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Medicine
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Human medicine European public assessment report (EPAR): Sildenafil Actavis (updated)
sildenafil, Erectile Dysfunction
Date of authorisation: 10/12/2009,
, Revision: 14, Authorised, Last updated: 12/05/2021
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Human medicine European public assessment report (EPAR): Kalydeco (updated)
ivacaftor, Cystic Fibrosis
Date of authorisation: 23/07/2012,
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, Revision: 28, Authorised, Last updated: 12/05/2021
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Human medicine European public assessment report (EPAR): Memantine Mylan (updated)
memantine hydrochloride, Alzheimer Disease
Date of authorisation: 21/04/2013,, Revision: 7, Authorised, Last updated: 12/05/2021
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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: 41, Authorised, Last updated: 12/05/2021
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Human medicine European public assessment report (EPAR): Increlex (updated)
Mecasermin, Laron Syndrome
Date of authorisation: 02/08/2007,, 
, Revision: 22, Authorised, Last updated: 12/05/2021
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Human medicine European public assessment report (EPAR): Lyumjev (previously Liumjev) (updated)
insulin lispro, Diabetes Mellitus
Date of authorisation: 24/03/2020,, Revision: 3, Authorised, Last updated: 12/05/2021
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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: 12/05/2021
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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: 6, Authorised, Last updated: 12/05/2021
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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: 6, Authorised, Last updated: 12/05/2021
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Human medicine European public assessment report (EPAR): Vitrakvi (updated)
larotrectinib sulfate, Abdominal Neoplasms
Date of authorisation: 19/09/2019,, , Revision: 3, Authorised, Last updated: 12/05/2021
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Human medicine European public assessment report (EPAR): Sylvant (updated)
siltuximab, Giant Lymph Node Hyperplasia
Date of authorisation: 22/05/2014,, , Revision: 11, Authorised, Last updated: 12/05/2021
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Human medicine European public assessment report (EPAR): Lamivudine Teva Pharma B.V. (updated)
lamivudine, HIV Infections
Date of authorisation: 10/12/2009,, Revision: 15, Authorised, Last updated: 12/05/2021
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Human medicine European public assessment report (EPAR): Arsenic trioxide Accord (updated)
Arsenic trioxide, Leukemia, Promyelocytic, Acute
Date of authorisation: 14/11/2019,, Revision: 3, Authorised, Last updated: 12/05/2021
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Human medicine European public assessment report (EPAR): Ziextenzo (updated)
pegfilgrastim, Neutropenia
Date of authorisation: 22/11/2018,, 
, Revision: 3, Authorised, Last updated: 12/05/2021
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Human medicine European public assessment report (EPAR): Nustendi (updated)
Bempedoic acid, Ezetimibe, Hypercholesterolemia, Dyslipidemias
Date of authorisation: 27/03/2020,, Revision: 3, Authorised, Last updated: 12/05/2021
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Human medicine European public assessment report (EPAR): Deltyba (updated)
Delamanid, Tuberculosis, Multidrug-Resistant
Date of authorisation: 27/04/2014,
Date of refusal: 25/07/2013,, , , Revision: 16, Authorised, Last updated: 11/05/2021
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Human medicine European public assessment report (EPAR): Ruxience (updated)
rituximab, Leukemia, Lymphocytic, Chronic, B-Cell, Arthritis, Rheumatoid, Microscopic Polyangiitis, Pemphigus
Date of authorisation: 01/04/2020,, , Revision: 3, Authorised, Last updated: 11/05/2021
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Human medicine European public assessment report (EPAR): Pregabalin Sandoz (updated)
pregabalin, Anxiety Disorders, Neuralgia, Epilepsy
Date of authorisation: 19/06/2015,, Revision: 6, Authorised, Last updated: 10/05/2021
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Human medicine European public assessment report (EPAR): Kyprolis (updated)
carfilzomib, Multiple Myeloma
Date of authorisation: 19/11/2015,, , Revision: 19, Authorised, Last updated: 07/05/2021
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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: 2, Authorised, Last updated: 12/05/2021
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Human medicine European public assessment report (EPAR): Lenalidomide Accord (updated)
lenalidomide, Multiple Myeloma
Date of authorisation: 20/09/2018,, Revision: 6, Authorised, Last updated: 07/05/2021
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Human medicine European public assessment report (EPAR): Ketoconazole HRA (updated)
Ketoconazole, Cushing Syndrome
Date of authorisation: 18/11/2014,, , , Revision: 10, Authorised, Last updated: 07/05/2021
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Human medicine European public assessment report (EPAR): Vaborem (updated)
meropenem trihydrate, vaborbactam, Urinary Tract Infections, Bacteremia, Bacterial Infections, Respiratory Tract Infections, Pneumonia, Pneumonia, Ventilator-Associated
Date of authorisation: 20/11/2018,, Revision: 4, Authorised, Last updated: 07/05/2021
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Human medicine European public assessment report (EPAR): Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan (updated)
efavirenz, emtricitabine, tenofovir disoproxil maleate, HIV Infections
Date of authorisation: 05/09/2017,, Revision: 10, Authorised, Last updated: 07/05/2021
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Human medicine European public assessment report (EPAR): Tegsedi (updated)
inotersen sodium, Amyloidosis
Date of authorisation: 05/07/2018,, , , Revision: 7, Authorised, Last updated: 06/05/2021