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Medicine type Exceptional circumstances Remove Exceptional circumstances filter Additional monitoring Remove Additional monitoring filter Biosimilar Remove Biosimilar filter

Medicine European public assessment reports (EPAR) Remove European public assessment reports (EPAR) filter Withdrawn applications Remove Withdrawn applications filter Orphan designations Remove Orphan designations filter

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Human medicine European public assessment report (EPAR): Zynlonta (updated)

loncastuximab tesirine, Lymphoma, Large B-Cell, Diffuse; Lymphoma, B-Cell
Date of authorisation: 20/12/2022, , , Revision: 2, Authorised, Last updated: 02/05/2023
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Human medicine European public assessment report (EPAR): Yselty (updated)

linzagolix choline, Leiomyoma
Date of authorisation: 14/06/2022, , Revision: 3, Authorised, Last updated: 02/05/2023
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Human medicine European public assessment report (EPAR): Imfinzi (updated)

durvalumab, Carcinoma, Non-Small-Cell Lung
Date of authorisation: 21/09/2018, , Revision: 16, Authorised, Last updated: 02/05/2023
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Human medicine European public assessment report (EPAR): Zejula

Niraparib (tosilate monohydrate), Fallopian Tube Neoplasms; Peritoneal Neoplasms; Ovarian Neoplasms
Date of authorisation: 16/11/2017, , , Revision: 20, Authorised, Last updated: 28/04/2023
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Human medicine European public assessment report (EPAR): Palynziq

Pegvaliase, Phenylketonurias
Date of authorisation: 03/05/2019, , , Revision: 7, Authorised, Last updated: 28/04/2023
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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