51 results
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Human medicine European public assessment report (EPAR): Hopveus (updated)
sodium oxybate, Substance Withdrawal Syndrome, Alcohol Abstinence
Date of refusal: 06/07/2020, Refused, Last updated: 13/07/2020 -
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Human medicine European public assessment report (EPAR): Esmya
ulipristal acetate, Leiomyoma
Date of authorisation: 22/02/2012,
, Revision: 15, Suspended, Last updated: 02/04/2020
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Human medicine European public assessment report (EPAR): Ulipristal Acetate Gedeon Richter
ulipristal acetate, Leiomyosarcoma
Date of authorisation: 27/08/2018,, Suspended, Last updated: 02/04/2020
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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): 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): 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): Aplidin
Plitidepsin, Multiple Myeloma
Date of refusal: 17/07/2018,
, Refused, Last updated: 01/08/2018
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Human medicine European public assessment report (EPAR): Alsitek
masitinib mesylate, 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): Xeljanz
Tofacitinib, Arthritis, Rheumatoid Refused, Last updated: 23/07/2018 -
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Human medicine European public assessment report (EPAR): Masipro
masitinib mesylate, Mastocytosis
Date of refusal: 18/12/2017,, Refused, Last updated: 04/04/2018
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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): Onzeald
etirinotecan pegol, Breast Neoplasms
Date of refusal: 08/01/2018, Refused, Last updated: 02/02/2018 -
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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): 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): 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): 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): 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): Solumarv
insulin human, Diabetes Mellitus
Date of refusal: 11/02/2016,
, Refused, Last updated: 16/02/2016
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Human medicine European public assessment report (EPAR): Lympreva
dasiprotimut-t, Lymphoma, Non-Hodgkin
Date of refusal: 03/07/2015,, Refused, Last updated: 17/07/2015
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Human medicine European public assessment report (EPAR): Masiviera
masitinib, Pancreatic Neoplasms, Refused, Last updated: 06/01/2015
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Human medicine European public assessment report (EPAR): Reasanz
Serelaxin, Heart Failure
Date of refusal: 05/08/2014, Refused, Last updated: 01/09/2014 -
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Human medicine European public assessment report (EPAR): Nerventra
laquinimod, Multiple Sclerosis
Date of refusal: 19/08/2014, Refused, Last updated: 01/09/2014 -
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Human medicine European public assessment report (EPAR): Masican
masitinib, Gastrointestinal Stromal Tumors
Date of refusal: 04/07/2014,, Refused, Last updated: 22/11/2013
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Human medicine European public assessment report (EPAR): Kynamro
mipomersen sodium, Hypercholesterolemia
Date of refusal: 29/05/2013, Refused, Last updated: 17/06/2013 -
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Human medicine European public assessment report (EPAR): Qsiva
phentermine, topiramate, Obesity
Date of refusal: 14/05/2013, Refused, Last updated: 13/06/2013