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Human medicine European public assessment report (EPAR): Inrebic (updated)
fedratinib dihydrochloride monohydrate, Myeloproliferative Disorders; Primary Myelofibrosis
Date of authorisation: 08/02/2021,,
, Revision: 4, Authorised, Last updated: 21/03/2023
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Human medicine European public assessment report (EPAR): Reblozyl (updated)
Luspatercept, Anemia; Myelodysplastic Syndromes; beta-Thalassemia
Date of authorisation: 25/06/2020,,
, Revision: 4, Authorised, Last updated: 20/03/2023
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Human medicine European public assessment report (EPAR): Isturisa (updated)
Osilodrostat phosphate, Cushing Syndrome
Date of authorisation: 09/01/2020,,
, Revision: 4, Authorised, Last updated: 20/03/2023
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Human medicine European public assessment report (EPAR): Docetaxel Accord (updated)
docetaxel, Head and Neck Neoplasms; Carcinoma, Non-Small-Cell Lung; Adenocarcinoma; Prostatic Neoplasms; Breast Neoplasms
Date of authorisation: 22/05/2012,, Revision: 16, Authorised, Last updated: 20/03/2023
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Human medicine European public assessment report (EPAR): Livtencity (updated)
Maribavir, Cytomegalovirus Infections
Date of authorisation: 09/11/2022,,
, Revision: 3, Authorised, Last updated: 17/03/2023
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Human medicine European public assessment report (EPAR): Zolgensma (updated)
onasemnogene abeparvovec, Muscular Atrophy, Spinal
Date of authorisation: 18/05/2020,,
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, Revision: 10, Authorised, Last updated: 17/03/2023
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Human medicine European public assessment report (EPAR): Miglustat Gen.Orph (updated)
miglustat, Gaucher Disease
Date of authorisation: 09/11/2017,, Revision: 9, Authorised, Last updated: 17/03/2023
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Human medicine European public assessment report (EPAR): Abiraterone Mylan (updated)
abiraterone acetate, Prostatic Neoplasms
Date of authorisation: 20/08/2021,, Revision: 2, Authorised, Last updated: 17/03/2023
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Human medicine European public assessment report (EPAR): Elzonris (updated)
tagraxofusp, Lymphoma
Date of authorisation: 07/01/2021,,
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, Revision: 6, Authorised, Last updated: 15/03/2023
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Human medicine European public assessment report (EPAR): Ayvakyt (updated)
avapritinib, Gastrointestinal Stromal Tumors
Date of authorisation: 24/09/2020,,
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, Revision: 6, Authorised, Last updated: 14/03/2023
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Human medicine European public assessment report (EPAR): Cablivi (updated)
Caplacizumab, Purpura, Thrombotic Thrombocytopenic
Date of authorisation: 30/08/2018,,
, Revision: 7, Authorised, Last updated: 14/03/2023
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Human medicine European public assessment report (EPAR): Ivozall (updated)
clofarabine, Precursor Cell Lymphoblastic Leukemia-Lymphoma
Date of authorisation: 14/11/2019,, Revision: 4, Authorised, Last updated: 13/03/2023
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Human medicine European public assessment report (EPAR): Adcetris (updated)
Brentuximab vedotin, Lymphoma, Non-Hodgkin; Hodgkin Disease
Date of authorisation: 25/10/2012,, Revision: 34, Authorised, Last updated: 13/03/2023
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Human medicine European public assessment report (EPAR): Nityr (updated)
nitisinone, Tyrosinemias
Date of authorisation: 26/07/2018,, Revision: 4, Authorised, Last updated: 10/03/2023
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Human medicine European public assessment report (EPAR): Ebvallo (updated)
Tabelecleucel, Lymphoproliferative Disorders
Date of authorisation: 16/12/2022,,
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, Revision: 2, Authorised, Last updated: 10/03/2023
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Human medicine European public assessment report (EPAR): Leflunomide medac (updated)
leflunomide, Arthritis, Rheumatoid
Date of authorisation: 27/07/2010,, Revision: 18, Authorised, Last updated: 09/03/2023
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Human medicine European public assessment report (EPAR): Olanzapine Apotex (updated)
olanzapine, Schizophrenia; Bipolar Disorder
Date of authorisation: 10/06/2010,, Revision: 13, Authorised, Last updated: 09/03/2023
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Human medicine European public assessment report (EPAR): Rivaroxaban Mylan (updated)
rivaroxaban, Venous Thromboembolism; Pulmonary Embolism; Acute Coronary Syndrome; Stroke; Coronary Artery Disease; Peripheral Arterial Disease; Atrial Fibrillation
Date of authorisation: 12/11/2021,, Revision: 1, Authorised, Last updated: 09/03/2023
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Human medicine European public assessment report (EPAR): Prevymis (updated)
Letermovir, Cytomegalovirus Infections
Date of authorisation: 08/01/2018,, Revision: 14, Authorised, Last updated: 08/03/2023
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Human medicine European public assessment report (EPAR): Abiraterone Krka (updated)
abiraterone acetate, Prostatic Neoplasms
Date of authorisation: 24/06/2021,, Revision: 2, Authorised, Last updated: 08/03/2023
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Human medicine European public assessment report (EPAR): Ecansya (previously Capecitabine Krka) (updated)
capecitabine, Colonic Neoplasms; Breast Neoplasms; Colorectal Neoplasms; Stomach Neoplasms
Date of authorisation: 20/04/2012,, Revision: 14, Authorised, Last updated: 07/03/2023
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Human medicine European public assessment report (EPAR): SomaKit TOC (updated)
edotreotide, Neuroendocrine Tumors; Radionuclide Imaging
Date of authorisation: 08/12/2016,, Revision: 14, Authorised, Last updated: 07/03/2023
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Human medicine European public assessment report (EPAR): Hemlibra (updated)
Emicizumab, Hemophilia A
Date of authorisation: 23/02/2018,, Revision: 13, Authorised, Last updated: 06/03/2023
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Human medicine European public assessment report (EPAR): Empliciti (updated)
Elotuzumab, Multiple Myeloma
Date of authorisation: 11/05/2016,, Revision: 11, Authorised, Last updated: 06/03/2023
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Human medicine European public assessment report (EPAR): Efavirenz Teva (updated)
efavirenz, HIV Infections
Date of authorisation: 09/01/2012,, Revision: 12, Authorised, Last updated: 03/03/2023