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167 results
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Human medicine European public assessment report (EPAR): Herzuma (updated)
trastuzumab, Stomach Neoplasms; Breast Neoplasms
Date of authorisation: 09/02/2018,
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, Revision: 18, 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): 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): 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): Remsima (updated)
infliximab, Arthritis, Psoriatic; Spondylitis, Ankylosing; Colitis, Ulcerative; Psoriasis; Crohn Disease; Arthritis, Rheumatoid
Date of authorisation: 10/09/2013,, Revision: 31, Authorised, Last updated: 17/01/2023
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Human medicine European public assessment report (EPAR): Atriance (updated)
nelarabine, Precursor T-Cell Lymphoblastic Leukemia-Lymphoma
Date of authorisation: 22/08/2007,, 
, Revision: 26, Authorised, Last updated: 16/01/2023
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Human medicine European public assessment report (EPAR): Vyndaqel (updated)
tafamidis, Amyloidosis
Date of authorisation: 16/11/2011,, 
, , Revision: 23, Authorised, Last updated: 16/01/2023
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Human medicine European public assessment report (EPAR): Hukyndra (updated)
adalimumab, Arthritis, Psoriatic; Arthritis, Juvenile Rheumatoid; Arthritis, Rheumatoid; Colitis, Ulcerative; Crohn Disease; Hidradenitis Suppurativa; Psoriasis; Spondylitis, Ankylosing; Uveitis
Date of authorisation: 15/11/2021,, Revision: 3, Authorised, Last updated: 16/01/2023
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Human medicine European public assessment report (EPAR): Orphacol (updated)
cholic acid, Digestive System Diseases; Metabolism, Inborn Errors
Date of authorisation: 12/09/2013,
Date of refusal: 25/05/2012,, , , Revision: 12, Authorised, Last updated: 16/01/2023
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Human medicine European public assessment report (EPAR): Nivestim (updated)
filgrastim, Neutropenia; Hematopoietic Stem Cell Transplantation; Cancer
Date of authorisation: 07/06/2010,, Revision: 26, Authorised, Last updated: 12/01/2023
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Human medicine European public assessment report (EPAR): Ebvallo (updated)
Tabelecleucel, Lymphoproliferative Disorders
Date of authorisation: 16/12/2022,, , , Authorised, Last updated: 12/01/2023
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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: 19, Authorised, Last updated: 12/01/2023
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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: 20, Authorised, Last updated: 12/01/2023
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Human medicine European public assessment report (EPAR): Libmyris (updated)
adalimumab, Arthritis, Rheumatoid; Arthritis, Juvenile Rheumatoid; Spondylitis, Ankylosing; Arthritis, Psoriatic; Psoriasis; Hidradenitis Suppurativa; Crohn Disease; Colitis, Ulcerative; Uveitis
Date of authorisation: 12/11/2021,, Revision: 1, Authorised, Last updated: 11/01/2023
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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: 18, Authorised, Last updated: 06/01/2023
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Human medicine European public assessment report (EPAR): Mvasi (updated)
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: 14, Authorised, Last updated: 05/01/2023
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Human medicine European public assessment report (EPAR): Onbevzi (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: 11/01/2021,, , Revision: 3, Authorised, Last updated: 05/01/2023
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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: 5, Authorised, Last updated: 05/01/2023
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Human medicine European public assessment report (EPAR): Zirabev (updated)
bevacizumab, Colorectal Neoplasms; Breast Neoplasms; Carcinoma, Non-Small-Cell Lung; Carcinoma, Renal Cell; Uterine Cervical Neoplasms
Date of authorisation: 14/02/2019,, , Revision: 12, Authorised, Last updated: 05/01/2023
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Human medicine European public assessment report (EPAR): Oyavas (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: 26/03/2021,, , Revision: 4, Authorised, Last updated: 05/01/2023
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Human medicine European public assessment report (EPAR): Imvanex
modified vaccinia Ankara - Bavarian Nordic (MVA-BN) virus, Smallpox Vaccine; Monkeypox virus
Date of authorisation: 31/07/2013,, , Revision: 23, Authorised, Last updated: 22/12/2022
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Human medicine European public assessment report (EPAR): Bemfola
follitropin alfa, Anovulation
Date of authorisation: 26/03/2014,, Revision: 10, Authorised, Last updated: 19/12/2022
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Human medicine European public assessment report (EPAR): Alymsys
bevacizumab, Colorectal Neoplasms; Breast Neoplasms; Ovarian Neoplasms; Peritoneal Neoplasms; Carcinoma, Non-Small-Cell Lung; Carcinoma, Renal Cell; Uterine Cervical Neoplasms
Date of authorisation: 26/03/2021,, , Revision: 4, Authorised, Last updated: 15/12/2022
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Human medicine European public assessment report (EPAR): Aybintio
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: 19/08/2020,, , Revision: 6, Authorised, Last updated: 15/12/2022