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

talquetamab, Multiple Myeloma
Date of authorisation: 21/08/2023, , , , Authorised, Last updated: 21/09/2023
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Human medicine European public assessment report (EPAR): Vaxzevria (previously COVID-19 Vaccine AstraZeneca) (updated)

ChAdOx1-SARS-COV-2, COVID-19 virus infection
Date of authorisation: 29/01/2021, , Revision: 30, Authorised, Last updated: 21/09/2023
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Human medicine European public assessment report (EPAR): Herzuma (updated)

trastuzumab, Stomach Neoplasms; Breast Neoplasms
Date of authorisation: 09/02/2018, , Revision: 20, Authorised, Last updated: 20/09/2023
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Human medicine European public assessment report (EPAR): Hefiya (updated)

adalimumab, Spondylitis, Ankylosing; Hidradenitis Suppurativa; Psoriasis; Arthritis, Juvenile Rheumatoid; Uveitis
Date of authorisation: 26/07/2018, , Revision: 14, Authorised, Last updated: 20/09/2023
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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: 13, Authorised, Last updated: 20/09/2023
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Human medicine European public assessment report (EPAR): Vaxneuvance (updated)

pneumococcal polysaccharide conjugate vaccine (adsorbed), Pneumococcal Infections
Date of authorisation: 13/12/2021, , Revision: 4, Authorised, Last updated: 20/09/2023
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Human medicine European public assessment report (EPAR): Omnitrope (updated)

somatropin, Turner Syndrome; Prader-Willi Syndrome; Dwarfism, Pituitary
Date of authorisation: 12/04/2006, , Revision: 22, Authorised, Last updated: 20/09/2023
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Human medicine European public assessment report (EPAR): Strimvelis (updated)

autologous CD34+ enriched cell fraction that contains CD34+ cells transduced with retroviral vector that encodes for the human adenosine deaminase (ADA) cDNA sequence from human haematopoietic stem/progenitor (CD34+) cells, Severe Combined Immunodeficiency
Date of authorisation: 26/05/2016, , , Revision: 9, Authorised, Last updated: 19/09/2023
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Human medicine European public assessment report (EPAR): Revlimid (updated)

lenalidomide, Multiple Myeloma; Lymphoma, Mantle-Cell; Myelodysplastic Syndromes
Date of authorisation: 14/06/2007, , Revision: 50, Authorised, Last updated: 19/09/2023
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Human medicine European public assessment report (EPAR): Veyvondi (updated)

vonicog alfa, von Willebrand Diseases
Date of authorisation: 31/08/2018, , Revision: 8, Authorised, Last updated: 19/09/2023
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Human medicine European public assessment report (EPAR): Litfulo (updated)

ritlecitinib tosilate, Alopecia Areata
Date of authorisation: 15/09/2023, , Authorised, Last updated: 18/09/2023
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Human medicine European public assessment report (EPAR): Chenodeoxycholic acid Leadiant (previously known as Chenodeoxycholic acid sigma-tau) (updated)

Chenodeoxycholic acid, Xanthomatosis, Cerebrotendinous; Metabolism, Inborn Errors
Date of authorisation: 10/04/2017, , , , Revision: 6, Authorised, Last updated: 18/09/2023
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Human medicine European public assessment report (EPAR): Jinarc (updated)

Tolvaptan, Polycystic Kidney, Autosomal Dominant
Date of authorisation: 27/05/2015, , Revision: 20, Authorised, Last updated: 18/09/2023
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Human medicine European public assessment report (EPAR): Zarzio (updated)

filgrastim, Neutropenia; Hematopoietic Stem Cell Transplantation; Cancer
Date of authorisation: 06/02/2009, , Revision: 23, Authorised, Last updated: 18/09/2023
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Human medicine European public assessment report (EPAR): GHRYVELIN (previously Macimorelin Aeterna Zentaris) (updated)

macimorelin acetate, Diagnostic Techniques, Endocrine
Date of authorisation: 11/01/2019, , Revision: 3, Authorised, Last updated: 18/09/2023
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Human medicine European public assessment report (EPAR): Rixathon (updated)

rituximab, Lymphoma, Non-Hodgkin; Arthritis, Rheumatoid; Leukemia, Lymphocytic, Chronic, B-Cell; Wegener Granulomatosis; Microscopic Polyangiitis; Pemphigus
Date of authorisation: 15/06/2017, , Revision: 11, Authorised, Last updated: 18/09/2023
List item

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

rituximab, Lymphoma, Non-Hodgkin; Arthritis, Rheumatoid; Microscopic Polyangiitis; Wegener Granulomatosis
Date of authorisation: 15/06/2017, , Revision: 13, Authorised, Last updated: 18/09/2023
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Human medicine European public assessment report (EPAR): Ranivisio (updated)

ranibizumab, Wet Macular Degeneration; Macular Edema; Diabetic Retinopathy; Diabetes Complications
Date of authorisation: 25/08/2022, , , Revision: 3, Authorised, Last updated: 18/09/2023
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Human medicine European public assessment report (EPAR): Pelgraz (updated)

pegfilgrastim, Neutropenia
Date of authorisation: 21/09/2018, , Revision: 11, Authorised, Last updated: 15/09/2023
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Human medicine European public assessment report (EPAR): Filgrastim Hexal (updated)

filgrastim, Neutropenia; Hematopoietic Stem Cell Transplantation; Cancer
Date of authorisation: 06/02/2009, , Revision: 22, Authorised, Last updated: 15/09/2023
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Human medicine European public assessment report (EPAR): Abrysvo (updated)

Respiratory syncytial virus, subgroup B, stabilized prefusion F protein 847B, Respiratory Syncytial Virus Infections
Date of authorisation: 23/08/2023, , , Authorised, Last updated: 15/09/2023
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Human medicine European public assessment report (EPAR): Mepsevii (updated)

vestronidase alfa, Mucopolysaccharidosis VII
Date of authorisation: 23/08/2018, , , , Revision: 7, Authorised, Last updated: 14/09/2023
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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: 21, Authorised, Last updated: 14/09/2023
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Human medicine European public assessment report (EPAR): Spikevax (previously COVID-19 Vaccine Moderna) (updated)

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: 40, Authorised, Last updated: 14/09/2023
List item

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

sacubitril, valsartan, Heart Failure
Date of authorisation: 26/05/2016, , Revision: 18, Authorised, Last updated: 13/09/2023