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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 Orphan designations Remove Orphan designations filter Summaries of opinion Remove Summaries of opinion filter Direct healthcare professional communication Remove Direct healthcare professional communication filter

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Human medicine European public assessment report (EPAR): Beyfortus

nirsevimab,
Date of authorisation: 31/10/2022, , Revision: 2, Authorised, Last updated: 28/04/2023
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Human medicine European public assessment report (EPAR): Ronapreve

casirivimab, imdevimab, COVID-19 virus infection
Date of authorisation: 12/11/2021, , Revision: 4, Authorised, Last updated: 28/04/2023
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Human medicine European public assessment report (EPAR): NexoBrid

proteolytic enzymes enriched in bromelain, Debridement
Date of authorisation: 18/12/2012, , Revision: 15, Authorised, Last updated: 26/04/2023
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Human medicine European public assessment report (EPAR): Lyumjev (previously Liumjev)

insulin lispro, Diabetes Mellitus
Date of authorisation: 24/03/2020, , Revision: 5, Authorised, Last updated: 25/04/2023
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Human medicine European public assessment report (EPAR): Translarna

Ataluren, Muscular Dystrophy, Duchenne
Date of authorisation: 31/07/2014, , , , Revision: 22, Authorised, Last updated: 25/04/2023
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Human medicine European public assessment report (EPAR): Sarclisa

Isatuximab, Multiple Myeloma
Date of authorisation: 30/05/2020, , Revision: 7, Authorised, Last updated: 25/04/2023
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Human medicine European public assessment report (EPAR): Rubraca

rucaparib camsylate, Ovarian Neoplasms
Date of authorisation: 23/05/2018, , , Revision: 12, Authorised, Last updated: 24/04/2023
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Human medicine European public assessment report (EPAR): Artesunate Amivas

artesunate, Malaria
Date of authorisation: 22/11/2021, , , Revision: 1, Authorised, Last updated: 24/04/2023
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Human medicine European public assessment report (EPAR): Rinvoq

upadacitinib, Arthritis, Rheumatoid
Date of authorisation: 16/12/2019, , , Revision: 14, Authorised, Last updated: 24/04/2023
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Human medicine European public assessment report (EPAR): Uplizna

Inebilizumab, Neuromyelitis Optica
Date of authorisation: 25/04/2022, , Revision: 2, Authorised, Last updated: 21/04/2023
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Human medicine European public assessment report (EPAR): Regkirona

Regdanvimab, COVID-19 virus infection
Date of authorisation: 12/11/2021, , Revision: 7, Authorised, Last updated: 21/04/2023
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Human medicine European public assessment report (EPAR): Lunsumio

mosunetuzumab, Lymphoma, Follicular
Date of authorisation: 03/06/2022, , , , Revision: 1, Authorised, Last updated: 20/04/2023
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Human medicine European public assessment report (EPAR): Fintepla

Fenfluramine hydrochloride, Epilepsies, Myoclonic
Date of authorisation: 18/12/2020, , , Revision: 5, Authorised, Last updated: 20/04/2023
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Human medicine European public assessment report (EPAR): Wakix

pitolisant, Narcolepsy
Date of authorisation: 31/03/2016, , , Revision: 14, Authorised, Last updated: 20/04/2023
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Human medicine European public assessment report (EPAR): Inpremzia

insulin human (rDNA), Diabetes Mellitus
Date of authorisation: 25/04/2022, , , Withdrawn, Last updated: 20/04/2023
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Human medicine European public assessment report (EPAR): Pelgraz

pegfilgrastim, Neutropenia
Date of authorisation: 21/09/2018, , , Revision: 9, Authorised, Last updated: 20/04/2023
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Human medicine European public assessment report (EPAR): Pluvicto

lutetium (177Lu) vipivotide tetraxetan, Prostatic Neoplasms, Castration-Resistant
Date of authorisation: 09/12/2022, , Revision: 2, Authorised, Last updated: 19/04/2023
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Human medicine European public assessment report (EPAR): Tezspire

tezepelumab, Asthma
Date of authorisation: 19/09/2022, , Revision: 3, Authorised, Last updated: 19/04/2023
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Human medicine European public assessment report (EPAR): Ceplene

Histamine dihydrochloride, Leukemia, Myeloid, Acute
Date of authorisation: 07/10/2008, , , Revision: 12, Authorised, Last updated: 19/04/2023
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Human medicine European public assessment report (EPAR): Alymsys

bevacizumab, Colorectal Neoplasms; Breast Neoplasms; Ovarian Neoplasms; Peritoneal Neoplasms; Carcinoma, Non-Small-Cell Lung; Carcinoma, Renal Cell; Uterine Cervical Neoplasms
Date of authorisation: 26/03/2021, , , Revision: 5, Authorised, Last updated: 18/04/2023
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Human medicine European public assessment report (EPAR): Lorviqua

Lorlatinib, Carcinoma, Non-Small-Cell Lung
Date of authorisation: 06/05/2019, , , Revision: 11, Authorised, Last updated: 18/04/2023
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Human medicine European public assessment report (EPAR): Byfavo

remimazolam besilate, Conscious Sedation
Date of authorisation: 26/03/2021, , Revision: 5, Authorised, Last updated: 18/04/2023
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Human medicine European public assessment report (EPAR): Adakveo

Crizanlizumab, Anemia, Sickle Cell
Date of authorisation: 28/10/2020, , , , Revision: 4, Authorised, Last updated: 17/04/2023
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Human medicine European public assessment report (EPAR): Libmeldy

atidarsagene autotemcel, Leukodystrophy, Metachromatic
Date of authorisation: 17/12/2020, , , Revision: 6, Authorised, Last updated: 17/04/2023
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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: 23, Authorised, Last updated: 14/04/2023