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Human medicine European public assessment report (EPAR): Herzuma (updated)
trastuzumab, Stomach Neoplasms, Breast Neoplasms
Date of authorisation: 08/02/2018,,
, Revision: 11, Authorised, Last updated: 01/03/2021
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Human medicine European public assessment report (EPAR): Epidyolex (updated)
Cannabidiol, Lennox Gastaut Syndrome, Epilepsies, Myoclonic
Date of authorisation: 19/09/2019,, Revision: 5, Authorised, Last updated: 01/03/2021
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Human medicine European public assessment report (EPAR): Pioglitazone Teva (updated)
pioglitazone hydrochloride, Diabetes Mellitus, Type 2
Date of authorisation: 26/03/2012,, Revision: 11, Authorised, Last updated: 01/03/2021
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Human medicine European public assessment report (EPAR): Braftovi (updated)
Encorafenib, Melanoma, Colorectal Neoplasms
Date of authorisation: 19/09/2018,, Revision: 5, Authorised, Last updated: 01/03/2021
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Human medicine European public assessment report (EPAR): Ondexxya (updated)
andexanet alfa, Drug-Related Side Effects and Adverse Reactions
Date of authorisation: 26/04/2019,,
, Revision: 8, Authorised, Last updated: 01/03/2021
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Human medicine European public assessment report (EPAR): Glivec (updated)
imatinib, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Gastrointestinal Stromal Tumors, Dermatofibrosarcoma, Myelodysplastic-Myeloproliferative Diseases, Leukemia, Myelogenous, Chronic, BCR-ABL Positive, Hypereosinophilic Syndrome
Date of authorisation: 07/11/2001,, Revision: 40, Authorised, Last updated: 01/03/2021
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Human medicine European public assessment report (EPAR): Praluent (updated)
Alirocumab, Dyslipidemias
Date of authorisation: 23/09/2015,, Revision: 16, Authorised, Last updated: 01/03/2021
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Human medicine European public assessment report (EPAR): Pioglitazone Accord (updated)
pioglitazone hydrochloride, Diabetes Mellitus, Type 2
Date of authorisation: 21/03/2012,, Revision: 6, Authorised, Last updated: 26/02/2021
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Human medicine European public assessment report (EPAR): Ilumetri (updated)
tildrakizumab, Psoriasis
Date of authorisation: 17/09/2018,, Revision: 3, Authorised, Last updated: 26/02/2021
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Human medicine European public assessment report (EPAR): Imbruvica (updated)
Ibrutinib, Lymphoma, Mantle-Cell, Leukemia, Lymphocytic, Chronic, B-Cell
Date of authorisation: 21/10/2014,, Revision: 21, Authorised, Last updated: 26/02/2021
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Human medicine European public assessment report (EPAR): Vpriv (updated)
velaglucerase alfa, Gaucher Disease
Date of authorisation: 26/08/2010,,
, Revision: 14, Authorised, Last updated: 26/02/2021
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Human medicine European public assessment report (EPAR): Lamivudine Teva (updated)
lamivudine, Hepatitis B, Chronic
Date of authorisation: 23/10/2009,, Revision: 10, Authorised, Last updated: 26/02/2021
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Human medicine European public assessment report (EPAR): Clopidogrel Teva (hydrogen sulphate) (updated)
clopidogrel (as hydrogen sulfate), Acute Coronary Syndrome, Peripheral Vascular Diseases, Myocardial Infarction, Stroke
Date of authorisation: 27/07/2009,, Revision: 16, Authorised, Last updated: 26/02/2021
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Human medicine European public assessment report (EPAR): Taltz (updated)
ixekizumab, Psoriasis
Date of authorisation: 25/04/2016,, Revision: 12, Authorised, Last updated: 26/02/2021
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Human medicine European public assessment report (EPAR): Myfenax (updated)
mycophenolate mofetil, Graft Rejection
Date of authorisation: 21/02/2008,, Revision: 23, Authorised, Last updated: 26/02/2021
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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,,
, Revision: 3, 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): 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): 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): 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): 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): 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): Cinryze (updated)
C1 inhibitor (human), Angioedemas, Hereditary
Date of authorisation: 15/06/2011,, Revision: 19, Authorised, Last updated: 24/02/2021