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374 results
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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,
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, 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): Trazimera (updated)
trastuzumab, Stomach Neoplasms, Breast Neoplasms
Date of authorisation: 26/07/2018,, 
, Revision: 7, Authorised, Last updated: 29/03/2021
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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): Ocrevus (updated)
ocrelizumab, Multiple Sclerosis
Date of authorisation: 08/01/2018,, Revision: 10, Authorised, Last updated: 29/03/2021
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Human medicine European public assessment report (EPAR): Axumin (updated)
Fluciclovine (18F), Prostatic Neoplasms, Radionuclide Imaging
Date of authorisation: 21/05/2017,, Revision: 11, Authorised, Last updated: 25/03/2021
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Human medicine European public assessment report (EPAR): Staquis (updated)
Crisaborole, Dermatitis, Atopic
Date of authorisation: 27/03/2020,, Revision: 3, 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): 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): Lemtrada (updated)
alemtuzumab, Multiple Sclerosis
Date of authorisation: 12/09/2013,
, , Revision: 11, Authorised, Last updated: 25/03/2021
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Human medicine European public assessment report (EPAR): Rizmoic (updated)
Naldemedine tosilate, Constipation
Date of authorisation: 18/02/2019,, Revision: 5, Authorised, Last updated: 24/03/2021
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Human medicine European public assessment report (EPAR): Giapreza (updated)
Angiotensin II acetate, Hypotension, Shock
Date of authorisation: 23/08/2019,, Revision: 1, Authorised, Last updated: 23/03/2021
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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): 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): Dectova (updated)
Zanamivir, Influenza, Human
Date of authorisation: 26/04/2019,, Revision: 3, Authorised, Last updated: 23/03/2021
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Human medicine European public assessment report (EPAR): Rekovelle (updated)
follitropin delta, Anovulation
Date of authorisation: 12/12/2016,, Revision: 2, 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): 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): Givlaari (updated)
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 (updated)
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): Daxas (updated)
roflumilast, Pulmonary Disease, Chronic Obstructive
Date of authorisation: 05/07/2010,, Revision: 16, Authorised, Last updated: 18/03/2021
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Human medicine European public assessment report (EPAR): Trumenba (updated)
Neisseria meningitidis serogroup B fHbp (recombinant lipidated fHbp (factor H binding protein)) subfamily A; Neisseria meningitidis serogroup B fHbp (recombinant lipidated fHbp (factor H binding protein)) subfamily B, Meningitis, Meningococcal
Date of authorisation: 24/05/2017,, Revision: 9, Authorised, Last updated: 17/03/2021
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Human medicine European public assessment report (EPAR): Kaftrio (updated)
ivacaftor, tezacaftor, elexacaftor, Cystic Fibrosis
Date of authorisation: 21/08/2020,, , Revision: 2, Authorised, Last updated: 17/03/2021