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Medicine
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Human medicine European public assessment report (EPAR): Docetaxel Kabi (updated)
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): Rivaroxaban Accord (updated)
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: 28/09/2023
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Human medicine European public assessment report (EPAR): Imatinib Teva (updated)
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 (updated)
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 (updated)
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 (updated)
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 (updated)
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 (updated)
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 (updated)
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 (updated)
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 (updated)
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 (updated)
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 (updated)
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): Levetiracetam Sun (updated)
levetiracetam, Epilepsy
Date of authorisation: 14/12/2011,, Revision: 19, Authorised, Last updated: 22/09/2023
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Human medicine European public assessment report (EPAR): Docetaxel Accord (updated)
docetaxel, Head and Neck Neoplasms; Carcinoma, Non-Small-Cell Lung; Adenocarcinoma; Prostatic Neoplasms; Breast Neoplasms
Date of authorisation: 22/05/2012,, Revision: 17, Authorised, Last updated: 14/09/2023
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Human medicine European public assessment report (EPAR): Deferasirox Accord (updated)
deferasirox, Iron Overload; beta-Thalassemia
Date of authorisation: 09/01/2020,, Revision: 5, Authorised, Last updated: 14/09/2023
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Human medicine European public assessment report (EPAR): Carmustine medac (previously Carmustine Obvius) (updated)
carmustine, Hodgkin Disease; Lymphoma, Non-Hodgkin
Date of authorisation: 18/07/2018,, Revision: 8, Authorised, Last updated: 14/09/2023
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Human medicine European public assessment report (EPAR): Lacosamide Adroiq (updated)
lacosamide, Epilepsy
Date of authorisation: 31/05/2023,, Revision: 1, Authorised, Last updated: 14/09/2023
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Human medicine European public assessment report (EPAR): Abiraterone Mylan (updated)
abiraterone acetate, Prostatic Neoplasms
Date of authorisation: 20/08/2021,, Revision: 4, Authorised, Last updated: 11/09/2023
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Human medicine European public assessment report (EPAR): Aripiprazole Mylan Pharma (previously Aripiprazole Pharmathen) (updated)
aripiprazole, Schizophrenia; Bipolar Disorder
Date of authorisation: 30/06/2015,, Revision: 16, Authorised, Last updated: 08/09/2023
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Human medicine European public assessment report (EPAR): Dimethyl fumarate Mylan (updated)
dimethyl fumarate, Multiple Sclerosis, Relapsing-Remitting
Date of authorisation: 13/05/2022,, Revision: 4, Authorised, Last updated: 08/09/2023
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Human medicine European public assessment report (EPAR): Irbesartan Teva (updated)
irbesartan, Hypertension
Date of authorisation: 30/10/2009,, Revision: 16, Authorised, Last updated: 05/09/2023
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Human medicine European public assessment report (EPAR): Kanuma
sebelipase alfa, Lipid Metabolism, Inborn Errors
Date of authorisation: 28/08/2015,, , 
, Revision: 10, Authorised, Last updated: 25/08/2023
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Human medicine European public assessment report (EPAR): Pirfenidone axunio (previously Pirfenidone AET)
Pirfenidone, Idiopathic Pulmonary Fibrosis
Date of authorisation: 20/06/2022,, Revision: 3, Authorised, Last updated: 25/08/2023
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Human medicine European public assessment report (EPAR): Duloxetine Mylan
duloxetine, Neuralgia; Diabetic Neuropathies; Depressive Disorder, Major; Anxiety Disorders
Date of authorisation: 19/06/2015,, Revision: 18, Authorised, Last updated: 25/08/2023