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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): Sildenafil Actavis (updated)
sildenafil, Erectile Dysfunction
Date of authorisation: 10/12/2009,
, Revision: 17, Authorised, Last updated: 13/11/2023
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Human medicine European public assessment report (EPAR): Silodosin Recordati (updated)
silodosin, Prostatic Hyperplasia
Date of authorisation: 07/01/2019,, Revision: 2, Authorised, Last updated: 09/11/2023
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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): Talmanco (previously Tadalafil Generics) (updated)
tadalafil, Hypertension, Pulmonary
Date of authorisation: 09/01/2017,, Revision: 8, 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): Degarelix Accord (updated)
degarelix acetate, Prostatic Neoplasms
Date of authorisation: 29/09/2023,, Authorised, Last updated: 08/11/2023
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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): Pemetrexed Accord
pemetrexed disodium hemipentahydrate, Carcinoma, Non-Small-Cell Lung; Mesothelioma
Date of authorisation: 18/01/2016,, Revision: 10, Authorised, Last updated: 27/10/2023
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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): Actelsar HCT
Telmisartan, hydrochlorothiazide, Essential Hypertension
Date of authorisation: 13/03/2013,, Revision: 17, Authorised, Last updated: 24/10/2023
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Human medicine European public assessment report (EPAR): Telmisartan Actavis
Telmisartan, Hypertension
Date of authorisation: 29/09/2010,, Revision: 13, Authorised, Last updated: 24/10/2023
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Human medicine European public assessment report (EPAR): Thiotepa Riemser
thiotepa, Hematopoietic Stem Cell Transplantation; Neoplasms
Date of authorisation: 26/03/2021,, Revision: 4, Authorised, Last updated: 23/10/2023
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Human medicine European public assessment report (EPAR): Imatinib Koanaa
imatinib mesilate, Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Myelodysplastic-Myeloproliferative Diseases; Hypereosinophilic Syndrome; Dermatofibrosarcoma; Gastrointestinal Stromal Tumors
Date of authorisation: 22/09/2021,, Withdrawn, Last updated: 19/10/2023
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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): Lacosamide Adroiq
lacosamide, Epilepsy
Date of authorisation: 31/05/2023,, Revision: 2, Authorised, Last updated: 13/10/2023
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Human medicine European public assessment report (EPAR): Pregabalin Sandoz GmbH
pregabalin, Anxiety Disorders; Epilepsy
Date of authorisation: 19/06/2015,, Revision: 16, Withdrawn, Last updated: 12/10/2023
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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): Rivaroxaban Accord
rivaroxaban, Acute Coronary Syndrome; Coronary Artery Disease; Peripheral Arterial Disease; Venous Thromboembolism; Stroke; Atrial Fibrillation; Pulmonary Embolism
Date of authorisation: 16/11/2020,, Revision: 5, 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