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Human medicine European public assessment report (EPAR): Nyvepria
pegfilgrastim, Neutropenia
Date of authorisation: 18/11/2020,
, 
, Authorised, Last updated: 23/11/2020
vepria is a medicine used in cancer patients to help with neutropenia … is a common side effect of cancer chemotherapy and can leave … in patients with the blood cancer chronic myeloid leukaemia … -
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Human medicine European public assessment report (EPAR): Azacitidine betapharm
azacitidine, Myelodysplastic Syndromes, Leukemia, Myelomonocytic, Chronic, Leukemia, Myeloid, Acute
Date of authorisation: 24/03/2020,
, Revision: 1, Authorised, Last updated: 20/11/2020
myeloid leukaemia (AML, a cancer affecting white blood cells … myelomonocytic leukaemia (a cancer affecting white blood cells … experienced in the use of cancer medicines. Before receiving … -
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Human medicine European public assessment report (EPAR): Calquence
Acalabrutinib, Leukemia, Lymphocytic, Chronic, B-Cell
Date of authorisation: 05/11/2020,, Authorised, Last updated: 11/11/2020
Calquence is a cancer medicine used to treat adults … leukaemia (CLL), a blood cancer affecting B cells (a type … or combined with another cancer medicine, obinutuzumab. Calquence … -
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Human medicine European public assessment report (EPAR): Cabazitaxel Accord
cabazitaxel, Prostatic Neoplasms, Castration-Resistant
Date of authorisation: 28/08/2020,, , Authorised, Last updated: 28/10/2020
Cabazitaxel Accord is a cancer medicine used to treat men … castration-resistant prostate cancer. This is a cancer that affects the prostate … Cabazitaxel Accord is used when the cancer has spread to other parts … -
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Human medicine European public assessment report (EPAR): Equidacent
bevacizumab, Colorectal Neoplasms, Breast Neoplasms, Ovarian Neoplasms, Carcinoma, Non-Small-Cell Lung, Carcinoma, Renal Cell
Date of authorisation: 24/09/2020,, , Revision: 1, Authorised, Last updated: 16/11/2020
Equidacent is a cancer medicine that is used to … adults with the following cancers: cancer of the colon (large bowel … parts of the body; breast cancer that has spread to other … -
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Human medicine European public assessment report (EPAR): Arsenic trioxide medac
Arsenic trioxide, Leukemia, Promyelocytic, Acute
Date of authorisation: 17/09/2020,, Authorised, Last updated: 01/10/2020
a rare form of leukaemia (cancer of the white blood cells … treatment with a retinoid and cancer medicines, or when their … -
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Human medicine European public assessment report (EPAR): Ayvakyt
avapritinib, Gastrointestinal Stromal Tumors
Date of authorisation: 24/09/2020,, 
, Revision: 1, Authorised, Last updated: 06/11/2020
Ayvakyt is a cancer medicine used to treat gastrointestinal … stromal tumour (GIST), a cancer of the stomach and bowel … Ayvakyt is used when the cancer cells have a D842V mutation … -
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Human medicine European public assessment report (EPAR): Blenrep (updated)
belantamab mafodotin, Multiple Myeloma
Date of authorisation: 25/08/2020,, , 
, Revision: 1, Authorised, Last updated: 29/01/2021
Blenrep is a cancer medicine used to treat multiple … treat multiple myeloma (a cancer of the bone marrow). It is … monoclonal antibody (types of cancer medicines), and whose … -
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Human medicine European public assessment report (EPAR): Rozlytrek
Entrectinib, Cancer, Carcinoma, Non-Small-Cell Lung
Date of authorisation: 31/07/2020,, Authorised, Last updated: 27/10/2020
Rozlytrek Cancer Carcinoma, Non-Small-Cell … Rozlytrek is a cancer medicine. It can be used … of age with solid tumours (cancer growths) that have a genetic … -
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Human medicine European public assessment report (EPAR): Aybintio
bevacizumab, Colorectal Neoplasms, Breast Neoplasms, Ovarian Neoplasms, Fallopian Tube Neoplasms, Peritoneal Neoplasms, Carcinoma, Non-Small-Cell Lung, Carcinoma, Renal Cell, Uterine Cervical Neoplasms
Date of authorisation: 19/08/2020,, , Revision: 1, Authorised, Last updated: 09/12/2020
Aybintio is a cancer medicine that is used to … adults with the following cancers: cancer of the colon (large bowel … parts of the body; breast cancer that has spread to other … -
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Human medicine European public assessment report (EPAR): Methylthioninium chloride Cosmo
methylthioninium chloride, Colorectal Neoplasms, Colonoscopy
Date of authorisation: 19/08/2020, Authorised, Last updated: 26/08/2020linked to increased risk of cancer) or carcinoma (a type of cancer) during colonoscopy. At least … in the risk of colorectal cancer if removed. The safety profile … -
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Human medicine European public assessment report (EPAR): Kaftrio
ivacaftor, tezacaftor, elexacaftor, Cystic Fibrosis
Date of authorisation: 21/08/2020,, , Revision: 1, Authorised, Last updated: 09/12/2020
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Human medicine European public assessment report (EPAR): Dovprela (previously Pretomanid FGK) (updated)
Pretomanid, Tuberculosis, Multidrug-Resistant
Date of authorisation: 31/07/2020,, , , Revision: 1, Authorised, Last updated: 09/02/2021
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Human medicine European public assessment report (EPAR): Piqray (updated)
Alpelisib, Breast Neoplasms
Date of authorisation: 27/07/2020,, Revision: 2, Authorised, Last updated: 16/02/2021
alpelisib Overview Piqray is a cancer medicine used to treat postmenopausal … women and men with breast cancer that is locally advanced … can only be used when the cancer cells have receptors for … -
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Human medicine European public assessment report (EPAR): Zercepac (updated)
trastuzumab, Breast Neoplasms, Stomach Neoplasms
Date of authorisation: 27/07/2020,, , Revision: 2, Authorised, Last updated: 09/02/2021
Zercepac is a cancer medicine used to treat the … conditions: early breast cancer (when the cancer has spread within the breast … chemotherapy (medicines to treat cancer), and radiotherapy (treatment … -
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Human medicine European public assessment report (EPAR): Daurismo
Glasdegib maleate, Leukemia, Myeloid, Acute
Date of authorisation: 26/06/2020,, , Revision: 1, Authorised, Last updated: 08/01/2021
glasdegib Overview Daurismo is a cancer medicine for treating adults … myeloid leukaemia (AML), a cancer of white blood cells. It … dose of cytarabine (another cancer medicine) when the patient … -
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Human medicine European public assessment report (EPAR): Reblozyl
Luspatercept, Anemia, Myelodysplastic Syndromes, beta-Thalassemia
Date of authorisation: 25/06/2020,, , Authorised, Last updated: 08/07/2020
myeloid leukaemia (a blood cancer) or of dying, and in whom … -
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Human medicine European public assessment report (EPAR): Sarclisa
Isatuximab, Multiple Myeloma
Date of authorisation: 30/05/2020,, Authorised, Last updated: 12/06/2020
Sarclisa is a cancer medicine used together with … treat multiple myeloma (a cancer of the bone marrow). It is … previous treatments for their cancer, including lenalidomide and … -
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Human medicine European public assessment report (EPAR): Nepexto (updated)
etanercept, Arthritis, Rheumatoid, Arthritis, Juvenile Rheumatoid, Arthritis, Psoriatic, Spondylarthropathies, Spondylitis, Ankylosing, Psoriasis
Date of authorisation: 20/05/2020,, , Revision: 3, Authorised, Last updated: 22/02/2021
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Human medicine European public assessment report (EPAR): Zeposia
ozanimod hydrochloride, Multiple Sclerosis, Relapsing-Remitting
Date of authorisation: 20/05/2020,, Authorised, Last updated: 26/10/2020
severe active infections, cancer or weakened immune system … -
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Human medicine European public assessment report (EPAR): Arsenic trioxide Mylan
Arsenic trioxide, Leukemia, Promyelocytic, Acute
Date of authorisation: 01/04/2020,, Authorised, Last updated: 17/04/2020
a rare form of leukaemia (cancer of the white blood cells … treatment with a retinoid and cancer medicines, or when their … -
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Human medicine European public assessment report (EPAR): Cinacalcet Accordpharma
cinacalcet hydrochloride, Hyperparathyroidism
Date of authorisation: 03/04/2020,, Revision: 1, Authorised, Last updated: 04/09/2020
calcium levels) in adults with cancer of the parathyroid glands … also have parathyroid gland cancer or primary hyperparathyroidism … -
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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: 2, Authorised, Last updated: 17/09/2020
treat the following blood cancers and inflammatory conditions … non-Hodgkin’s lymphoma, a blood cancer); chronic lymphocytic leukaemia … leukaemia (CLL, another blood cancer affecting white blood cells … -
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Human medicine European public assessment report (EPAR): Azacitidine Mylan
azacitidine, Myelodysplastic Syndromes, Leukemia, Myelomonocytic, Chronic, Leukemia, Myeloid, Acute
Date of authorisation: 27/03/2020,, Revision: 1, Authorised, Last updated: 16/09/2020
myeloid leukaemia (AML, a cancer affecting white blood cells … myelomonocytic leukaemia (a cancer affecting white blood cells … experienced in the use of cancer medicines. Before receiving … -
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Human medicine European public assessment report (EPAR): Nubeqa
darolutamide, Prostatic Neoplasms, Castration-Resistant
Date of authorisation: 27/03/2020,, Revision: 2, Authorised, Last updated: 13/11/2020
to treat men with prostate cancer. It is used when the cancer is castration-resistant (worsens … the treatment of prostate cancer. The recommended dose of Nubeqa … from stimulating prostate cancer cells from growing. What …