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

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Human medicine European public assessment report (EPAR): Qarziba (previously Dinutuximab beta EUSA and Dinutuximab beta Apeiron)

dinutuximab beta, Neuroblastoma
Date of authorisation: 08/05/2017, , , , Revision: 13, Authorised, Last updated: 22/02/2023
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Human medicine European public assessment report (EPAR): Ilumetri

tildrakizumab, Psoriasis
Date of authorisation: 17/09/2018, , Revision: 8, Authorised, Last updated: 22/02/2023
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Human medicine European public assessment report (EPAR): Hyrimoz

adalimumab, Arthritis, Rheumatoid; Arthritis, Psoriatic; Spondylitis, Ankylosing; Uveitis; Hidradenitis Suppurativa; Colitis, Ulcerative; Arthritis, Juvenile Rheumatoid; Crohn Disease; Skin Diseases, Papulosquamous
Date of authorisation: 26/07/2018, , , Revision: 10, Authorised, Last updated: 22/02/2023
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Human medicine European public assessment report (EPAR): Lamzede

velmanase alfa, alpha-Mannosidosis
Date of authorisation: 23/03/2018, , , , Revision: 6, Authorised, Last updated: 22/02/2023
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Human medicine European public assessment report (EPAR): Natpar

parathyroid hormone, Hypoparathyroidism
Date of authorisation: 24/04/2017, , , , Revision: 14, Authorised, Last updated: 22/02/2023
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Human medicine European public assessment report (EPAR): Trodelvy

Sacituzumab govitecan, Breast Neoplasms; Triple Negative Breast Neoplasms
Date of authorisation: 22/11/2021, , Revision: 2, Authorised, Last updated: 22/02/2023
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Human medicine European public assessment report (EPAR): Verzenios

abemaciclib, Breast Neoplasms
Date of authorisation: 26/09/2018, , Revision: 9, Authorised, Last updated: 22/02/2023
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Human medicine European public assessment report (EPAR): Namuscla

Mexiletine hydrochloride, Myotonic Disorders
Date of authorisation: 18/12/2018, , Revision: 5, Authorised, Last updated: 22/02/2023
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Human medicine European public assessment report (EPAR): Spikevax (previously COVID-19 Vaccine Moderna)

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: 35, Authorised, Last updated: 21/02/2023
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Human medicine European public assessment report (EPAR): Pifeltro

doravirine, HIV Infections
Date of authorisation: 22/11/2018, , Revision: 7, Authorised, Last updated: 20/02/2023
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Human medicine European public assessment report (EPAR): Delstrigo

doravirine, lamivudine, tenofovir disoproxil fumarate, HIV Infections
Date of authorisation: 22/11/2018, , Revision: 10, Authorised, Last updated: 20/02/2023
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Human medicine European public assessment report (EPAR): Tezspire

tezepelumab, Asthma
Date of authorisation: 19/09/2022, , Revision: 2, Authorised, Last updated: 20/02/2023
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Human medicine European public assessment report (EPAR): Nexpovio

Selinexor, Multiple Myeloma
Date of authorisation: 26/03/2021, , Revision: 7, Authorised, Last updated: 20/02/2023
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Human medicine European public assessment report (EPAR): Piqray

Alpelisib, Breast Neoplasms
Date of authorisation: 27/07/2020, , Revision: 8, Authorised, Last updated: 20/02/2023
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Human medicine European public assessment report (EPAR): Oxbryta

Voxelotor, Anemia; Anemia, Hemolytic; Anemia, Sickle Cell
Date of authorisation: 14/02/2022, , , Revision: 2, Authorised, Last updated: 20/02/2023
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Human medicine European public assessment report (EPAR): Yselty

linzagolix choline, Leiomyoma
Date of authorisation: 14/06/2022, , Revision: 2, Authorised, Last updated: 20/02/2023
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Human medicine European public assessment report (EPAR): Epidyolex

Cannabidiol, Lennox Gastaut Syndrome; Epilepsies, Myoclonic
Date of authorisation: 19/09/2019, , Revision: 13, Authorised, Last updated: 20/02/2023
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Human medicine European public assessment report (EPAR): Sixmo

Buprenorphine hydrochloride, Opioid-Related Disorders
Date of authorisation: 19/06/2019, , Revision: 4, Authorised, Last updated: 20/02/2023
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Human medicine European public assessment report (EPAR): Kerendia

Finerenone, Renal Insufficiency, Chronic; Diabetes Mellitus, Type 2
Date of authorisation: 16/02/2022, , Revision: 1, Authorised, Last updated: 20/02/2023
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Human medicine European public assessment report (EPAR): Nulibry

fosdenopterin hydrobromide dihydrate, Metal Metabolism, Inborn Errors
Date of authorisation: 15/09/2022, , , Revision: 1, Authorised, Last updated: 20/02/2023
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Human medicine European public assessment report (EPAR): COVID-19 Vaccine (inactivated, adjuvanted) Valneva

SARS-CoV-2 virus (inactivated) Wuhan strain hCoV-19 / Italy / INMI1-isl / 2020, COVID-19 virus infection
Date of authorisation: 24/06/2022, , Revision: 5, Authorised, Last updated: 17/02/2023
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Human medicine European public assessment report (EPAR): Jcovden (previously COVID-19 Vaccine Janssen)

adenovirus type 26 encoding the SARS-CoV-2 spike glycoprotein (Ad26.COV2-S), COVID-19 virus infection
Date of authorisation: 11/03/2021, , , Revision: 28, Authorised, Last updated: 17/02/2023
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Human medicine European public assessment report (EPAR): Amglidia

glibenclamide, Diabetes Mellitus
Date of authorisation: 24/05/2018, , Revision: 5, Authorised, Last updated: 16/02/2023
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Human medicine European public assessment report (EPAR): Roclanda

Latanoprost, Netarsudil mesilate, Glaucoma, Open-Angle; Ocular Hypertension
Date of authorisation: 07/01/2021, , Revision: 4, Authorised, Last updated: 16/02/2023
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Human medicine European public assessment report (EPAR): Apexxnar

Pneumococcal polysaccharide serotype 1, Pneumococcal polysaccharide serotype 3, Pneumococcal polysaccharide serotype 4, Pneumococcal polysaccharide serotype 5, Pneumococcal polysaccharide serotype 6A, Pneumococcal polysaccharide serotype 6B, Pneumococcal polysaccharide serotype 7F, Pneumococcal polysaccharide serotype 8, Pneumococcal polysaccharide serotype 9V, Pneumococcal polysaccharide serotype 10A, Pneumococcal polysaccharide serotype 11A, Pneumococcal polysaccharide serotype 12F, Pneumococcal polysaccharide serotype 14, Pneumococcal polysaccharide serotype 15b, Pneumococcal polysaccharide serotype 18C, Pneumococcal polysaccharide serotype 19A, Pneumococcal polysaccharide serotype 19F, Pneumococcal polysaccharide serotype 22F, Pneumococcal polysaccharide serotype 23F, Pneumococcal polysaccharide serotype 33F, Pneumococcal Infections
Date of authorisation: 14/02/2022, , Revision: 4, Authorised, Last updated: 16/02/2023