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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, , Revision: 3, Authorised, Last updated: 16/01/2023
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Human medicine European public assessment report (EPAR): Koselugo (updated)

Selumetinib sulfate, Neurofibromatosis 1
Date of authorisation: 17/06/2021, , , , Revision: 4, Authorised, Last updated: 16/01/2023
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Human medicine European public assessment report (EPAR): Kaftrio (updated)

ivacaftor, tezacaftor, elexacaftor, Cystic Fibrosis
Date of authorisation: 21/08/2020, , , Revision: 11, Authorised, Last updated: 16/01/2023
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Human medicine European public assessment report (EPAR): Fluad Tetra (updated)

A/Victoria/2570/2019 (H1N1)pdm09 like strain (A/Victoria/2570/2019 IVR‐215) A/Darwin/9/2021 (H3N2) like strain (A/Darwin/6/2021 IVR-227) B/Austria/1359417/2021 like strain (B/Austria/1359417/2021 BVR-26) B/Phuket/3073/2013 like strain (B/Phuket/3073/2013 BVR‐1B), Influenza, Human
Date of authorisation: 20/05/2020, , Revision: 5, Authorised, Last updated: 16/01/2023
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Human medicine European public assessment report (EPAR): Idefirix (updated)

Imlifidase, Desensitization, Immunologic; Kidney Transplantation
Date of authorisation: 25/08/2020, , , , Revision: 3, Authorised, Last updated: 16/01/2023
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Human medicine European public assessment report (EPAR): Trogarzo (updated)

Ibalizumab, HIV Infections
Date of authorisation: 26/09/2019, , Revision: 7, Withdrawn, Last updated: 16/01/2023
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Human medicine European public assessment report (EPAR): Kesimpta (updated)

ofatumumab, Multiple Sclerosis, Relapsing-Remitting
Date of authorisation: 26/03/2021, , Revision: 4, Authorised, Last updated: 16/01/2023
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Human medicine European public assessment report (EPAR): Hukyndra (updated)

adalimumab, Arthritis, Psoriatic; Arthritis, Juvenile Rheumatoid; Arthritis, Rheumatoid; Colitis, Ulcerative; Crohn Disease; Hidradenitis Suppurativa; Psoriasis; Spondylitis, Ankylosing; Uveitis
Date of authorisation: 15/11/2021, , Revision: 3, Authorised, Last updated: 16/01/2023
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Human medicine European public assessment report (EPAR): Orphacol (updated)

cholic acid, Digestive System Diseases; Metabolism, Inborn Errors
Date of authorisation: 12/09/2013,
Date of refusal: 25/05/2012, , , , Revision: 12, Authorised, Last updated: 16/01/2023
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Human medicine European public assessment report (EPAR): Nivestim (updated)

filgrastim, Neutropenia; Hematopoietic Stem Cell Transplantation; Cancer
Date of authorisation: 07/06/2010, , Revision: 26, Authorised, Last updated: 12/01/2023
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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): Ebvallo (updated)

Tabelecleucel, Lymphoproliferative Disorders
Date of authorisation: 16/12/2022, , , , Authorised, Last updated: 12/01/2023
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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: 7, Authorised, Last updated: 12/01/2023
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Human medicine European public assessment report (EPAR): Alofisel (updated)

darvadstrocel, Rectal Fistula
Date of authorisation: 23/03/2018, , , Revision: 9, Authorised, Last updated: 12/01/2023
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Human medicine European public assessment report (EPAR): Lokelma (updated)

sodium zirconium cyclosilicate, Hyperkalemia
Date of authorisation: 22/03/2018, , Revision: 7, Authorised, Last updated: 12/01/2023
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Human medicine European public assessment report (EPAR): Filgrastim Hexal (updated)

filgrastim, Neutropenia; Hematopoietic Stem Cell Transplantation; Cancer
Date of authorisation: 06/02/2009, , Revision: 19, Authorised, Last updated: 12/01/2023
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Human medicine European public assessment report (EPAR): Zarzio (updated)

filgrastim, Neutropenia; Hematopoietic Stem Cell Transplantation; Cancer
Date of authorisation: 06/02/2009, , Revision: 20, Authorised, Last updated: 12/01/2023
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Human medicine European public assessment report (EPAR): Duaklir Genuair (updated)

aclidinium bromide, formoterol fumarate dihydrate, Pulmonary Disease, Chronic Obstructive
Date of authorisation: 19/11/2014, , Revision: 15, Authorised, Last updated: 11/01/2023
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Human medicine European public assessment report (EPAR): Eklira Genuair (updated)

aclidinium bromide, Pulmonary Disease, Chronic Obstructive
Date of authorisation: 20/07/2012, , Revision: 20, Authorised, Last updated: 11/01/2023
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Human medicine European public assessment report (EPAR): Libmyris (updated)

adalimumab, Arthritis, Rheumatoid; Arthritis, Juvenile Rheumatoid; Spondylitis, Ankylosing; Arthritis, Psoriatic; Psoriasis; Hidradenitis Suppurativa; Crohn Disease; Colitis, Ulcerative; Uveitis
Date of authorisation: 12/11/2021, , Revision: 1, Authorised, Last updated: 11/01/2023
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Human medicine European public assessment report (EPAR): Natpar (updated)

parathyroid hormone, Hypoparathyroidism
Date of authorisation: 24/04/2017, , , , Revision: 13, Authorised, Last updated: 11/01/2023
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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: 27, Authorised, Last updated: 10/01/2023
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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: 7, Authorised, Last updated: 10/01/2023
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Human medicine European public assessment report (EPAR): Amvuttra (updated)

vutrisiran sodium, Amyloid Neuropathies, Familial
Date of authorisation: 15/09/2022, , , Revision: 1, Authorised, Last updated: 10/01/2023
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Human medicine European public assessment report (EPAR): Adakveo (updated)

Crizanlizumab, Anemia, Sickle Cell
Date of authorisation: 28/10/2020, , , , Revision: 3, Authorised, Last updated: 10/01/2023