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475 results
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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): Daxas
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
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
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
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
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
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
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)
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
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
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
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Human medicine European public assessment report (EPAR): Incruse Ellipta (previously Incruse)
umeclidinium bromide, Pulmonary Disease, Chronic Obstructive
Date of authorisation: 28/04/2014,, Revision: 15, Authorised, Last updated: 10/03/2021
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Human medicine European public assessment report (EPAR): Trelegy Ellipta
fluticasone furoate, umeclidinium bromide, vilanterol trifenatate, Pulmonary Disease, Chronic Obstructive
Date of authorisation: 15/11/2017,, Revision: 7, Authorised, Last updated: 09/03/2021
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Human medicine European public assessment report (EPAR): Libmeldy
autologous CD34+ cell enriched population that contains hematopoietic stem and progenitor cells transduced ex vivo using a lentiviral vector encoding the human arylsulfatase A gene, Leukodystrophy, Metachromatic
Date of authorisation: 17/12/2020,,
, Revision: 1, Authorised, Last updated: 09/03/2021
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Human medicine European public assessment report (EPAR): Spravato
esketamine hydrochloride, Depressive Disorder
Date of authorisation: 18/12/2019,, Revision: 2, Authorised, Last updated: 08/03/2021
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Human medicine European public assessment report (EPAR): Tecentriq
atezolizumab, Carcinoma, Transitional Cell, Carcinoma, Non-Small-Cell Lung, Urologic Neoplasms, Breast Neoplasms, Small Cell Lung Carcinoma
Date of authorisation: 20/09/2017,, Revision: 13, Authorised, Last updated: 05/03/2021
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Human medicine European public assessment report (EPAR): Ninlaro
ixazomib citrate, Multiple Myeloma
Date of authorisation: 21/11/2016,,
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, 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,,
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, Revision: 18, Authorised, Last updated: 02/03/2021
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Human medicine European public assessment report (EPAR): Flixabi
infliximab, Spondylitis, Ankylosing, Arthritis, Rheumatoid, Crohn Disease, Colitis, Ulcerative, Arthritis, Psoriatic, Psoriasis
Date of authorisation: 26/05/2016,,
, Revision: 16, Authorised, Last updated: 01/03/2021
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Human medicine European public assessment report (EPAR): Herzuma
trastuzumab, Stomach Neoplasms, Breast Neoplasms
Date of authorisation: 08/02/2018,,
, Revision: 11, Authorised, Last updated: 01/03/2021