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Medicine
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Human medicine European public assessment report (EPAR): Darzalex (updated)
Daratumumab, Multiple Myeloma
Date of authorisation: 20/05/2016,
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, Revision: 15, Authorised, Last updated: 26/01/2021
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Human medicine European public assessment report (EPAR): Invanz (updated)
ertapenem sodium, Community-Acquired Infections, Streptococcal Infections, Staphylococcal Infections, Gram-Negative Bacterial Infections, Surgical Wound Infection, Pneumonia, Bacterial
Date of authorisation: 18/04/2002, Revision: 23, Authorised, Last updated: 26/01/2021 -
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Human medicine European public assessment report (EPAR): Tecentriq (updated)
atezolizumab, Carcinoma, Transitional Cell, Carcinoma, Non-Small-Cell Lung, Urologic Neoplasms, Breast Neoplasms
Date of authorisation: 20/09/2017,, Revision: 12, Authorised, Last updated: 26/01/2021
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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,, 
, Authorised, Last updated: 26/01/2021
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Human medicine European public assessment report (EPAR): Viread (updated)
tenofovir disoproxil fumarate, Hepatitis B, Chronic, HIV Infections
Date of authorisation: 04/02/2002, Revision: 55, Authorised, Last updated: 25/01/2021 -
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Human medicine European public assessment report (EPAR): Takhzyro (updated)
lanadelumab, Angioedemas, Hereditary
Date of authorisation: 22/11/2018,, , , Revision: 4, Authorised, Last updated: 25/01/2021
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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: 8, Authorised, Last updated: 25/01/2021
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Human medicine European public assessment report (EPAR): Bevespi Aerosphere (updated)
glycopyrronium, formoterol fumarate dihydrate, Pulmonary Disease, Chronic Obstructive
Date of authorisation: 18/12/2018, Revision: 3, Authorised, Last updated: 25/01/2021 -
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Human medicine European public assessment report (EPAR): Clopidogrel ratiopharm GmbH (updated)
clopidogrel, Peripheral Vascular Diseases, Acute Coronary Syndrome, Myocardial Infarction, Stroke
Date of authorisation: 28/07/2009,
, Revision: 12, Withdrawn, Last updated: 25/01/2021
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Human medicine European public assessment report (EPAR): Ofev (updated)
nintedanib, Idiopathic Pulmonary Fibrosis
Date of authorisation: 14/01/2015,, Revision: 17, Authorised, Last updated: 25/01/2021
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Human medicine European public assessment report (EPAR): Kovaltry (updated)
octocog alfa, Hemophilia A
Date of authorisation: 18/02/2016, Revision: 10, Authorised, Last updated: 25/01/2021 -
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Human medicine European public assessment report (EPAR): Ocrevus (updated)
ocrelizumab, Multiple Sclerosis
Date of authorisation: 08/01/2018,, Revision: 9, Authorised, Last updated: 22/01/2021
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Human medicine European public assessment report (EPAR): Zerbaxa (updated)
ceftolozane sulfate, tazobactam sodium, Bacterial Infections
Date of authorisation: 18/09/2015, Revision: 13, Authorised, Last updated: 22/01/2021 -
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Human medicine European public assessment report (EPAR): Symkevi (updated)
tezacaftor, ivacaftor, Cystic Fibrosis
Date of authorisation: 31/10/2018,, , Revision: 7, Authorised, Last updated: 22/01/2021
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Human medicine European public assessment report (EPAR): Dupixent (updated)
dupilumab, Dermatitis, Atopic
Date of authorisation: 27/09/2017,, Revision: 9, Authorised, Last updated: 22/01/2021
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Human medicine European public assessment report (EPAR): Blincyto (updated)
blinatumomab, Precursor Cell Lymphoblastic Leukemia-Lymphoma
Date of authorisation: 23/11/2015,, , Revision: 11, Authorised, Last updated: 22/01/2021
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Human medicine European public assessment report (EPAR): Kalydeco (updated)
ivacaftor, Cystic Fibrosis
Date of authorisation: 23/07/2012,, , Revision: 27, Authorised, Last updated: 22/01/2021
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Human medicine European public assessment report (EPAR): ViraferonPeg (updated)
peginterferon alfa-2b, Hepatitis C, Chronic
Date of authorisation: 28/05/2000, Revision: 36, Withdrawn, Last updated: 22/01/2021 -
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Human medicine European public assessment report (EPAR): Tafinlar (updated)
dabrafenib mesylate, Melanoma
Date of authorisation: 26/08/2013, Revision: 22, Authorised, Last updated: 22/01/2021 -
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Human medicine European public assessment report (EPAR): Tremfya (updated)
guselkumab, Psoriasis
Date of authorisation: 10/11/2017,, Revision: 5, Authorised, Last updated: 22/01/2021
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Human medicine European public assessment report (EPAR): Tasigna (updated)
nilotinib, Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Date of authorisation: 19/11/2007, Revision: 38, Authorised, Last updated: 22/01/2021 -
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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: 2, Authorised, Last updated: 22/01/2021
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Human medicine European public assessment report (EPAR): Wakix (updated)
pitolisant, Narcolepsy
Date of authorisation: 31/03/2016,, , Revision: 9, Authorised, Last updated: 21/01/2021
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Human medicine European public assessment report (EPAR): Zebinix (updated)
eslicarbazepine acetate, Epilepsy
Date of authorisation: 21/04/2009, Revision: 27, Authorised, Last updated: 21/01/2021 -
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Human medicine European public assessment report (EPAR): Mysimba (updated)
bupropion hydrochloride, naltrexone hydrochloride, Obesity, Overweight
Date of authorisation: 26/03/2015,, Revision: 18, Authorised, Last updated: 21/01/2021