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301 results
Medicine
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Human medicine European public assessment report (EPAR): Strensiq (updated)
asfotase alfa, Hypophosphatasia
Date of authorisation: 28/08/2015,
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, Revision: 14, Authorised, Last updated: 25/03/2021
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Human medicine European public assessment report (EPAR): Deferiprone Lipomed (updated)
Deferiprone, Iron Overload, beta-Thalassemia
Date of authorisation: 19/09/2018,
, Revision: 3, Authorised, Last updated: 25/03/2021
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Human medicine European public assessment report (EPAR): Bortezomib Fresenius Kabi (updated)
bortezomib, Multiple Myeloma
Date of authorisation: 14/11/2019,, Revision: 4, Authorised, Last updated: 24/03/2021
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Human medicine European public assessment report (EPAR): Bortezomib Hospira (updated)
bortezomib, Multiple Myeloma
Date of authorisation: 22/07/2016,, Revision: 10, Authorised, Last updated: 24/03/2021
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Human medicine European public assessment report (EPAR): Bortezomib Accord (updated)
bortezomib, Multiple Myeloma
Date of authorisation: 20/07/2015,, Revision: 9, Authorised, Last updated: 24/03/2021
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Veterinary medicine European public assessment report (EPAR): Kriptazen (updated)
halofuginone, Calves, newborn
Date of authorisation: 08/02/2019,, Revision: 1, Authorised, Last updated: 24/03/2021
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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): Deltyba (updated)
Delamanid, Tuberculosis, Multidrug-Resistant
Date of authorisation: 27/04/2014,
Date of refusal: 25/07/2013,, , 
, Revision: 15, 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): 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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Veterinary medicine European public assessment report (EPAR): Rheumocam (updated)
meloxicam, Dogs, Horses, Cats, Cattle, Pigs
Date of authorisation: 10/01/2008,, Revision: 16, Authorised, Last updated: 22/03/2021
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Veterinary medicine European public assessment report (EPAR): Inflacam
meloxicam, Horses, Dogs, Cats, Cattle, Pigs
Date of authorisation: 09/12/2011,, Revision: 12, Authorised, Last updated: 19/03/2021
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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): Blenrep
belantamab mafodotin, Multiple Myeloma
Date of authorisation: 25/08/2020,, , , Revision: 2, 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,, , 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