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891 results
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Human medicine European public assessment report (EPAR): Brukinsa (updated)
zanubrutinib, Waldenstrom Macroglobulinemia
Date of authorisation: 22/11/2021,
, Revision: 7, Authorised, Last updated: 29/09/2023
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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): Lyfnua (updated)
Gefapixant, Cough
Date of authorisation: 15/09/2023,, Authorised, Last updated: 29/09/2023
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Human medicine European public assessment report (EPAR): Adakveo (updated)
Crizanlizumab, Anemia, Sickle Cell
Date of authorisation: 28/10/2020,, 
, Revision: 6, Withdrawn, Last updated: 29/09/2023
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Human medicine European public assessment report (EPAR): Spikevax (previously COVID-19 Vaccine Moderna) (updated)
Single-stranded, 5’-capped messenger RNA (mRNA) produced using a cell-free in vitro transcription from the corresponding DNA templates, encoding the viral spike (S) protein of SARS-CoV-2, COVID-19 virus infection
Date of authorisation: 06/01/2021,
, , Revision: 40, Authorised, Last updated: 28/09/2023
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Human medicine European public assessment report (EPAR): Hepcludex (updated)
Bulevirtide acetate, Hepatitis D, Chronic
Date of authorisation: 31/07/2020,, 
, Revision: 11, Authorised, Last updated: 28/09/2023
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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): Comirnaty (updated)
Single-stranded, 5’-capped messenger RNA produced using a cell-free in vitro transcription from the corresponding DNA templates, encoding the viral spike (S) protein of SARS-CoV-2, COVID-19 virus infection
Date of authorisation: 21/12/2020,, , Revision: 44, 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): Tyruko (updated)
natalizumab, Multiple Sclerosis, Relapsing-Remitting; Multiple Sclerosis
Date of authorisation: 22/09/2023,, 
, Authorised, Last updated: 28/09/2023
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Human medicine European public assessment report (EPAR): COVID-19 Vaccine (inactivated, adjuvanted) Valneva (updated)
SARS-CoV-2 virus (inactivated) Wuhan strain hCoV-19 / Italy / INMI1-isl / 2020, COVID-19 virus infection
Date of authorisation: 24/06/2022,, Revision: 6, Authorised, Last updated: 27/09/2023
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Human medicine European public assessment report (EPAR): Zavicefta (updated)
avibactam sodium, ceftazidime pentahydrate, Pneumonia, Bacterial; Soft Tissue Infections; Pneumonia; Urinary Tract Infections; Gram-Negative Bacterial Infections
Date of authorisation: 23/06/2016,, Revision: 15, Authorised, Last updated: 27/09/2023
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Human medicine European public assessment report (EPAR): Kirsty (previously Kixelle) (updated)
insulin aspart, Diabetes Mellitus
Date of authorisation: 05/02/2021,, , Revision: 3, Authorised, Last updated: 27/09/2023
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Human medicine European public assessment report (EPAR): Erleada (updated)
apalutamide, Prostatic Neoplasms
Date of authorisation: 14/01/2019,, Revision: 11, Authorised, Last updated: 27/09/2023
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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): Ultomiris (updated)
ravulizumab, Hemoglobinuria, Paroxysmal
Date of authorisation: 02/07/2019,, Revision: 13, Authorised, Last updated: 26/09/2023
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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): Brimica Genuair (updated)
formoterol fumarate dihydrate, aclidinium bromide, Pulmonary Disease, Chronic Obstructive
Date of authorisation: 19/11/2014,, Revision: 14, 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): Orphacol (updated)
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
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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): Tezspire (updated)
tezepelumab, Asthma
Date of authorisation: 19/09/2022,, Revision: 7, Authorised, Last updated: 22/09/2023
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Human medicine European public assessment report (EPAR): Rybrevant (updated)
amivantamab, Carcinoma, Non-Small-Cell Lung
Date of authorisation: 09/12/2021,, , Revision: 3, Authorised, Last updated: 22/09/2023