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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): 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): Omnitrope (updated)

somatropin, Turner Syndrome, Prader-Willi Syndrome, Dwarfism, Pituitary
Date of authorisation: 12/04/2006, , Revision: 17, 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): Abasaglar (previously Abasria) (updated)

insulin glargine, Diabetes Mellitus
Date of authorisation: 09/09/2014, , Revision: 11, 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, , , , 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