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Medicine
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Human medicine European public assessment report (EPAR): Verkazia (updated)
ciclosporin, Conjunctivitis, Keratitis
Date of authorisation: 06/07/2018,
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, Revision: 4, Authorised, Last updated: 10/07/2020
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Human medicine European public assessment report (EPAR): Myfenax (updated)
mycophenolate mofetil, Graft Rejection
Date of authorisation: 21/02/2008,
, Revision: 22, Authorised, Last updated: 10/07/2020
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Human medicine European public assessment report (EPAR): Aripiprazole Sandoz (updated)
aripiprazole, Schizophrenia, Bipolar Disorder
Date of authorisation: 20/08/2015,, Revision: 8, Authorised, Last updated: 10/07/2020
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Human medicine European public assessment report (EPAR): Darzalex (updated)
Daratumumab, Multiple Myeloma
Date of authorisation: 20/05/2016,
, , , Revision: 12, Authorised, Last updated: 10/07/2020
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Human medicine European public assessment report (EPAR): Temozolomide Teva (updated)
temozolomide, Glioma, Glioblastoma
Date of authorisation: 28/01/2010,, Revision: 19, Authorised, Last updated: 10/07/2020
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Human medicine European public assessment report (EPAR): Olanzapine Glenmark Europe (updated)
olanzapine, Schizophrenia, Bipolar Disorder
Date of authorisation: 03/12/2009,, Revision: 13, Authorised, Last updated: 09/07/2020
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Human medicine European public assessment report (EPAR): Actelsar HCT (updated)
telmisartan, hydrochlorothiazide,
Date of authorisation: 13/03/2013,, Revision: 10, Authorised, Last updated: 09/07/2020
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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: 1, Authorised, Last updated: 08/07/2020
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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): Soliris (updated)
Eculizumab, Hemoglobinuria, Paroxysmal
Date of authorisation: 20/06/2007,, , Revision: 29, 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): 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): Epidyolex (updated)
Cannabidiol, Lennox Gastaut Syndrome, Epilepsies, Myoclonic
Date of authorisation: 19/09/2019,, Revision: 2, Authorised, Last updated: 26/06/2020
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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): 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): Lamivudine Teva (updated)
lamivudine, Hepatitis B, Chronic
Date of authorisation: 23/10/2009,, Revision: 9, Authorised, Last updated: 24/06/2020
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Human medicine European public assessment report (EPAR): Deferasirox Mylan (updated)
deferasirox, Iron Overload, beta-Thalassemia
Date of authorisation: 26/09/2019,, Authorised, Last updated: 24/06/2020
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Human medicine European public assessment report (EPAR): Galafold (updated)
migalastat hydrochloride, Fabry Disease
Date of authorisation: 25/05/2016,, , Revision: 10, Authorised, Last updated: 24/06/2020
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Human medicine European public assessment report (EPAR): Pazenir (updated)
paclitaxel, Breast Neoplasms
Date of authorisation: 06/05/2019,, Revision: 5, Authorised, Last updated: 24/06/2020
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Human medicine European public assessment report (EPAR): Zoledronic acid medac (updated)
zoledronic acid monohydrate, Fractures, Bone, Cancer
Date of authorisation: 03/08/2012,, Revision: 12, Authorised, Last updated: 24/06/2020
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Human medicine European public assessment report (EPAR): Aripiprazole Mylan Pharma (previously Aripiprazole Pharmathen) (updated)
aripiprazole, Schizophrenia, Bipolar Disorder
Date of authorisation: 30/06/2015,, Revision: 10, Authorised, Last updated: 24/06/2020