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Medicine European public assessment reports (EPAR) Remove European public assessment reports (EPAR) filter Paediatric investigation plans Remove Paediatric investigation plans filter

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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
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Human medicine European public assessment report (EPAR): Rizmoic

Naldemedine tosilate, Constipation
Date of authorisation: 18/02/2019, , Revision: 7, Authorised, Last updated: 22/12/2022
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Human medicine European public assessment report (EPAR): Imvanex

modified vaccinia Ankara - Bavarian Nordic (MVA-BN) virus, Smallpox Vaccine; Monkeypox virus
Date of authorisation: 31/07/2013, , , Revision: 23, Authorised, Last updated: 22/12/2022
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Human medicine European public assessment report (EPAR): Quinsair

levofloxacin, Cystic Fibrosis; Respiratory Tract Infections
Date of authorisation: 25/03/2015, , Revision: 15, Authorised, Last updated: 22/12/2022
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Human medicine European public assessment report (EPAR): Hepcludex

Bulevirtide acetate, Hepatitis D, Chronic
Date of authorisation: 31/07/2020, , , , Revision: 8, Authorised, Last updated: 22/12/2022
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Human medicine European public assessment report (EPAR): Exjade

deferasirox, beta-Thalassemia; Iron Overload
Date of authorisation: 28/08/2006, , Revision: 51, Authorised, Last updated: 22/12/2022
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Human medicine European public assessment report (EPAR): Esperoct

Turoctocog alfa pegol, Hemophilia A
Date of authorisation: 20/06/2019, , Revision: 4, Authorised, Last updated: 22/12/2022
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Human medicine European public assessment report (EPAR): Spikevax (previously COVID-19 Vaccine Moderna)

CX-024414 (single-stranded, 5’-capped messenger RNA (mRNA) produced using a cell-free in vitro transcription from the corresponding DNA templates, encoding the viral spike (S) protein of SARS-CoV-2), COVID-19 virus infection
Date of authorisation: 06/01/2021, , , Revision: 35, Authorised, Last updated: 22/12/2022
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Human medicine European public assessment report (EPAR): Opsumit

Macitentan, Hypertension, Pulmonary
Date of authorisation: 20/12/2013, , Revision: 21, Authorised, Last updated: 22/12/2022
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Human medicine European public assessment report (EPAR): Ronapreve

casirivimab, imdevimab, COVID-19 virus infection
Date of authorisation: 12/11/2021, , Revision: 2, Authorised, Last updated: 21/12/2022
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Human medicine European public assessment report (EPAR): Abecma

idecabtagene vicleucel, Multiple Myeloma; Neoplasms; Cancer; Neoplasms, Plasma Cell; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Infectious Mononucleosis; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases
Date of authorisation: 18/08/2021, , , , Revision: 5, Authorised, Last updated: 21/12/2022
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Human medicine European public assessment report (EPAR): Retsevmo

Selpercatinib, Carcinoma, Non-Small-Cell Lung; Thyroid Neoplasms
Date of authorisation: 11/02/2021, , , Revision: 5, Authorised, Last updated: 20/12/2022