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Human medicine European public assessment report (EPAR): Irbesartan Teva (updated)
irbesartan, Hypertension
Date of authorisation: 30/10/2009,
, Revision: 16, Authorised, Last updated: 05/09/2023
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Human medicine European public assessment report (EPAR): Ziextenzo (updated)
pegfilgrastim, Neutropenia
Date of authorisation: 22/11/2018,
, Revision: 8, Authorised, Last updated: 05/09/2023
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Human medicine European public assessment report (EPAR): Pirfenidone axunio (previously Pirfenidone AET) (updated)
Pirfenidone, Idiopathic Pulmonary Fibrosis
Date of authorisation: 20/06/2022,, Revision: 3, Authorised, Last updated: 25/08/2023
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Human medicine European public assessment report (EPAR): Duloxetine Mylan (updated)
duloxetine, Neuralgia; Diabetic Neuropathies; Depressive Disorder, Major; Anxiety Disorders
Date of authorisation: 19/06/2015,, Revision: 18, Authorised, Last updated: 25/08/2023
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Human medicine European public assessment report (EPAR): Ecansya (previously Capecitabine Krka) (updated)
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 (updated)
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): Binocrit
epoetin alfa, Anemia; Kidney Failure, Chronic
Date of authorisation: 28/08/2007,, Revision: 21, Authorised, Last updated: 21/08/2023
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Human medicine European public assessment report (EPAR): Abseamed
epoetin alfa, Anemia; Kidney Failure, Chronic; Cancer
Date of authorisation: 27/08/2007,
Date of refusal: 18/06/2009,, Revision: 22, Authorised, Last updated: 21/08/2023
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Human medicine European public assessment report (EPAR): Epoetin Alfa Hexal
epoetin alfa, Anemia; Kidney Failure, Chronic; Cancer
Date of authorisation: 27/08/2007,, Revision: 23, 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): Ovaleap
follitropin alfa, Anovulation
Date of authorisation: 27/09/2013,, Revision: 10, 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): Tolvaptan Accord
Tolvaptan, Inappropriate ADH Syndrome, Authorised, Last updated: 14/08/2023
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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): Erelzi
etanercept, Arthritis, Psoriatic; Psoriasis; Arthritis, Juvenile Rheumatoid; Arthritis, Rheumatoid; Spondylitis, Ankylosing
Date of authorisation: 23/06/2017,, Revision: 13, Authorised, Last updated: 04/08/2023
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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): 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): Terrosa
teriparatide, Osteoporosis
Date of authorisation: 04/01/2017,, , Revision: 6, Authorised, Last updated: 28/07/2023
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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): Inhixa
enoxaparin sodium, Venous Thromboembolism
Date of authorisation: 15/09/2016,, Revision: 25, 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