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

Palbociclib, Breast Neoplasms
Date of authorisation: 09/11/2016, , Revision: 16, Authorised, Last updated: 06/06/2023
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Human medicine European public assessment report (EPAR): Tezspire (updated)

tezepelumab, Asthma
Date of authorisation: 19/09/2022, , Revision: 4, Authorised, Last updated: 05/06/2023
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Human medicine European public assessment report (EPAR): Vydura (updated)

Rimegepant, Migraine Disorders
Date of authorisation: 25/04/2022, , Revision: 5, Authorised, Last updated: 05/06/2023
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Human medicine European public assessment report (EPAR): Xerava (updated)

eravacycline, Infection; Bacterial Infections
Date of authorisation: 20/09/2018, , Revision: 7, Authorised, Last updated: 05/06/2023
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Human medicine European public assessment report (EPAR): Onpattro (updated)

patisiran sodium, Amyloidosis, Familial
Date of authorisation: 27/08/2018, , , , Revision: 11, Authorised, Last updated: 02/06/2023
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Human medicine European public assessment report (EPAR): Adynovi (updated)

rurioctocog alfa pegol, Hemophilia A
Date of authorisation: 08/01/2018, , Revision: 9, Authorised, Last updated: 02/06/2023
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Human medicine European public assessment report (EPAR): Rinvoq (updated)

upadacitinib, Arthritis, Rheumatoid
Date of authorisation: 16/12/2019, , , Revision: 15, Authorised, Last updated: 02/06/2023
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Human medicine European public assessment report (EPAR): Oxervate (updated)

Recombinant human nerve growth factor, Keratitis
Date of authorisation: 06/07/2017, , , , Revision: 2, Authorised, Last updated: 02/06/2023
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Human medicine European public assessment report (EPAR): Vildagliptin / Metformin hydrochloride Accord (updated)

metformin hydrochloride, vildagliptin, Diabetes Mellitus, Type 2
Date of authorisation: 24/03/2022, , , Revision: 2, Authorised, Last updated: 01/06/2023
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Human medicine European public assessment report (EPAR): Empliciti (updated)

Elotuzumab, Multiple Myeloma
Date of authorisation: 11/05/2016, , Revision: 12, Authorised, Last updated: 01/06/2023
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Human medicine European public assessment report (EPAR): Benepali (updated)

etanercept, Arthritis, Psoriatic; Arthritis, Rheumatoid; Psoriasis
Date of authorisation: 13/01/2016, , Revision: 20, Authorised, Last updated: 01/06/2023
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Human medicine European public assessment report (EPAR): Epysqli (updated)

Eculizumab, Hemoglobinuria, Paroxysmal
Date of authorisation: 26/05/2023, , , Authorised, Last updated: 31/05/2023
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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: 37, Authorised, Last updated: 31/05/2023
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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: 35, Authorised, Last updated: 30/05/2023
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Human medicine European public assessment report (EPAR): Ondexxya (updated)

andexanet alfa, Drug-Related Side Effects and Adverse Reactions
Date of authorisation: 26/04/2019, , , Revision: 15, Authorised, Last updated: 30/05/2023
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Human medicine European public assessment report (EPAR): Jyseleca (updated)

filgotinib maleate, Arthritis, Rheumatoid
Date of authorisation: 24/09/2020, , , Revision: 9, Authorised, Last updated: 30/05/2023
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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: 11, Authorised, Last updated: 30/05/2023
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Human medicine European public assessment report (EPAR): Pombiliti (updated)

Cipaglucosidase alfa, Glycogen Storage Disease Type II
Date of authorisation: 20/03/2023, , Authorised, Last updated: 30/05/2023
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Human medicine European public assessment report (EPAR): Qinlock (updated)

ripretinib, Gastrointestinal Stromal Tumors
Date of authorisation: 18/11/2021, , , Revision: 3, Authorised, Last updated: 30/05/2023
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Human medicine European public assessment report (EPAR): Ratiograstim (updated)

filgrastim, Neutropenia; Hematopoietic Stem Cell Transplantation; Cancer
Date of authorisation: 15/09/2008, , Revision: 16, Authorised, Last updated: 30/05/2023
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Human medicine European public assessment report (EPAR): Beovu (updated)

brolucizumab, Wet Macular Degeneration
Date of authorisation: 13/02/2020, , Revision: 8, Authorised, Last updated: 26/05/2023
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Human medicine European public assessment report (EPAR): Breyanzi (updated)

CD19-directed genetically modified autologous cell-based product consisting of purified CD8+ T-cells (CD8+ cells), CD19-directed genetically modified autologous cell-based product consisting of purified CD4+ T cells (CD4+ cells), Lymphoma, Large B-Cell, Diffuse; Lymphoma, Follicular; Mediastinal Neoplasms
Date of authorisation: 04/04/2022, , Revision: 1, Authorised, Last updated: 25/05/2023
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Human medicine European public assessment report (EPAR): Livmarli (updated)

Maralixibat chloride, Alagille Syndrome
Date of authorisation: 09/12/2022, , , , Revision: 1, Authorised, Last updated: 25/05/2023
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Human medicine European public assessment report (EPAR): Galafold (updated)

Migalastat hydrochloride, Fabry Disease
Date of authorisation: 25/05/2016, , , Revision: 16, Authorised, Last updated: 25/05/2023
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Human medicine European public assessment report (EPAR): Evoltra (updated)

clofarabine, Precursor Cell Lymphoblastic Leukemia-Lymphoma
Date of authorisation: 29/05/2006, , , Revision: 33, Authorised, Last updated: 25/05/2023