274 results
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Human medicine European public assessment report (EPAR): Granupas (previously Para-aminosalicylic acid Lucane)
Para-aminosalicylic acid, Tuberculosis
Date of authorisation: 07/04/2014,
, Revision: 10, Authorised, Last updated: 11/10/2022
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Human medicine European public assessment report (EPAR): Xarelto (updated)
rivaroxaban, Arthroplasty, Replacement; Venous Thromboembolism
Date of authorisation: 30/09/2008, Revision: 39, Authorised, Last updated: 18/01/2023 -
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Human medicine European public assessment report (EPAR): Neuraceq
florbetaben (18F), Radionuclide Imaging; Alzheimer Disease
Date of authorisation: 20/02/2014, Revision: 19, Authorised, Last updated: 18/11/2022 -
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Human medicine European public assessment report (EPAR): Busilvex (updated)
busulfan, Hematopoietic Stem Cell Transplantation
Date of authorisation: 09/07/2003, Revision: 20, Withdrawn, Last updated: 27/01/2023 -
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Human medicine European public assessment report (EPAR): Neofordex (updated)
dexamethasone, Multiple Myeloma
Date of authorisation: 16/03/2016, Revision: 10, Authorised, Last updated: 23/01/2023 -
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Human medicine European public assessment report (EPAR): Febuxostat Mylan
febuxostat, Hyperuricemia; Arthritis, Gouty; Gout
Date of authorisation: 15/06/2017,
, Revision: 8, Authorised, Last updated: 03/10/2022
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Human medicine European public assessment report (EPAR): Dasatinib Accord (updated)
dasatinib, Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Date of authorisation: 24/03/2022,, Revision: 1, Authorised, Last updated: 20/01/2023
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Human medicine European public assessment report (EPAR): Ibandronic Acid Teva
ibandronic acid, Breast Neoplasms; Neoplasm Metastasis; Fractures, Bone; Osteoporosis, Postmenopausal
Date of authorisation: 17/09/2010,, Revision: 12, Authorised, Last updated: 22/11/2022
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Human medicine European public assessment report (EPAR): Adenuric
febuxostat, Gout
Date of authorisation: 21/04/2008, Revision: 22, Authorised, Last updated: 09/08/2022 -
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Human medicine European public assessment report (EPAR): Oncaspar (updated)
pegaspargase, Precursor Cell Lymphoblastic Leukemia-Lymphoma
Date of authorisation: 14/01/2016, Revision: 16, Authorised, Last updated: 25/01/2023 -
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Human medicine European public assessment report (EPAR): DuoPlavin
clopidogrel, acetylsalicylic acid, Acute Coronary Syndrome; Myocardial Infarction
Date of authorisation: 14/03/2010, Revision: 26, Authorised, Last updated: 20/12/2022 -
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Human medicine European public assessment report (EPAR): Vyndaqel (updated)
tafamidis, Amyloidosis
Date of authorisation: 16/11/2011,
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, Revision: 23, Authorised, Last updated: 16/01/2023
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Human medicine European public assessment report (EPAR): Apixaban Accord
Apixaban, Venous Thromboembolism; Stroke; Arthroplasty
Date of authorisation: 23/07/2020,, Revision: 2, Authorised, Last updated: 19/05/2022
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Human medicine European public assessment report (EPAR): Dynastat
parecoxib sodium, Pain, Postoperative
Date of authorisation: 22/03/2002, Revision: 32, Authorised, Last updated: 17/08/2022 -
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Human medicine European public assessment report (EPAR): Ocaliva (updated)
Obeticholic acid, Liver Cirrhosis, Biliary
Date of authorisation: 12/12/2016,, , 
, Revision: 15, Authorised, Last updated: 04/01/2023
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Human medicine European public assessment report (EPAR): Lixiana
edoxaban tosilate, Stroke; Venous Thromboembolism
Date of authorisation: 19/06/2015, Revision: 15, Authorised, Last updated: 09/06/2022 -
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Human medicine European public assessment report (EPAR): Repatha (updated)
Evolocumab, Dyslipidemias; Hypercholesterolemia
Date of authorisation: 17/07/2015, Revision: 23, Authorised, Last updated: 23/01/2023 -
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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: 37, Authorised, Last updated: 25/01/2023
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Human medicine European public assessment report (EPAR): Pedea
Ibuprofen, Ductus Arteriosus, Patent
Date of authorisation: 28/07/2004, Revision: 15, Authorised, Last updated: 08/11/2022 -
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Human medicine European public assessment report (EPAR): Dimethyl fumarate Mylan
dimethyl fumarate, Multiple Sclerosis, Relapsing-Remitting
Date of authorisation: 13/05/2022,, Revision: 3, Authorised, Last updated: 12/12/2022
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Human medicine European public assessment report (EPAR): Febuxostat Krka
febuxostat, Hyperuricemia; Gout
Date of authorisation: 28/03/2019,, Revision: 3, Authorised, Last updated: 07/04/2022
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Human medicine European public assessment report (EPAR): Dasatinib Accordpharma
dasatinib, Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Date of authorisation: 24/03/2022,, Revision: 1, Authorised, Last updated: 24/10/2022
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Human medicine European public assessment report (EPAR): Raylumis
Tanezumab, Osteoarthritis; Pain
Date of refusal: 15/11/2021, Refused, Last updated: 15/02/2022 -
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Human medicine European public assessment report (EPAR): Vocabria (updated)
Cabotegavir sodium, Cabotegravir, HIV Infections
Date of authorisation: 17/12/2020,, Revision: 8, Authorised, Last updated: 12/01/2023
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Human medicine European public assessment report (EPAR): Efient
prasugrel, Acute Coronary Syndrome; Angina, Unstable; Myocardial Infarction
Date of authorisation: 24/02/2009, Revision: 24, Authorised, Last updated: 21/11/2022