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383 results
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Human medicine European public assessment report (EPAR): Luxturna (updated)
voretigene neparvovec, Leber Congenital Amaurosis; Retinitis Pigmentosa
Date of authorisation: 22/11/2018,
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, Revision: 5, Authorised, Last updated: 19/08/2022
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Human medicine European public assessment report (EPAR): Leqvio (updated)
inclisiran, Hypercholesterolemia; Dyslipidemias
Date of authorisation: 09/12/2020,, Revision: 4, Authorised, Last updated: 19/08/2022
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Human medicine European public assessment report (EPAR): Yselty (updated)
linzagolix choline, Leiomyoma
Date of authorisation: 14/06/2022,, Revision: 1, Authorised, Last updated: 19/08/2022
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Human medicine European public assessment report (EPAR): Venclyxto (updated)
Venetoclax, Leukemia, Lymphocytic, Chronic, B-Cell
Date of authorisation: 04/12/2016,, Revision: 14, Authorised, Last updated: 19/08/2022
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Human medicine European public assessment report (EPAR): Orgovyx (updated)
relugolix, Prostatic Neoplasms
Date of authorisation: 29/04/2022,, Revision: 4, Authorised, Last updated: 17/08/2022
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Human medicine European public assessment report (EPAR): Lokelma (updated)
sodium zirconium cyclosilicate, Hyperkalemia
Date of authorisation: 22/03/2018,, Revision: 6, Authorised, Last updated: 16/08/2022
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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): Veklury (updated)
remdesivir, Coronavirus Infections
Date of authorisation: 03/07/2020,, Revision: 12, Authorised, Last updated: 12/08/2022
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Human medicine European public assessment report (EPAR): Alecensa (updated)
alectinib hydrochloride, Carcinoma, Non-Small-Cell Lung
Date of authorisation: 16/02/2017,, Revision: 12, Authorised, Last updated: 11/08/2022
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Human medicine European public assessment report (EPAR): Grasustek (updated)
pegfilgrastim, Neutropenia
Date of authorisation: 20/06/2019,, 
, Revision: 3, Authorised, Last updated: 10/08/2022
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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): Zejula (updated)
Niraparib (tosilate monohydrate), Fallopian Tube Neoplasms; Peritoneal Neoplasms; Ovarian Neoplasms
Date of authorisation: 16/11/2017,, , Revision: 18, Authorised, Last updated: 09/08/2022
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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: 8, Authorised, Last updated: 09/08/2022
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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: 14, Authorised, Last updated: 09/08/2022
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Human medicine European public assessment report (EPAR): Cometriq (updated)
cabozantinib, Thyroid Neoplasms
Date of authorisation: 21/03/2014,, Revision: 25, Authorised, Last updated: 08/08/2022
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Human medicine European public assessment report (EPAR): Rinvoq (updated)
upadacitinib, Arthritis, Rheumatoid
Date of authorisation: 16/12/2019,, Revision: 11, Authorised, Last updated: 05/08/2022
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Human medicine European public assessment report (EPAR): Braftovi (updated)
Encorafenib, Melanoma; Colorectal Neoplasms
Date of authorisation: 19/09/2018,, Revision: 10, Authorised, Last updated: 05/08/2022
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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): Ervebo (updated)
recombinant vesicular stomatitis virus (strain indiana) with a deletion of the envelope glycoprotein, replaced with the zaire ebolavirus (strain kikwit 1995) surface glycoprotein, Hemorrhagic Fever, Ebola
Date of authorisation: 11/11/2019,, Revision: 7, Authorised, Last updated: 04/08/2022
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Human medicine European public assessment report (EPAR): Nexviadyme (updated)
Avalglucosidase alfa, Glycogen Storage Disease Type II
Date of authorisation: 24/06/2022,, Authorised, Last updated: 02/08/2022
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Human medicine European public assessment report (EPAR): COVID-19 Vaccine (inactivated, adjuvanted) Valneva (updated)
SARS-CoV-2 virus (inactivated) Wuhan strain hCoV-19 / Italy / INMI1-isl / 2020, COVID-19 virus infection
Date of authorisation: 24/06/2022,, Revision: 1, Authorised, Last updated: 02/08/2022
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Human medicine European public assessment report (EPAR): Fluad Tetra (updated)
A/Victoria/2570/2019 (H1N1)pdm09 like strain (A/Victoria/2570/2019 IVR‐215) A/Darwin/9/2021 (H3N2) like strain (A/Darwin/6/2021 IVR-227) B/Austria/1359417/2021 like strain (B/Austria/1359417/2021 BVR-26) B/Phuket/3073/2013 like strain (B/Phuket/3073/2013 BVR‐1B), Influenza, Human
Date of authorisation: 20/05/2020,, Revision: 4, Authorised, Last updated: 02/08/2022