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315 results
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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): Lytgobi
Futibatinib, Cholangiocarcinoma
Date of authorisation: 04/07/2023,,
, Revision: 1, Authorised, Last updated: 19/10/2023
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Human medicine European public assessment report (EPAR): Zolgensma
onasemnogene abeparvovec, Muscular Atrophy, Spinal
Date of authorisation: 18/05/2020,,
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, Revision: 13, Authorised, Last updated: 18/10/2023
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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): 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
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Human medicine European public assessment report (EPAR): Bortezomib Hospira
bortezomib, Multiple Myeloma
Date of authorisation: 22/07/2016,, Revision: 13, Authorised, Last updated: 09/10/2023
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Human medicine European public assessment report (EPAR): Kalydeco
ivacaftor, Cystic Fibrosis
Date of authorisation: 23/07/2012,, Revision: 37, Authorised, Last updated: 06/10/2023
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Human medicine European public assessment report (EPAR): Azacitidine Mylan
azacitidine, Myelodysplastic Syndromes; Leukemia, Myelomonocytic, Chronic; Leukemia, Myeloid, Acute
Date of authorisation: 27/03/2020,, Revision: 7, Authorised, Last updated: 05/10/2023
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Human medicine European public assessment report (EPAR): Tepkinly
epcoritamab, Lymphoma, Large B-Cell, Diffuse
Date of authorisation: 22/09/2023,,
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, Authorised, Last updated: 05/10/2023
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Human medicine European public assessment report (EPAR): Docetaxel Kabi
docetaxel, Head and Neck Neoplasms; Carcinoma, Non-Small-Cell Lung; Adenocarcinoma; Prostatic Neoplasms; Breast Neoplasms
Date of authorisation: 22/05/2012,, Revision: 15, Authorised, Last updated: 29/09/2023
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Human medicine European public assessment report (EPAR): Imatinib Teva
imatinib, Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Myelodysplastic-Myeloproliferative Diseases; Hypereosinophilic Syndrome; Dermatofibrosarcoma
Date of authorisation: 07/01/2013,, Revision: 19, Authorised, Last updated: 28/09/2023
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Human medicine European public assessment report (EPAR): Clopidogrel / Acetylsalicylic acid Mylan
Acetylsalicylic acid, clopidogrel hydrogen sulfate, Acute Coronary Syndrome; Myocardial Infarction
Date of authorisation: 09/01/2020,, Revision: 5, Authorised, Last updated: 27/09/2023
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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): Myfenax
mycophenolate mofetil, Graft Rejection
Date of authorisation: 21/02/2008,, Revision: 27, Authorised, Last updated: 26/09/2023
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Human medicine European public assessment report (EPAR): Abiraterone Accord
abiraterone acetate, Prostatic Neoplasms
Date of authorisation: 26/04/2021,, Revision: 1, Authorised, Last updated: 25/09/2023
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Human medicine European public assessment report (EPAR): Olanzapine Teva
olanzapine, Schizophrenia; Bipolar Disorder
Date of authorisation: 12/12/2007,, Revision: 30, Authorised, Last updated: 25/09/2023
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Human medicine European public assessment report (EPAR): Lenalidomide Accord
lenalidomide, Multiple Myeloma
Date of authorisation: 20/09/2018,, Revision: 11, Authorised, Last updated: 22/09/2023
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Human medicine European public assessment report (EPAR): Evrysdi
Risdiplam, Muscular Atrophy, Spinal
Date of authorisation: 26/03/2021,, Revision: 5, Authorised, Last updated: 22/09/2023
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Human medicine European public assessment report (EPAR): Rybrevant
amivantamab, Carcinoma, Non-Small-Cell Lung
Date of authorisation: 09/12/2021,,
, Revision: 3, Authorised, Last updated: 22/09/2023