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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: 4, Authorised, Last updated: 07/07/2020
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Human medicine European public assessment report (EPAR): Taltz (updated)

ixekizumab, Psoriasis
Date of authorisation: 25/04/2016, , Revision: 10, Authorised, Last updated: 07/07/2020
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Human medicine European public assessment report (EPAR): Tavlesse (updated)

Fostamatinib disodium, Thrombocytopenia
Date of authorisation: 09/01/2020, , Revision: 2, Authorised, Last updated: 06/07/2020
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Human medicine European public assessment report (EPAR): Intuniv (updated)

guanfacine hydrochloride, Attention Deficit Disorder with Hyperactivity
Date of authorisation: 17/09/2015, , Revision: 7, Authorised, Last updated: 06/07/2020
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Human medicine European public assessment report (EPAR): Biktarvy (updated)

bictegravir, emtricitabine, tenofovir alafenamide, fumarate, HIV Infections
Date of authorisation: 21/06/2018, , Revision: 6, Authorised, Last updated: 03/07/2020
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Human medicine European public assessment report (EPAR): Synjardy (updated)

empagliflozin, metformin, Diabetes Mellitus, Type 2
Date of authorisation: 27/05/2015, , Revision: 16, Authorised, Last updated: 03/07/2020
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Human medicine European public assessment report (EPAR): Zoely (updated)

Nomegestrol acetate, estradiol, Contraception
Date of authorisation: 26/07/2011, , Revision: 19, Authorised, Last updated: 03/07/2020
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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: 14, Authorised, Last updated: 03/07/2020
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Human medicine European public assessment report (EPAR): Dupixent (updated)

dupilumab, Dermatitis, Atopic
Date of authorisation: 27/09/2017, , Revision: 8, Authorised, Last updated: 02/07/2020
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Human medicine European public assessment report (EPAR): Vemlidy (updated)

tenofovir alafenamide fumarate, Hepatitis B
Date of authorisation: 09/01/2017, , Revision: 7, Authorised, Last updated: 02/07/2020
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Human medicine European public assessment report (EPAR): Bortezomib Fresenius Kabi (updated)

bortezomib, Multiple Myeloma
Date of authorisation: 14/11/2019, , Revision: 1, Authorised, Last updated: 01/07/2020
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Human medicine European public assessment report (EPAR): Kymriah (updated)

tisagenlecleucel, Precursor B-Cell Lymphoblastic Leukemia-Lymphoma, Lymphoma, Large B-Cell, Diffuse
Date of authorisation: 22/08/2018, , , Revision: 2, Authorised, Last updated: 29/06/2020
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Human medicine European public assessment report (EPAR): Capecitabine Teva (updated)

capecitabine, Colonic Neoplasms, Breast Neoplasms, Colorectal Neoplasms, Stomach Neoplasms
Date of authorisation: 20/04/2012, , , Revision: 12, Authorised, Last updated: 29/06/2020
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Human medicine European public assessment report (EPAR): Spherox (updated)

spheroids of human autologous matrix-associated chondrocytes, Cartilage Diseases
Date of authorisation: 10/07/2017, , Revision: 4, Authorised, Last updated: 29/06/2020
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Human medicine European public assessment report (EPAR): Grastofil (updated)

filgrastim, Neutropenia
Date of authorisation: 17/10/2013, , Revision: 12, Authorised, Last updated: 29/06/2020
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Human medicine European public assessment report (EPAR): Idelvion (updated)

albutrepenonacog alfa, Hemophilia B
Date of authorisation: 11/05/2016, , , Revision: 7, Authorised, Last updated: 29/06/2020
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Human medicine European public assessment report (EPAR): Symkevi (updated)

tezacaftor, ivacaftor, Cystic Fibrosis
Date of authorisation: 31/10/2018, , , Revision: 6, Authorised, Last updated: 26/06/2020
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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: 4, Authorised, Last updated: 26/06/2020
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Human medicine European public assessment report (EPAR): Xermelo (updated)

telotristat etiprate, Carcinoid Tumor, Neuroendocrine Tumors
Date of authorisation: 17/09/2017, , , Revision: 10, Authorised, Last updated: 26/06/2020
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Human medicine European public assessment report (EPAR): Yescarta (updated)

axicabtagene ciloleucel, Lymphoma, Follicular, Lymphoma, Large B-Cell, Diffuse
Date of authorisation: 23/08/2018, , , Revision: 6, Authorised, Last updated: 26/06/2020
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Human medicine European public assessment report (EPAR): Exjade (updated)

deferasirox, beta-Thalassemia, Iron Overload
Date of authorisation: 28/08/2006, , Revision: 44, Authorised, Last updated: 26/06/2020
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Human medicine European public assessment report (EPAR): Pregabalin Sandoz GmbH (updated)

pregabalin, Anxiety Disorders, Epilepsy
Date of authorisation: 19/06/2015, , Revision: 5, Authorised, Last updated: 25/06/2020
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Human medicine European public assessment report (EPAR): Nilemdo (updated)

Bempedoic acid, Hypercholesterolemia, Dyslipidemias
Date of authorisation: 01/04/2020, , Authorised, Last updated: 24/06/2020
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Human medicine European public assessment report (EPAR): Elaprase (updated)

idursulfase, Mucopolysaccharidosis II
Date of authorisation: 08/01/2007, , , Revision: 20, Authorised, Last updated: 24/06/2020
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Human medicine European public assessment report (EPAR): Lamivudine Teva (updated)

lamivudine, Hepatitis B, Chronic
Date of authorisation: 23/10/2009, , Revision: 9, Authorised, Last updated: 24/06/2020