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Human medicine European public assessment report (EPAR): Darunavir Krka d.d. (updated)
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 (updated)
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 (updated)
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): Naglazyme
galsulfase, Mucopolysaccharidosis VI
Date of authorisation: 23/01/2006,
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, Revision: 18, 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): Foclivia
influenza virus surface antigens, inactivated: A/Viet Nam/1194/2004 (H5N1), Influenza, Human, Immunization, Disease Outbreaks
Date of authorisation: 18/10/2009,, Revision: 11, Authorised, Last updated: 10/03/2021
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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
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Human medicine European public assessment report (EPAR): Temozolomide Accord
temozolomide, Glioma, Glioblastoma
Date of authorisation: 15/03/2010,, Revision: 20, Authorised, Last updated: 09/03/2021
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Human medicine European public assessment report (EPAR): Pramipexole Teva
pramipexole dihydrochloride monohydrate, Parkinson Disease
Date of authorisation: 18/12/2008,, Revision: 21, Authorised, Last updated: 09/03/2021
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Human medicine European public assessment report (EPAR): Vizarsin
sildenafil, Erectile Dysfunction
Date of authorisation: 21/09/2009,, Revision: 16, Authorised, Last updated: 05/03/2021
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Human medicine European public assessment report (EPAR): Pemetrexed Accord
pemetrexed disodium hemipentahydrate, Carcinoma, Non-Small-Cell Lung, Mesothelioma
Date of authorisation: 18/01/2016,, Revision: 6, Authorised, Last updated: 05/03/2021
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Human medicine European public assessment report (EPAR): Vyndaqel
tafamidis, Amyloidosis
Date of authorisation: 16/11/2011,, 
, , Revision: 18, Authorised, Last updated: 02/03/2021