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

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

Sirolimus, Angiofibroma; Tuberous Sclerosis
Date of authorisation: 15/05/2023, , Revision: 2, Authorised, Last updated: 25/09/2023
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Human medicine European public assessment report (EPAR): Amglidia (updated)

glibenclamide, Diabetes Mellitus
Date of authorisation: 24/05/2018, , Revision: 7, Authorised, Last updated: 25/09/2023
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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): Lutathera (updated)

lutetium (177Lu) oxodotreotide, Neuroendocrine Tumors
Date of authorisation: 26/09/2017, , Revision: 10, 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): 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): 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