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Human medicine European public assessment report (EPAR): Zessly (updated)
infliximab, Arthritis, Psoriatic; Psoriasis; Crohn Disease; Arthritis, Rheumatoid; Colitis, Ulcerative; Spondylitis, Ankylosing
Date of authorisation: 18/05/2018,,
, Revision: 9, Authorised, Last updated: 23/05/2022
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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: 28, Authorised, Last updated: 17/05/2022
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Human medicine European public assessment report (EPAR): Zytiga (updated)
abiraterone acetate, Prostatic Neoplasms
Date of authorisation: 05/09/2011,, Revision: 24, Authorised, Last updated: 13/05/2022
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Human medicine European public assessment report (EPAR): Kalydeco (updated)
ivacaftor, Cystic Fibrosis
Date of authorisation: 23/07/2012,,
, Revision: 33, Authorised, Last updated: 12/05/2022
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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: 16, Authorised, Last updated: 12/05/2022
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Human medicine European public assessment report (EPAR): Inflectra (updated)
infliximab, Arthritis, Psoriatic; Spondylitis, Ankylosing; Colitis, Ulcerative; Psoriasis; Crohn Disease; Arthritis, Rheumatoid
Date of authorisation: 10/09/2013,, Revision: 29, Authorised, Last updated: 12/05/2022
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Human medicine European public assessment report (EPAR): Iclusig (updated)
ponatinib, Leukemia, Myeloid; Leukemia, Lymphoid
Date of authorisation: 01/07/2013,,
, Revision: 23, Authorised, Last updated: 11/05/2022
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Human medicine European public assessment report (EPAR): Hemlibra (updated)
Emicizumab, Hemophilia A
Date of authorisation: 23/02/2018,,
, Revision: 10, Authorised, Last updated: 10/05/2022
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Human medicine European public assessment report (EPAR): Vidaza (updated)
azacitidine, Myelodysplastic Syndromes
Date of authorisation: 17/12/2008,, Revision: 24, Authorised, Last updated: 03/05/2022
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Human medicine European public assessment report (EPAR): Ofev
nintedanib, Idiopathic Pulmonary Fibrosis
Date of authorisation: 14/01/2015,, Revision: 22, Authorised, Last updated: 26/04/2022
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Human medicine European public assessment report (EPAR): Erelzi
etanercept, Arthritis, Psoriatic; Psoriasis; Arthritis, Juvenile Rheumatoid; Arthritis, Rheumatoid; Spondylitis, Ankylosing
Date of authorisation: 23/06/2017,,
, Revision: 10, Authorised, Last updated: 21/04/2022
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Human medicine European public assessment report (EPAR): Maviret
glecaprevir, pibrentasvir, Hepatitis C, Chronic
Date of authorisation: 26/07/2017,,
, Revision: 15, Authorised, Last updated: 21/04/2022
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Human medicine European public assessment report (EPAR): Truxima
rituximab, Lymphoma, Non-Hodgkin; Arthritis, Rheumatoid; Wegener Granulomatosis; Leukemia, Lymphocytic, Chronic, B-Cell; Microscopic Polyangiitis
Date of authorisation: 17/02/2017,, Revision: 16, Authorised, Last updated: 12/04/2022
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Human medicine European public assessment report (EPAR): Blitzima
rituximab, Lymphoma, Non-Hodgkin; Leukemia, Lymphocytic, Chronic, B-Cell
Date of authorisation: 13/07/2017,,
, Revision: 14, Authorised, Last updated: 12/04/2022
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Human medicine European public assessment report (EPAR): Byooviz
ranibizumab, Wet Macular Degeneration; Macular Edema; Diabetic Retinopathy; Myopia, Degenerative
Date of authorisation: 18/08/2021,,
, Revision: 2, Authorised, Last updated: 11/04/2022
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Human medicine European public assessment report (EPAR): Abevmy
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: 21/04/2021,,
, Revision: 3, Authorised, Last updated: 11/04/2022
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Human medicine European public assessment report (EPAR): Vosevi
Sofosbuvir, velpatasvir, voxilaprevi, Hepatitis C, Chronic
Date of authorisation: 26/07/2017,,
, Revision: 11, Authorised, Last updated: 11/04/2022
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Human medicine European public assessment report (EPAR): Tagrisso
osimertinib mesilate, Carcinoma, Non-Small-Cell Lung
Date of authorisation: 01/02/2016,, Revision: 15, Authorised, Last updated: 07/04/2022
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Human medicine European public assessment report (EPAR): Insulin lispro Sanofi
insulin lispro, Diabetes Mellitus
Date of authorisation: 19/07/2017,,
, Revision: 7, Authorised, Last updated: 07/04/2022
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Human medicine European public assessment report (EPAR): Herzuma
trastuzumab, Stomach Neoplasms; Breast Neoplasms
Date of authorisation: 09/02/2018,,
, Revision: 16, Authorised, Last updated: 06/04/2022
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Human medicine European public assessment report (EPAR): Oxervate
Recombinant human nerve growth factor, Keratitis
Date of authorisation: 06/07/2017,,
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, Revision: 1, Authorised, Last updated: 04/04/2022
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Human medicine European public assessment report (EPAR): Stimufend
pegfilgrastim, Neutropenia
Date of authorisation: 28/03/2022,,
, Authorised, Last updated: 04/04/2022
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Human medicine European public assessment report (EPAR): Darzalex
Daratumumab, Multiple Myeloma
Date of authorisation: 20/05/2016,,
, Revision: 18, Authorised, Last updated: 01/04/2022
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Human medicine European public assessment report (EPAR): Zirabev
bevacizumab, Colorectal Neoplasms; Breast Neoplasms; Carcinoma, Non-Small-Cell Lung; Carcinoma, Renal Cell; Uterine Cervical Neoplasms
Date of authorisation: 14/02/2019,,
, Revision: 10, Authorised, Last updated: 29/03/2022
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Human medicine European public assessment report (EPAR): Ruxience
rituximab, Leukemia, Lymphocytic, Chronic, B-Cell; Arthritis, Rheumatoid; Microscopic Polyangiitis; Pemphigus
Date of authorisation: 01/04/2020,,
, Revision: 7, Authorised, Last updated: 21/03/2022