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Human medicine European public assessment report (EPAR): Yescarta
axicabtagene ciloleucel, Lymphoma, Follicular; Lymphoma, Large B-Cell, Diffuse
Date of authorisation: 23/08/2018,,
, Revision: 10, Authorised, Last updated: 16/12/2022
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Human medicine European public assessment report (EPAR): Anagrelide Mylan
Anagrelide hydrochloride, Thrombocythemia, Essential
Date of authorisation: 15/02/2018,, Revision: 6, Authorised, Last updated: 15/12/2022
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Human medicine European public assessment report (EPAR): Elaprase
idursulfase, Mucopolysaccharidosis II
Date of authorisation: 08/01/2007,,
, Revision: 25, Authorised, Last updated: 15/12/2022
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Human medicine European public assessment report (EPAR): Nyxthracis (previously Obiltoxaximab SFL)
nyxthracis, Anthrax
Date of authorisation: 18/11/2020,,
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, Revision: 3, Authorised, Last updated: 15/12/2022
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Human medicine European public assessment report (EPAR): Scemblix
asciminib hydrochloride, Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Date of authorisation: 25/08/2022,,
, Revision: 1, Authorised, Last updated: 15/12/2022
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Human medicine European public assessment report (EPAR): Nityr
nitisinone, Tyrosinemias
Date of authorisation: 26/07/2018,, Revision: 3, Authorised, Last updated: 15/12/2022
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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: 14, Authorised, Last updated: 14/12/2022
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Human medicine European public assessment report (EPAR): Mylotarg
gemtuzumab ozogamicin, Leukemia, Myeloid, Acute
Date of authorisation: 19/04/2018,,
, Revision: 11, Authorised, Last updated: 14/12/2022
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Human medicine European public assessment report (EPAR): Livmarli
Maralixibat chloride, Alagille Syndrome
Date of authorisation: 09/12/2022,,
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, Authorised, Last updated: 14/12/2022
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Human medicine European public assessment report (EPAR): Qarziba (previously Dinutuximab beta EUSA and Dinutuximab beta Apeiron)
dinutuximab beta, Neuroblastoma
Date of authorisation: 08/05/2017,,
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, Revision: 12, Authorised, Last updated: 14/12/2022
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Human medicine European public assessment report (EPAR): Imatinib Accord
imatinib, Precursor Cell Lymphoblastic Leukemia-Lymphoma; Dermatofibrosarcoma; Myelodysplastic-Myeloproliferative Diseases; Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Hypereosinophilic Syndrome
Date of authorisation: 30/06/2013,, Revision: 20, Authorised, Last updated: 14/12/2022
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Human medicine European public assessment report (EPAR): Repaglinide Krka
repaglinide, Diabetes Mellitus, Type 2
Date of authorisation: 03/11/2009,, Revision: 8, Authorised, Last updated: 14/12/2022
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Human medicine European public assessment report (EPAR): Enyglid
repaglinide, Diabetes Mellitus, Type 2
Date of authorisation: 13/10/2009,, Revision: 9, Authorised, Last updated: 14/12/2022
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Human medicine European public assessment report (EPAR): Namuscla
Mexiletine hydrochloride, Myotonic Disorders
Date of authorisation: 18/12/2018,, Revision: 4, Authorised, Last updated: 13/12/2022
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Human medicine European public assessment report (EPAR): Onivyde pegylated liposomal (previously known as Onivyde)
irinotecan anhydrous free-base, Pancreatic Neoplasms
Date of authorisation: 14/10/2016,, Revision: 11, Authorised, Last updated: 13/12/2022
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Human medicine European public assessment report (EPAR): Takhzyro
lanadelumab, Angioedemas, Hereditary
Date of authorisation: 22/11/2018,,
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, Revision: 10, Authorised, Last updated: 13/12/2022
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Human medicine European public assessment report (EPAR): Xermelo
telotristat etiprate, Carcinoid Tumor; Neuroendocrine Tumors
Date of authorisation: 17/09/2017,, Revision: 15, Authorised, Last updated: 12/12/2022
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Human medicine European public assessment report (EPAR): Dimethyl fumarate Mylan
dimethyl fumarate, Multiple Sclerosis, Relapsing-Remitting
Date of authorisation: 13/05/2022,, Revision: 3, Authorised, Last updated: 12/12/2022
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Human medicine European public assessment report (EPAR): Jorveza
budesonide, Esophageal Diseases
Date of authorisation: 08/01/2018,,
, Revision: 6, Authorised, Last updated: 06/12/2022
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Human medicine European public assessment report (EPAR): Nexavar
sorafenib, Carcinoma, Hepatocellular; Carcinoma, Renal Cell
Date of authorisation: 19/07/2006,, Revision: 32, Authorised, Last updated: 06/12/2022
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Human medicine European public assessment report (EPAR): Ngenla
somatrogon, Growth and Development
Date of authorisation: 14/02/2022,,
, Revision: 4, Authorised, Last updated: 06/12/2022
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Human medicine European public assessment report (EPAR): Striascan
ioflupane (123l), Radionuclide Imaging; Dementia; Movement Disorders
Date of authorisation: 25/06/2019,, Revision: 2, Authorised, Last updated: 05/12/2022
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Human medicine European public assessment report (EPAR): Pyrukynd
mitapivat sulfate, Genetic Diseases, Inborn; Anemia, Hemolytic
Date of authorisation: 09/11/2022,,
, Authorised, Last updated: 05/12/2022
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Human medicine European public assessment report (EPAR): Efavirenz/Emtricitabine/Tenofovir disoproxil Krka
efavirenz, emtricitabine, tenofovir disoproxil succinate, HIV Infections
Date of authorisation: 08/02/2018,, Revision: 9, Authorised, Last updated: 05/12/2022
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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: 3, Authorised, Last updated: 02/12/2022