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Medicine European public assessment reports (EPAR) Remove European public assessment reports (EPAR) filter Summaries of opinion Remove Summaries of opinion filter Orphan designations Remove Orphan designations filter Direct healthcare professional communication Remove Direct healthcare professional communication filter

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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Date of authorisation: 26/09/2019, , Revision: 7, Withdrawn, Last updated: 16/01/2023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, , , , Revision: 12, Authorised, Last updated: 16/01/2023
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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, , , , 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): 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, , , , Revision: 13, Authorised, Last updated: 11/01/2023
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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): Adakveo (updated)

Crizanlizumab, Anemia, Sickle Cell
Date of authorisation: 28/10/2020, , , , Revision: 3, Authorised, Last updated: 10/01/2023
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Human medicine European public assessment report (EPAR): Veklury (updated)

remdesivir, Coronavirus Infections
Date of authorisation: 03/07/2020, , Revision: 16, 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, , , , 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): Onbevzi (updated)

bevacizumab, Colorectal Neoplasms; Breast Neoplasms; Ovarian Neoplasms; Fallopian Tube Neoplasms; Peritoneal Neoplasms; Carcinoma, Non-Small-Cell Lung; Carcinoma, Renal Cell; Uterine Cervical Neoplasms
Date of authorisation: 11/01/2021, , , Revision: 3, Authorised, Last updated: 05/01/2023
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Human medicine European public assessment report (EPAR): Byooviz (updated)

ranibizumab, Wet Macular Degeneration; Macular Edema; Diabetic Retinopathy; Myopia, Degenerative
Date of authorisation: 18/08/2021, , , Revision: 5, Authorised, Last updated: 05/01/2023
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Human medicine European public assessment report (EPAR): Zirabev (updated)

bevacizumab, Colorectal Neoplasms; Breast Neoplasms; Carcinoma, Non-Small-Cell Lung; Carcinoma, Renal Cell; Uterine Cervical Neoplasms
Date of authorisation: 14/02/2019, , , Revision: 12, Authorised, Last updated: 05/01/2023
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Human medicine European public assessment report (EPAR): Oyavas (updated)

bevacizumab, Colorectal Neoplasms; Breast Neoplasms; Ovarian Neoplasms; Fallopian Tube Neoplasms; Peritoneal Neoplasms; Carcinoma, Non-Small-Cell Lung; Carcinoma, Renal Cell; Uterine Cervical Neoplasms
Date of authorisation: 26/03/2021, , , Revision: 4, Authorised, Last updated: 05/01/2023
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Human medicine European public assessment report (EPAR): Bretaris Genuair (updated)

aclidinium bromide, Pulmonary Disease, Chronic Obstructive
Date of authorisation: 20/07/2012, , Revision: 18, Authorised, Last updated: 05/01/2023
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Human medicine European public assessment report (EPAR): Brimica Genuair (updated)

formoterol fumarate dihydrate, aclidinium bromide, Pulmonary Disease, Chronic Obstructive
Date of authorisation: 19/11/2014, , Revision: 13, Authorised, Last updated: 04/01/2023
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Human medicine European public assessment report (EPAR): Ocaliva (updated)

Obeticholic acid, Liver Cirrhosis, Biliary
Date of authorisation: 12/12/2016, , , , Revision: 15, Authorised, Last updated: 04/01/2023