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Human medicine European public assessment report (EPAR): Vyndaqel
tafamidis, Amyloidosis
Date of authorisation: 16/11/2011,,
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, Revision: 25, Authorised, Last updated: 02/03/2023
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Human medicine European public assessment report (EPAR): Onpattro
patisiran sodium, Amyloidosis, Familial
Date of authorisation: 27/08/2018,,
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, Revision: 10, Authorised, Last updated: 28/02/2023
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Human medicine European public assessment report (EPAR): Temozolomide Hexal
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Date of authorisation: 15/03/2010,, Revision: 17, Withdrawn, Last updated: 27/02/2023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): 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): 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): Lamzede
velmanase alfa, alpha-Mannosidosis
Date of authorisation: 23/03/2018,,
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, Revision: 6, 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): 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): Strensiq
asfotase alfa, Hypophosphatasia
Date of authorisation: 28/08/2015,,
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, Revision: 16, Authorised, Last updated: 15/02/2023
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Human medicine European public assessment report (EPAR): Azacitidine betapharm
azacitidine, Myelodysplastic Syndromes; Leukemia, Myelomonocytic, Chronic; Leukemia, Myeloid, Acute
Date of authorisation: 24/03/2020,, Revision: 5, Authorised, Last updated: 13/02/2023
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Human medicine European public assessment report (EPAR): Sylvant
siltuximab, Giant Lymph Node Hyperplasia
Date of authorisation: 22/05/2014,,
, Revision: 12, Authorised, Last updated: 09/02/2023
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Human medicine European public assessment report (EPAR): Harvoni
ledipasvir, Sofosbuvir, Hepatitis C, Chronic
Date of authorisation: 17/11/2014,, Revision: 27, Authorised, Last updated: 09/02/2023
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Human medicine European public assessment report (EPAR): Sovaldi
Sofosbuvir, Hepatitis C, Chronic
Date of authorisation: 16/01/2014,, Revision: 27, Authorised, Last updated: 09/02/2023
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Human medicine European public assessment report (EPAR): Defitelio
defibrotide, Hepatic Veno-Occlusive Disease
Date of authorisation: 18/10/2013,,
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, Revision: 14, Authorised, Last updated: 09/02/2023
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Human medicine European public assessment report (EPAR): Pregabalin Zentiva
pregabalin, Anxiety Disorders; Epilepsy
Date of authorisation: 17/07/2015,, Revision: 15, Authorised, Last updated: 09/02/2023
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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: 12, Authorised, Last updated: 06/02/2023