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Medicine
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Human medicine European public assessment report (EPAR): Sixmo (updated)
Buprenorphine hydrochloride, Opioid-Related Disorders
Date of authorisation: 19/06/2019,
, Revision: 1, Authorised, Last updated: 23/10/2020
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Human medicine European public assessment report (EPAR): Beovu (updated)
brolucizumab, Wet Macular Degeneration
Date of authorisation: 13/02/2020,, Revision: 1, Authorised, Last updated: 22/10/2020
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Human medicine European public assessment report (EPAR): Briviact (in Italy: Nubriveo) (updated)
Brivaracetam, Epilepsy
Date of authorisation: 13/01/2016,, Revision: 9, Authorised, Last updated: 22/10/2020
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Human medicine European public assessment report (EPAR): Glyxambi (updated)
empagliflozin, linagliptin, Diabetes Mellitus, Type 2
Date of authorisation: 11/11/2016,, Revision: 10, Authorised, Last updated: 22/10/2020
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Human medicine European public assessment report (EPAR): Sunosi (updated)
solriamfetol hydrochloride, Narcolepsy, Sleep Apnea, Obstructive
Date of authorisation: 16/01/2020,, Revision: 1, Authorised, Last updated: 22/10/2020
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Human medicine European public assessment report (EPAR): Zoledronic acid Actavis (updated)
zoledronic acid monohydrate, Fractures, Bone
Date of authorisation: 20/04/2012,
, Revision: 13, Authorised, Last updated: 22/10/2020
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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: 17, Authorised, Last updated: 21/10/2020
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Human medicine European public assessment report (EPAR): Carmustine Obvius (updated)
carmustine, Hodgkin Disease, Lymphoma, Non-Hodgkin
Date of authorisation: 18/07/2018,, Revision: 5, Authorised, Last updated: 21/10/2020
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Human medicine European public assessment report (EPAR): Aripiprazole Accord (updated)
aripiprazole, Schizophrenia, Bipolar Disorder
Date of authorisation: 15/11/2015,, Revision: 11, Authorised, Last updated: 21/10/2020
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Human medicine European public assessment report (EPAR): Eptifibatide Accord (updated)
eptifibatide, Myocardial Infarction
Date of authorisation: 11/01/2016,, Revision: 3, Authorised, Last updated: 21/10/2020
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Human medicine European public assessment report (EPAR): SomaKit TOC (updated)
edotreotide, Neuroendocrine Tumors, Radionuclide Imaging
Date of authorisation: 08/12/2016,, 
, Revision: 6, Authorised, Last updated: 20/10/2020
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Human medicine European public assessment report (EPAR): Skyrizi (updated)
Risankizumab, Psoriasis
Date of authorisation: 26/04/2019,, Revision: 3, Authorised, Last updated: 20/10/2020
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Human medicine European public assessment report (EPAR): Viekirax (updated)
Ombitasvir, paritaprevir, ritonavir, Hepatitis C, Chronic
Date of authorisation: 14/01/2015,, 
, Revision: 21, Authorised, Last updated: 20/10/2020
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Human medicine European public assessment report (EPAR): Naglazyme (updated)
galsulfase, Mucopolysaccharidosis VI
Date of authorisation: 23/01/2006,, 
, Revision: 17, Authorised, Last updated: 20/10/2020
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Human medicine European public assessment report (EPAR): Ucedane (updated)
carglumic acid, Hyperammonemia, Amino Acid Metabolism, Inborn Errors
Date of authorisation: 23/06/2017,, Revision: 6, Authorised, Last updated: 20/10/2020
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Human medicine European public assessment report (EPAR): Obizur (updated)
susoctocog alfa, Hemophilia A
Date of authorisation: 11/11/2015,, , Revision: 5, Authorised, Last updated: 20/10/2020
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Human medicine European public assessment report (EPAR): Fulphila (updated)
pegfilgrastim, Neutropenia
Date of authorisation: 20/11/2018,, 
, Revision: 5, Authorised, Last updated: 19/10/2020
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Human medicine European public assessment report (EPAR): Xeljanz (updated)
tofacitinib citrate, Arthritis, Rheumatoid
Date of authorisation: 21/03/2017,
Date of refusal: 25/04/2013,
, , Revision: 13, Authorised, Last updated: 19/10/2020
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Human medicine European public assessment report (EPAR): Jivi (updated)
Damoctocog alfa pegol, Hemophilia A
Date of authorisation: 22/11/2018,, Revision: 2, Authorised, Last updated: 19/10/2020
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Human medicine European public assessment report (EPAR): VeraSeal (updated)
human fibrinogen, human thrombin, Hemostasis, Surgical
Date of authorisation: 10/11/2017,, Revision: 3, Authorised, Last updated: 19/10/2020
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Human medicine European public assessment report (EPAR): Juluca (updated)
dolutegravir sodium, rilpivirine hydrochloride, HIV Infections
Date of authorisation: 16/05/2018,, Revision: 5, Authorised, Last updated: 19/10/2020
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Human medicine European public assessment report (EPAR): Libtayo (updated)
Cemiplimab, Carcinoma, Squamous Cell
Date of authorisation: 28/06/2019,, 
, Revision: 4, Authorised, Last updated: 19/10/2020
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Human medicine European public assessment report (EPAR): Pemetrexed Hospira (updated)
pemetrexed, Carcinoma, Non-Small-Cell Lung, Mesothelioma
Date of authorisation: 19/11/2015,, Revision: 10, Authorised, Last updated: 19/10/2020
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Human medicine European public assessment report (EPAR): Mysimba (updated)
bupropion hydrochloride, naltrexone hydrochloride, Obesity, Overweight
Date of authorisation: 26/03/2015,, Revision: 16, Authorised, Last updated: 19/10/2020
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Human medicine European public assessment report (EPAR): Mayzent (updated)
Siponimod fumaric acid, Multiple Sclerosis, Relapsing-Remitting
Date of authorisation: 13/01/2020,, Revision: 3, Authorised, Last updated: 19/10/2020