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506 results
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Human medicine European public assessment report (EPAR): Pioglitazone Teva (updated)
pioglitazone hydrochloride, Diabetes Mellitus, Type 2
Date of authorisation: 26/03/2012,
, Revision: 12, Withdrawn, Last updated: 04/05/2023
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Human medicine European public assessment report (EPAR): Ocaliva
Obeticholic acid, Liver Cirrhosis, Biliary
Date of authorisation: 12/12/2016,
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, Revision: 16, Authorised, Last updated: 02/05/2023
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Human medicine European public assessment report (EPAR): Zynlonta
loncastuximab tesirine, Lymphoma, Large B-Cell, Diffuse; Lymphoma, B-Cell
Date of authorisation: 20/12/2022,, , Revision: 2, Authorised, Last updated: 02/05/2023
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Human medicine European public assessment report (EPAR): Fingolimod Mylan
fingolimod hydrochloride , Multiple Sclerosis, Relapsing-Remitting
Date of authorisation: 18/08/2021,, Revision: 4, Authorised, Last updated: 02/05/2023
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Human medicine European public assessment report (EPAR): Cinacalcet Mylan
cinacalcet hydrochloride, Hyperparathyroidism, Secondary; Hypercalcemia
Date of authorisation: 19/11/2015,, Revision: 15, Authorised, Last updated: 26/04/2023
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Human medicine European public assessment report (EPAR): Ambrisentan Mylan
ambrisentan, Hypertension, Pulmonary
Date of authorisation: 20/06/2019,, Revision: 4, Authorised, Last updated: 26/04/2023
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Human medicine European public assessment report (EPAR): Nemdatine
memantine, Alzheimer Disease
Date of authorisation: 22/04/2013,
Date of refusal: 22/02/2013,, Revision: 12, Authorised, Last updated: 25/04/2023
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Human medicine European public assessment report (EPAR): Translarna
Ataluren, Muscular Dystrophy, Duchenne
Date of authorisation: 31/07/2014,, , , Revision: 22, Authorised, Last updated: 25/04/2023
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Human medicine European public assessment report (EPAR): Lamivudine Teva Pharma B.V.
lamivudine, HIV Infections
Date of authorisation: 10/12/2009,, Revision: 19, Authorised, Last updated: 21/04/2023
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Human medicine European public assessment report (EPAR): Eptifibatide Accord
eptifibatide, Myocardial Infarction
Date of authorisation: 11/01/2016,, Revision: 6, Authorised, Last updated: 21/04/2023
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Human medicine European public assessment report (EPAR): Lunsumio
mosunetuzumab, Lymphoma, Follicular
Date of authorisation: 03/06/2022,, , , Revision: 1, Authorised, Last updated: 20/04/2023
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Human medicine European public assessment report (EPAR): Inpremzia
insulin human (rDNA), Diabetes Mellitus
Date of authorisation: 25/04/2022,, 
, Withdrawn, Last updated: 20/04/2023
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Human medicine European public assessment report (EPAR): Pelgraz
pegfilgrastim, Neutropenia
Date of authorisation: 21/09/2018,, , Revision: 9, Authorised, Last updated: 20/04/2023
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Human medicine European public assessment report (EPAR): Zoledronic acid Mylan
zoledronic acid, Fractures, Bone
Date of authorisation: 23/08/2012,, Revision: 14, Authorised, Last updated: 20/04/2023
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Human medicine European public assessment report (EPAR): Entecavir Mylan
entecavir monohydrate, Hepatitis B
Date of authorisation: 18/09/2017,, Revision: 6, Authorised, Last updated: 19/04/2023
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Human medicine European public assessment report (EPAR): Ceplene
Histamine dihydrochloride, Leukemia, Myeloid, Acute
Date of authorisation: 07/10/2008,, 
, Revision: 12, Authorised, Last updated: 19/04/2023
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Human medicine European public assessment report (EPAR): Alymsys
bevacizumab, Colorectal Neoplasms; Breast Neoplasms; Ovarian Neoplasms; Peritoneal Neoplasms; Carcinoma, Non-Small-Cell Lung; Carcinoma, Renal Cell; Uterine Cervical Neoplasms
Date of authorisation: 26/03/2021,, , Revision: 5, Authorised, Last updated: 18/04/2023
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Human medicine European public assessment report (EPAR): Lorviqua
Lorlatinib, Carcinoma, Non-Small-Cell Lung
Date of authorisation: 06/05/2019,, , Revision: 11, Authorised, Last updated: 18/04/2023
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Human medicine European public assessment report (EPAR): Hefiya
adalimumab, Spondylitis, Ankylosing; Hidradenitis Suppurativa; Psoriasis; Arthritis, Juvenile Rheumatoid; Uveitis
Date of authorisation: 26/07/2018,, Revision: 12, Authorised, Last updated: 18/04/2023
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Human medicine European public assessment report (EPAR): Hyrimoz
adalimumab, Arthritis, Rheumatoid; Arthritis, Psoriatic; Spondylitis, Ankylosing; Uveitis; Hidradenitis Suppurativa; Colitis, Ulcerative; Arthritis, Juvenile Rheumatoid; Crohn Disease; Skin Diseases, Papulosquamous
Date of authorisation: 26/07/2018,, Revision: 11, Authorised, Last updated: 17/04/2023
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Human medicine European public assessment report (EPAR): Adakveo
Crizanlizumab, Anemia, Sickle Cell
Date of authorisation: 28/10/2020,, , , Revision: 4, Authorised, Last updated: 17/04/2023
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Human medicine European public assessment report (EPAR): Deltyba
Delamanid, Tuberculosis, Multidrug-Resistant
Date of authorisation: 27/04/2014,
Date of refusal: 25/07/2013,, , , Revision: 23, Authorised, Last updated: 14/04/2023
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Human medicine European public assessment report (EPAR): Carvykti
ciltacabtagene autoleucel, Multiple Myeloma
Date of authorisation: 25/05/2022,, , , Revision: 3, Authorised, Last updated: 14/04/2023
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Human medicine European public assessment report (EPAR): Byooviz
ranibizumab, Wet Macular Degeneration; Macular Edema; Diabetic Retinopathy; Myopia, Degenerative
Date of authorisation: 18/08/2021,, , Revision: 6, Authorised, Last updated: 14/04/2023
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Human medicine European public assessment report (EPAR): Dimethyl fumarate Neuraxpharm
dimethyl fumarate, Multiple Sclerosis, Relapsing-Remitting
Date of authorisation: 13/05/2022,, Revision: 4, Authorised, Last updated: 13/04/2023