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250 results
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Human medicine European public assessment report (EPAR): Kauliv (updated)
teriparatide, Osteoporosis; Osteoporosis, Postmenopausal
Date of authorisation: 12/01/2023,
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, Revision: 1, Authorised, Last updated: 20/11/2023
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Human medicine European public assessment report (EPAR): Livmarli (updated)
Maralixibat chloride, Alagille Syndrome
Date of authorisation: 09/12/2022,, 
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, Revision: 3, Authorised, Last updated: 13/11/2023
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Human medicine European public assessment report (EPAR): Zirabev (updated)
bevacizumab, Colorectal Neoplasms; Breast Neoplasms; Carcinoma, Non-Small-Cell Lung; Carcinoma, Renal Cell; Uterine Cervical Neoplasms
Date of authorisation: 14/02/2019,, , Revision: 13, Authorised, Last updated: 09/11/2023
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Human medicine European public assessment report (EPAR): Oyavas (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: 26/03/2021,, , Revision: 6, Authorised, Last updated: 09/11/2023
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Human medicine European public assessment report (EPAR): Zokinvy (updated)
Lonafarnib, Progeria; Laminopathies
Date of authorisation: 18/07/2022,, , , Revision: 2, Authorised, Last updated: 09/11/2023
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Human medicine European public assessment report (EPAR): Idacio (updated)
adalimumab, Arthritis, Rheumatoid; Arthritis, Psoriatic; Psoriasis; Spondylitis, Ankylosing; Uveitis; Hidradenitis Suppurativa; Colitis, Ulcerative; Crohn Disease; Arthritis, Juvenile Rheumatoid
Date of authorisation: 02/04/2019,, Revision: 11, Authorised, Last updated: 07/11/2023
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Human medicine European public assessment report (EPAR): Lojuxta (updated)
Lomitapide, Hypercholesterolemia
Date of authorisation: 31/07/2013,, , Revision: 18, Authorised, Last updated: 06/11/2023
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Human medicine European public assessment report (EPAR): Raxone
idebenone, Optic Atrophy, Hereditary, Leber
Date of authorisation: 08/09/2015,, , , Revision: 9, Authorised, Last updated: 30/10/2023
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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,, , , Revision: 16, Authorised, Last updated: 27/10/2023
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Human medicine European public assessment report (EPAR): Defitelio
defibrotide, Hepatic Veno-Occlusive Disease
Date of authorisation: 18/10/2013,, , Revision: 15, Authorised, Last updated: 25/10/2023
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Human medicine European public assessment report (EPAR): Myalepta
Metreleptin, Lipodystrophy, Familial Partial
Date of authorisation: 29/07/2018,, , , Revision: 9, Authorised, Last updated: 18/10/2023
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Human medicine European public assessment report (EPAR): Ranivisio
ranibizumab, Wet Macular Degeneration; Macular Edema; Diabetic Retinopathy; Diabetes Complications
Date of authorisation: 25/08/2022,, , Revision: 4, Authorised, Last updated: 13/10/2023
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Human medicine European public assessment report (EPAR): Spinraza
nusinersen sodium, Muscular Atrophy, Spinal
Date of authorisation: 30/05/2017,
, , Revision: 14, Authorised, Last updated: 12/10/2023
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Human medicine European public assessment report (EPAR): Cabometyx
cabozantinib (s)-malate, Carcinoma, Renal Cell; Carcinomas, Hepatocellular
Date of authorisation: 09/09/2016,, Revision: 18, Authorised, Last updated: 10/10/2023
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Human medicine European public assessment report (EPAR): Remsima
infliximab, Arthritis, Psoriatic; Spondylitis, Ankylosing; Colitis, Ulcerative; Psoriasis; Crohn Disease; Arthritis, Rheumatoid
Date of authorisation: 10/09/2013,, Revision: 37, Authorised, Last updated: 06/10/2023
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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: 24, Authorised, Last updated: 04/10/2023
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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: 23, Authorised, Last updated: 04/10/2023
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Human medicine European public assessment report (EPAR): Yesafili
aflibercept, Macular Edema; Retinal Vein Occlusion; Diabetic Retinopathy; Myopia, Degenerative; Diabetes Complications
Date of authorisation: 15/09/2023,, , Authorised, Last updated: 03/10/2023
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Human medicine European public assessment report (EPAR): Foclivia
influenza virus surface antigens, inactivated: A/Viet Nam/1194/2004 (H5N1), Influenza, Human; Immunization; Disease Outbreaks
Date of authorisation: 18/10/2009,, Revision: 13, Authorised, Last updated: 03/10/2023
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Human medicine European public assessment report (EPAR): Tyenne
tocilizumab, Arthritis, Rheumatoid; Cytokine Release Syndrome; Arthritis, Juvenile Rheumatoid; COVID-19 virus infection; Giant Cell Arteritis
Date of authorisation: 15/09/2023,, Authorised, Last updated: 02/10/2023
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Human medicine European public assessment report (EPAR): Sovaldi
Sofosbuvir, Hepatitis C, Chronic
Date of authorisation: 16/01/2014,, Revision: 28, Authorised, Last updated: 27/09/2023
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Human medicine European public assessment report (EPAR): Harvoni
ledipasvir, Sofosbuvir, Hepatitis C, Chronic
Date of authorisation: 17/11/2014,, Revision: 28, Authorised, Last updated: 27/09/2023
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Human medicine European public assessment report (EPAR): Epclusa
Sofosbuvir, velpatasvir, Hepatitis C, Chronic
Date of authorisation: 06/07/2016,, Revision: 22, Authorised, Last updated: 27/09/2023
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Human medicine European public assessment report (EPAR): Abrysvo
Respiratory syncytial virus, subgroup A, stabilized prefusion F protein / Respiratory syncytial virus, subgroup B, stabilized prefusion F protein, Respiratory Syncytial Virus Infections
Date of authorisation: 23/08/2023,, , Authorised, Last updated: 26/09/2023
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Human medicine European public assessment report (EPAR): Orphacol
cholic acid, Digestive System Diseases; Metabolism, Inborn Errors
Date of authorisation: 12/09/2013,
Date of refusal: 25/05/2012,, , Revision: 13, Authorised, Last updated: 25/09/2023