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Human medicine European public assessment report (EPAR): Naglazyme (updated)
galsulfase, Mucopolysaccharidosis VI
Date of authorisation: 23/01/2006,,
, Revision: 19, Authorised, Last updated: 10/05/2022
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Human medicine European public assessment report (EPAR): Fampridine Accord (updated)
Fampridine, Multiple Sclerosis
Date of authorisation: 24/09/2020,, Revision: 1, Authorised, Last updated: 10/05/2022
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Human medicine European public assessment report (EPAR): Rivastigmine Actavis (updated)
rivastigmine hydrogen tartrate, Dementia; Alzheimer Disease; Parkinson Disease
Date of authorisation: 16/06/2011,, Revision: 16, Authorised, Last updated: 10/05/2022
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Human medicine European public assessment report (EPAR): Nexavar (updated)
sorafenib, Carcinoma, Hepatocellular; Carcinoma, Renal Cell
Date of authorisation: 19/07/2006,, Revision: 30, Authorised, Last updated: 10/05/2022
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Human medicine European public assessment report (EPAR): Tenofovir disoproxil Mylan (updated)
tenofovir disoproxil, HIV Infections
Date of authorisation: 08/12/2016,, Revision: 15, Authorised, Last updated: 10/05/2022
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Human medicine European public assessment report (EPAR): Lutathera (updated)
lutetium (177Lu) oxodotreotide, Neuroendocrine Tumors
Date of authorisation: 26/09/2017,,
, Revision: 6, Authorised, Last updated: 10/05/2022
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Human medicine European public assessment report (EPAR): Gazyvaro (updated)
Obinutuzumab, Leukemia, Lymphocytic, Chronic, B-Cell
Date of authorisation: 22/07/2014,,
, Revision: 13, Authorised, Last updated: 10/05/2022
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Human medicine European public assessment report (EPAR): Ritonavir Mylan (updated)
ritonavir, HIV Infections
Date of authorisation: 09/11/2017,, Revision: 12, Authorised, Last updated: 06/05/2022
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Human medicine European public assessment report (EPAR): Pregabalin Zentiva k.s. (updated)
pregabalin, Anxiety Disorders; Neuralgia; Epilepsy
Date of authorisation: 27/02/2017,, Revision: 12, Authorised, Last updated: 05/05/2022
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Human medicine European public assessment report (EPAR): Emtricitabine/Tenofovir disoproxil Mylan (updated)
emtricitabine, tenofovir disoproxil maleate, HIV Infections
Date of authorisation: 16/12/2016,, Revision: 11, Authorised, Last updated: 05/05/2022
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Human medicine European public assessment report (EPAR): Pregabalin Zentiva (updated)
pregabalin, Anxiety Disorders; Epilepsy
Date of authorisation: 17/07/2015,, Revision: 13, Authorised, Last updated: 03/05/2022
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Human medicine European public assessment report (EPAR): Poteligeo (updated)
Mogamulizumab, Sezary Syndrome; Mycosis Fungoides
Date of authorisation: 22/11/2018,,
, Revision: 5, Authorised, Last updated: 28/04/2022
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Human medicine European public assessment report (EPAR): Hepcludex (updated)
Bulevirtide acetate, Hepatitis D, Chronic
Date of authorisation: 31/07/2020,,
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, Revision: 6, Authorised, Last updated: 28/04/2022
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Human medicine European public assessment report (EPAR): Pandemic Influenza Vaccine H5N1 Baxter AG (updated)
influenza vaccine (whole virion, inactivated) containing antigen of: A/Vietnam/1203/2004 (H5N1), Influenza, Human; Immunization; Disease Outbreaks
Date of authorisation: 16/10/2009,, Revision: 7, Authorised, Last updated: 26/04/2022
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Human medicine European public assessment report (EPAR): Gefitinib Mylan (updated)
gefitinib, Carcinoma, Non-Small-Cell Lung
Date of authorisation: 27/09/2018,, Revision: 4, Authorised, Last updated: 26/04/2022
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Human medicine European public assessment report (EPAR): Arsenic trioxide medac (updated)
Arsenic trioxide, Leukemia, Promyelocytic, Acute
Date of authorisation: 17/09/2020,, Revision: 2, Authorised, Last updated: 26/04/2022
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Human medicine European public assessment report (EPAR): Zessly (updated)
infliximab, Arthritis, Psoriatic; Psoriasis; Crohn Disease; Arthritis, Rheumatoid; Colitis, Ulcerative; Spondylitis, Ankylosing
Date of authorisation: 18/05/2018,,
, Revision: 8, Authorised, Last updated: 26/04/2022
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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: 10, Authorised, Last updated: 25/04/2022
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Human medicine European public assessment report (EPAR): Voriconazole Accord (updated)
voriconazole, Aspergillosis; Candidiasis; Mycoses
Date of authorisation: 16/05/2013,, Revision: 16, Authorised, Last updated: 25/04/2022
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Human medicine European public assessment report (EPAR): Voriconazole Hikma (previously Voriconazole Hospira) (updated)
voriconazole, Bacterial Infections and Mycoses; Aspergillosis; Candidiasis
Date of authorisation: 27/05/2015,, Revision: 11, Authorised, Last updated: 25/04/2022
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Human medicine European public assessment report (EPAR): Capecitabine Medac (updated)
capecitabine, Colorectal Neoplasms
Date of authorisation: 19/11/2012,, Revision: 12, Authorised, Last updated: 25/04/2022
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Human medicine European public assessment report (EPAR): Duloxetine Mylan (updated)
duloxetine, Neuralgia; Diabetic Neuropathies; Depressive Disorder, Major; Anxiety Disorders
Date of authorisation: 19/06/2015,, Revision: 17, Authorised, Last updated: 25/04/2022
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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: 11, Authorised, Last updated: 21/04/2022
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Human medicine European public assessment report (EPAR): Erelzi (updated)
etanercept, Arthritis, Psoriatic; Psoriasis; Arthritis, Juvenile Rheumatoid; Arthritis, Rheumatoid; Spondylitis, Ankylosing
Date of authorisation: 23/06/2017,,
, Revision: 10, Authorised, Last updated: 21/04/2022
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Human medicine European public assessment report (EPAR): Pregabalin Accord (updated)
pregabalin, Anxiety Disorders; Epilepsy
Date of authorisation: 28/08/2015,, Revision: 14, Authorised, Last updated: 21/04/2022