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422 results
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Human medicine European public assessment report (EPAR): Temozolomide Sun (updated)
temozolomide, Glioma, Glioblastoma
Date of authorisation: 13/07/2011,
, Revision: 17, Authorised, Last updated: 25/05/2021
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Human medicine European public assessment report (EPAR): Pazenir (updated)
paclitaxel, Breast Neoplasms
Date of authorisation: 06/05/2019,, Revision: 6, Authorised, Last updated: 25/05/2021
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Human medicine European public assessment report (EPAR): Enhertu (updated)
trastuzumab deruxtecan, Breast Neoplasms
Date of authorisation: 18/01/2021,
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, Revision: 1, Authorised, Last updated: 25/05/2021
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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: 19, Authorised, Last updated: 19/05/2021
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Human medicine European public assessment report (EPAR): Adcetris
Brentuximab vedotin, Lymphoma, Non-Hodgkin, Hodgkin Disease
Date of authorisation: 25/10/2012,, , , Revision: 29, Authorised, Last updated: 18/05/2021
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Human medicine European public assessment report (EPAR): Efavirenz/Emtricitabine/Tenofovir disoproxil Zentiva
efavirenz, emtricitabine, tenofovir disoproxil phosphate, HIV Infections
Date of authorisation: 17/07/2017,, Revision: 7, Authorised, Last updated: 18/05/2021
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Human medicine European public assessment report (EPAR): Clopidogrel Mylan
clopidogrel (as hydrochloride), Peripheral Vascular Diseases, Stroke, Myocardial Infarction
Date of authorisation: 21/09/2009,, Revision: 17, Authorised, Last updated: 18/05/2021
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Human medicine European public assessment report (EPAR): Libtayo
Cemiplimab, Carcinoma, Squamous Cell
Date of authorisation: 28/06/2019,, , Revision: 7, Authorised, Last updated: 18/05/2021
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Human medicine European public assessment report (EPAR): Busulfan Fresenius Kabi
busulfan, Hematopoietic Stem Cell Transplantation
Date of authorisation: 22/09/2014,, Revision: 9, Authorised, Last updated: 18/05/2021
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Human medicine European public assessment report (EPAR): Pemetrexed Fresenius Kabi
pemetrexed, Carcinoma, Non-Small-Cell Lung, Mesothelioma
Date of authorisation: 22/07/2016,, Revision: 11, Authorised, Last updated: 18/05/2021
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Human medicine European public assessment report (EPAR): Sildenafil Actavis
sildenafil, Erectile Dysfunction
Date of authorisation: 10/12/2009,, Revision: 14, Authorised, Last updated: 12/05/2021
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Human medicine European public assessment report (EPAR): Kalydeco
ivacaftor, Cystic Fibrosis
Date of authorisation: 23/07/2012,
, , Revision: 28, Authorised, Last updated: 12/05/2021
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Human medicine European public assessment report (EPAR): Memantine Mylan
memantine hydrochloride, Alzheimer Disease
Date of authorisation: 21/04/2013,, Revision: 7, Authorised, Last updated: 12/05/2021
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Human medicine European public assessment report (EPAR): Zonisamide Mylan
zonisamide, Epilepsy
Date of authorisation: 31/03/2016,, Revision: 6, Authorised, Last updated: 12/05/2021
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Human medicine European public assessment report (EPAR): Increlex
Mecasermin, Laron Syndrome
Date of authorisation: 02/08/2007,, , Revision: 22, Authorised, Last updated: 12/05/2021
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Human medicine European public assessment report (EPAR): Vitrakvi
larotrectinib sulfate, Abdominal Neoplasms
Date of authorisation: 19/09/2019,, , Revision: 3, Authorised, Last updated: 12/05/2021
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Human medicine European public assessment report (EPAR): Sylvant
siltuximab, Giant Lymph Node Hyperplasia
Date of authorisation: 22/05/2014,, , Revision: 11, Authorised, Last updated: 12/05/2021
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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: 15, Authorised, Last updated: 12/05/2021
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Human medicine European public assessment report (EPAR): Arsenic trioxide Accord
Arsenic trioxide, Leukemia, Promyelocytic, Acute
Date of authorisation: 14/11/2019,, Revision: 3, Authorised, Last updated: 12/05/2021
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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: 16, Authorised, Last updated: 11/05/2021
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Human medicine European public assessment report (EPAR): Pregabalin Sandoz
pregabalin, Anxiety Disorders, Neuralgia, Epilepsy
Date of authorisation: 19/06/2015,, Revision: 6, Authorised, Last updated: 10/05/2021
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Human medicine European public assessment report (EPAR): Kyprolis
carfilzomib, Multiple Myeloma
Date of authorisation: 19/11/2015,, , Revision: 19, Authorised, Last updated: 07/05/2021
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Human medicine European public assessment report (EPAR): Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan
efavirenz, emtricitabine, tenofovir disoproxil maleate, HIV Infections
Date of authorisation: 05/09/2017,, Revision: 10, Authorised, Last updated: 07/05/2021
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Human medicine European public assessment report (EPAR): Tegsedi
inotersen sodium, Amyloidosis
Date of authorisation: 06/07/2018,, , , Revision: 7, Authorised, Last updated: 06/05/2021
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Human medicine European public assessment report (EPAR): Bortezomib Hospira
bortezomib, Multiple Myeloma
Date of authorisation: 22/07/2016,, Revision: 11, Authorised, Last updated: 06/05/2021