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54 results
Medicine
European public assessment reports (EPAR) Remove European public assessment reports (EPAR) filter
Periodic safety update report single assessments Remove Periodic safety update report single assessments filter
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Human medicine European public assessment report (EPAR): Acrescent
memantine hydrochloride, donepezil hydrochloride, Alzheimer Disease
Date of refusal: 20/02/2013, Refused, Last updated: 11/03/2013 -
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Human medicine European public assessment report (EPAR): Adlumiz
anamorelin hydrochloride, Cachexia, Anorexia, Carcinoma, Non-Small-Cell Lung
Date of refusal: 16/11/2017, Refused, Last updated: 30/11/2017 -
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Human medicine European public assessment report (EPAR): Alpheon
recombinant human interferon alfa-2a, Hepatitis C, Chronic
Date of refusal: 05/09/2006,
, Refused, Last updated: 28/06/2006
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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): Balaxur
memantine hydrochloride, donepezil hydrochloride, Alzheimer Disease
Date of refusal: 20/02/2013, Refused, Last updated: 11/03/2013 -
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Human medicine European public assessment report (EPAR): Cabazitaxel Teva
cabazitaxel, Prostatic Neoplasms
Date of refusal: 11/07/2019, Refused, Last updated: 24/07/2019 -
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Human medicine European public assessment report (EPAR): Cimzia
Certolizumab pegol, Crohn Disease
Date of refusal: 21/05/2008, Refused, Last updated: 20/03/2008 -
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Human medicine European public assessment report (EPAR): Dexxience
betrixaban maleate, Venous Thromboembolism
Date of refusal: 20/09/2018, Refused, Last updated: 09/10/2018 -
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Human medicine European public assessment report (EPAR): Doxolipad
doxorubicin hydrochloride, Breast Neoplasms, Ovarian Neoplasms
Date of refusal: 08/08/2019, Refused, Last updated: 26/08/2019 -
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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): Eladynos
abaloparatide, Osteoporosis
Date of refusal: 07/01/2019, Refused, Last updated: 14/02/2019 -
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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): EnCyzix
enclomifene citrate, Hypogonadism
Date of refusal: 06/04/2018, Refused, Last updated: 26/01/2018 -
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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): Fanaptum
iloperidone, Schizophrenia
Date of refusal: 15/01/2018, Refused, Last updated: 19/03/2018 -
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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 (updated)
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): Gemesis
becaplermin, Guided Tissue Regeneration, Periodontal
Date of refusal: 29/01/2010, Refused, Last updated: 20/11/2009 -
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Human medicine European public assessment report (EPAR): Genasense
oblimersen, Melanoma
Date of refusal: 15/10/2007, Refused, Last updated: 31/12/2009 -
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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): Hopveus
sodium oxybate, Substance Withdrawal Syndrome, Alcohol Abstinence
Date of refusal: 06/07/2020, Refused, Last updated: 13/07/2020 -
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Veterinary medicine European public assessment report (EPAR): Horse Allo 20
allogeneic equine adipose-derived mesenchymal stem cells, Horses
Date of refusal: 13/05/2019, Refused, Last updated: 12/09/2019 -
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Human medicine European public assessment report (EPAR): Human IGG1 monoclonal antibody specific for human interleukin-1 alpha XBiotech
human IgG1 monoclonal antibody specific for human interleukin-1 alpha, Colorectal Neoplasms
Date of refusal: 08/12/2017, Refused, Last updated: 13/11/2017 -
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Human medicine European public assessment report (EPAR): Impulsor
milnacipran, Fibromyalgia
Date of refusal: 08/04/2010, Refused, Last updated: 26/04/2010 -
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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