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Medicine European public assessment reports (EPAR) Remove European public assessment reports (EPAR) filter Orphan designations Remove Orphan designations filter

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

adalimumab, Arthritis, Rheumatoid; Arthritis, Psoriatic; Psoriasis; Spondylitis, Ankylosing; Uveitis; Hidradenitis Suppurativa; Colitis, Ulcerative; Crohn Disease; Arthritis, Juvenile Rheumatoid
Date of authorisation: 11/02/2021, , Revision: 9, Authorised, Last updated: 30/01/2023
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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: 21, Authorised, Last updated: 30/01/2023
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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: 2, Authorised, Last updated: 30/01/2023
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Human medicine European public assessment report (EPAR): Zynlonta (updated)

loncastuximab tesirine, Lymphoma, Large B-Cell, Diffuse; Lymphoma, B-Cell
Date of authorisation: 20/12/2022, , , Authorised, Last updated: 26/01/2023
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Human medicine European public assessment report (EPAR): Fingolimod Mylan (updated)

fingolimod hydrochloride , Multiple Sclerosis, Relapsing-Remitting
Date of authorisation: 18/08/2021, , Revision: 3, Authorised, Last updated: 26/01/2023
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Human medicine European public assessment report (EPAR): Coagadex (updated)

Human coagulation factor X, Factor X Deficiency
Date of authorisation: 16/03/2016, , , Revision: 9, Authorised, Last updated: 25/01/2023
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Human medicine European public assessment report (EPAR): Paxlovid (updated)

nirmatrelvir, ritonavir, COVID-19 virus infection
Date of authorisation: 28/01/2022, , Revision: 8, Authorised, Last updated: 25/01/2023
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Human medicine European public assessment report (EPAR): Tabrecta (updated)

capmatinib dihydrochloride monohydrate, Carcinoma, Non-Small-Cell Lung
Date of authorisation: 20/06/2022, , Revision: 1, Authorised, Last updated: 25/01/2023
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Human medicine European public assessment report (EPAR): Dexmedetomidine Accord (updated)

dexmedetomidine, Premedication
Date of authorisation: 13/02/2020, , Revision: 6, Authorised, Last updated: 25/01/2023
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Human medicine European public assessment report (EPAR): Herzuma (updated)

trastuzumab, Stomach Neoplasms; Breast Neoplasms
Date of authorisation: 09/02/2018, , , Revision: 18, Authorised, Last updated: 25/01/2023
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Human medicine European public assessment report (EPAR): NexoBrid (updated)

proteolytic enzymes enriched in bromelain, Debridement
Date of authorisation: 18/12/2012, , , Revision: 14, Authorised, Last updated: 25/01/2023
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Human medicine European public assessment report (EPAR): Besremi (updated)

ropeginterferon alfa-2b, Polycythemia Vera
Date of authorisation: 15/02/2019, , Revision: 4, Authorised, Last updated: 25/01/2023
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Human medicine European public assessment report (EPAR): Beovu (updated)

brolucizumab, Wet Macular Degeneration
Date of authorisation: 13/02/2020, , Revision: 6, Authorised, Last updated: 25/01/2023
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Human medicine European public assessment report (EPAR): Pelgraz (updated)

pegfilgrastim, Neutropenia
Date of authorisation: 21/09/2018, , , Revision: 8, Authorised, Last updated: 23/01/2023
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Human medicine European public assessment report (EPAR): Alecensa (updated)

alectinib hydrochloride, Carcinoma, Non-Small-Cell Lung
Date of authorisation: 16/02/2017, , Revision: 13, Authorised, Last updated: 23/01/2023
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Human medicine European public assessment report (EPAR): Omnitrope (updated)

somatropin, Turner Syndrome; Prader-Willi Syndrome; Dwarfism, Pituitary
Date of authorisation: 12/04/2006, , Revision: 21, Authorised, Last updated: 23/01/2023
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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: 15, Authorised, Last updated: 23/01/2023
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Human medicine European public assessment report (EPAR): Dasatinib Accord (updated)

dasatinib, Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Date of authorisation: 24/03/2022, , Revision: 1, Authorised, Last updated: 20/01/2023
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Human medicine European public assessment report (EPAR): Xofluza (updated)

Baloxavir marboxil, Influenza, Human
Date of authorisation: 07/01/2021, , Revision: 4, Authorised, Last updated: 19/01/2023
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Human medicine European public assessment report (EPAR): Pemetrexed Baxter (updated)

pemetrexed disodium heptahydrate, Carcinoma, Non-Small-Cell Lung; Mesothelioma
Date of authorisation: 09/12/2022, , Authorised, Last updated: 19/01/2023
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Human medicine European public assessment report (EPAR): Amgevita (updated)

adalimumab, Arthritis, Psoriatic; Colitis, Ulcerative; Arthritis, Juvenile Rheumatoid; Spondylitis, Ankylosing; Psoriasis; Crohn Disease; Arthritis, Rheumatoid
Date of authorisation: 21/03/2017, , Revision: 11, Authorised, Last updated: 18/01/2023
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Human medicine European public assessment report (EPAR): Praxbind (updated)

idarucizumab, Hemorrhage
Date of authorisation: 20/11/2015, , Revision: 11, Authorised, Last updated: 18/01/2023
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Human medicine European public assessment report (EPAR): Sarclisa (updated)

Isatuximab, Multiple Myeloma
Date of authorisation: 30/05/2020, , Revision: 6, Authorised, Last updated: 18/01/2023
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Human medicine European public assessment report (EPAR): Venclyxto (updated)

Venetoclax, Leukemia, Lymphocytic, Chronic, B-Cell
Date of authorisation: 04/12/2016, , Revision: 15, Authorised, Last updated: 18/01/2023
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Human medicine European public assessment report (EPAR): Benlysta (updated)

belimumab, Lupus Erythematosus, Systemic
Date of authorisation: 13/07/2011, , Revision: 29, Authorised, Last updated: 18/01/2023