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296 results
Medicine
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Human medicine European public assessment report (EPAR): Ecansya (previously Capecitabine Krka)
capecitabine, Colonic Neoplasms; Breast Neoplasms; Colorectal Neoplasms; Stomach Neoplasms
Date of authorisation: 20/04/2012,
, Revision: 15, Authorised, Last updated: 25/08/2023
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Human medicine European public assessment report (EPAR): Tolucombi
Telmisartan, hydrochlorothiazide, Hypertension
Date of authorisation: 13/03/2013,, Revision: 11, Authorised, Last updated: 24/08/2023
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Human medicine European public assessment report (EPAR): Soliris
Eculizumab, Hemoglobinuria, Paroxysmal
Date of authorisation: 20/06/2007,
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, Revision: 36, Authorised, Last updated: 21/08/2023
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Human medicine European public assessment report (EPAR): Fingolimod Accord
fingolimod hydrochloride , Multiple Sclerosis, Relapsing-Remitting
Date of authorisation: 25/06/2020,, Revision: 4, Authorised, Last updated: 18/08/2023
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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: 13, Authorised, Last updated: 17/08/2023
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Human medicine European public assessment report (EPAR): Amlodipine / Valsartan Mylan
Amlodipine besilate, valsartan, Hypertension
Date of authorisation: 22/03/2016,, Revision: 11, Authorised, Last updated: 17/08/2023
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Human medicine European public assessment report (EPAR): Lacosamide Accord
lacosamide, Epilepsy
Date of authorisation: 18/09/2017,, Revision: 12, Authorised, Last updated: 16/08/2023
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Human medicine European public assessment report (EPAR): Takhzyro
lanadelumab, Angioedemas, Hereditary
Date of authorisation: 22/11/2018,, , Revision: 11, Authorised, Last updated: 16/08/2023
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Human medicine European public assessment report (EPAR): Tolvaptan Accord
Tolvaptan, Inappropriate ADH Syndrome, Authorised, Last updated: 14/08/2023
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Human medicine European public assessment report (EPAR): Tagrisso
osimertinib mesilate, Carcinoma, Non-Small-Cell Lung
Date of authorisation: 01/02/2016,, Revision: 18, Authorised, Last updated: 11/08/2023
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Human medicine European public assessment report (EPAR): Vpriv
velaglucerase alfa, Gaucher Disease
Date of authorisation: 26/08/2010,, Revision: 20, Authorised, Last updated: 08/08/2023
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Human medicine European public assessment report (EPAR): Plerixafor Accord
Plerixafor, Multiple Myeloma; Hematopoietic Stem Cell Transplantation
Date of authorisation: 16/12/2022,
, , Revision: 1, Authorised, Last updated: 07/08/2023
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Human medicine European public assessment report (EPAR): Capecitabine Accord
capecitabine, Colonic Neoplasms; Breast Neoplasms; Colorectal Neoplasms; Stomach Neoplasms
Date of authorisation: 20/04/2012,, Revision: 16, Authorised, Last updated: 03/08/2023
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Human medicine European public assessment report (EPAR): Ofev
nintedanib, Idiopathic Pulmonary Fibrosis
Date of authorisation: 14/01/2015,, Revision: 24, Authorised, Last updated: 01/08/2023
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Human medicine European public assessment report (EPAR): Oprymea
pramipexole dihydrochloride monohydrate, Parkinson Disease
Date of authorisation: 12/09/2008,, Revision: 22, Authorised, Last updated: 31/07/2023
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Human medicine European public assessment report (EPAR): Cabazitaxel Accord
cabazitaxel, Prostatic Neoplasms, Castration-Resistant
Date of authorisation: 28/08/2020,, Revision: 5, Authorised, Last updated: 27/07/2023
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Human medicine European public assessment report (EPAR): Gefitinib Mylan
gefitinib, Carcinoma, Non-Small-Cell Lung
Date of authorisation: 27/09/2018,, Revision: 6, Authorised, Last updated: 27/07/2023
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Human medicine European public assessment report (EPAR): Emtricitabine/Tenofovir disoproxil Mylan
emtricitabine, tenofovir disoproxil maleate, HIV Infections
Date of authorisation: 16/12/2016,, Revision: 14, Authorised, Last updated: 27/07/2023
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Human medicine European public assessment report (EPAR): Lenalidomide Krka (previously Lenalidomide Krka d.d. Novo mesto)
lenalidomide hydrochloride monohydrate, Multiple Myeloma; Myelodysplastic Syndromes; Lymphoma, Follicular; Lymphoma, Mantle-Cell
Date of authorisation: 11/02/2021,, Revision: 4, Authorised, Last updated: 26/07/2023
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Human medicine European public assessment report (EPAR): Miglustat Dipharma
miglustat, Gaucher Disease
Date of authorisation: 18/02/2019,, Revision: 7, Authorised, Last updated: 26/07/2023
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Human medicine European public assessment report (EPAR): Kisplyx
lenvatinib mesilate, Carcinoma, Renal Cell
Date of authorisation: 25/08/2016,, Revision: 20, Authorised, Last updated: 25/07/2023
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Human medicine European public assessment report (EPAR): Lenvima
lenvatinib mesilate, Thyroid Neoplasms
Date of authorisation: 28/05/2015,, , Revision: 19, Authorised, Last updated: 25/07/2023
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Human medicine European public assessment report (EPAR): Sugammadex Piramal
sugammadex sodium, Neuromuscular Blockade
Date of authorisation: 23/06/2023,, Authorised, Last updated: 18/07/2023
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Human medicine European public assessment report (EPAR): Sylvant
siltuximab, Giant Lymph Node Hyperplasia
Date of authorisation: 22/05/2014,, , Revision: 13, Authorised, Last updated: 17/07/2023
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Human medicine European public assessment report (EPAR): Olanzapine Mylan
olanzapine, Schizophrenia; Bipolar Disorder
Date of authorisation: 06/10/2008,, Revision: 19, Authorised, Last updated: 14/07/2023