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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,,
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, 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,,
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, 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): 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,,
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, 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
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Human medicine European public assessment report (EPAR): Jemperli
dostarlimab, Endometrial Neoplasms
Date of authorisation: 21/04/2021,,
, Revision: 6, Authorised, Last updated: 19/12/2022
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Human medicine European public assessment report (EPAR): Brukinsa
zanubrutinib, Waldenstrom Macroglobulinemia
Date of authorisation: 22/11/2021,, Revision: 4, Authorised, Last updated: 16/12/2022
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Human medicine European public assessment report (EPAR): Refixia
Nonacog beta pegol, Hemophilia B
Date of authorisation: 02/06/2017,, Revision: 3, Authorised, Last updated: 16/12/2022
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Human medicine European public assessment report (EPAR): Mysimba
bupropion hydrochloride, naltrexone hydrochloride, Obesity; Overweight
Date of authorisation: 26/03/2015,, Revision: 23, Authorised, Last updated: 15/12/2022
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Human medicine European public assessment report (EPAR): Alymsys
bevacizumab, Colorectal Neoplasms; Breast Neoplasms; Ovarian 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: 15/12/2022
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Human medicine European public assessment report (EPAR): Aybintio
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: 19/08/2020,,
, Revision: 6, Authorised, Last updated: 15/12/2022
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Human medicine European public assessment report (EPAR): Elaprase
idursulfase, Mucopolysaccharidosis II
Date of authorisation: 08/01/2007,,
, Revision: 25, Authorised, Last updated: 15/12/2022