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Human medicine European public assessment report (EPAR): Deferiprone Lipomed (updated)
Deferiprone, Iron Overload; beta-Thalassemia
Date of authorisation: 19/09/2018,
, Revision: 6, Authorised, Last updated: 08/06/2022
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Human medicine European public assessment report (EPAR): Rixathon (updated)
rituximab, Lymphoma, Non-Hodgkin; Arthritis, Rheumatoid; Leukemia, Lymphocytic, Chronic, B-Cell; Wegener Granulomatosis; Microscopic Polyangiitis; Pemphigus
Date of authorisation: 15/06/2017,
, Revision: 8, Authorised, Last updated: 08/06/2022
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Human medicine European public assessment report (EPAR): Clopidogrel ratiopharm (updated)
clopidogrel (as hydrogen sulfate), Myocardial Infarction; Acute Coronary Syndrome; Peripheral Vascular Diseases; Stroke
Date of authorisation: 18/02/2015,, Revision: 13, Authorised, Last updated: 07/06/2022
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Human medicine European public assessment report (EPAR): Imraldi (updated)
adalimumab, Spondylitis, Ankylosing; Arthritis, Rheumatoid; Uveitis; Colitis, Ulcerative; Psoriasis; Arthritis, Psoriatic; Crohn Disease; Hidradenitis Suppurativa; Arthritis
Date of authorisation: 24/08/2017,, Revision: 17, Authorised, Last updated: 07/06/2022
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Human medicine European public assessment report (EPAR): Lenalidomide Mylan
lenalidomide, Multiple Myeloma
Date of authorisation: 18/12/2020,, Revision: 4, Authorised, Last updated: 31/05/2022
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Human medicine European public assessment report (EPAR): Temozolomide Hexal
temozolomide, Glioma; Glioblastoma
Date of authorisation: 15/03/2010,, Revision: 17, Authorised, Last updated: 30/05/2022
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Human medicine European public assessment report (EPAR): Temozolomide Sandoz
temozolomide, Glioma; Glioblastoma
Date of authorisation: 15/03/2010,, Revision: 17, Authorised, Last updated: 30/05/2022
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Human medicine European public assessment report (EPAR): Amifampridine SERB
amifampridine phosphate, Lambert-Eaton Myasthenic Syndrome; Paraneoplastic Syndromes, Nervous System; Nervous System Neoplasms; Paraneoplastic Syndromes; Nervous System Diseases; Autoimmune Diseases of the Nervous System; Neurodegenerative Diseases; Neuromuscular Diseases; Neuromuscular Junction Diseases; Immune System Diseases; Autoimmune Diseases; Autoimmune Diseases of the Nervous System; Cancer; Neoplasms
Date of authorisation: 19/05/2022,, Authorised, Last updated: 24/05/2022
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Human medicine European public assessment report (EPAR): Dimethyl fumarate Mylan
dimethyl fumarate, Multiple Sclerosis, Relapsing-Remitting
Date of authorisation: 13/05/2022,, Authorised, Last updated: 24/05/2022
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Human medicine European public assessment report (EPAR): Efavirenz/Emtricitabine/Tenofovir disoproxil Krka
efavirenz, emtricitabine, tenofovir disoproxil succinate, HIV Infections
Date of authorisation: 08/02/2018,, Revision: 8, Authorised, Last updated: 24/05/2022
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Human medicine European public assessment report (EPAR): Tenofovir disoproxil Mylan
tenofovir disoproxil, HIV Infections
Date of authorisation: 08/12/2016,, Revision: 15, Authorised, Last updated: 23/05/2022
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Human medicine European public assessment report (EPAR): Zessly
infliximab, Arthritis, Psoriatic; Psoriasis; Crohn Disease; Arthritis, Rheumatoid; Colitis, Ulcerative; Spondylitis, Ankylosing
Date of authorisation: 18/05/2018,
, , Revision: 9, Authorised, Last updated: 23/05/2022
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Human medicine European public assessment report (EPAR): Pregabalin Mylan
pregabalin, Anxiety Disorders; Epilepsy
Date of authorisation: 24/06/2015,, Revision: 13, Authorised, Last updated: 23/05/2022
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Human medicine European public assessment report (EPAR): Apixaban Accord
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
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
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): Remsima
infliximab, Arthritis, Psoriatic; Spondylitis, Ankylosing; Colitis, Ulcerative; Psoriasis; Crohn Disease; Arthritis, Rheumatoid
Date of authorisation: 10/09/2013,, Revision: 28, Authorised, Last updated: 17/05/2022
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Human medicine European public assessment report (EPAR): Deferasirox Mylan
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
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
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
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
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)
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
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): Inflectra
infliximab, Arthritis, Psoriatic; Spondylitis, Ankylosing; Colitis, Ulcerative; Psoriasis; Crohn Disease; Arthritis, Rheumatoid
Date of authorisation: 10/09/2013,, Revision: 29, Authorised, Last updated: 12/05/2022