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Medicine Direct healthcare professional communication Remove Direct healthcare professional communication filter European public assessment reports (EPAR) Remove European public assessment reports (EPAR) filter Orphan designations Remove Orphan designations filter Summaries of opinion Remove Summaries of opinion filter

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

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 (updated)

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 (updated)

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 (updated)

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 (updated)

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 (updated)

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

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 (updated)

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 (updated)

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 (updated)

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 (updated)

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 (updated)

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 (updated)

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): Sixmo (updated)

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 (updated)

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 (updated)

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): 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
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Human medicine European public assessment report (EPAR): Intuniv

guanfacine hydrochloride, Attention Deficit Disorder with Hyperactivity
Date of authorisation: 17/09/2015, , Revision: 12, Authorised, Last updated: 16/02/2023
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Human medicine European public assessment report (EPAR): Byfavo

remimazolam, Conscious Sedation
Date of authorisation: 26/03/2021, , Revision: 4, Authorised, Last updated: 16/02/2023
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Human medicine European public assessment report (EPAR): Enhertu

trastuzumab deruxtecan, Breast Neoplasms
Date of authorisation: 18/01/2021, , , Revision: 10, Authorised, Last updated: 16/02/2023
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Human medicine European public assessment report (EPAR): Ondexxya

andexanet alfa, Drug-Related Side Effects and Adverse Reactions
Date of authorisation: 26/04/2019, , , Revision: 13, Authorised, Last updated: 15/02/2023