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Medicine
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Human medicine European public assessment report (EPAR): Kyprolis (updated)
carfilzomib, Multiple Myeloma
Date of authorisation: 19/11/2015,
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, Revision: 19, Authorised, Last updated: 07/05/2021
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Human medicine European public assessment report (EPAR): COVID-19 Vaccine Moderna (updated)
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,
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, Revision: 2, Authorised, Last updated: 07/05/2021
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Human medicine European public assessment report (EPAR): Lenalidomide Accord (updated)
lenalidomide, Multiple Myeloma
Date of authorisation: 20/09/2018,
, Revision: 6, Authorised, Last updated: 07/05/2021
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Human medicine European public assessment report (EPAR): 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: 2, Authorised, Last updated: 07/05/2021
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Human medicine European public assessment report (EPAR): Ketoconazole HRA (updated)
Ketoconazole, Cushing Syndrome
Date of authorisation: 18/11/2014,, , , Revision: 10, Authorised, Last updated: 07/05/2021
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Human medicine European public assessment report (EPAR): Vaborem (updated)
meropenem trihydrate, vaborbactam, Urinary Tract Infections, Bacteremia, Bacterial Infections, Respiratory Tract Infections, Pneumonia, Pneumonia, Ventilator-Associated
Date of authorisation: 20/11/2018,, Revision: 4, Authorised, Last updated: 07/05/2021
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Human medicine European public assessment report (EPAR): Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan (updated)
efavirenz, emtricitabine, tenofovir disoproxil maleate, HIV Infections
Date of authorisation: 05/09/2017,, Revision: 10, Authorised, Last updated: 07/05/2021
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Human medicine European public assessment report (EPAR): Tegsedi (updated)
inotersen sodium, Amyloidosis
Date of authorisation: 05/07/2018,, , , Revision: 7, Authorised, Last updated: 06/05/2021
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Human medicine European public assessment report (EPAR): Jinarc (updated)
Tolvaptan, Polycystic Kidney, Autosomal Dominant
Date of authorisation: 27/05/2015,, Revision: 16, Authorised, Last updated: 06/05/2021
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Human medicine European public assessment report (EPAR): Kaftrio (updated)
ivacaftor, tezacaftor, elexacaftor, Cystic Fibrosis
Date of authorisation: 21/08/2020,, , Revision: 3, Authorised, Last updated: 06/05/2021
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Human medicine European public assessment report (EPAR): Flixabi (updated)
infliximab, Spondylitis, Ankylosing, Arthritis, Rheumatoid, Crohn Disease, Colitis, Ulcerative, Arthritis, Psoriatic, Psoriasis
Date of authorisation: 26/05/2016,, 
, Revision: 17, Authorised, Last updated: 06/05/2021
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Human medicine European public assessment report (EPAR): Bortezomib Hospira (updated)
bortezomib, Multiple Myeloma
Date of authorisation: 22/07/2016,, Revision: 11, Authorised, Last updated: 06/05/2021
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Human medicine European public assessment report (EPAR): Jyseleca (updated)
filgotinib maleate, Arthritis, Rheumatoid
Date of authorisation: 24/09/2020,, Revision: 1, Authorised, Last updated: 05/05/2021
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Human medicine European public assessment report (EPAR): Daurismo (updated)
Glasdegib maleate, Leukemia, Myeloid, Acute
Date of authorisation: 26/06/2020,, , Revision: 2, Authorised, Last updated: 05/05/2021
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Human medicine European public assessment report (EPAR): Translarna (updated)
Ataluren, Muscular Dystrophy, Duchenne
Date of authorisation: 31/07/2014,, , , Revision: 19, Authorised, Last updated: 05/05/2021
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Human medicine European public assessment report (EPAR): Ifirmasta (previously Irbesartan Krka) (updated)
irbesartan hydrochloride, Hypertension
Date of authorisation: 01/12/2008,, Revision: 13, Authorised, Last updated: 05/05/2021
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Human medicine European public assessment report (EPAR): Inhixa (updated)
enoxaparin sodium, Venous Thromboembolism
Date of authorisation: 15/09/2016,, , Revision: 18, Authorised, Last updated: 05/05/2021
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Human medicine European public assessment report (EPAR): Aybintio (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: 19/08/2020,, , Revision: 3, Authorised, Last updated: 05/05/2021
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Human medicine European public assessment report (EPAR): Ifirmacombi (updated)
irbesartan, hydrochlorothiazide, Hypertension
Date of authorisation: 04/03/2011,, Revision: 12, Authorised, Last updated: 04/05/2021
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Human medicine European public assessment report (EPAR): Evoltra (updated)
clofarabine, Precursor Cell Lymphoblastic Leukemia-Lymphoma
Date of authorisation: 29/05/2006,, 
, Revision: 30, Authorised, Last updated: 04/05/2021
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Human medicine European public assessment report (EPAR): Ninlaro (updated)
ixazomib citrate, Multiple Myeloma
Date of authorisation: 21/11/2016,, , , Revision: 10, Authorised, Last updated: 30/04/2021
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Human medicine European public assessment report (EPAR): Shingrix (updated)
Recombinant varicella zoster virus glycoprotein E, Herpes Zoster
Date of authorisation: 21/03/2018,, Revision: 6, Authorised, Last updated: 30/04/2021
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Human medicine European public assessment report (EPAR): Dacogen (updated)
Decitabine, Leukemia, Myeloid
Date of authorisation: 20/09/2012,, Revision: 14, Authorised, Last updated: 30/04/2021
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Human medicine European public assessment report (EPAR): Nemdatine (updated)
memantine, Alzheimer Disease
Date of authorisation: 22/04/2013,
Date of refusal: 22/02/2013,, Revision: 10, Authorised, Last updated: 29/04/2021
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Human medicine European public assessment report (EPAR): Onivyde pegylated liposomal (previously known as Onivyde) (updated)
irinotecan anhydrous free-base, Pancreatic Neoplasms
Date of authorisation: 14/10/2016,, Revision: 8, Authorised, Last updated: 29/04/2021