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Human medicine European public assessment report (EPAR): Caprelsa (updated)
Vandetanib, Thyroid Neoplasms
Date of authorisation: 16/02/2012,
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, Revision: 19, Authorised, Last updated: 23/06/2021
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Human medicine European public assessment report (EPAR): Ondexxya (updated)
andexanet alfa, Drug-Related Side Effects and Adverse Reactions
Date of authorisation: 26/04/2019,, , Revision: 9, Authorised, Last updated: 23/06/2021
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Human medicine European public assessment report (EPAR): Kisplyx (updated)
lenvatinib mesilate, Carcinoma, Renal Cell
Date of authorisation: 25/08/2016,
, Revision: 15, Authorised, Last updated: 23/06/2021
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Human medicine European public assessment report (EPAR): Spikevax (previously 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: 8, Authorised, Last updated: 23/06/2021
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Human medicine European public assessment report (EPAR): Waylivra (updated)
Volanesorsen sodium, Hyperlipoproteinemia Type I
Date of authorisation: 03/05/2019,, 
, , Revision: 3, Authorised, Last updated: 22/06/2021
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Human medicine European public assessment report (EPAR): Vaxzevria (previously COVID-19 Vaccine AstraZeneca) (updated)
ChAdOx1-SARS-COV-2, COVID-19 virus infection
Date of authorisation: 29/01/2021,, , Revision: 8, Authorised, Last updated: 18/06/2021
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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,, , Revision: 2, Authorised, Last updated: 18/06/2021
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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,, , Revision: 8, Authorised, Last updated: 18/06/2021
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Human medicine European public assessment report (EPAR): Ofev (updated)
nintedanib, Idiopathic Pulmonary Fibrosis
Date of authorisation: 14/01/2015,, Revision: 19, Authorised, Last updated: 17/06/2021
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Human medicine European public assessment report (EPAR): Cometriq (updated)
cabozantinib, Thyroid Neoplasms
Date of authorisation: 21/03/2014,, , , Revision: 22, Authorised, Last updated: 10/06/2021
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Human medicine European public assessment report (EPAR): Ketoconazole HRA (updated)
Ketoconazole, Cushing Syndrome
Date of authorisation: 18/11/2014,, , , Revision: 10, Authorised, Last updated: 07/06/2021
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Human medicine European public assessment report (EPAR): Nexpovio (updated)
Selinexor, Multiple Myeloma
Date of authorisation: 26/03/2021,, , Authorised, Last updated: 07/06/2021
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Human medicine European public assessment report (EPAR): Polivy (updated)
polatuzumab vedotin, Lymphoma, B-Cell
Date of authorisation: 16/01/2020,, , , Revision: 3, Authorised, Last updated: 04/06/2021
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Human medicine European public assessment report (EPAR): Enhertu (updated)
trastuzumab deruxtecan, Breast Neoplasms
Date of authorisation: 18/01/2021,, , Revision: 1, Authorised, Last updated: 25/05/2021
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Human medicine European public assessment report (EPAR): Vyndaqel
tafamidis, Amyloidosis
Date of authorisation: 16/11/2011,, , 
, Revision: 19, Authorised, Last updated: 19/05/2021
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Human medicine European public assessment report (EPAR): Adcetris
Brentuximab vedotin, Lymphoma, Non-Hodgkin, Hodgkin Disease
Date of authorisation: 25/10/2012,, , , Revision: 29, Authorised, Last updated: 18/05/2021
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Human medicine European public assessment report (EPAR): Libtayo
Cemiplimab, Carcinoma, Squamous Cell
Date of authorisation: 28/06/2019,, , Revision: 7, Authorised, Last updated: 18/05/2021
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Human medicine European public assessment report (EPAR): Kalydeco
ivacaftor, Cystic Fibrosis
Date of authorisation: 23/07/2012,, , Revision: 28, Authorised, Last updated: 12/05/2021
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Human medicine European public assessment report (EPAR): Increlex
Mecasermin, Laron Syndrome
Date of authorisation: 02/08/2007,, , Revision: 22, Authorised, Last updated: 12/05/2021
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Human medicine European public assessment report (EPAR): Vitrakvi
larotrectinib sulfate, Abdominal Neoplasms
Date of authorisation: 19/09/2019,, , Revision: 3, Authorised, Last updated: 12/05/2021
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Human medicine European public assessment report (EPAR): Sylvant
siltuximab, Giant Lymph Node Hyperplasia
Date of authorisation: 22/05/2014,, , Revision: 11, Authorised, Last updated: 12/05/2021
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Human medicine European public assessment report (EPAR): Deltyba
Delamanid, Tuberculosis, Multidrug-Resistant
Date of authorisation: 27/04/2014,
Date of refusal: 25/07/2013,, , , Revision: 16, Authorised, Last updated: 11/05/2021
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Human medicine European public assessment report (EPAR): Kyprolis
carfilzomib, Multiple Myeloma
Date of authorisation: 19/11/2015,, , Revision: 19, Authorised, Last updated: 07/05/2021
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Human medicine European public assessment report (EPAR): Tegsedi
inotersen sodium, Amyloidosis
Date of authorisation: 06/07/2018,, , , Revision: 7, Authorised, Last updated: 06/05/2021
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Human medicine European public assessment report (EPAR): Translarna
Ataluren, Muscular Dystrophy, Duchenne
Date of authorisation: 31/07/2014,, , , Revision: 19, Authorised, Last updated: 05/05/2021