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292 results
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Human medicine European public assessment report (EPAR): Ziextenzo (updated)
pegfilgrastim, Neutropenia
Date of authorisation: 22/11/2018,
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, Revision: 5, Authorised, Last updated: 26/07/2022
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Human medicine European public assessment report (EPAR): Revestive (updated)
teduglutide, Malabsorption Syndromes
Date of authorisation: 30/08/2012,, 
, Revision: 20, Authorised, Last updated: 26/07/2022
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Human medicine European public assessment report (EPAR): Aybintio (updated)
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: 5, Authorised, Last updated: 21/07/2022
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Human medicine European public assessment report (EPAR): Onbevzi (updated)
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: 11/01/2021,, , Revision: 2, Authorised, Last updated: 21/07/2022
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Human medicine European public assessment report (EPAR): Mylotarg (updated)
gemtuzumab ozogamicin, Leukemia, Myeloid, Acute
Date of authorisation: 19/04/2018,, , Revision: 10, Authorised, Last updated: 21/07/2022
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Human medicine European public assessment report (EPAR): Zolgensma (updated)
onasemnogene abeparvovec, Muscular Atrophy, Spinal
Date of authorisation: 18/05/2020,, , 
, Revision: 6, Authorised, Last updated: 21/07/2022
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Human medicine European public assessment report (EPAR): Kinpeygo (updated)
budesonide, Glomerulonephritis, IGA
Date of authorisation: 15/07/2022,, , , Authorised, Last updated: 18/07/2022
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Human medicine European public assessment report (EPAR): Filgrastim Hexal
filgrastim, Neutropenia; Hematopoietic Stem Cell Transplantation; Cancer
Date of authorisation: 06/02/2009,, Revision: 18, Authorised, Last updated: 15/07/2022
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Human medicine European public assessment report (EPAR): Zarzio
filgrastim, Neutropenia; Hematopoietic Stem Cell Transplantation; Cancer
Date of authorisation: 06/02/2009,, Revision: 19, Authorised, Last updated: 15/07/2022
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Human medicine European public assessment report (EPAR): Lutathera
lutetium (177Lu) oxodotreotide, Neuroendocrine Tumors
Date of authorisation: 26/09/2017,, Revision: 7, Authorised, Last updated: 14/07/2022
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Human medicine European public assessment report (EPAR): Mvasi
bevacizumab, Carcinoma, Renal Cell; Peritoneal Neoplasms; Ovarian Neoplasms; Breast Neoplasms; Carcinoma, Non-Small-Cell Lung; Fallopian Tube Neoplasms
Date of authorisation: 15/01/2018,, , Revision: 12, Authorised, Last updated: 14/07/2022
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Human medicine European public assessment report (EPAR): Evoltra
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): Blitzima
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): Yescarta
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): Darzalex
Daratumumab, Multiple Myeloma
Date of authorisation: 20/05/2016,
, , Revision: 19, Authorised, Last updated: 11/07/2022
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Human medicine European public assessment report (EPAR): Dovprela (previously Pretomanid FGK)
Pretomanid, Tuberculosis, Multidrug-Resistant
Date of authorisation: 31/07/2020,, , , Revision: 6, Authorised, Last updated: 08/07/2022
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Human medicine European public assessment report (EPAR): Zynteglo
Autologous CD34+ cell enriched population that contains haematopoietic stem cells transduced with lentiviral vector encoding the βA-T87Q-globin gene, beta-Thalassemia
Date of authorisation: 29/05/2019,
, , , , , Revision: 5, Withdrawn, Last updated: 08/07/2022
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Human medicine European public assessment report (EPAR): Harvoni
ledipasvir, Sofosbuvir, Hepatitis C, Chronic
Date of authorisation: 17/11/2014,, Revision: 25, Authorised, Last updated: 06/07/2022
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Human medicine European public assessment report (EPAR): Sovaldi
Sofosbuvir, Hepatitis C, Chronic
Date of authorisation: 16/01/2014,, Revision: 25, Authorised, Last updated: 06/07/2022
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Human medicine European public assessment report (EPAR): Epclusa
Sofosbuvir, velpatasvir, Hepatitis C, Chronic
Date of authorisation: 06/07/2016,, Revision: 18, Authorised, Last updated: 06/07/2022
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Human medicine European public assessment report (EPAR): Alymsys
bevacizumab, Colorectal Neoplasms; Breast Neoplasms; Ovarian Neoplasms; Peritoneal Neoplasms; Carcinoma, Non-Small-Cell Lung; Carcinoma, Renal Cell; Uterine Cervical Neoplasms
Date of authorisation: 26/03/2021,, , Revision: 3, Authorised, Last updated: 06/07/2022
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Human medicine European public assessment report (EPAR): Oyavas
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: 26/03/2021,, , Revision: 3, Authorised, Last updated: 05/07/2022
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Human medicine European public assessment report (EPAR): Filsuvez
dry extract from birch bark (DER 5-10 : 1), extraction solvent n-heptane 95% (w/w), Epidermolysis Bullosa Dystrophica; Epidermolysis Bullosa, Junctional
Date of authorisation: 21/06/2022,, Authorised, Last updated: 04/07/2022
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Human medicine European public assessment report (EPAR): Rydapt
Midostaurin, Leukemia, Myeloid, Acute; Mastocytosis
Date of authorisation: 18/09/2017,, Revision: 8, Authorised, Last updated: 01/07/2022
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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: 13, Authorised, Last updated: 01/07/2022