20/05/2021, Withdrawn, Last updated: 30/03/2022 -
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Orphan designation: begelomab for: Treatment of dermatomyositis
Date of designation: 20/05/2021, Positive, Last updated: 16/03/2022 -
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Orphan designation: Macitentan for: Treatment of functional single ventricle congenital heart disease
Date of designation: 20/05/2021, Positive, Last updated: 16/03/2022 -
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Orphan designation: Eflornithine for: Treatment of neuroblastoma
Date of designation: 20/05/2021, Positive, Last updated: 17/03/2022 -
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Orphan designation: Elamipretide for: Treatment of Barth syndrome
Date of designation: 20/05/2021, Positive, Last updated: 17/03/2022 -
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Orphan designation: Human IgG1 monoclonal antibody against alpha-synuclein for: Treatment of multiple system atrophy
Date of designation: 20/05/2021, Positive, Last updated: 17/03/2022