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393 results
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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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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): Deltyba (updated)
Delamanid, Tuberculosis, Multidrug-Resistant
Date of authorisation: 27/04/2014,
Date of refusal: 25/07/2013,,
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, 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): 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
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Human medicine European public assessment report (EPAR): Nustendi (updated)
Bempedoic acid, Ezetimibe, Hypercholesterolemia, Dyslipidemias
Date of authorisation: 27/03/2020,, Revision: 3, Authorised, Last updated: 17/03/2021
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Human medicine European public assessment report (EPAR): Blenrep (updated)
belantamab mafodotin, Multiple Myeloma
Date of authorisation: 25/08/2020,,
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, 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): Alprolix (updated)
eftrenonacog alfa, Hemophilia B
Date of authorisation: 12/05/2016,,
, Revision: 7, Authorised, Last updated: 17/03/2021
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Human medicine European public assessment report (EPAR): Laventair Ellipta (previously Laventair) (updated)
umeclidinium bromide, vilanterol, Pulmonary Disease, Chronic Obstructive
Date of authorisation: 08/05/2014,, Revision: 15, Authorised, Last updated: 12/03/2021
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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): Temybric Ellipta (updated)
fluticasone furoate, umeclidinium bromide, vilanterol trifenatate, Pulmonary Disease, Chronic Obstructive
Date of authorisation: 12/06/2019,, Revision: 3, Authorised, Last updated: 12/03/2021
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Human medicine European public assessment report (EPAR): Anoro Ellipta (previously Anoro)
umeclidinium bromide, vilanterol trifenatate, Pulmonary Disease, Chronic Obstructive
Date of authorisation: 08/05/2014,, Revision: 16, Authorised, Last updated: 11/03/2021
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Human medicine European public assessment report (EPAR): Wakix
pitolisant, Narcolepsy
Date of authorisation: 31/03/2016,,
, Revision: 10, Authorised, Last updated: 11/03/2021
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Human medicine European public assessment report (EPAR): Recarbrio
imipenem monohydrate, cilastatin sodium, relebactam monohydrate, Gram-Negative Bacterial Infections
Date of authorisation: 13/02/2020,, Revision: 2, Authorised, Last updated: 11/03/2021
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Human medicine European public assessment report (EPAR): Vocabria
Cabotegavir sodium, Cabotegravir, HIV Infections
Date of authorisation: 17/12/2020,, Revision: 1, Authorised, Last updated: 11/03/2021