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Medicine
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Human medicine European public assessment report (EPAR): Comirnaty (updated)
Single-stranded, 5’-capped messenger RNA 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: 21/12/2020,
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, Revision: 3, Authorised, Last updated: 25/02/2021
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Human medicine European public assessment report (EPAR): Revolade (updated)
Eltrombopag, Purpura, Thrombocytopenic, Idiopathic
Date of authorisation: 11/03/2010, Revision: 26, Authorised, Last updated: 25/02/2021 -
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Human medicine European public assessment report (EPAR): Telzir (updated)
fosamprenavir calcium, HIV Infections
Date of authorisation: 12/07/2004, Revision: 45, Authorised, Last updated: 25/02/2021 -
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Human medicine European public assessment report (EPAR): Ervebo (updated)
recombinant vesicular stomatitis virus (strain indiana) with a deletion of the envelope glycoprotein, replaced with the zaire ebolavirus (strain kikwit 1995) surface glycoprotein, Hemorrhagic Fever, Ebola
Date of authorisation: 11/11/2019,, Revision: 4, Authorised, Last updated: 25/02/2021
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Human medicine European public assessment report (EPAR): Neuraceq (updated)
florbetaben (18F), Radionuclide Imaging, Alzheimer Disease
Date of authorisation: 20/02/2014, Revision: 16, Authorised, Last updated: 25/02/2021 -
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Human medicine European public assessment report (EPAR): Tesavel (updated)
sitagliptin, Diabetes Mellitus, Type 2
Date of authorisation: 10/01/2008, Revision: 24, Authorised, Last updated: 25/02/2021 -
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Human medicine European public assessment report (EPAR): Dectova (updated)
Zanamivir, Influenza, Human
Date of authorisation: 26/04/2019,, Revision: 2, Authorised, Last updated: 25/02/2021
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Human medicine European public assessment report (EPAR): Trizivir (updated)
abacavir (as sulfate), lamivudine, zidovudine, HIV Infections
Date of authorisation: 27/12/2000, Revision: 36, Authorised, Last updated: 25/02/2021 -
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Human medicine European public assessment report (EPAR): Entecavir Mylan (updated)
entecavir monohydrate, Hepatitis B
Date of authorisation: 18/09/2017,
, Revision: 3, Authorised, Last updated: 25/02/2021
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Human medicine European public assessment report (EPAR): Kivexa (updated)
abacavir, lamivudine, HIV Infections
Date of authorisation: 16/12/2004, Revision: 33, Authorised, Last updated: 25/02/2021 -
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Human medicine European public assessment report (EPAR): Xaluprine (previously Mercaptopurine Nova Laboratories) (updated)
6-mercaptopurine monohydrate, Leukemia, Lymphoid
Date of authorisation: 09/03/2012,
, Revision: 11, Authorised, Last updated: 25/02/2021
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Human medicine European public assessment report (EPAR): Truberzi (updated)
eluxadoline, Irritable Bowel Syndrome, Diarrhea
Date of authorisation: 19/09/2016,, Revision: 6, Withdrawn, Last updated: 25/02/2021
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Human medicine European public assessment report (EPAR): Janumet (updated)
sitagliptin, metformin hydrochloride, Diabetes Mellitus, Type 2
Date of authorisation: 16/07/2008,
Date of refusal: 18/02/2009, Revision: 27, Authorised, Last updated: 25/02/2021 -
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Human medicine European public assessment report (EPAR): Ristaben (updated)
sitagliptin, Diabetes Mellitus, Type 2
Date of authorisation: 15/03/2010, Revision: 23, Authorised, Last updated: 25/02/2021 -
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Human medicine European public assessment report (EPAR): Ziagen (updated)
abacavir, HIV Infections
Date of authorisation: 08/07/1999, Revision: 42, Authorised, Last updated: 24/02/2021 -
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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: 9, Authorised, Last updated: 24/02/2021
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Human medicine European public assessment report (EPAR): Levetiracetam Sun (updated)
levetiracetam, Epilepsy
Date of authorisation: 14/12/2011,, Revision: 14, Authorised, Last updated: 24/02/2021
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Human medicine European public assessment report (EPAR): Inhixa (updated)
enoxaparin sodium, Venous Thromboembolism
Date of authorisation: 15/09/2016,, 
, Revision: 17, Authorised, Last updated: 24/02/2021
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Human medicine European public assessment report (EPAR): Ristfor (updated)
sitagliptin, metformin hydrochloride, Diabetes Mellitus, Type 2
Date of authorisation: 15/03/2010, Revision: 23, Authorised, Last updated: 24/02/2021 -
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Human medicine European public assessment report (EPAR): Xtandi (updated)
enzalutamide, Prostatic Neoplasms
Date of authorisation: 21/06/2013,
Date of refusal: 26/04/2013, Revision: 16, Authorised, Last updated: 24/02/2021 -
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Human medicine European public assessment report (EPAR): Efficib (updated)
sitagliptin, metformin hydrochloride, Diabetes Mellitus, Type 2
Date of authorisation: 15/07/2008, Revision: 28, Authorised, Last updated: 24/02/2021 -
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Human medicine European public assessment report (EPAR): Neparvis (updated)
sacubitril, valsartan, Heart Failure
Date of authorisation: 26/05/2016,, Revision: 11, Authorised, Last updated: 24/02/2021
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Human medicine European public assessment report (EPAR): Descovy (updated)
emtricitabine, tenofovir alafenamide, HIV Infections
Date of authorisation: 21/04/2016, Revision: 17, Authorised, Last updated: 24/02/2021 -
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Human medicine European public assessment report (EPAR): Cinryze (updated)
C1 inhibitor (human), Angioedemas, Hereditary
Date of authorisation: 15/06/2011,, Revision: 19, Authorised, Last updated: 24/02/2021
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Human medicine European public assessment report (EPAR): Rolufta Ellipta (previously Rolufta) (updated)
umeclidinium bromide, Pulmonary Disease, Chronic Obstructive
Date of authorisation: 20/03/2017,, Revision: 9, Authorised, Last updated: 24/02/2021