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Medicine
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Human medicine European public assessment report (EPAR): Trogarzo (updated)
Ibalizumab, HIV Infections
Date of authorisation: 26/09/2019,, Revision: 7, Withdrawn, Last updated: 16/01/2023
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Human medicine European public assessment report (EPAR): Kesimpta (updated)
ofatumumab, Multiple Sclerosis, Relapsing-Remitting
Date of authorisation: 26/03/2021,, Revision: 4, Authorised, Last updated: 16/01/2023
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Human medicine European public assessment report (EPAR): Orphacol (updated)
cholic acid, Digestive System Diseases; Metabolism, Inborn Errors
Date of authorisation: 12/09/2013,
Date of refusal: 25/05/2012,,
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, Revision: 12, Authorised, Last updated: 16/01/2023
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Human medicine European public assessment report (EPAR): Sugammadex Amomed (updated)
sugammadex sodium, Neuromuscular Blockade
Date of authorisation: 10/01/2023,, Authorised, Last updated: 13/01/2023
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Human medicine European public assessment report (EPAR): Pregabalin Mylan (updated)
pregabalin, Anxiety Disorders; Epilepsy
Date of authorisation: 24/06/2015,, Revision: 16, Authorised, Last updated: 13/01/2023
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Human medicine European public assessment report (EPAR): Vocabria (updated)
Cabotegavir sodium, Cabotegravir, HIV Infections
Date of authorisation: 17/12/2020,, Revision: 8, Authorised, Last updated: 12/01/2023
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Human medicine European public assessment report (EPAR): Ebvallo (updated)
Tabelecleucel, Lymphoproliferative Disorders
Date of authorisation: 16/12/2022,,
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, Authorised, Last updated: 12/01/2023
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Human medicine European public assessment report (EPAR): Xevudy (updated)
Sotrovimab, COVID-19 virus infection
Date of authorisation: 17/12/2021,, Revision: 7, Authorised, Last updated: 12/01/2023
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Human medicine European public assessment report (EPAR): Alofisel (updated)
darvadstrocel, Rectal Fistula
Date of authorisation: 23/03/2018,,
, Revision: 9, Authorised, Last updated: 12/01/2023
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Human medicine European public assessment report (EPAR): Lokelma (updated)
sodium zirconium cyclosilicate, Hyperkalemia
Date of authorisation: 22/03/2018,, Revision: 7, Authorised, Last updated: 12/01/2023
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Human medicine European public assessment report (EPAR): Aripiprazole Mylan Pharma (previously Aripiprazole Pharmathen) (updated)
aripiprazole, Schizophrenia; Bipolar Disorder
Date of authorisation: 30/06/2015,, Revision: 15, Authorised, Last updated: 12/01/2023
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Human medicine European public assessment report (EPAR): Duaklir Genuair (updated)
aclidinium bromide, formoterol fumarate dihydrate, Pulmonary Disease, Chronic Obstructive
Date of authorisation: 19/11/2014,, Revision: 15, Authorised, Last updated: 11/01/2023
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Human medicine European public assessment report (EPAR): Eklira Genuair (updated)
aclidinium bromide, Pulmonary Disease, Chronic Obstructive
Date of authorisation: 20/07/2012,, Revision: 20, Authorised, Last updated: 11/01/2023
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Human medicine European public assessment report (EPAR): Natpar (updated)
parathyroid hormone, Hypoparathyroidism
Date of authorisation: 24/04/2017,,
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, Revision: 13, Authorised, Last updated: 11/01/2023
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Human medicine European public assessment report (EPAR): Tacforius (updated)
tacrolimus monohydrate, Liver Transplantation; Kidney Transplantation
Date of authorisation: 08/12/2017,, Revision: 7, Authorised, Last updated: 10/01/2023
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Human medicine European public assessment report (EPAR): Jcovden (previously COVID-19 Vaccine Janssen) (updated)
adenovirus type 26 encoding the SARS-CoV-2 spike glycoprotein (Ad26.COV2-S), COVID-19 virus infection
Date of authorisation: 11/03/2021,,
, Revision: 27, Authorised, Last updated: 10/01/2023
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Human medicine European public assessment report (EPAR): Nuvaxovid (updated)
SARS-CoV-2 recombinant spike protein, COVID-19 virus infection
Date of authorisation: 20/12/2021,,
, Revision: 7, Authorised, Last updated: 10/01/2023
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Human medicine European public assessment report (EPAR): Amvuttra (updated)
vutrisiran sodium, Amyloid Neuropathies, Familial
Date of authorisation: 15/09/2022,,
, Revision: 1, Authorised, Last updated: 10/01/2023
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Human medicine European public assessment report (EPAR): Deferasirox Mylan (updated)
deferasirox, Iron Overload; beta-Thalassemia
Date of authorisation: 26/09/2019,, Revision: 8, Authorised, Last updated: 10/01/2023
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Human medicine European public assessment report (EPAR): Adakveo (updated)
Crizanlizumab, Anemia, Sickle Cell
Date of authorisation: 28/10/2020,,
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, Revision: 3, Authorised, Last updated: 10/01/2023
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Human medicine European public assessment report (EPAR): Pregabalin Accord (updated)
pregabalin, Anxiety Disorders; Epilepsy
Date of authorisation: 28/08/2015,, Revision: 15, Authorised, Last updated: 09/01/2023
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Human medicine European public assessment report (EPAR): Pemazyre (updated)
pemigatinib, Cholangiocarcinoma
Date of authorisation: 26/03/2021,,
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, Revision: 4, Authorised, Last updated: 09/01/2023
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Human medicine European public assessment report (EPAR): Byfavo (updated)
remimazolam, Conscious Sedation
Date of authorisation: 26/03/2021,, Revision: 3, Authorised, Last updated: 06/01/2023
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Human medicine European public assessment report (EPAR): Pregabalin Sandoz GmbH
pregabalin, Anxiety Disorders; Epilepsy
Date of authorisation: 19/06/2015,, Revision: 14, Authorised, Last updated: 05/01/2023
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Human medicine European public assessment report (EPAR): Pregabalin Sandoz
pregabalin, Anxiety Disorders; Neuralgia; Epilepsy
Date of authorisation: 19/06/2015,, Revision: 15, Authorised, Last updated: 05/01/2023