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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: 9, Authorised, Last updated: 13/09/2023
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Human medicine European public assessment report (EPAR): Pandemic Influenza Vaccine H5N1 Baxter AG (updated)

influenza vaccine (whole virion, inactivated) containing antigen of: A/Vietnam/1203/2004 (H5N1), Influenza, Human; Immunization; Disease Outbreaks
Date of authorisation: 16/10/2009, , Revision: 8, Withdrawn, Last updated: 13/09/2023
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Human medicine European public assessment report (EPAR): Beovu (updated)

brolucizumab, Wet Macular Degeneration
Date of authorisation: 13/02/2020, , Revision: 10, Authorised, Last updated: 13/09/2023
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Human medicine European public assessment report (EPAR): Imnovid (previously Pomalidomide Celgene) (updated)

Pomalidomide, Multiple Myeloma
Date of authorisation: 05/08/2013, , Revision: 24, Authorised, Last updated: 13/09/2023
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Human medicine European public assessment report (EPAR): Mektovi (updated)

binimetinib, Melanoma
Date of authorisation: 20/09/2018, , Revision: 7, Authorised, Last updated: 12/09/2023
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Human medicine European public assessment report (EPAR): Roctavian (updated)

valoctocogene roxaparvovec,
Date of authorisation: 24/08/2022, , , , Revision: 3, Authorised, Last updated: 12/09/2023
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Human medicine European public assessment report (EPAR): Pemazyre (updated)

pemigatinib, Cholangiocarcinoma
Date of authorisation: 26/03/2021, , , , Revision: 6, Authorised, Last updated: 12/09/2023
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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: 4, Authorised, Last updated: 12/09/2023
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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: 44, Authorised, Last updated: 11/09/2023
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Human medicine European public assessment report (EPAR): Tremelimumab AstraZeneca (updated)

Tremelimumab, Carcinoma, Non-Small-Cell Lung
Date of authorisation: 20/02/2023, , Revision: 1, Authorised, Last updated: 11/09/2023
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Human medicine European public assessment report (EPAR): Benlysta (updated)

belimumab, Lupus Erythematosus, Systemic
Date of authorisation: 13/07/2011, , Revision: 31, Authorised, Last updated: 11/09/2023
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Human medicine European public assessment report (EPAR): Natpar (updated)

parathyroid hormone, Hypoparathyroidism
Date of authorisation: 24/04/2017, , , , Revision: 16, Authorised, Last updated: 08/09/2023
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Human medicine European public assessment report (EPAR): Emgality (updated)

Galcanezumab, Migraine Disorders
Date of authorisation: 14/11/2018, , Revision: 10, Authorised, Last updated: 07/09/2023
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Human medicine European public assessment report (EPAR): Nepexto (updated)

etanercept, Arthritis, Rheumatoid; Arthritis, Juvenile Rheumatoid; Arthritis, Psoriatic; Spondylarthropathies; Spondylitis, Ankylosing; Psoriasis
Date of authorisation: 20/05/2020, , , Revision: 10, Authorised, Last updated: 07/09/2023
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Human medicine European public assessment report (EPAR): Voxzogo (updated)

Vosoritide, Achondroplasia
Date of authorisation: 26/08/2021, , , Revision: 3, Authorised, Last updated: 06/09/2023
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Human medicine European public assessment report (EPAR): Ninlaro (updated)

ixazomib citrate, Multiple Myeloma
Date of authorisation: 21/11/2016, , , , Revision: 16, Authorised, Last updated: 05/09/2023
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Human medicine European public assessment report (EPAR): Rekambys (updated)

rilpivirine, HIV Infections
Date of authorisation: 17/12/2020, , Revision: 8, Authorised, Last updated: 05/09/2023
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Human medicine European public assessment report (EPAR): Skyrizi (updated)

Risankizumab, Psoriasis; Arthritis, Psoriatic
Date of authorisation: 26/04/2019, , Revision: 16, Authorised, Last updated: 04/09/2023
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Human medicine European public assessment report (EPAR): Bimervax (updated)

SARS-CoV-2 virus recombinant spike (S) protein receptor binding domain (RBD) fusion heterodimer – B.1.351-B.1.1.7 strains, COVID-19 virus infection
Date of authorisation: 30/03/2023, , Revision: 2, Authorised, Last updated: 01/09/2023
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Human medicine European public assessment report (EPAR): Fintepla (updated)

Fenfluramine hydrochloride, Epilepsies, Myoclonic
Date of authorisation: 18/12/2020, , , Revision: 6, Authorised, Last updated: 01/09/2023
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Human medicine European public assessment report (EPAR): Qinlock (updated)

ripretinib, Gastrointestinal Stromal Tumors
Date of authorisation: 18/11/2021, , , Revision: 5, Authorised, Last updated: 30/08/2023
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Human medicine European public assessment report (EPAR): Bavencio (updated)

avelumab, Neuroendocrine Tumors
Date of authorisation: 18/09/2017, , Revision: 16, Authorised, Last updated: 30/08/2023
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Human medicine European public assessment report (EPAR): Zolgensma (updated)

onasemnogene abeparvovec, Muscular Atrophy, Spinal
Date of authorisation: 18/05/2020, , , , Revision: 12, Authorised, Last updated: 29/08/2023
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Human medicine European public assessment report (EPAR): Rinvoq (updated)

upadacitinib, Arthritis, Rheumatoid
Date of authorisation: 16/12/2019, , , Revision: 17, Authorised, Last updated: 29/08/2023
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Human medicine European public assessment report (EPAR): Lupkynis (updated)

Voclosporin, Lupus Nephritis
Date of authorisation: 15/09/2022, , Revision: 2, Authorised, Last updated: 29/08/2023