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Human medicine European public assessment report (EPAR): Xaluprine (previously Mercaptopurine Nova Laboratories) (updated)
6-mercaptopurine monohydrate, Leukemia, Lymphoid
Date of authorisation: 09/03/2012,
, Revision: 12, Authorised, Last updated: 31/03/2021
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Human medicine European public assessment report (EPAR): Amglidia (updated)
glibenclamide, Diabetes Mellitus
Date of authorisation: 24/05/2018,, Revision: 4, Authorised, Last updated: 31/03/2021
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Human medicine European public assessment report (EPAR): COVID-19 Vaccine Moderna (updated)
CX-024414 (single-stranded, 5’-capped messenger RNA (mRNA) produced using a cell-free in vitro transcription from the corresponding DNA templates, encoding the viral spike (S) protein of SARS-CoV-2), COVID-19 virus infection
Date of authorisation: 06/01/2021,
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, Revision: 1, Authorised, Last updated: 30/03/2021
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Human medicine European public assessment report (EPAR): Cometriq (updated)
cabozantinib, Thyroid Neoplasms
Date of authorisation: 21/03/2014,, , , Revision: 21, Authorised, Last updated: 29/03/2021
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Human medicine European public assessment report (EPAR): Telmisartan Teva (updated)
telmisartan, Hypertension
Date of authorisation: 25/01/2010,
, Revision: 11, Authorised, Last updated: 25/03/2021
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Human medicine European public assessment report (EPAR): Zoledronic Acid Hospira (updated)
zoledronic acid monohydrate, Hypercalcemia
Date of authorisation: 19/11/2012,, Revision: 17, Authorised, Last updated: 25/03/2021
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Human medicine European public assessment report (EPAR): Strensiq (updated)
asfotase alfa, Hypophosphatasia
Date of authorisation: 28/08/2015,, , 
, 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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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): Gamifant (updated)
Emapalumab, Immune System Diseases
Date of refusal: 07/01/2021,, Refused, 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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Human medicine European public assessment report (EPAR): Trepulmix (updated)
Treprostinil sodium, Hypertension, Pulmonary
Date of authorisation: 03/04/2020,, Revision: 1, 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): Givlaari
Givosiran, Porphyrias, Hepatic
Date of authorisation: 02/03/2020,, , Revision: 1, Authorised, Last updated: 18/03/2021
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Human medicine European public assessment report (EPAR): Cerdelga
eliglustat, Gaucher Disease
Date of authorisation: 19/01/2015,, , Revision: 12, 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): Kaftrio
ivacaftor, tezacaftor, elexacaftor, Cystic Fibrosis
Date of authorisation: 21/08/2020,, , Revision: 2, Authorised, Last updated: 17/03/2021