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Medicine European public assessment reports (EPAR) Remove European public assessment reports (EPAR) filter Direct healthcare professional communication Remove Direct healthcare professional communication filter Paediatric investigation plans Remove Paediatric investigation plans filter Orphan designations Remove Orphan designations filter

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

ravulizumab, Hemoglobinuria, Paroxysmal
Date of authorisation: 02/07/2019, , Revision: 13, Authorised, Last updated: 26/09/2023
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Human medicine European public assessment report (EPAR): Abrysvo (updated)

Respiratory syncytial virus, subgroup A, stabilized prefusion F protein / Respiratory syncytial virus, subgroup B, stabilized prefusion F protein, Respiratory Syncytial Virus Infections
Date of authorisation: 23/08/2023, , , Authorised, Last updated: 26/09/2023
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Human medicine European public assessment report (EPAR): Brimica Genuair (updated)

formoterol fumarate dihydrate, aclidinium bromide, Pulmonary Disease, Chronic Obstructive
Date of authorisation: 19/11/2014, , Revision: 14, Authorised, Last updated: 26/09/2023
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Human medicine European public assessment report (EPAR): Orphacol (updated)

cholic acid, Digestive System Diseases; Metabolism, Inborn Errors
Date of authorisation: 12/09/2013,
Date of refusal: 25/05/2012, , , Revision: 13, Authorised, Last updated: 25/09/2023
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Human medicine European public assessment report (EPAR): Erleada (updated)

apalutamide, Prostatic Neoplasms
Date of authorisation: 14/01/2019, , Revision: 10, Authorised, Last updated: 22/09/2023
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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: 22/09/2023
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Human medicine European public assessment report (EPAR): Evrysdi (updated)

Risdiplam, Muscular Atrophy, Spinal
Date of authorisation: 26/03/2021, , Revision: 5, Authorised, Last updated: 22/09/2023
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Human medicine European public assessment report (EPAR): Tezspire (updated)

tezepelumab, Asthma
Date of authorisation: 19/09/2022, , Revision: 7, Authorised, Last updated: 22/09/2023
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Human medicine European public assessment report (EPAR): Rybrevant (updated)

amivantamab, Carcinoma, Non-Small-Cell Lung
Date of authorisation: 09/12/2021, , , Revision: 3, Authorised, Last updated: 22/09/2023
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Human medicine European public assessment report (EPAR): Alunbrig (updated)

brigatinib, Carcinoma, Non-Small-Cell Lung
Date of authorisation: 22/11/2018, , Revision: 9, Authorised, Last updated: 22/09/2023
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Human medicine European public assessment report (EPAR): Enhertu (updated)

trastuzumab deruxtecan, Breast Neoplasms
Date of authorisation: 18/01/2021, , , Revision: 12, Authorised, Last updated: 22/09/2023
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Human medicine European public assessment report (EPAR): Vyndaqel (updated)

tafamidis, Amyloidosis
Date of authorisation: 16/11/2011, , , , Revision: 27, Authorised, Last updated: 22/09/2023
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Human medicine European public assessment report (EPAR): Scemblix (updated)

asciminib hydrochloride, Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Date of authorisation: 25/08/2022, , , Revision: 3, Authorised, Last updated: 22/09/2023
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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: 5, Authorised, Last updated: 22/09/2023
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Human medicine European public assessment report (EPAR): Imjudo (updated)

Tremelimumab, Carcinoma, Hepatocellular
Date of authorisation: 20/02/2023, , Revision: 2, Authorised, Last updated: 22/09/2023
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Human medicine European public assessment report (EPAR): Retsevmo (updated)

Selpercatinib, Carcinoma, Non-Small-Cell Lung; Thyroid Neoplasms
Date of authorisation: 11/02/2021, , , Revision: 8, Authorised, Last updated: 22/09/2023
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Human medicine European public assessment report (EPAR): Vitrakvi (updated)

larotrectinib sulfate, Abdominal Neoplasms
Date of authorisation: 19/09/2019, , , Revision: 10, Authorised, Last updated: 22/09/2023
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Human medicine European public assessment report (EPAR): Semglee (updated)

insulin glargine, Diabetes Mellitus
Date of authorisation: 23/03/2018, , Revision: 9, Authorised, Last updated: 22/09/2023
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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): 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