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Human medicine European public assessment report (EPAR): Evrenzo (updated)
Roxadustat, Anemia; Kidney Failure, Chronic
Date of authorisation: 18/08/2021,, Revision: 3, Authorised, Last updated: 08/06/2023
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Human medicine European public assessment report (EPAR): Rekambys (updated)
rilpivirine, HIV Infections
Date of authorisation: 17/12/2020,, Revision: 8, Authorised, Last updated: 08/06/2023
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Human medicine European public assessment report (EPAR): Ryeqo (updated)
relugolix, norethisterone acetate, estradiol hemihydrate, Leiomyoma
Date of authorisation: 16/07/2021,, Revision: 5, Authorised, Last updated: 08/06/2023
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Human medicine European public assessment report (EPAR): Omvoh (updated)
Mirikizumab, Colitis, Ulcerative
Date of authorisation: 26/05/2023,, Authorised, Last updated: 08/06/2023
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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: 12, Authorised, Last updated: 07/06/2023
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Human medicine European public assessment report (EPAR): Ibrance (updated)
Palbociclib, Breast Neoplasms
Date of authorisation: 09/11/2016,, Revision: 16, Authorised, Last updated: 06/06/2023
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Human medicine European public assessment report (EPAR): Tobi Podhaler (updated)
Tobramycin, Cystic Fibrosis; Respiratory Tract Infections
Date of authorisation: 20/07/2011,, Revision: 20, Authorised, Last updated: 05/06/2023
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Human medicine European public assessment report (EPAR): Tezspire (updated)
tezepelumab, Asthma
Date of authorisation: 19/09/2022,, Revision: 4, Authorised, Last updated: 05/06/2023
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Human medicine European public assessment report (EPAR): Vydura (updated)
Rimegepant, Migraine Disorders
Date of authorisation: 25/04/2022,, Revision: 5, Authorised, Last updated: 05/06/2023
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Human medicine European public assessment report (EPAR): Xerava (updated)
eravacycline, Infection; Bacterial Infections
Date of authorisation: 20/09/2018,, Revision: 7, Authorised, Last updated: 05/06/2023
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Human medicine European public assessment report (EPAR): Onpattro (updated)
patisiran sodium, Amyloidosis, Familial
Date of authorisation: 27/08/2018,,
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, Revision: 11, Authorised, Last updated: 02/06/2023
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Human medicine European public assessment report (EPAR): Adynovi (updated)
rurioctocog alfa pegol, Hemophilia A
Date of authorisation: 08/01/2018,, Revision: 9, Authorised, Last updated: 02/06/2023
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Human medicine European public assessment report (EPAR): Rinvoq (updated)
upadacitinib, Arthritis, Rheumatoid
Date of authorisation: 16/12/2019,,
, Revision: 15, Authorised, Last updated: 02/06/2023
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Human medicine European public assessment report (EPAR): Oxervate (updated)
Recombinant human nerve growth factor, Keratitis
Date of authorisation: 06/07/2017,,
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, Revision: 2, Authorised, Last updated: 02/06/2023
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Human medicine European public assessment report (EPAR): Vildagliptin / Metformin hydrochloride Accord (updated)
metformin hydrochloride, vildagliptin, Diabetes Mellitus, Type 2
Date of authorisation: 24/03/2022,,
, Revision: 2, Authorised, Last updated: 01/06/2023
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Human medicine European public assessment report (EPAR): Benepali (updated)
etanercept, Arthritis, Psoriatic; Arthritis, Rheumatoid; Psoriasis
Date of authorisation: 13/01/2016,, Revision: 20, Authorised, Last updated: 01/06/2023
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Human medicine European public assessment report (EPAR): Epysqli (updated)
Eculizumab, Hemoglobinuria, Paroxysmal
Date of authorisation: 26/05/2023,,
, Authorised, Last updated: 31/05/2023
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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: 37, Authorised, Last updated: 31/05/2023
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Human medicine European public assessment report (EPAR): Remsima (updated)
infliximab, Arthritis, Psoriatic; Spondylitis, Ankylosing; Colitis, Ulcerative; Psoriasis; Crohn Disease; Arthritis, Rheumatoid
Date of authorisation: 10/09/2013,, Revision: 35, Authorised, Last updated: 30/05/2023
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Human medicine European public assessment report (EPAR): Ondexxya (updated)
andexanet alfa, Drug-Related Side Effects and Adverse Reactions
Date of authorisation: 26/04/2019,,
, Revision: 15, Authorised, Last updated: 30/05/2023
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Human medicine European public assessment report (EPAR): Jyseleca (updated)
filgotinib maleate, Arthritis, Rheumatoid
Date of authorisation: 24/09/2020,,
, Revision: 9, Authorised, Last updated: 30/05/2023
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Human medicine European public assessment report (EPAR): Zolgensma (updated)
onasemnogene abeparvovec, Muscular Atrophy, Spinal
Date of authorisation: 18/05/2020,,
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, Revision: 11, Authorised, Last updated: 30/05/2023
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Human medicine European public assessment report (EPAR): Pombiliti (updated)
Cipaglucosidase alfa, Glycogen Storage Disease Type II
Date of authorisation: 20/03/2023,, Authorised, Last updated: 30/05/2023
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Human medicine European public assessment report (EPAR): Qinlock (updated)
ripretinib, Gastrointestinal Stromal Tumors
Date of authorisation: 18/11/2021,,
, Revision: 3, Authorised, Last updated: 30/05/2023
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Human medicine European public assessment report (EPAR): Ratiograstim (updated)
filgrastim, Neutropenia; Hematopoietic Stem Cell Transplantation; Cancer
Date of authorisation: 15/09/2008,, Revision: 16, Authorised, Last updated: 30/05/2023