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Human medicine European public assessment report (EPAR): Firdapse (previously Zenas) (updated)
amifampridine, Lambert-Eaton Myasthenic Syndrome
Date of authorisation: 23/12/2009,
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, Revision: 21, Authorised, Last updated: 23/05/2022
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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: 23/05/2022
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Human medicine European public assessment report (EPAR): Revestive (updated)
teduglutide, Malabsorption Syndromes
Date of authorisation: 30/08/2012,, 
, Revision: 19, Authorised, Last updated: 23/05/2022
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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: 9, Authorised, Last updated: 23/05/2022
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Human medicine European public assessment report (EPAR): Pregabalin Mylan (updated)
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): Xospata (updated)
gilteritinib fumarate, Leukemia, Myeloid, Acute
Date of authorisation: 24/10/2019,, , Revision: 3, Authorised, Last updated: 20/05/2022
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Human medicine European public assessment report (EPAR): Elaprase (updated)
idursulfase, Mucopolysaccharidosis II
Date of authorisation: 08/01/2007,, , Revision: 22, Authorised, Last updated: 20/05/2022
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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: 11, Authorised, Last updated: 19/05/2022
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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): Uplizna (updated)
Inebilizumab, Neuromyelitis Optica
Date of authorisation: 25/04/2022,, Authorised, Last updated: 19/05/2022
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Human medicine European public assessment report (EPAR): Ayvakyt (updated)
avapritinib, Gastrointestinal Stromal Tumors
Date of authorisation: 24/09/2020,, , Revision: 4, Authorised, Last updated: 18/05/2022
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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): Cometriq (updated)
cabozantinib, Thyroid Neoplasms
Date of authorisation: 21/03/2014,, Revision: 24, Authorised, Last updated: 18/05/2022
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Human medicine European public assessment report (EPAR): Remsima (updated)
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 (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): Tobi Podhaler (updated)
Tobramycin, Cystic Fibrosis; Respiratory Tract Infections
Date of authorisation: 20/07/2011,, Revision: 19, Authorised, Last updated: 13/05/2022
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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): Kalydeco (updated)
ivacaftor, Cystic Fibrosis
Date of authorisation: 23/07/2012,
, , Revision: 33, Authorised, Last updated: 12/05/2022
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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: 16, Authorised, Last updated: 12/05/2022
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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: 11, Authorised, Last updated: 12/05/2022
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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