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421 results
Medicine
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Human medicine European public assessment report (EPAR): Pifeltro (updated)
doravirine, HIV Infections
Date of authorisation: 22/11/2018,
, Revision: 7, Authorised, Last updated: 20/02/2023
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Human medicine European public assessment report (EPAR): Delstrigo (updated)
doravirine, lamivudine, tenofovir disoproxil fumarate, HIV Infections
Date of authorisation: 22/11/2018,, Revision: 10, Authorised, Last updated: 20/02/2023
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Human medicine European public assessment report (EPAR): Tezspire (updated)
tezepelumab, Asthma
Date of authorisation: 19/09/2022,, Revision: 2, Authorised, Last updated: 20/02/2023
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Human medicine European public assessment report (EPAR): Nexpovio (updated)
Selinexor, Multiple Myeloma
Date of authorisation: 26/03/2021,, Revision: 7, Authorised, Last updated: 20/02/2023
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Human medicine European public assessment report (EPAR): Piqray (updated)
Alpelisib, Breast Neoplasms
Date of authorisation: 27/07/2020,, Revision: 8, Authorised, Last updated: 20/02/2023
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Human medicine European public assessment report (EPAR): Oxbryta (updated)
Voxelotor, Anemia; Anemia, Hemolytic; Anemia, Sickle Cell
Date of authorisation: 14/02/2022,, 
, Revision: 2, Authorised, Last updated: 20/02/2023
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Human medicine European public assessment report (EPAR): Yselty (updated)
linzagolix choline, Leiomyoma
Date of authorisation: 14/06/2022,, Revision: 2, Authorised, Last updated: 20/02/2023
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Human medicine European public assessment report (EPAR): Sixmo (updated)
Buprenorphine hydrochloride, Opioid-Related Disorders
Date of authorisation: 19/06/2019,, Revision: 4, Authorised, Last updated: 20/02/2023
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Human medicine European public assessment report (EPAR): Kerendia (updated)
Finerenone, Renal Insufficiency, Chronic; Diabetes Mellitus, Type 2
Date of authorisation: 16/02/2022,, Revision: 1, Authorised, Last updated: 20/02/2023
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Human medicine European public assessment report (EPAR): Nulibry (updated)
fosdenopterin hydrobromide dihydrate, Metal Metabolism, Inborn Errors
Date of authorisation: 15/09/2022,, , Revision: 1, Authorised, Last updated: 20/02/2023
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Human medicine European public assessment report (EPAR): COVID-19 Vaccine (inactivated, adjuvanted) Valneva
SARS-CoV-2 virus (inactivated) Wuhan strain hCoV-19 / Italy / INMI1-isl / 2020, COVID-19 virus infection
Date of authorisation: 24/06/2022,, Revision: 5, Authorised, Last updated: 17/02/2023
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Human medicine European public assessment report (EPAR): Jcovden (previously COVID-19 Vaccine Janssen)
adenovirus type 26 encoding the SARS-CoV-2 spike glycoprotein (Ad26.COV2-S), COVID-19 virus infection
Date of authorisation: 11/03/2021,
, , Revision: 28, Authorised, Last updated: 17/02/2023
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Human medicine European public assessment report (EPAR): Roclanda
Latanoprost, Netarsudil mesilate, Glaucoma, Open-Angle; Ocular Hypertension
Date of authorisation: 07/01/2021,, Revision: 4, Authorised, Last updated: 16/02/2023
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Human medicine European public assessment report (EPAR): Apexxnar
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,, Revision: 4, Authorised, Last updated: 16/02/2023
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Human medicine European public assessment report (EPAR): Intuniv
guanfacine hydrochloride, Attention Deficit Disorder with Hyperactivity
Date of authorisation: 17/09/2015,, Revision: 12, Authorised, Last updated: 16/02/2023
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Human medicine European public assessment report (EPAR): Byfavo
remimazolam, Conscious Sedation
Date of authorisation: 26/03/2021,, Revision: 4, Authorised, Last updated: 16/02/2023
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Human medicine European public assessment report (EPAR): Enhertu
trastuzumab deruxtecan, Breast Neoplasms
Date of authorisation: 18/01/2021,, 
, Revision: 10, Authorised, Last updated: 16/02/2023
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Human medicine European public assessment report (EPAR): Ondexxya
andexanet alfa, Drug-Related Side Effects and Adverse Reactions
Date of authorisation: 26/04/2019,, , Revision: 13, Authorised, Last updated: 15/02/2023
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Human medicine European public assessment report (EPAR): Strensiq
asfotase alfa, Hypophosphatasia
Date of authorisation: 28/08/2015,, , 
, Revision: 16, Authorised, Last updated: 15/02/2023
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Human medicine European public assessment report (EPAR): NexoBrid
proteolytic enzymes enriched in bromelain, Debridement
Date of authorisation: 18/12/2012,, Revision: 14, Authorised, Last updated: 15/02/2023
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Human medicine European public assessment report (EPAR): Venclyxto
Venetoclax, Leukemia, Lymphocytic, Chronic, B-Cell
Date of authorisation: 04/12/2016,, Revision: 15, Authorised, Last updated: 14/02/2023
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Human medicine European public assessment report (EPAR): Zejula
Niraparib (tosilate monohydrate), Fallopian Tube Neoplasms; Peritoneal Neoplasms; Ovarian Neoplasms
Date of authorisation: 16/11/2017,, , Revision: 19, Authorised, Last updated: 13/02/2023
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Human medicine European public assessment report (EPAR): Hefiya
adalimumab, Spondylitis, Ankylosing; Hidradenitis Suppurativa; Psoriasis; Arthritis, Juvenile Rheumatoid; Uveitis
Date of authorisation: 26/07/2018,, 
, Revision: 11, Authorised, Last updated: 13/02/2023
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Human medicine European public assessment report (EPAR): Brukinsa
zanubrutinib, Waldenstrom Macroglobulinemia
Date of authorisation: 22/11/2021,, Revision: 5, Authorised, Last updated: 13/02/2023
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Human medicine European public assessment report (EPAR): Tavneos
Avacopan, Microscopic Polyangiitis; Wegener Granulomatosis
Date of authorisation: 11/01/2022,, , Revision: 2, Authorised, Last updated: 13/02/2023