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Human medicine European public assessment report (EPAR): Vaxzevria (previously COVID-19 Vaccine AstraZeneca) (updated)

ChAdOx1-SARS-COV-2, COVID-19 virus infection
Date of authorisation: 29/01/2021, , , Revision: 8, Authorised, Last updated: 18/06/2021
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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, , , Revision: 7, Authorised, Last updated: 18/06/2021
List item

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: 18/06/2021
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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: 8, Authorised, Last updated: 18/06/2021
List item

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

etelcalcetide hydrochloride, Hyperparathyroidism, Secondary
Date of authorisation: 11/11/2016, , Revision: 8, Authorised, Last updated: 17/06/2021
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Human medicine European public assessment report (EPAR): Palynziq (updated)

Pegvaliase, Phenylketonurias
Date of authorisation: 03/05/2019, , , Revision: 2, Authorised, Last updated: 17/06/2021
List item

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

bictegravir, emtricitabine, tenofovir alafenamide, fumarate, HIV Infections
Date of authorisation: 21/06/2018, , Revision: 12, Authorised, Last updated: 17/06/2021
List item

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

trastuzumab, Breast Neoplasms, Stomach Neoplasms
Date of authorisation: 27/07/2020, , , Revision: 4, Authorised, Last updated: 17/06/2021
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Human medicine European public assessment report (EPAR): Ofev (updated)

nintedanib, Idiopathic Pulmonary Fibrosis
Date of authorisation: 14/01/2015, , Revision: 19, Authorised, Last updated: 17/06/2021
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Human medicine European public assessment report (EPAR): Nyvepria (updated)

pegfilgrastim, Neutropenia
Date of authorisation: 18/11/2020, , , Revision: 2, Authorised, Last updated: 16/06/2021
List item

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

recombinant human n-acetylgalactosamine-6-sulfatase, Mucopolysaccharidosis IV
Date of authorisation: 27/04/2014, , , Revision: 12, Authorised, Last updated: 16/06/2021
List item

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

rituximab, Lymphoma, Non-Hodgkin, Arthritis, Rheumatoid, Microscopic Polyangiitis, Wegener Granulomatosis
Date of authorisation: 15/06/2017, , , Revision: 5, Authorised, Last updated: 15/06/2021
List item

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

blinatumomab, Precursor Cell Lymphoblastic Leukemia-Lymphoma
Date of authorisation: 23/11/2015, , , Revision: 13, Authorised, Last updated: 15/06/2021
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Human medicine European public assessment report (EPAR): Rixathon (updated)

rituximab, Lymphoma, Non-Hodgkin, Arthritis, Rheumatoid, Leukemia, Lymphocytic, Chronic, B-Cell, Wegener Granulomatosis, Microscopic Polyangiitis, Pemphigus
Date of authorisation: 15/06/2017, , , Revision: 4, Authorised, Last updated: 15/06/2021
List item

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

erenumab, Migraine Disorders
Date of authorisation: 26/07/2018, , Revision: 6, Authorised, Last updated: 15/06/2021
List item

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

sacubitril, valsartan, Heart Failure
Date of authorisation: 26/05/2016, , Revision: 12, Authorised, Last updated: 11/06/2021
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Human medicine European public assessment report (EPAR): Skyrizi (updated)

Risankizumab, Psoriasis
Date of authorisation: 26/04/2019, , Revision: 5, Authorised, Last updated: 11/06/2021
List item

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

Niraparib (tosilate monohydrate), Fallopian Tube Neoplasms, Peritoneal Neoplasms, Ovarian Neoplasms
Date of authorisation: 16/11/2017, , , Revision: 13, Authorised, Last updated: 11/06/2021
List item

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

eravacycline, Infection, Bacterial Infections
Date of authorisation: 20/09/2018, , Revision: 2, Authorised, Last updated: 10/06/2021
List item

Human medicine European public assessment report (EPAR): Clopidogrel ratiopharm (updated)

clopidogrel (as hydrogen sulfate), Myocardial Infarction, Acute Coronary Syndrome, Peripheral Vascular Diseases, Stroke
Date of authorisation: 18/02/2015, , Revision: 11, Authorised, Last updated: 10/06/2021
List item

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

cabozantinib, Thyroid Neoplasms
Date of authorisation: 21/03/2014, , , , Revision: 22, Authorised, Last updated: 10/06/2021
List item

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

olanzapine, Schizophrenia, Bipolar Disorder
Date of authorisation: 27/09/2007, , Revision: 18, Authorised, Last updated: 10/06/2021
List item

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

etanercept, Arthritis, Psoriatic, Psoriasis, Arthritis, Juvenile Rheumatoid, Arthritis, Rheumatoid, Spondylitis, Ankylosing
Date of authorisation: 23/06/2017, , , Revision: 9, Authorised, Last updated: 10/06/2021
List item

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: 17, Authorised, Last updated: 10/06/2021
List item

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

belimumab, Lupus Erythematosus, Systemic
Date of authorisation: 13/07/2011, , Revision: 26, Authorised, Last updated: 09/06/2021