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Human medicine European public assessment report (EPAR): Ambrisentan Mylan (updated)
ambrisentan, Hypertension, Pulmonary
Date of authorisation: 20/06/2019,
, Revision: 2, Authorised, Last updated: 23/03/2021
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Human medicine European public assessment report (EPAR): Omnitrope (updated)
somatropin, Turner Syndrome, Prader-Willi Syndrome, Dwarfism, Pituitary
Date of authorisation: 12/04/2006,
, Revision: 17, Authorised, Last updated: 23/03/2021
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Human medicine European public assessment report (EPAR): Olanzapine Mylan (updated)
olanzapine, Schizophrenia, Bipolar Disorder
Date of authorisation: 06/10/2008,, Revision: 16, Authorised, Last updated: 23/03/2021
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Human medicine European public assessment report (EPAR): Nyvepria (updated)
pegfilgrastim, Neutropenia
Date of authorisation: 18/11/2020,
, , Revision: 1, Authorised, Last updated: 23/03/2021
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Human medicine European public assessment report (EPAR): Abasaglar (previously Abasria) (updated)
insulin glargine, Diabetes Mellitus
Date of authorisation: 09/09/2014,, Revision: 11, Authorised, Last updated: 22/03/2021
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Human medicine European public assessment report (EPAR): Capecitabine Accord (updated)
capecitabine, Colonic Neoplasms, Breast Neoplasms, Colorectal Neoplasms, Stomach Neoplasms
Date of authorisation: 20/04/2012,
, , Revision: 13, Authorised, Last updated: 22/03/2021
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Human medicine European public assessment report (EPAR): Nityr
nitisinone, Tyrosinemias
Date of authorisation: 26/07/2018,, Revision: 2, Authorised, Last updated: 19/03/2021
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Human medicine European public assessment report (EPAR): Darunavir Krka d.d.
darunavir, HIV Infections
Date of authorisation: 18/01/2018,, Revision: 6, Authorised, Last updated: 19/03/2021
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Human medicine European public assessment report (EPAR): Aripiprazole Zentiva
aripiprazole, Schizophrenia, Bipolar Disorder
Date of authorisation: 25/06/2015,, Revision: 8, Authorised, Last updated: 19/03/2021
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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: 9, Authorised, Last updated: 18/03/2021
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Human medicine European public assessment report (EPAR): Nevirapine Teva
nevirapine, HIV Infections
Date of authorisation: 30/11/2009,, Revision: 10, Authorised, Last updated: 18/03/2021
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Human medicine European public assessment report (EPAR): Pregabalin Zentiva k.s.
pregabalin, Anxiety Disorders, Neuralgia, Epilepsy
Date of authorisation: 27/02/2017,, Revision: 7, Authorised, Last updated: 17/03/2021
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Human medicine European public assessment report (EPAR): Ribavirin Teva Pharma B.V.
Ribavirin, Hepatitis C, Chronic
Date of authorisation: 01/07/2009,, Revision: 14, Authorised, Last updated: 17/03/2021
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Human medicine European public assessment report (EPAR): Capecitabine Teva
capecitabine, Colonic Neoplasms, Breast Neoplasms, Colorectal Neoplasms, Stomach Neoplasms
Date of authorisation: 20/04/2012,, , Revision: 14, Authorised, Last updated: 17/03/2021
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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: 7, Authorised, Last updated: 17/03/2021
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Human medicine European public assessment report (EPAR): Ifirmasta (previously Irbesartan Krka)
irbesartan hydrochloride, Hypertension
Date of authorisation: 01/12/2008,, Revision: 12, Authorised, Last updated: 16/03/2021
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Human medicine European public assessment report (EPAR): Repaglinide Teva
repaglinide, Diabetes Mellitus, Type 2
Date of authorisation: 28/06/2009,, Revision: 8, Authorised, Last updated: 12/03/2021
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Human medicine European public assessment report (EPAR): Pregabalin Zentiva
pregabalin, Anxiety Disorders, Epilepsy
Date of authorisation: 17/07/2015,, Revision: 8, Authorised, Last updated: 12/03/2021
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Human medicine European public assessment report (EPAR): Desloratadine Teva
desloratadine, Rhinitis, Allergic, Perennial, Rhinitis, Allergic, Seasonal
Date of authorisation: 24/11/2011,, Revision: 16, Authorised, Last updated: 11/03/2021
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Human medicine European public assessment report (EPAR): Levetiracetam Hospira
levetiracetam, Epilepsy
Date of authorisation: 07/01/2014,, Revision: 17, Authorised, Last updated: 11/03/2021
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Human medicine European public assessment report (EPAR): Irbesartan Teva
irbesartan, Hypertension
Date of authorisation: 30/10/2009,, Revision: 13, Authorised, Last updated: 11/03/2021
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Human medicine European public assessment report (EPAR): Entacapone Teva
entacapone, Parkinson Disease
Date of authorisation: 18/02/2011,, Revision: 9, Authorised, Last updated: 11/03/2021
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Human medicine European public assessment report (EPAR): Capecitabine Medac
capecitabine, Colorectal Neoplasms
Date of authorisation: 19/11/2012,, , Revision: 11, Authorised, Last updated: 10/03/2021
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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: 9, Authorised, Last updated: 10/03/2021
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Human medicine European public assessment report (EPAR): Clopidogrel ratiopharm
clopidogrel (as hydrogen sulfate), Myocardial Infarction, Acute Coronary Syndrome, Peripheral Vascular Diseases, Stroke
Date of authorisation: 18/02/2015,, Revision: 10, Authorised, Last updated: 10/03/2021