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155 results
Medicine
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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: 19, Authorised, Last updated: 19/10/2021
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Human medicine European public assessment report (EPAR): Herzuma (updated)
trastuzumab, Stomach Neoplasms; Breast Neoplasms
Date of authorisation: 08/02/2018,
, , Revision: 13, Authorised, Last updated: 18/10/2021
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Human medicine European public assessment report (EPAR): Ruxience (updated)
rituximab, Leukemia, Lymphocytic, Chronic, B-Cell; Arthritis, Rheumatoid; Microscopic Polyangiitis; Pemphigus
Date of authorisation: 01/04/2020,, , Revision: 5, Authorised, Last updated: 15/10/2021
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Human medicine European public assessment report (EPAR): Abseamed (updated)
epoetin alfa, Anemia; Kidney Failure, Chronic; Cancer
Date of authorisation: 27/08/2007,
Date of refusal: 18/06/2009,, Revision: 22, Authorised, Last updated: 14/10/2021
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Human medicine European public assessment report (EPAR): Epclusa (updated)
Sofosbuvir, velpatasvir, Hepatitis C, Chronic
Date of authorisation: 06/07/2016,, 
, Revision: 16, Authorised, Last updated: 12/10/2021
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Human medicine European public assessment report (EPAR): Hulio (updated)
adalimumab, Hidradenitis Suppurativa; Psoriasis; Crohn Disease; Uveitis; Arthritis, Rheumatoid; Colitis, Ulcerative; Spondylitis, Ankylosing; Arthritis, Psoriatic
Date of authorisation: 17/09/2018,, , Revision: 9, Authorised, Last updated: 12/10/2021
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Human medicine European public assessment report (EPAR): Sovaldi (updated)
Sofosbuvir, Hepatitis C, Chronic
Date of authorisation: 16/01/2014,, , Revision: 24, Authorised, Last updated: 12/10/2021
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Human medicine European public assessment report (EPAR): Fulphila (updated)
pegfilgrastim, Neutropenia
Date of authorisation: 20/11/2018,, , Revision: 8, Authorised, Last updated: 11/10/2021
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Human medicine European public assessment report (EPAR): Vpriv (updated)
velaglucerase alfa, Gaucher Disease
Date of authorisation: 26/08/2010,, 
, Revision: 15, Authorised, Last updated: 05/10/2021
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Human medicine European public assessment report (EPAR): Zynteglo (updated)
Autologous CD34+ cell enriched population that contains hematopoietic stem cells transduced with lentiglobin BB305 lentiviral vector encoding the beta-A-T87Q-globin gene, beta-Thalassemia
Date of authorisation: 29/05/2019,, , , 
, Revision: 4, Authorised, Last updated: 04/10/2021
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Human medicine European public assessment report (EPAR): Abasaglar (previously Abasria) (updated)
insulin glargine, Diabetes Mellitus
Date of authorisation: 09/09/2014,, Revision: 12, Authorised, Last updated: 24/09/2021
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Human medicine European public assessment report (EPAR): Harvoni
ledipasvir, Sofosbuvir, Hepatitis C, Chronic
Date of authorisation: 17/11/2014,, , Revision: 23, Authorised, Last updated: 23/09/2021
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Human medicine European public assessment report (EPAR): Hemlibra
Emicizumab, Hemophilia A
Date of authorisation: 23/02/2018,, , Revision: 8, Authorised, Last updated: 23/09/2021
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Human medicine European public assessment report (EPAR): Riximyo
rituximab, Lymphoma, Non-Hodgkin; Arthritis, Rheumatoid; Microscopic Polyangiitis; Wegener Granulomatosis
Date of authorisation: 15/06/2017,, , Revision: 6, Authorised, Last updated: 21/09/2021
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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: 11, Authorised, Last updated: 15/09/2021
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Human medicine European public assessment report (EPAR): Kirsty (previously Kixelle)
insulin aspart, Diabetes Mellitus
Date of authorisation: 05/02/2021,, , Revision: 1, Authorised, Last updated: 14/09/2021
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Human medicine European public assessment report (EPAR): Inhixa
enoxaparin sodium, Venous Thromboembolism
Date of authorisation: 15/09/2016,, Revision: 19, Authorised, Last updated: 13/09/2021
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Human medicine European public assessment report (EPAR): Kanjinti
trastuzumab, Stomach Neoplasms; Breast Neoplasms
Date of authorisation: 16/05/2018,, , Revision: 8, Authorised, Last updated: 13/09/2021
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Human medicine European public assessment report (EPAR): Rixathon
rituximab, Lymphoma, Non-Hodgkin; Arthritis, Rheumatoid; Leukemia, Lymphocytic, Chronic, B-Cell; Wegener Granulomatosis; Microscopic Polyangiitis; Pemphigus
Date of authorisation: 15/06/2017,, , Revision: 5, Authorised, Last updated: 10/09/2021
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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: 4, Authorised, Last updated: 10/09/2021
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Human medicine European public assessment report (EPAR): Onbevzi
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: 1, Authorised, Last updated: 10/09/2021
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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: 13, Authorised, Last updated: 10/09/2021
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Human medicine European public assessment report (EPAR): Soliris
Eculizumab, Hemoglobinuria, Paroxysmal
Date of authorisation: 20/06/2007,, , Revision: 31, Authorised, Last updated: 09/09/2021
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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,, , Authorised, Last updated: 08/09/2021
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Human medicine European public assessment report (EPAR): Remsima
infliximab, Arthritis, Psoriatic; Spondylitis, Ankylosing; Colitis, Ulcerative; Psoriasis; Crohn Disease; Arthritis, Rheumatoid
Date of authorisation: 10/09/2013,, Revision: 24, Authorised, Last updated: 06/09/2021