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451 results
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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: 14, Authorised, Last updated: 07/03/2023
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Human medicine European public assessment report (EPAR): Temozolomide Sandoz (updated)
temozolomide, Glioma; Glioblastoma
Date of authorisation: 15/03/2010,, Revision: 17, Withdrawn, Last updated: 06/03/2023
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Human medicine European public assessment report (EPAR): Inhixa (updated)
enoxaparin sodium, Venous Thromboembolism
Date of authorisation: 15/09/2016,
, Revision: 23, Authorised, Last updated: 06/03/2023
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Human medicine European public assessment report (EPAR): Efavirenz Teva (updated)
efavirenz, HIV Infections
Date of authorisation: 09/01/2012,, Revision: 12, Authorised, Last updated: 03/03/2023
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Human medicine European public assessment report (EPAR): Temozolomide Hexal (updated)
temozolomide, Glioma; Glioblastoma
Date of authorisation: 15/03/2010,, Revision: 17, Withdrawn, Last updated: 27/02/2023
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Human medicine European public assessment report (EPAR): Pelmeg
pegfilgrastim, Neutropenia
Date of authorisation: 20/11/2018,
, , Revision: 7, Authorised, Last updated: 24/02/2023
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Human medicine European public assessment report (EPAR): Cegfila (previously Pegfilgrastim Mundipharma)
pegfilgrastim, Neutropenia
Date of authorisation: 19/12/2019,, , Revision: 7, Authorised, Last updated: 24/02/2023
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Human medicine European public assessment report (EPAR): Telmisartan Actavis
telmisartan, Hypertension
Date of authorisation: 29/09/2010,, Revision: 11, Authorised, Last updated: 24/02/2023
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Human medicine European public assessment report (EPAR): Fulvestrant Mylan
fulvestrant, Breast Neoplasms
Date of authorisation: 08/01/2018,, Revision: 5, Authorised, Last updated: 24/02/2023
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Human medicine European public assessment report (EPAR): Vizarsin
sildenafil, Erectile Dysfunction
Date of authorisation: 21/09/2009,, Revision: 19, Authorised, Last updated: 24/02/2023
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Human medicine European public assessment report (EPAR): Rasagiline Mylan
rasagiline tartrate, Parkinson Disease
Date of authorisation: 04/04/2016,, Revision: 7, Authorised, Last updated: 23/02/2023
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Human medicine European public assessment report (EPAR): Anagrelide Mylan
Anagrelide hydrochloride, Thrombocythemia, Essential
Date of authorisation: 15/02/2018,, Revision: 7, Authorised, Last updated: 23/02/2023
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Human medicine European public assessment report (EPAR): Azacitidine Mylan
azacitidine, Myelodysplastic Syndromes; Leukemia, Myelomonocytic, Chronic; Leukemia, Myeloid, Acute
Date of authorisation: 27/03/2020,, Revision: 5, Authorised, Last updated: 22/02/2023
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Human medicine European public assessment report (EPAR): Zalasta
olanzapine, Schizophrenia; Bipolar Disorder
Date of authorisation: 27/09/2007,, Revision: 20, Authorised, Last updated: 22/02/2023
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Human medicine European public assessment report (EPAR): Pemetrexed Krka
pemetrexed disodium, Carcinoma, Non-Small-Cell Lung; Mesothelioma
Date of authorisation: 22/05/2018,, Revision: 6, Authorised, Last updated: 22/02/2023
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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: 10, Authorised, Last updated: 22/02/2023
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Human medicine European public assessment report (EPAR): Nimvastid
rivastigmine, Dementia; Alzheimer Disease; Parkinson Disease
Date of authorisation: 11/05/2009,, Revision: 10, Authorised, Last updated: 22/02/2023
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Human medicine European public assessment report (EPAR): Tolura
telmisartan, Hypertension
Date of authorisation: 04/06/2010,, Revision: 11, Authorised, Last updated: 22/02/2023
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Human medicine European public assessment report (EPAR): Yargesa
miglustat, Gaucher Disease
Date of authorisation: 22/03/2017,, Revision: 5, Authorised, Last updated: 22/02/2023
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Human medicine European public assessment report (EPAR): Nitisinone MDK (previously Nitisinone MendeliKABS)
nitisinone, Tyrosinemias
Date of authorisation: 24/08/2017,, Revision: 6, Authorised, Last updated: 20/02/2023
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Human medicine European public assessment report (EPAR): Sapropterin Dipharma
Sapropterin dihydrochloride, Phenylketonurias
Date of authorisation: 16/02/2022,, Revision: 3, Authorised, Last updated: 20/02/2023
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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: 32, Authorised, Last updated: 20/02/2023
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Human medicine European public assessment report (EPAR): Accofil
filgrastim, Neutropenia
Date of authorisation: 17/09/2014,, Revision: 13, Authorised, Last updated: 16/02/2023
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Human medicine European public assessment report (EPAR): Thiotepa Riemser
thiotepa, Hematopoietic Stem Cell Transplantation; Neoplasms
Date of authorisation: 26/03/2021,, Revision: 3, Authorised, Last updated: 16/02/2023
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Human medicine European public assessment report (EPAR): Darunavir Krka
darunavir, HIV Infections
Date of authorisation: 26/01/2018,, Revision: 9, Authorised, Last updated: 16/02/2023