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Human medicine European public assessment report (EPAR): Roctavian (updated)

valoctocogene roxaparvovec,
Date of authorisation: 24/08/2022, , , , Authorised, Last updated: 28/09/2022
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Human medicine European public assessment report (EPAR): Vyvgart (updated)

Efgartigimod alfa, Myasthenia Gravis
Date of authorisation: 10/08/2022, , , Revision: 1, Authorised, Last updated: 28/09/2022
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Human medicine European public assessment report (EPAR): Imcivree (updated)

Setmelanotide, Obesity
Date of authorisation: 16/07/2021, , , Revision: 4, Authorised, Last updated: 28/09/2022
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Human medicine European public assessment report (EPAR): Obiltoxaximab SFL (updated)

Obiltoxaximab, Anthrax
Date of authorisation: 18/11/2020, , , , Revision: 2, Authorised, Last updated: 28/09/2022
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Human medicine European public assessment report (EPAR): Remsima (updated)

infliximab, Arthritis, Psoriatic; Spondylitis, Ankylosing; Colitis, Ulcerative; Psoriasis; Crohn Disease; Arthritis, Rheumatoid
Date of authorisation: 10/09/2013, , Revision: 29, Authorised, Last updated: 28/09/2022
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Human medicine European public assessment report (EPAR): Ozempic (updated)

semaglutide, Diabetes Mellitus
Date of authorisation: 08/02/2018, , Revision: 9, Authorised, Last updated: 28/09/2022
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Human medicine European public assessment report (EPAR): Lemtrada (updated)

alemtuzumab, Multiple Sclerosis
Date of authorisation: 12/09/2013, , Revision: 20, Authorised, Last updated: 27/09/2022
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Human medicine European public assessment report (EPAR): Tukysa (updated)

Tucatinib, Breast Neoplasms; Neoplasm Metastasis
Date of authorisation: 11/02/2021, , Revision: 2, Authorised, Last updated: 27/09/2022
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Human medicine European public assessment report (EPAR): Hemlibra (updated)

Emicizumab, Hemophilia A
Date of authorisation: 23/02/2018, , , Revision: 12, Authorised, Last updated: 27/09/2022
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Human medicine European public assessment report (EPAR): Deltyba (updated)

Delamanid, Tuberculosis, Multidrug-Resistant
Date of authorisation: 27/04/2014,
Date of refusal: 25/07/2013, , , , Revision: 21, Authorised, Last updated: 27/09/2022
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Human medicine European public assessment report (EPAR): Vaxchora (updated)

vibrio cholerae, strain cvd 103-hgr, live, Cholera
Date of authorisation: 01/04/2020, , Revision: 6, Authorised, Last updated: 27/09/2022
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Human medicine European public assessment report (EPAR): Reblozyl (updated)

Luspatercept, Anemia; Myelodysplastic Syndromes; beta-Thalassemia
Date of authorisation: 25/06/2020, , , Revision: 3, Authorised, Last updated: 27/09/2022
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Human medicine European public assessment report (EPAR): Rybrevant (updated)

amivantamab, Carcinoma, Non-Small-Cell Lung
Date of authorisation: 09/12/2021, , , Revision: 1, Authorised, Last updated: 26/09/2022
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Human medicine European public assessment report (EPAR): Vegzelma (updated)

bevacizumab, Colorectal Neoplasms; Breast Neoplasms; Ovarian Neoplasms; Fallopian Tube Neoplasms; Peritoneal Neoplasms; Carcinoma, Non-Small-Cell Lung; Carcinoma, Renal Cell; Uterine Cervical Neoplasms
Date of authorisation: 17/08/2022, , , Revision: 1, Authorised, Last updated: 26/09/2022
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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: 25, Authorised, Last updated: 26/09/2022
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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, , Revision: 1, Authorised, Last updated: 26/09/2022
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Human medicine European public assessment report (EPAR): Epidyolex (updated)

Cannabidiol, Lennox Gastaut Syndrome; Epilepsies, Myoclonic
Date of authorisation: 19/09/2019, , Revision: 11, Authorised, Last updated: 26/09/2022
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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, , Revision: 1, Authorised, Last updated: 26/09/2022
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Human medicine European public assessment report (EPAR): Evkeeza (updated)

Evinacumab, Hypercholesterolemia
Date of authorisation: 17/06/2021, , , Revision: 1, Authorised, Last updated: 23/09/2022
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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, , , , Revision: 29, Authorised, Last updated: 23/09/2022
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Human medicine European public assessment report (EPAR): Elzonris (updated)

tagraxofusp, Lymphoma
Date of authorisation: 07/01/2021, , , , Revision: 5, Authorised, Last updated: 23/09/2022
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Human medicine European public assessment report (EPAR): Rydapt (updated)

Midostaurin, Leukemia, Myeloid, Acute; Mastocytosis
Date of authorisation: 18/09/2017, , Revision: 9, Authorised, Last updated: 23/09/2022
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Human medicine European public assessment report (EPAR): Nexpovio (updated)

Selinexor, Multiple Myeloma
Date of authorisation: 26/03/2021, , Revision: 5, Authorised, Last updated: 23/09/2022
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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: 29, Authorised, Last updated: 23/09/2022
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Human medicine European public assessment report (EPAR): Veklury (updated)

remdesivir, Coronavirus Infections
Date of authorisation: 03/07/2020, , Revision: 13, Authorised, Last updated: 23/09/2022