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121 results
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Human medicine European public assessment report (EPAR): Kolbam
cholic acid, Metabolism, Inborn Errors
Date of authorisation: 20/11/2015,
, Revision: 14, Withdrawn, Last updated: 15/07/2020
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Human medicine European public assessment report (EPAR): Kromeya
adalimumab, Arthritis, Rheumatoid; Arthritis, Juvenile Rheumatoid; Psoriasis; Arthritis, Psoriatic; Spondylitis, Ankylosing; Uveitis; Colitis, Ulcerative; Crohn Disease
Date of authorisation: 02/04/2019,
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, Revision: 4, Withdrawn, Last updated: 25/03/2020
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Human medicine European public assessment report (EPAR): Varuby
rolapitant, Vomiting; Nausea; Cancer
Date of authorisation: 19/04/2017,, Revision: 3, Withdrawn, Last updated: 02/03/2020
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Human medicine European public assessment report (EPAR): Iblias
octocog alfa, Hemophilia A
Date of authorisation: 18/02/2016,, Revision: 4, Withdrawn, Last updated: 18/02/2020
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Human medicine European public assessment report (EPAR): Fexeric
ferric citrate coordination complex, Hyperphosphatemia; Renal Dialysis
Date of authorisation: 23/09/2015,, Revision: 2, Withdrawn, Last updated: 04/02/2020
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Human medicine European public assessment report (EPAR): Thorinane
enoxaparin sodium, Venous Thromboembolism
Date of authorisation: 14/09/2016,, , Revision: 2, Withdrawn, Last updated: 24/10/2019
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Human medicine European public assessment report (EPAR): Imatinib medac
imatinib, Precursor Cell Lymphoblastic Leukemia-Lymphoma; Dermatofibrosarcoma; Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Myelodysplastic-Myeloproliferative Diseases; Hypereosinophilic Syndrome
Date of authorisation: 25/09/2013,
, Revision: 5, Withdrawn, Last updated: 16/10/2019
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Human medicine European public assessment report (EPAR): Taxespira (previously Docetaxel Hospira UK Limited )
docetaxel trihydrate, Stomach Neoplasms; Prostatic Neoplasms; Breast Neoplasms; Head and Neck Neoplasms; Carcinoma, Non-Small-Cell Lung
Date of authorisation: 28/08/2015,, Revision: 8, Withdrawn, Last updated: 15/10/2019
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Human medicine European public assessment report (EPAR): Lartruvo
Olaratumab, Sarcoma
Date of authorisation: 09/11/2016,, 
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, Revision: 3, Withdrawn, Last updated: 02/09/2019
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Human medicine European public assessment report (EPAR): Rituzena (previously Tuxella)
rituximab, Lymphoma, Non-Hodgkin; Microscopic Polyangiitis; Leukemia, Lymphocytic, Chronic, B-Cell; Wegener Granulomatosis
Date of authorisation: 13/07/2017,, , Revision: 7, Withdrawn, Last updated: 08/07/2019
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Human medicine European public assessment report (EPAR): ATryn
Antithrombin alfa, Antithrombin III Deficiency
Date of authorisation: 28/07/2006,, , Revision: 16, Withdrawn, Last updated: 02/07/2019
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Human medicine European public assessment report (EPAR): Topotecan Actavis
topotecan, Uterine Cervical Neoplasms; Small Cell Lung Carcinoma
Date of authorisation: 24/07/2009,, Revision: 6, Withdrawn, Last updated: 07/03/2019
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Human medicine European public assessment report (EPAR): Cyltezo
adalimumab, Hidradenitis Suppurativa; Arthritis, Psoriatic; Psoriasis; Crohn Disease; Arthritis, Juvenile Rheumatoid; Uveitis; Arthritis, Rheumatoid; Colitis, Ulcerative; Spondylitis, Ankylosing
Date of authorisation: 10/11/2017,, , Revision: 2, Withdrawn, Last updated: 06/03/2019
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Human medicine European public assessment report (EPAR): Solymbic
adalimumab, Arthritis, Psoriatic; Spondylitis, Ankylosing; Crohn Disease; Colitis, Ulcerative; Hidradenitis Suppurativa; Psoriasis; Arthritis, Rheumatoid
Date of authorisation: 22/03/2017,, , Revision: 2, Withdrawn, Last updated: 05/03/2019
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Human medicine European public assessment report (EPAR): Lusduna
insulin glargine, Diabetes Mellitus
Date of authorisation: 03/01/2017,, Revision: 2, Withdrawn, Last updated: 22/01/2019
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Human medicine European public assessment report (EPAR): Ivabradine JensonR
ivabradine hydrochloride, Angina Pectoris; Heart Failure
Date of authorisation: 11/11/2016,, Withdrawn, Last updated: 20/12/2018
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Human medicine European public assessment report (EPAR): Zoledronic acid Teva Pharma
zoledronic acid, Osteoporosis; Osteitis Deformans; Osteoporosis, Postmenopausal
Date of authorisation: 15/08/2012,, Revision: 11, Withdrawn, Last updated: 12/12/2018
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Human medicine European public assessment report (EPAR): Raplixa
human fibrinogen, human thrombin, Hemostasis, Surgical
Date of authorisation: 19/03/2015,, Revision: 6, Withdrawn, Last updated: 10/10/2018
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Human medicine European public assessment report (EPAR): Imatinib Teva B.V.
imatinib mesilate, Dermatofibrosarcoma; Gastrointestinal Stromal Tumors; Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Date of authorisation: 15/11/2017,, Withdrawn, Last updated: 09/10/2018
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Human medicine European public assessment report (EPAR): Alsitek
Masitinib mesilate, Amyotrophic Lateral Sclerosis
Date of refusal: 26/07/2018,
, Refused, Last updated: 31/07/2018
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Human medicine European public assessment report (EPAR): Topotecan Teva
topotecan, Ovarian Neoplasms; Uterine Cervical Neoplasms; Small Cell Lung Carcinoma
Date of authorisation: 21/09/2009,, Revision: 8, Withdrawn, Last updated: 13/07/2018
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Human medicine European public assessment report (EPAR): Zinbryta
daclizumab, Multiple Sclerosis
Date of authorisation: 01/07/2016,, Revision: 8, Withdrawn, Last updated: 28/06/2018
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Human medicine European public assessment report (EPAR): Olysio
simeprevir, Hepatitis C, Chronic
Date of authorisation: 14/05/2014,, Revision: 13, Withdrawn, Last updated: 23/05/2018
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Human medicine European public assessment report (EPAR): Vibativ
telavancin, Pneumonia, Bacterial; Cross Infection
Date of authorisation: 02/09/2011,, Revision: 10, Withdrawn, Last updated: 16/05/2018
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Human medicine European public assessment report (EPAR): Masipro
Masitinib mesilate, Mastocytosis
Date of refusal: 18/12/2017,, Refused, Last updated: 04/04/2018