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Medicine European public assessment reports (EPAR) Remove European public assessment reports (EPAR) filter Paediatric investigation plans Remove Paediatric investigation plans filter

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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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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): 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): Givlaari

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

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, , , , 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