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2015 results
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Human medicine European public assessment report (EPAR): Ondexxya (updated)
andexanet alfa, Drug-Related Side Effects and Adverse Reactions
Date of authorisation: 26/04/2019,,
, Revision: 15, Authorised, Last updated: 30/05/2023
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Human medicine European public assessment report (EPAR): Jyseleca (updated)
filgotinib maleate, Arthritis, Rheumatoid
Date of authorisation: 24/09/2020,,
, Revision: 9, Authorised, Last updated: 30/05/2023
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Human medicine European public assessment report (EPAR): Zolgensma (updated)
onasemnogene abeparvovec, Muscular Atrophy, Spinal
Date of authorisation: 18/05/2020,,
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, Revision: 11, Authorised, Last updated: 30/05/2023
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Human medicine European public assessment report (EPAR): Rivaroxaban Mylan (updated)
rivaroxaban, Venous Thromboembolism; Pulmonary Embolism; Acute Coronary Syndrome; Stroke; Coronary Artery Disease; Peripheral Arterial Disease; Atrial Fibrillation
Date of authorisation: 12/11/2021,, Revision: 3, Authorised, Last updated: 30/05/2023
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Human medicine European public assessment report (EPAR): Pombiliti (updated)
Cipaglucosidase alfa, Glycogen Storage Disease Type II
Date of authorisation: 20/03/2023,, Authorised, Last updated: 30/05/2023
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Human medicine European public assessment report (EPAR): Qinlock (updated)
ripretinib, Gastrointestinal Stromal Tumors
Date of authorisation: 18/11/2021,,
, Revision: 3, Authorised, Last updated: 30/05/2023
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Human medicine European public assessment report (EPAR): Ratiograstim (updated)
filgrastim, Neutropenia; Hematopoietic Stem Cell Transplantation; Cancer
Date of authorisation: 15/09/2008,, Revision: 16, Authorised, Last updated: 30/05/2023
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Human medicine European public assessment report (EPAR): Vokanamet (updated)
canagliflozin, metformin hydrochloride, Diabetes Mellitus, Type 2
Date of authorisation: 23/04/2014, Revision: 21, Authorised, Last updated: 30/05/2023 -
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Human medicine European public assessment report (EPAR): Cinqaero (updated)
Reslizumab, Asthma
Date of authorisation: 15/08/2016, Revision: 11, Authorised, Last updated: 26/05/2023 -
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Human medicine European public assessment report (EPAR): Procysbi (updated)
mercaptamine bitartrate, Cystinosis
Date of authorisation: 05/09/2013,, Revision: 16, Authorised, Last updated: 26/05/2023
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Human medicine European public assessment report (EPAR): Ogluo (updated)
Glucagon, Diabetes Mellitus
Date of authorisation: 11/02/2021, Revision: 5, Authorised, Last updated: 26/05/2023 -
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Human medicine European public assessment report (EPAR): Lyrica (updated)
pregabalin, Epilepsy; Anxiety Disorders; Neuralgia
Date of authorisation: 05/07/2004, Revision: 60, Authorised, Last updated: 26/05/2023 -
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Human medicine European public assessment report (EPAR): Beovu (updated)
brolucizumab, Wet Macular Degeneration
Date of authorisation: 13/02/2020,, Revision: 8, Authorised, Last updated: 26/05/2023
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Human medicine European public assessment report (EPAR): Ixiaro (updated)
Japanese-encephalitis virus, inactivated (attenuated strain SA14-14-2 grown in vero cells), Encephalitis, Japanese; Immunization
Date of authorisation: 31/03/2009, Revision: 17, Authorised, Last updated: 25/05/2023 -
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Human medicine European public assessment report (EPAR): Breyanzi (updated)
CD19-directed genetically modified autologous cell-based product consisting of purified CD8+ T-cells (CD8+ cells), CD19-directed genetically modified autologous cell-based product consisting of purified CD4+ T cells (CD4+ cells), Lymphoma, Large B-Cell, Diffuse; Lymphoma, Follicular; Mediastinal Neoplasms
Date of authorisation: 04/04/2022,, Revision: 1, Authorised, Last updated: 25/05/2023
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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: 1, Authorised, Last updated: 25/05/2023
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Human medicine European public assessment report (EPAR): Galafold (updated)
Migalastat hydrochloride, Fabry Disease
Date of authorisation: 25/05/2016,,
, Revision: 16, Authorised, Last updated: 25/05/2023
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Human medicine European public assessment report (EPAR): Xaluprine (previously Mercaptopurine Nova Laboratories) (updated)
6-mercaptopurine monohydrate, Leukemia, Lymphoid
Date of authorisation: 09/03/2012, Revision: 15, Authorised, Last updated: 25/05/2023 -
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Human medicine European public assessment report (EPAR): Sustiva (updated)
efavirenz, HIV Infections
Date of authorisation: 28/05/1999, Revision: 48, Authorised, Last updated: 25/05/2023 -
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Human medicine European public assessment report (EPAR): Dupixent (updated)
dupilumab, Dermatitis, Atopic; Prurigo; Esophageal Diseases; Asthma; Sinusitis
Date of authorisation: 26/09/2017, Revision: 26, Authorised, Last updated: 25/05/2023 -
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Human medicine European public assessment report (EPAR): Pantozol Control (updated)
pantoprazole, Gastroesophageal Reflux
Date of authorisation: 11/06/2009, Revision: 17, Authorised, Last updated: 25/05/2023 -
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Human medicine European public assessment report (EPAR): Olumiant (updated)
Baricitinib, Arthritis, Rheumatoid
Date of authorisation: 13/02/2017,, Revision: 13, Authorised, Last updated: 25/05/2023
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Human medicine European public assessment report (EPAR): Lixiana (updated)
edoxaban tosilate, Stroke; Venous Thromboembolism
Date of authorisation: 19/06/2015, Revision: 16, Authorised, Last updated: 25/05/2023 -
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Human medicine European public assessment report (EPAR): Elfabrio (updated)
Pegunigalsidase alfa, Fabry Disease
Date of authorisation: 04/05/2023, Revision: 1, Authorised, Last updated: 25/05/2023 -
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Human medicine European public assessment report (EPAR): Tenkasi (previously Orbactiv) (updated)
oritavancin diphosphate, Soft Tissue Infections; Skin Diseases, Bacterial
Date of authorisation: 19/03/2015, Revision: 12, Authorised, Last updated: 25/05/2023