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416 results
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Human medicine European public assessment report (EPAR): Elaprase (updated)
idursulfase, Mucopolysaccharidosis II
Date of authorisation: 08/01/2007,
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, Revision: 22, Authorised, Last updated: 20/05/2022
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Human medicine European public assessment report (EPAR): Apixaban Accord (updated)
Apixaban, Venous Thromboembolism; Stroke; Arthroplasty
Date of authorisation: 23/07/2020,
, Revision: 2, Authorised, Last updated: 19/05/2022
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Human medicine European public assessment report (EPAR): Duloxetine Zentiva (updated)
duloxetine, Neuralgia; Depressive Disorder, Major; Anxiety Disorders; Diabetes Mellitus
Date of authorisation: 20/08/2015,, Revision: 10, Authorised, Last updated: 19/05/2022
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Human medicine European public assessment report (EPAR): Efavirenz/Emtricitabine/Tenofovir disoproxil Zentiva (updated)
efavirenz, emtricitabine, tenofovir disoproxil phosphate, HIV Infections
Date of authorisation: 17/07/2017,, Revision: 8, Authorised, Last updated: 18/05/2022
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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,, Revision: 7, Authorised, Last updated: 17/05/2022
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Human medicine European public assessment report (EPAR): Leflunomide ratiopharm (updated)
leflunomide, Arthritis, Rheumatoid
Date of authorisation: 28/11/2010,, Revision: 16, Authorised, Last updated: 17/05/2022
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Human medicine European public assessment report (EPAR): Leflunomide medac (updated)
leflunomide, Arthritis, Rheumatoid
Date of authorisation: 27/07/2010,, Revision: 16, Authorised, Last updated: 16/05/2022
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Human medicine European public assessment report (EPAR): Anagrelide Mylan (updated)
Anagrelide hydrochloride, Thrombocythemia, Essential
Date of authorisation: 15/02/2018,, Revision: 5, Authorised, Last updated: 13/05/2022
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Human medicine European public assessment report (EPAR): Arsenic trioxide Mylan (updated)
Arsenic trioxide, Leukemia, Promyelocytic, Acute
Date of authorisation: 01/04/2020,, Revision: 3, Authorised, Last updated: 13/05/2022
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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: 13, Authorised, Last updated: 12/05/2022
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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: 5, Authorised, Last updated: 12/05/2022
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Human medicine European public assessment report (EPAR): Lenalidomide Mylan (updated)
lenalidomide, Multiple Myeloma
Date of authorisation: 18/12/2020,, Revision: 4, Authorised, Last updated: 11/05/2022
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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): 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): 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): Pregabalin Mylan Pharma (updated)
pregabalin, Anxiety Disorders; Neuralgia; Epilepsy
Date of authorisation: 25/06/2015,, Revision: 7, Withdrawn, Last updated: 26/04/2022
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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): Ucedane (updated)
carglumic acid, Hyperammonemia; Amino Acid Metabolism, Inborn Errors
Date of authorisation: 23/06/2017,, Revision: 10, Authorised, Last updated: 25/04/2022