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220 results
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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: 30, Authorised, Last updated: 25/11/2022
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Human medicine European public assessment report (EPAR): Rubraca (updated)
rucaparib camsylate, Ovarian Neoplasms
Date of authorisation: 23/05/2018,
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, Revision: 10, Authorised, Last updated: 25/11/2022
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Human medicine European public assessment report (EPAR): Byooviz (updated)
ranibizumab, Wet Macular Degeneration; Macular Edema; Diabetic Retinopathy; Myopia, Degenerative
Date of authorisation: 18/08/2021,, , Revision: 3, Authorised, Last updated: 23/11/2022
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Human medicine European public assessment report (EPAR): Paxlovid (updated)
nirmatrelvir, COVID-19 virus infection
Date of authorisation: 28/01/2022,, Revision: 6, Authorised, Last updated: 23/11/2022
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Human medicine European public assessment report (EPAR): Kinpeygo (updated)
budesonide, micronised, Glomerulonephritis, IGA
Date of authorisation: 15/07/2022,, 
, , Revision: 2, Authorised, Last updated: 23/11/2022
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Human medicine European public assessment report (EPAR): Jcovden (previously COVID-19 Vaccine Janssen) (updated)
adenovirus type 26 encoding the SARS-CoV-2 spike glycoprotein (Ad26.COV2-S), COVID-19 virus infection
Date of authorisation: 11/03/2021,, , , Revision: 25, Authorised, Last updated: 22/11/2022
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Human medicine European public assessment report (EPAR): Enhertu (updated)
trastuzumab deruxtecan, Breast Neoplasms
Date of authorisation: 18/01/2021,, , Revision: 9, Authorised, Last updated: 17/11/2022
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Human medicine European public assessment report (EPAR): Nuvaxovid (updated)
SARS-CoV-2 recombinant spike protein, COVID-19 virus infection
Date of authorisation: 20/12/2021,, , Revision: 6, Authorised, Last updated: 16/11/2022
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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: 17, Authorised, Last updated: 15/11/2022
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Human medicine European public assessment report (EPAR): Fulphila (updated)
pegfilgrastim, Neutropenia
Date of authorisation: 20/11/2018,, , Revision: 10, Authorised, Last updated: 14/11/2022
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Human medicine European public assessment report (EPAR): Blitzima (updated)
rituximab, Lymphoma, Non-Hodgkin; Leukemia, Lymphocytic, Chronic, B-Cell
Date of authorisation: 13/07/2017,, Revision: 17, Authorised, Last updated: 14/11/2022
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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: 8, Authorised, Last updated: 14/11/2022
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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: 18, Authorised, Last updated: 11/11/2022
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Human medicine European public assessment report (EPAR): Retsevmo (updated)
Selpercatinib, Carcinoma, Non-Small-Cell Lung; Thyroid Neoplasms
Date of authorisation: 11/02/2021,, , Revision: 4, Authorised, Last updated: 09/11/2022
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Human medicine European public assessment report (EPAR): Roctavian (updated)
valoctocogene roxaparvovec,
Date of authorisation: 24/08/2022,, , , Revision: 1, Authorised, Last updated: 09/11/2022
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Human medicine European public assessment report (EPAR): Waylivra (updated)
Volanesorsen sodium, Hyperlipoproteinemia Type I
Date of authorisation: 03/05/2019,, , , Revision: 6, Authorised, Last updated: 08/11/2022
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Human medicine European public assessment report (EPAR): Jemperli (updated)
dostarlimab, Endometrial Neoplasms
Date of authorisation: 21/04/2021,, , Revision: 5, Authorised, Last updated: 03/11/2022
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Human medicine European public assessment report (EPAR): Imraldi (updated)
adalimumab, Spondylitis, Ankylosing; Arthritis, Rheumatoid; Uveitis; Colitis, Ulcerative; Psoriasis; Arthritis, Psoriatic; Crohn Disease; Hidradenitis Suppurativa; Arthritis
Date of authorisation: 24/08/2017,, Revision: 19, Authorised, Last updated: 31/10/2022
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Human medicine European public assessment report (EPAR): Natpar
parathyroid hormone, Hypoparathyroidism
Date of authorisation: 24/04/2017,, , , Revision: 12, Authorised, Last updated: 27/10/2022
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Human medicine European public assessment report (EPAR): Mvasi
bevacizumab, Carcinoma, Renal Cell; Peritoneal Neoplasms; Ovarian Neoplasms; Breast Neoplasms; Carcinoma, Non-Small-Cell Lung; Fallopian Tube Neoplasms
Date of authorisation: 15/01/2018,, Revision: 13, Authorised, Last updated: 26/10/2022
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Human medicine European public assessment report (EPAR): Lorviqua
Lorlatinib, Carcinoma, Non-Small-Cell Lung
Date of authorisation: 06/05/2019,, , Revision: 10, Authorised, Last updated: 20/10/2022
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Human medicine European public assessment report (EPAR): Tecvayli
Teclistamab, Multiple Myeloma
Date of authorisation: 23/08/2022,, , Authorised, Last updated: 20/10/2022
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Human medicine European public assessment report (EPAR): Idacio
adalimumab, Arthritis, Rheumatoid; Arthritis, Psoriatic; Psoriasis; Spondylitis, Ankylosing; Uveitis; Hidradenitis Suppurativa; Colitis, Ulcerative; Crohn Disease; Arthritis, Juvenile Rheumatoid
Date of authorisation: 02/04/2019,, , Revision: 10, Authorised, Last updated: 18/10/2022
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Human medicine European public assessment report (EPAR): Tecartus
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, Lymphoma, Mantle-Cell
Date of authorisation: 14/12/2020,, , , Revision: 2, Authorised, Last updated: 18/10/2022
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Human medicine European public assessment report (EPAR): Deltyba
Delamanid, Tuberculosis, Multidrug-Resistant
Date of authorisation: 27/04/2014,
Date of refusal: 25/07/2013,, , , Revision: 22, Authorised, Last updated: 18/10/2022