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Medicine
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Human medicine European public assessment report (EPAR): Xgeva (updated)
denosumab, Fractures, Bone, Neoplasm Metastasis
Date of authorisation: 13/07/2011, Revision: 20, Authorised, Last updated: 07/08/2020 -
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Human medicine European public assessment report (EPAR): Adcetris (updated)
Brentuximab vedotin, Lymphoma, Non-Hodgkin, Hodgkin Disease
Date of authorisation: 25/10/2012,
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, Revision: 26, Authorised, Last updated: 07/08/2020
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Human medicine European public assessment report (EPAR): Darunavir Krka (updated)
darunavir, HIV Infections
Date of authorisation: 26/01/2018,
, Revision: 5, Authorised, Last updated: 07/08/2020
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Human medicine European public assessment report (EPAR): Libtayo (updated)
Cemiplimab, Carcinoma, Squamous Cell
Date of authorisation: 28/06/2019,, , Revision: 3, Authorised, Last updated: 07/08/2020
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Human medicine European public assessment report (EPAR): Invokana (updated)
canagliflozin, Diabetes Mellitus, Type 2
Date of authorisation: 15/11/2013, Revision: 16, Authorised, Last updated: 06/08/2020 -
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Human medicine European public assessment report (EPAR): Flucelvax Tetra (updated)
Influenza virus surface antigens (haemagglutinin and neuraminidase)* , inactivated, of the following strains: A/xxxxx (H3N2)-like strain (reassortant used)/ A/xxxxx H1N1- like strain (reassortant used)/ B/xxxxx (Yamagata Lineage) – like strain (reassortant used)/ B/xxxxx (Victoria Lineage) – like strain (reassortant used), Influenza, Human
Date of authorisation: 12/12/2018,, Revision: 5, Authorised, Last updated: 06/08/2020
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Human medicine European public assessment report (EPAR): Fluenz Tetra (updated)
reassortant influenza virus (live attenuated) of the following four strains:A/California/7/2009 (H1N1)pdm09 - like strain(A/Bolivia/559/2013, MEDI 255962)A/Hong Kong/4801/2014 (H3N2) - like strain(A/New Caledonia/71/2014, MEDI 263122)B/Brisbane/60/2008 - like strain(B/Brisbane/60/2008, MEDI 228030)B/Phuket/3073/2013 - like strain(B/Phuket/3073/2013, MEDI 254977), Influenza, Human
Date of authorisation: 04/12/2013, Revision: 19, Authorised, Last updated: 06/08/2020 -
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Human medicine European public assessment report (EPAR): Cymbalta (updated)
duloxetine, Anxiety Disorders, Diabetic Neuropathies, Depressive Disorder, Major
Date of authorisation: 17/12/2004, Revision: 29, Authorised, Last updated: 06/08/2020 -
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Human medicine European public assessment report (EPAR): Capecitabine Medac (updated)
capecitabine, Colorectal Neoplasms
Date of authorisation: 19/11/2012,
, , Revision: 10, Authorised, Last updated: 05/08/2020
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Human medicine European public assessment report (EPAR): Ninlaro (updated)
ixazomib citrate, Multiple Myeloma
Date of authorisation: 21/11/2016,, , , Revision: 6, Authorised, Last updated: 04/08/2020
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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: 37, Authorised, Last updated: 04/08/2020 -
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Human medicine European public assessment report (EPAR): Votubia (updated)
everolimus, Tuberous Sclerosis
Date of authorisation: 02/09/2011,, Revision: 26, Authorised, Last updated: 04/08/2020
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Human medicine European public assessment report (EPAR): Pemetrexed Fresenius Kabi (updated)
pemetrexed, Carcinoma, Non-Small-Cell Lung, Mesothelioma
Date of authorisation: 22/07/2016,, Revision: 8, Authorised, Last updated: 03/08/2020
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Human medicine European public assessment report (EPAR): Capecitabine Accord (updated)
capecitabine, Colonic Neoplasms, Breast Neoplasms, Colorectal Neoplasms, Stomach Neoplasms
Date of authorisation: 20/04/2012,, , Revision: 12, Authorised, Last updated: 03/08/2020
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Human medicine European public assessment report (EPAR): Kisqali (updated)
ribociclib succinate, Breast Neoplasms
Date of authorisation: 22/08/2017,, Revision: 6, Authorised, Last updated: 03/08/2020
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Human medicine European public assessment report (EPAR): Shingrix (updated)
Varicella Zoster Virus glycoprotein E antigen, Herpes Zoster
Date of authorisation: 21/03/2018,, Revision: 4, Authorised, Last updated: 31/07/2020
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Human medicine European public assessment report (EPAR): Olazax (updated)
olanzapine, Schizophrenia, Bipolar Disorder
Date of authorisation: 11/12/2009,, Revision: 12, Authorised, Last updated: 31/07/2020
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Human medicine European public assessment report (EPAR): Cimzia (updated)
Certolizumab pegol, Arthritis, Rheumatoid
Date of authorisation: 01/10/2009, Revision: 28, Authorised, Last updated: 31/07/2020 -
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Human medicine European public assessment report (EPAR): Vitrakvi (updated)
larotrectinib sulfate, Abdominal Neoplasms
Date of authorisation: 19/09/2019,, , Revision: 1, Authorised, Last updated: 31/07/2020
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Human medicine European public assessment report (EPAR): BiResp Spiromax (updated)
budesonide, formoterol fumarate dihydrate, Pulmonary Disease, Chronic Obstructive, Asthma
Date of authorisation: 28/04/2014, Revision: 10, Authorised, Last updated: 31/07/2020 -
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Human medicine European public assessment report (EPAR): Tagrisso (updated)
osimertinib mesylate, Carcinoma, Non-Small-Cell Lung
Date of authorisation: 01/02/2016,, 
, Revision: 11, Authorised, Last updated: 31/07/2020
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Human medicine European public assessment report (EPAR): Instanyl (updated)
Fentanyl citrate, Pain, Cancer
Date of authorisation: 20/07/2009, Revision: 25, Authorised, Last updated: 31/07/2020 -
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Human medicine European public assessment report (EPAR): Translarna (updated)
Ataluren, Muscular Dystrophy, Duchenne
Date of authorisation: 31/07/2014,, , , Revision: 17, Authorised, Last updated: 31/07/2020
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Human medicine European public assessment report (EPAR): Ecalta (updated)
anidulafungin, Candidiasis
Date of authorisation: 20/09/2007, Revision: 22, Authorised, Last updated: 31/07/2020 -
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Human medicine European public assessment report (EPAR): Nimenrix (updated)
Neisseria meningitidis serogroup A polysaccharide conjugated to tetanus toxoid, Neisseria meningitidis serogroup C polysaccharide conjugated to tetanus toxoid / Neisseria meningitidis serogroup W-135 polysaccharide conjugated to tetanus toxoid, Neisseria meningitidis serogroup Y polysaccharide conjugated to tetanus toxoid, Meningitis, Meningococcal
Date of authorisation: 20/04/2012, Revision: 30, Authorised, Last updated: 31/07/2020