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351 results
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Human medicine European public assessment report (EPAR): Reagila (updated)
cariprazine hydrochloride, Schizophrenia
Date of authorisation: 13/07/2017,
, Revision: 6, Authorised, Last updated: 04/05/2022
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Human medicine European public assessment report (EPAR): Leqvio (updated)
inclisiran, Hypercholesterolemia; Dyslipidemias
Date of authorisation: 09/12/2020,, Revision: 3, Authorised, Last updated: 03/05/2022
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Human medicine European public assessment report (EPAR): Jyseleca (updated)
filgotinib maleate, Arthritis, Rheumatoid
Date of authorisation: 24/09/2020,, Revision: 5, Authorised, Last updated: 03/05/2022
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Human medicine European public assessment report (EPAR): Brukinsa (updated)
zanubrutinib, Waldenstrom Macroglobulinemia
Date of authorisation: 22/11/2021,, Revision: 3, Authorised, Last updated: 03/05/2022
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Human medicine European public assessment report (EPAR): Vazkepa (updated)
Icosapent ethyl, Dyslipidemias
Date of authorisation: 26/03/2021,, Revision: 3, Authorised, Last updated: 02/05/2022
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Human medicine European public assessment report (EPAR): Ultomiris (updated)
ravulizumab, Hemoglobinuria, Paroxysmal
Date of authorisation: 02/07/2019,, Revision: 8, Authorised, Last updated: 29/04/2022
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Human medicine European public assessment report (EPAR): Imfinzi (updated)
durvalumab, Carcinoma, Non-Small-Cell Lung
Date of authorisation: 21/09/2018,, Revision: 11, Authorised, Last updated: 29/04/2022
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Human medicine European public assessment report (EPAR): MenQuadfi (updated)
Neisseria meningitidis group C polysaccharide conjugated to tetanus toxoid, Neisseria meningitidis group A polysaccharide conjugated to tetanus toxoid, Neisseria meningitidis group Y polysaccharide conjugated to tetanus toxoid, Neisseria meningitidis group W-135 polysaccharide conjugated to tetanus toxoid, Meningitis, Meningococcal
Date of authorisation: 18/11/2020,, Revision: 5, Authorised, Last updated: 29/04/2022
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Human medicine European public assessment report (EPAR): Paxlovid (updated)
(1R,2S,5S)-N-((1S)-1-Cyano-2-((3S)-2-oxopyrrolidin-3-yl)ethyl)-3-((2S)-3,3-dimethyl-2-(2,2,2-trifluoroacetamido) butanoyl)-6,6-dimethyl-3-azabicyclo[3.1.0]hexane-2-carboxamide [PF-07321332], ritonavir, COVID-19 virus infection
Date of authorisation: 28/01/2022,
, Revision: 1, Authorised, Last updated: 29/04/2022
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Human medicine European public assessment report (EPAR): Byfavo (updated)
remimazolam, Conscious Sedation
Date of authorisation: 26/03/2021,, Revision: 1, Authorised, Last updated: 28/04/2022
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Human medicine European public assessment report (EPAR): Poteligeo (updated)
Mogamulizumab, Sezary Syndrome; Mycosis Fungoides
Date of authorisation: 22/11/2018,, 
, Revision: 5, Authorised, Last updated: 28/04/2022
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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: 6, Authorised, Last updated: 28/04/2022
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Human medicine European public assessment report (EPAR): Kapruvia (updated)
difelikefalin, Pruritus
Date of authorisation: 25/04/2022,, Authorised, Last updated: 28/04/2022
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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: 13, Authorised, Last updated: 28/04/2022
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Human medicine European public assessment report (EPAR): Bavencio (updated)
avelumab, Neuroendocrine Tumors
Date of authorisation: 18/09/2017,, Revision: 12, Authorised, Last updated: 26/04/2022
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Human medicine European public assessment report (EPAR): Zessly (updated)
infliximab, Arthritis, Psoriatic; Psoriasis; Crohn Disease; Arthritis, Rheumatoid; Colitis, Ulcerative; Spondylitis, Ankylosing
Date of authorisation: 18/05/2018,, 
, Revision: 8, Authorised, Last updated: 26/04/2022
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Human medicine European public assessment report (EPAR): Vaxneuvance (updated)
pneumococcal polysaccharide conjugate vaccine (adsorbed), Pneumococcal Infections
Date of authorisation: 13/12/2021,, Revision: 1, Authorised, Last updated: 25/04/2022
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Human medicine European public assessment report (EPAR): Enhertu (updated)
trastuzumab deruxtecan, Breast Neoplasms
Date of authorisation: 18/01/2021,, , Revision: 4, Authorised, Last updated: 25/04/2022
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Human medicine European public assessment report (EPAR): Nustendi (updated)
Bempedoic acid, Ezetimibe, Hypercholesterolemia; Dyslipidemias
Date of authorisation: 27/03/2020,, Revision: 5, Authorised, Last updated: 21/04/2022
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Human medicine European public assessment report (EPAR): Erelzi (updated)
etanercept, Arthritis, Psoriatic; Psoriasis; Arthritis, Juvenile Rheumatoid; Arthritis, Rheumatoid; Spondylitis, Ankylosing
Date of authorisation: 23/06/2017,, , Revision: 10, Authorised, Last updated: 21/04/2022
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Human medicine European public assessment report (EPAR): Maviret (updated)
glecaprevir, pibrentasvir, Hepatitis C, Chronic
Date of authorisation: 26/07/2017,, 
, Revision: 15, Authorised, Last updated: 21/04/2022
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Human medicine European public assessment report (EPAR): Verzenios (updated)
abemaciclib, Breast Neoplasms
Date of authorisation: 26/09/2018,, Revision: 8, Authorised, Last updated: 21/04/2022
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Human medicine European public assessment report (EPAR): Nubeqa (updated)
darolutamide, Prostatic Neoplasms, Castration-Resistant
Date of authorisation: 27/03/2020,, Revision: 3, Authorised, Last updated: 20/04/2022
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Human medicine European public assessment report (EPAR): Rinvoq (updated)
upadacitinib, Arthritis, Rheumatoid
Date of authorisation: 16/12/2019,, Revision: 8, Authorised, Last updated: 20/04/2022
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Human medicine European public assessment report (EPAR): Glyxambi
empagliflozin, linagliptin, Diabetes Mellitus, Type 2
Date of authorisation: 11/11/2016,, Revision: 15, Authorised, Last updated: 13/04/2022