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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, Small Cell Lung Carcinoma
Date of authorisation: 20/09/2017, , Revision: 13, Authorised, Last updated: 05/03/2021
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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: 04/03/2021
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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: 04/03/2021
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Human medicine European public assessment report (EPAR): Ninlaro (updated)

ixazomib citrate, Multiple Myeloma
Date of authorisation: 21/11/2016, , , , Revision: 9, Authorised, Last updated: 03/03/2021
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Human medicine European public assessment report (EPAR): Maviret (updated)

glecaprevir, pibrentasvir, Hepatitis C, Chronic
Date of authorisation: 26/07/2017, , , Revision: 11, Authorised, Last updated: 03/03/2021
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Human medicine European public assessment report (EPAR): Vyndaqel (updated)

tafamidis, Amyloidosis
Date of authorisation: 16/11/2011, , , , Revision: 18, Authorised, Last updated: 02/03/2021
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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: 16, Authorised, Last updated: 01/03/2021
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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): 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): 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): 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): 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): 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): 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): 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
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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
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Human medicine European public assessment report (EPAR): Prepandrix (updated)

A/Indonesia/05/2005 (H5N1) like strain used (PR8-IBCDC-RG2), Influenza, Human, Immunization, Disease Outbreaks
Date of authorisation: 14/05/2008, , Revision: 13, Withdrawn, Last updated: 23/02/2021
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Human medicine European public assessment report (EPAR): Remsima (updated)

infliximab, Arthritis, Psoriatic, Spondylitis, Ankylosing, Colitis, Ulcerative, Psoriasis, Crohn Disease, Arthritis, Rheumatoid
Date of authorisation: 10/09/2013, , Revision: 22, Authorised, Last updated: 23/02/2021
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Human medicine European public assessment report (EPAR): Galafold (updated)

migalastat hydrochloride, Fabry Disease
Date of authorisation: 25/05/2016, , , Revision: 11, Authorised, Last updated: 23/02/2021
List item

Human medicine European public assessment report (EPAR): Benepali (updated)

etanercept, Arthritis, Psoriatic, Arthritis, Rheumatoid, Psoriasis
Date of authorisation: 13/01/2016, , Revision: 13, Authorised, Last updated: 23/02/2021