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Human medicine European public assessment report (EPAR): Brineura (updated)
cerliponase alfa, Neuronal Ceroid-Lipofuscinoses
Date of authorisation: 30/05/2017,
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, Revision: 6, Authorised, Last updated: 16/08/2022
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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,
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, Revision: 23, Authorised, Last updated: 12/08/2022
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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: 27, Authorised, Last updated: 10/08/2022
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Human medicine European public assessment report (EPAR): Upstaza (updated)
Eladocagene exuparvovec, Amino Acid Metabolism, Inborn Errors
Date of authorisation: 18/07/2022,, , , Authorised, Last updated: 10/08/2022
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Human medicine European public assessment report (EPAR): Imvanex (updated)
modified vaccinia Ankara - Bavarian Nordic (MVA-BN) virus, Smallpox Vaccine; Monkeypox virus
Date of authorisation: 31/07/2013,, , Revision: 21, Authorised, Last updated: 09/08/2022
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Human medicine European public assessment report (EPAR): Elaprase (updated)
idursulfase, Mucopolysaccharidosis II
Date of authorisation: 08/01/2007,, , Revision: 24, Authorised, Last updated: 04/08/2022
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Human medicine European public assessment report (EPAR): Enhertu (updated)
trastuzumab deruxtecan, Breast Neoplasms
Date of authorisation: 18/01/2021,, , Revision: 6, Authorised, Last updated: 01/08/2022
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Human medicine European public assessment report (EPAR): Nuvaxovid (updated)
SARS-CoV-2 recombinant spike protein, COVID-19 virus infection
Date of authorisation: 20/12/2021,, , Revision: 3, Authorised, Last updated: 01/08/2022
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Human medicine European public assessment report (EPAR): Elzonris (updated)
tagraxofusp, Lymphoma
Date of authorisation: 07/01/2021,, , , Revision: 4, Authorised, Last updated: 29/07/2022
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Human medicine European public assessment report (EPAR): Libtayo (updated)
Cemiplimab, Carcinoma, Squamous Cell
Date of authorisation: 28/06/2019,, , Revision: 12, Authorised, Last updated: 28/07/2022
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Human medicine European public assessment report (EPAR): Jcovden (previously 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: 22, Authorised, Last updated: 28/07/2022
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Human medicine European public assessment report (EPAR): Vitrakvi (updated)
larotrectinib sulfate, Abdominal Neoplasms
Date of authorisation: 19/09/2019,, , Revision: 6, Authorised, Last updated: 26/07/2022
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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: 26, Authorised, Last updated: 22/07/2022
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Human medicine European public assessment report (EPAR): Zolgensma (updated)
onasemnogene abeparvovec, Muscular Atrophy, Spinal
Date of authorisation: 18/05/2020,, , , Revision: 6, Authorised, Last updated: 21/07/2022
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Human medicine European public assessment report (EPAR): Kinpeygo
budesonide, Glomerulonephritis, IGA
Date of authorisation: 15/07/2022,, , , Authorised, Last updated: 18/07/2022
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Human medicine European public assessment report (EPAR): Evoltra
clofarabine, Precursor Cell Lymphoblastic Leukemia-Lymphoma
Date of authorisation: 29/05/2006,, , Revision: 31, Authorised, Last updated: 13/07/2022
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Human medicine European public assessment report (EPAR): Dovprela (previously Pretomanid FGK)
Pretomanid, Tuberculosis, Multidrug-Resistant
Date of authorisation: 31/07/2020,, , , Revision: 6, Authorised, Last updated: 08/07/2022
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Human medicine European public assessment report (EPAR): Zynteglo
Autologous CD34+ cell enriched population that contains haematopoietic stem cells transduced with lentiviral vector encoding the βA-T87Q-globin gene, beta-Thalassemia
Date of authorisation: 29/05/2019,, , , , , Revision: 5, Withdrawn, Last updated: 08/07/2022
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Human medicine European public assessment report (EPAR): Paxlovid
(1R,2S,5S)-N-((1S)-1-Cyano-2-((3S)-2-oxopyrrolidin-3-yl)ethyl)-3-((2S)-3,3-dimethyl-2-(2,2,2-trifluoroacetamido) butanoyl)-6,6-dimethyl-3-azabicyclo[3.1.0]hexane-2-carboxamide [PF-07321332], ritonavir, COVID-19 virus infection
Date of authorisation: 28/01/2022,, Revision: 2, Authorised, Last updated: 06/07/2022
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Human medicine European public assessment report (EPAR): Caprelsa
Vandetanib, Thyroid Neoplasms
Date of authorisation: 16/02/2012,, , Revision: 22, Authorised, Last updated: 30/06/2022
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Human medicine European public assessment report (EPAR): Ocaliva
Obeticholic acid, Liver Cirrhosis, Biliary
Date of authorisation: 12/12/2016,, , , Revision: 13, Authorised, Last updated: 30/06/2022
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Human medicine European public assessment report (EPAR): Rozlytrek
Entrectinib, Cancer; Carcinoma, Non-Small-Cell Lung
Date of authorisation: 31/07/2020,, , Revision: 4, Authorised, Last updated: 27/06/2022
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Human medicine European public assessment report (EPAR): Lunsumio
mosunetuzumab, Lymphoma, Follicular
Date of authorisation: 03/06/2022,, , , Authorised, Last updated: 23/06/2022
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Human medicine European public assessment report (EPAR): Carvykti
ciltacabtagene autoleucel, Multiple Myeloma
Date of authorisation: 25/05/2022,, , , Authorised, Last updated: 17/06/2022
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Human medicine European public assessment report (EPAR): Ondexxya
andexanet alfa, Drug-Related Side Effects and Adverse Reactions
Date of authorisation: 26/04/2019,, , Revision: 12, Authorised, Last updated: 17/06/2022