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189 results
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Human medicine European public assessment report (EPAR): Coagadex (updated)
Human coagulation factor X, Factor X Deficiency
Date of authorisation: 16/03/2016,
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, Revision: 7, Authorised, Last updated: 09/04/2021
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Human medicine European public assessment report (EPAR): Dovprela (previously Pretomanid FGK) (updated)
Pretomanid, Tuberculosis, Multidrug-Resistant
Date of authorisation: 31/07/2020,, , 
, Revision: 3, Authorised, Last updated: 09/04/2021
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Human medicine European public assessment report (EPAR): Rubraca (updated)
rucaparib camsylate, Ovarian Neoplasms
Date of authorisation: 23/05/2018,, , Revision: 6, Authorised, Last updated: 09/04/2021
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Human medicine European public assessment report (EPAR): Vaxzevria (previously COVID-19 Vaccine AstraZeneca) (updated)
ChAdOx1-SARS-COV-2, COVID-19 virus infection
Date of authorisation: 29/01/2021,, , Revision: 3, Authorised, Last updated: 08/04/2021
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Human medicine European public assessment report (EPAR): Brineura (updated)
cerliponase alfa, Neuronal Ceroid-Lipofuscinoses
Date of authorisation: 30/05/2017,, , , 
, Revision: 5, Authorised, Last updated: 08/04/2021
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Human medicine European public assessment report (EPAR): Libtayo (updated)
Cemiplimab, Carcinoma, Squamous Cell
Date of authorisation: 28/06/2019,, , Revision: 6, Authorised, Last updated: 07/04/2021
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Human medicine European public assessment report (EPAR): Kisplyx (updated)
lenvatinib mesilate, Carcinoma, Renal Cell
Date of authorisation: 25/08/2016,, , Revision: 13, Authorised, Last updated: 07/04/2021
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Human medicine European public assessment report (EPAR): Exviera (updated)
dasabuvir sodium, Hepatitis C, Chronic
Date of authorisation: 14/01/2015,, , Revision: 19, Authorised, Last updated: 06/04/2021
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Human medicine European public assessment report (EPAR): Epclusa (updated)
Sofosbuvir, velpatasvir, Hepatitis C, Chronic
Date of authorisation: 06/07/2016,, , Revision: 14, Authorised, Last updated: 31/03/2021
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Human medicine European public assessment report (EPAR): Comirnaty (updated)
Single-stranded, 5’-capped messenger RNA 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: 21/12/2020,, , Revision: 4, Authorised, Last updated: 30/03/2021
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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,, , 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): 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): Lenvima (updated)
lenvatinib mesilate, Thyroid Neoplasms
Date of authorisation: 28/05/2015,, , Revision: 15, Authorised, Last updated: 25/03/2021
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Veterinary medicine European public assessment report (EPAR): Nobilis Influenza H5N2 (updated)
inactivated whole avian influenza virus antigen of H5N2 subtype (strain A/duck/Potsdam/1402/86), Chicken
Date of authorisation: 01/09/2006,, Revision: 8, Authorised, Last updated: 25/03/2021
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Human medicine European public assessment report (EPAR): Vidaza (updated)
azacitidine, Myelodysplastic Syndromes
Date of authorisation: 17/12/2008,, Revision: 21, 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): COVID-19 Vaccine Janssen (updated)
adenovirus type 26 encoding the SARS-CoV-2 spike glycoprotein (Ad26.COV2-S), COVID-19 virus infection
Date of authorisation: 11/03/2021,, , Authorised, Last updated: 19/03/2021
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Human medicine European public assessment report (EPAR): Blenrep (updated)
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 (updated)
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): Viekirax (updated)
Ombitasvir, paritaprevir, ritonavir, Hepatitis C, Chronic
Date of authorisation: 14/01/2015,, , Revision: 22, Authorised, Last updated: 12/03/2021
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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): Ninlaro
ixazomib citrate, Multiple Myeloma
Date of authorisation: 21/11/2016,, , , Revision: 9, Authorised, Last updated: 03/03/2021
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Human medicine European public assessment report (EPAR): Maviret
glecaprevir, pibrentasvir, Hepatitis C, Chronic
Date of authorisation: 26/07/2017,, , Revision: 11, Authorised, Last updated: 03/03/2021
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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