133 results
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Human medicine European public assessment report (EPAR): Busilvex
busulfan, Hematopoietic Stem Cell Transplantation
Date of authorisation: 09/07/2003, Revision: 19, Authorised, Last updated: 09/02/2022treatment with another medicine, fludarabine. The medicine can only be … used in combination with fludarabine, the recommended dose of Busilvex … infusion immediately after fludarabine, for 2 or 3 consecutive days … -
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Human medicine European public assessment report (EPAR): Arzerra
ofatumumab, Leukemia, Lymphocytic, Chronic, B-Cell
Date of authorisation: 19/04/2010, Revision: 16, Withdrawn, Last updated: 10/05/2019who are not eligible for fludarabine-based therapy … -
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Human medicine European public assessment report (EPAR): Trecondi
Treosulfan, Hematopoietic Stem Cell Transplantation
Date of authorisation: 20/06/2019,
, Revision: 2, Authorised, Last updated: 07/09/2020
with another medicine called fludarabine in adults and children from … before the transplantation. Fludarabine is given once a day for 5 … patients given Trecondi (with fludarabine) had a successful transplant … -
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Human medicine European public assessment report (EPAR): Busulfan Fresenius Kabi
busulfan, Hematopoietic Stem Cell Transplantation
Date of authorisation: 22/09/2014,
, Revision: 9, Authorised, Last updated: 18/05/2021
treatment with another medicine, fludarabine. Busulfan Fresenius Kabi is … used in combination with fludarabine, the recommended dose of Busulfan … infusion immediately after fludarabine, for 2 or 3 consecutive days … -
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Human medicine European public assessment report (EPAR): Gazyvaro
Obinutuzumab, Leukemia, Lymphocytic, Chronic, B-Cell
Date of authorisation: 22/07/2014,
, , Revision: 13, Authorised, Last updated: 10/05/2022
whom the cancer medicine fludarabine is not recommended; follicular … therefore ineligible for fludarabine-based therapy. In one main study … -
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Human medicine European public assessment report (EPAR): Torisel
Temsirolimus, Carcinoma, Renal Cell; Lymphoma, Mantle-Cell
Date of authorisation: 19/11/2007, Revision: 33, Authorised, Last updated: 21/06/2022medicines (such as gemcitabine or fludarabine) in a main study involving … -
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Human medicine European public assessment report (EPAR): MabCampath
alemtuzumab, Leukemia, Lymphocytic, Chronic, B-Cell
Date of authorisation: 06/07/2001, Revision: 14, Withdrawn, Last updated: 15/08/2012leukaemia (BCLL) for whom fludarabine combination chemotherapy … leukaemia (B-CLL) for whom fludarabine combination chemotherapy … combinations including fludarabine (another medicine used in … -
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Press release: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP), 18-21 January 2010
CHMP, Last updated: 28/01/2010leukaemia who are refractory to fludarabine and alemtuzumab. The review … of Arzerra in the double (fludarabine and alemtuzumab) refractory … the use of Arzerra in the fludarabine-refractory, bulky lymphadenopathy population … -
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Press release: European Medicines Agency recommends approval of Gazyvaro for chronic lymphocytic leukaemia
CHMP, Last updated: 23/05/2014be treated with full dose fludarabine-based therapy. Chronic lymphocytic … be treated with full dose fludarabine-based therapy. Chronic lymphocytic … -
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Referral: Levact
bendamustine, associated names: Ribomustin, Article 29(4) referrals
Status: European Commission final decision, opinion/position date: 18/03/2010, EC decision date: 07/07/2010, Last updated: 08/09/2011patients for whom treatment with fludarabine (another anticancer medicine … patients for whom treatment with fludarabine (another anticancer medicine … -
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Orphan designation: ofatumumab for: Treatment of chronic lymphocytic leukaemia
Date of designation: 07/11/2008, Withdrawn, Last updated: 18/10/2018patients who are refractory to fludarabine and alemtuzumab. Opinions … patients who are refractory to fludarabine and alemtuzumab’. This … such as alemtuzumab and fludarabine were authorised in the EU … -
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Orphan designation: Obinutuzumab for: Treatment of chronic lymphocytic leukaemia
Date of designation: 10/10/2012, Positive, Last updated: 21/02/2018unsuitable for full-dose fludarabine based therapy. More information … unsuitable for full-dose fludarabine based therapy. More information … -
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Human medicine European public assessment report (EPAR): Vyxeos liposomal (previously known as Vyxeos) (updated)
daunorubicin hydrochloride, cytarabine, Leukemia, Myeloid, Acute
Date of authorisation: 23/08/2018,, Revision: 7, Authorised, Last updated: 27/07/2022
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Human medicine European public assessment report (EPAR): Imbruvica (updated)
Ibrutinib, Lymphoma, Mantle-Cell; Leukemia, Lymphocytic, Chronic, B-Cell
Date of authorisation: 21/10/2014, Revision: 25, Authorised, Last updated: 12/07/2022 -
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Human medicine European public assessment report (EPAR): Yescarta (updated)
axicabtagene ciloleucel, Lymphoma, Follicular; Lymphoma, Large B-Cell, Diffuse
Date of authorisation: 23/08/2018,, , Revision: 8, Authorised, Last updated: 12/07/2022
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Human medicine European public assessment report (EPAR): Copiktra (updated)
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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Human medicine European public assessment report (EPAR): Carvykti
ciltacabtagene autoleucel, Multiple Myeloma
Date of authorisation: 25/05/2022,, , 
, Authorised, Last updated: 17/06/2022
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Human medicine European public assessment report (EPAR): Evoltra (updated)
clofarabine, Precursor Cell Lymphoblastic Leukemia-Lymphoma
Date of authorisation: 29/05/2006,, 
, Revision: 31, Authorised, Last updated: 13/07/2022
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Human medicine European public assessment report (EPAR): MabThera
rituximab, Lymphoma, Non-Hodgkin; Arthritis, Rheumatoid; Leukemia, Lymphocytic, Chronic, B-Cell
Date of authorisation: 02/06/1998, Revision: 56, Authorised, Last updated: 28/04/2022 -
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Human medicine European public assessment report (EPAR): Kymriah
tisagenlecleucel, Precursor B-Cell Lymphoblastic Leukemia-Lymphoma; Lymphoma, Large B-Cell, Diffuse
Date of authorisation: 22/08/2018,, , Revision: 11, Authorised, Last updated: 19/05/2022
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Human medicine European public assessment report (EPAR): Skysona
elivaldogene autotemcel, Adrenoleukodystrophy
Date of authorisation: 16/07/2021,, Withdrawn, Last updated: 04/04/2022
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Human medicine European public assessment report (EPAR): Blitzima (updated)
rituximab, Lymphoma, Non-Hodgkin; Leukemia, Lymphocytic, Chronic, B-Cell
Date of authorisation: 13/07/2017,
, Revision: 15, Authorised, Last updated: 13/07/2022
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Human medicine European public assessment report (EPAR): Ruxience
rituximab, Leukemia, Lymphocytic, Chronic, B-Cell; Arthritis, Rheumatoid; Microscopic Polyangiitis; Pemphigus
Date of authorisation: 01/04/2020,, , Revision: 7, Authorised, Last updated: 21/03/2022
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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): Abecma
idecabtagene vicleucel, Multiple Myeloma; Neoplasms; Cancer; Neoplasms, Plasma Cell; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Infectious Mononucleosis; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases
Date of authorisation: 18/08/2021,, , , Revision: 4, Authorised, Last updated: 07/04/2022