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115 results
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Human medicine European public assessment report (EPAR): Docetaxel Teva Pharma
docetaxel, Carcinoma, Non-Small-Cell Lung; Breast Neoplasms; Prostatic Neoplasms
Date of authorisation: 21/01/2011,
, Revision: 6, Withdrawn, Last updated: 21/01/2014
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Human medicine European public assessment report (EPAR): Dropcys
mercaptamine, Corneal Diseases; Cystinosis
Date of refusal: 24/06/2016,
, Refused, Last updated: 25/07/2016
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Human medicine European public assessment report (EPAR): Duzallo
allopurinol, lesinurad, Gout
Date of authorisation: 23/08/2018,
, Revision: 2, Withdrawn, Last updated: 06/08/2020
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Human medicine European public assessment report (EPAR): Elelyso
Taliglucerase alfa, Gaucher Disease
Date of refusal: 25/10/2012,, Refused, Last updated: 23/11/2012
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Human medicine European public assessment report (EPAR): Enzepi
pancreas powder, Exocrine Pancreatic Insufficiency
Date of authorisation: 29/06/2016,, Revision: 1, Withdrawn, Last updated: 17/02/2021
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Human medicine European public assessment report (EPAR): Equidacent
bevacizumab, Colorectal Neoplasms; Breast Neoplasms; Ovarian Neoplasms; Carcinoma, Non-Small-Cell Lung; Carcinoma, Renal Cell
Date of authorisation: 24/09/2020,, 
, Revision: 3, Withdrawn, Last updated: 25/11/2021
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Human medicine European public assessment report (EPAR): Evarrest
human fibrinogen, human thrombin, Hemostasis
Date of authorisation: 25/09/2013,, Revision: 4, Withdrawn, Last updated: 03/04/2018
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Human medicine European public assessment report (EPAR): Exondys
eteplirsen, Muscular Dystrophy, Duchenne
Date of refusal: 06/12/2018,, Refused, Last updated: 12/12/2018
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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Date of authorisation: 23/09/2015,, Revision: 2, Withdrawn, Last updated: 04/02/2020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): Filgrastim ratiopharm
filgrastim, Neutropenia; Hematopoietic Stem Cell Transplantation; Cancer
Date of authorisation: 15/09/2008,, Revision: 1, Withdrawn, Last updated: 20/07/2011
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Human medicine European public assessment report (EPAR): Fluenz
Reassortant influenza virus (live attenuated) of the following strains:A/California/7/2009 (H1N1)pdm09 like strain, A/Victoria/361/2011 (H3N2) like strain, B/Massachusetts/2/2012 like strain, Influenza, Human; Immunization
Date of authorisation: 27/01/2011,, Revision: 4, Withdrawn, Last updated: 03/12/2014
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Human medicine European public assessment report (EPAR): Folotyn
Pralatrexate, Lymphoma, T-Cell
Date of refusal: 21/06/2012,, Refused, Last updated: 11/07/2012
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Human medicine European public assessment report (EPAR): Gamifant
Emapalumab, Immune System Diseases
Date of refusal: 07/01/2021,, Refused, Last updated: 23/03/2021
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Human medicine European public assessment report (EPAR): Glidipion (previously Pioglitazone Actavis Group)
pioglitazone hydrochloride, Diabetes Mellitus, Type 2
Date of authorisation: 15/03/2012,, Revision: 8, Withdrawn, Last updated: 17/10/2022
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Human medicine European public assessment report (EPAR): Glybera
alipogene tiparvovec, Hyperlipoproteinemia Type I
Date of authorisation: 25/10/2012,, 
, Revision: 8, Withdrawn, Last updated: 30/10/2017
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Human medicine European public assessment report (EPAR): Halimatoz
adalimumab, Hidradenitis Suppurativa; Psoriasis; Arthritis, Juvenile Rheumatoid; Uveitis; Arthritis, Rheumatoid; Spondylitis, Ankylosing; Arthritis, Psoriatic
Date of authorisation: 26/07/2018,, , Revision: 8, Withdrawn, Last updated: 29/01/2021
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Human medicine European public assessment report (EPAR): Heparesc
Human heterologous liver cells, Urea Cycle Disorders, Inborn
Date of refusal: 21/12/2015,, Refused, Last updated: 04/04/2016
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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): Imatinib Actavis
imatinib, Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Myelodysplastic-Myeloproliferative Diseases; Hypereosinophilic Syndrome; Dermatofibrosarcoma
Date of authorisation: 17/04/2013,, Revision: 13, Withdrawn, Last updated: 05/07/2022
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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): 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): Incivo
telaprevir, Hepatitis C, Chronic
Date of authorisation: 19/09/2011,, Revision: 19, Withdrawn, Last updated: 06/10/2016
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Human medicine European public assessment report (EPAR): Ipreziv
Azilsartan medoxomil, Hypertension
Date of authorisation: 07/12/2011,, Revision: 4, Withdrawn, Last updated: 19/12/2014
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Human medicine European public assessment report (EPAR): Istodax
romidepsin, Lymphoma, Non-Hodgkin
Date of refusal: 12/02/2013,, Refused, Last updated: 14/03/2013
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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