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

Medicine type Biosimilar Remove Biosimilar filter Additional monitoring Remove Additional monitoring filter Exceptional circumstances Remove Exceptional circumstances filter

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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: 30/11/2023
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Human medicine European public assessment report (EPAR): Mayzent (updated)

Siponimod fumaric acid, Multiple Sclerosis, Relapsing-Remitting
Date of authorisation: 13/01/2020, , Revision: 9, Authorised, Last updated: 31/01/2023
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Human medicine European public assessment report (EPAR): Skytrofa (previously Lonapegsomatropin Ascendis Pharma) (updated)

Lonapegsomatropin, Growth and Development
Date of authorisation: 11/01/2022, , , Revision: 3, Authorised, Last updated: 31/01/2023
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Human medicine European public assessment report (EPAR): Truxima (updated)

rituximab, Lymphoma, Non-Hodgkin; Arthritis, Rheumatoid; Wegener Granulomatosis; Leukemia, Lymphocytic, Chronic, B-Cell; Microscopic Polyangiitis
Date of authorisation: 17/02/2017, , Revision: 19, Authorised, Last updated: 31/01/2023
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Human medicine European public assessment report (EPAR): Ceplene (updated)

Histamine dihydrochloride, Leukemia, Myeloid, Acute
Date of authorisation: 07/10/2008, , , Revision: 12, Authorised, Last updated: 30/01/2023
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Human medicine European public assessment report (EPAR): Tecartus (updated)

Autologous peripheral blood T cells CD4 and CD8 selected and CD3 and CD28 activated transduced with retroviral vector expressing anti-CD19 CD28/CD3-zeta chimeric antigen receptor and cultured (brexucabtagene autoleucel), Lymphoma, Mantle-Cell
Date of authorisation: 14/12/2020, , , , Revision: 4, Authorised, Last updated: 30/01/2023
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Human medicine European public assessment report (EPAR): Qdenga (updated)

Dengue virus, serotype 2, expressing Dengue virus, serotype 1, surface proteins, live, attenuated, Dengue virus, serotype 2, expressing Dengue virus, serotype 3, surface proteins, live, attenuated, Dengue virus, serotype 2, expressing Dengue virus, serotype 4, surface proteins, live, attenuated, Dengue virus, serotype 2, live, attenuated, Dengue
Date of authorisation: 05/12/2022, , Authorised, Last updated: 30/01/2023
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Human medicine European public assessment report (EPAR): Beyfortus (updated)

nirsevimab,
Date of authorisation: 31/10/2022, , Authorised, Last updated: 30/01/2023
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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: 20, Authorised, Last updated: 30/01/2023
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Human medicine European public assessment report (EPAR): Yescarta (updated)

axicabtagene ciloleucel, Lymphoma, Follicular; Lymphoma, Large B-Cell, Diffuse
Date of authorisation: 23/08/2018, , , Revision: 11, Authorised, Last updated: 30/01/2023
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Human medicine European public assessment report (EPAR): Ranivisio (updated)

ranibizumab, Wet Macular Degeneration; Macular Edema; Diabetic Retinopathy; Diabetes Complications
Date of authorisation: 25/08/2022, , , Revision: 2, Authorised, Last updated: 30/01/2023
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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): 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): 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): 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): 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: 37, 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): Xofluza (updated)

Baloxavir marboxil, Influenza, Human
Date of authorisation: 07/01/2021, , Revision: 4, Authorised, Last updated: 19/01/2023