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321 results
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Human medicine European public assessment report (EPAR): Ocaliva (updated)
Obeticholic acid, Liver Cirrhosis, Biliary
Date of authorisation: 12/12/2016,
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, Revision: 13, Authorised, Last updated: 30/06/2022
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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: 24, Authorised, Last updated: 29/06/2022
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Human medicine European public assessment report (EPAR): Opsumit (updated)
Macitentan, Hypertension, Pulmonary
Date of authorisation: 20/12/2013,, Revision: 20, Authorised, Last updated: 29/06/2022
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Human medicine European public assessment report (EPAR): Rozlytrek (updated)
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): Votubia (updated)
everolimus, Tuberous Sclerosis
Date of authorisation: 02/09/2011,, Revision: 30, Authorised, Last updated: 27/06/2022
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Human medicine European public assessment report (EPAR): Libmeldy (updated)
atidarsagene autotemcel, Leukodystrophy, Metachromatic
Date of authorisation: 17/12/2020,, , Revision: 4, Authorised, Last updated: 24/06/2022
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Human medicine European public assessment report (EPAR): Lunsumio (updated)
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): Evrysdi (updated)
Risdiplam, Muscular Atrophy, Spinal
Date of authorisation: 26/03/2021,
, , Revision: 2, Authorised, Last updated: 22/06/2022
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Human medicine European public assessment report (EPAR): Givlaari (updated)
Givosiran, Porphyrias, Hepatic
Date of authorisation: 02/03/2020,, , Revision: 4, Authorised, Last updated: 22/06/2022
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Human medicine European public assessment report (EPAR): Zejula (updated)
Niraparib (tosilate monohydrate), Fallopian Tube Neoplasms; Peritoneal Neoplasms; Ovarian Neoplasms
Date of authorisation: 16/11/2017,, , Revision: 17, Authorised, Last updated: 22/06/2022
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Human medicine European public assessment report (EPAR): Kanuma (updated)
sebelipase alfa, Lipid Metabolism, Inborn Errors
Date of authorisation: 28/08/2015,, , , Revision: 8, Authorised, Last updated: 21/06/2022
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Human medicine European public assessment report (EPAR): Adcetris (updated)
Brentuximab vedotin, Lymphoma, Non-Hodgkin; Hodgkin Disease
Date of authorisation: 25/10/2012,, , Revision: 33, Authorised, Last updated: 21/06/2022
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Human medicine European public assessment report (EPAR): Carvykti (updated)
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 (updated)
andexanet alfa, Drug-Related Side Effects and Adverse Reactions
Date of authorisation: 26/04/2019,, , Revision: 12, Authorised, Last updated: 17/06/2022
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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: 20, Authorised, Last updated: 17/06/2022
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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: 25, Authorised, Last updated: 17/06/2022
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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,, , , Revision: 21, Authorised, Last updated: 17/06/2022
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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: 2, Authorised, Last updated: 17/06/2022
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Human medicine European public assessment report (EPAR): Ninlaro (updated)
ixazomib citrate, Multiple Myeloma
Date of authorisation: 21/11/2016,, , , Revision: 14, Authorised, Last updated: 17/06/2022
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Human medicine European public assessment report (EPAR): Kyprolis (updated)
carfilzomib, Multiple Myeloma
Date of authorisation: 19/11/2015,, , Revision: 20, Authorised, Last updated: 15/06/2022
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Human medicine European public assessment report (EPAR): Pemazyre (updated)
pemigatinib, Cholangiocarcinoma
Date of authorisation: 26/03/2021,, , , Revision: 3, Authorised, Last updated: 15/06/2022
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Human medicine European public assessment report (EPAR): Signifor (updated)
pasireotide, Acromegaly; Pituitary ACTH Hypersecretion
Date of authorisation: 24/04/2012,, Revision: 13, Authorised, Last updated: 14/06/2022
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Human medicine European public assessment report (EPAR): Enhertu (updated)
trastuzumab deruxtecan, Breast Neoplasms
Date of authorisation: 18/01/2021,, , Revision: 5, Authorised, Last updated: 13/06/2022
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Human medicine European public assessment report (EPAR): Minjuvi (updated)
Tafasitamab, Lymphoma, Large B-Cell, Diffuse
Date of authorisation: 26/08/2021,, , , Revision: 3, Authorised, Last updated: 13/06/2022
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Human medicine European public assessment report (EPAR): Jemperli (updated)
dostarlimab, Endometrial Neoplasms
Date of authorisation: 21/04/2021,, , Revision: 3, Authorised, Last updated: 10/06/2022