380 results
Medicine
European public assessment reports (EPAR) Remove European public assessment reports (EPAR) filter
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Human medicine European public assessment report (EPAR): Imraldi (updated)
adalimumab, Spondylitis, Ankylosing; Arthritis, Rheumatoid; Uveitis; Colitis, Ulcerative; Psoriasis; Arthritis, Psoriatic; Crohn Disease; Hidradenitis Suppurativa; Arthritis
Date of authorisation: 24/08/2017,
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, Revision: 16, Authorised, Last updated: 12/05/2022
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Human medicine European public assessment report (EPAR): Spikevax (previously COVID-19 Vaccine Moderna) (updated)
CX-024414 (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,
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, Revision: 22, Authorised, Last updated: 12/05/2022
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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: 25, Authorised, Last updated: 12/05/2022
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Human medicine European public assessment report (EPAR): Nuvaxovid (updated)
SARS-CoV-2 recombinant spike protein, COVID-19 virus infection
Date of authorisation: 20/12/2021,, , Revision: 2, Authorised, Last updated: 12/05/2022
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Human medicine European public assessment report (EPAR): Jcovden (previously COVID-19 Vaccine Janssen) (updated)
adenovirus type 26 encoding the SARS-CoV-2 spike glycoprotein (Ad26.COV2-S), COVID-19 virus infection
Date of authorisation: 11/03/2021,, , , Revision: 19, Authorised, Last updated: 12/05/2022
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Human medicine European public assessment report (EPAR): Inflectra (updated)
infliximab, Arthritis, Psoriatic; Spondylitis, Ankylosing; Colitis, Ulcerative; Psoriasis; Crohn Disease; Arthritis, Rheumatoid
Date of authorisation: 10/09/2013,, Revision: 29, Authorised, Last updated: 12/05/2022
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Human medicine European public assessment report (EPAR): Galafold (updated)
migalastat hydrochloride, Fabry Disease
Date of authorisation: 25/05/2016,, 
, Revision: 15, Authorised, Last updated: 12/05/2022
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Human medicine European public assessment report (EPAR): Vydura (updated)
Rimegepant, Migraine Disorders
Date of authorisation: 25/04/2022,, Authorised, Last updated: 11/05/2022
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Human medicine European public assessment report (EPAR): Apexxnar (updated)
Pneumococcal polysaccharide serotype 1, Pneumococcal polysaccharide serotype 3, Pneumococcal polysaccharide serotype 4, Pneumococcal polysaccharide serotype 5, Pneumococcal polysaccharide serotype 6A, Pneumococcal polysaccharide serotype 6B, Pneumococcal polysaccharide serotype 7F, Pneumococcal polysaccharide serotype 8, Pneumococcal polysaccharide serotype 9V, Pneumococcal polysaccharide serotype 10A, Pneumococcal polysaccharide serotype 11A, Pneumococcal polysaccharide serotype 12F, Pneumococcal polysaccharide serotype 14, Pneumococcal polysaccharide serotype 15b, Pneumococcal polysaccharide serotype 18C, Pneumococcal polysaccharide serotype 19A, Pneumococcal polysaccharide serotype 19F, Pneumococcal polysaccharide serotype 22F, Pneumococcal polysaccharide serotype 23F, Pneumococcal polysaccharide serotype 33F, Pneumococcal Infections
Date of authorisation: 14/02/2022,, Authorised, Last updated: 11/05/2022
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Human medicine European public assessment report (EPAR): Rhokiinsa (updated)
Netarsudil, Glaucoma, Open-Angle; Ocular Hypertension
Date of authorisation: 19/11/2019,, Revision: 1, Authorised, Last updated: 11/05/2022
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Human medicine European public assessment report (EPAR): Kevzara (updated)
sarilumab, Arthritis, Rheumatoid
Date of authorisation: 23/06/2017,, Revision: 8, Authorised, Last updated: 11/05/2022
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Human medicine European public assessment report (EPAR): Naglazyme (updated)
galsulfase, Mucopolysaccharidosis VI
Date of authorisation: 23/01/2006,, 
, Revision: 19, Authorised, Last updated: 10/05/2022
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Human medicine European public assessment report (EPAR): Kengrexal (updated)
cangrelor, Acute Coronary Syndrome; Vascular Surgical Procedures
Date of authorisation: 23/03/2015,, Revision: 13, Authorised, Last updated: 10/05/2022
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Human medicine European public assessment report (EPAR): Orgovyx (updated)
relugolix, Prostatic Neoplasms
Date of authorisation: 29/04/2022,, Authorised, Last updated: 10/05/2022
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Human medicine European public assessment report (EPAR): Hemlibra (updated)
Emicizumab, Hemophilia A
Date of authorisation: 23/02/2018,, 
, Revision: 10, Authorised, Last updated: 10/05/2022
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Human medicine European public assessment report (EPAR): Lutathera (updated)
lutetium (177Lu) oxodotreotide, Neuroendocrine Tumors
Date of authorisation: 26/09/2017,, , Revision: 6, Authorised, Last updated: 10/05/2022
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Human medicine European public assessment report (EPAR): Gazyvaro (updated)
Obinutuzumab, Leukemia, Lymphocytic, Chronic, B-Cell
Date of authorisation: 22/07/2014,, , Revision: 13, Authorised, Last updated: 10/05/2022
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Human medicine European public assessment report (EPAR): Nerlynx (updated)
neratinib, Breast Neoplasms
Date of authorisation: 31/08/2018,, Revision: 10, Authorised, Last updated: 06/05/2022
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Human medicine European public assessment report (EPAR): Xevudy (updated)
Sotrovimab, COVID-19 virus infection
Date of authorisation: 17/12/2021,, Revision: 1, Authorised, Last updated: 06/05/2022
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Human medicine European public assessment report (EPAR): Evusheld (updated)
tixagevimab, cilgavimab, COVID-19 virus infection
Date of authorisation: 25/03/2022,, Authorised, Last updated: 05/05/2022
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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