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Medicine European public assessment reports (EPAR) Remove European public assessment reports (EPAR) filter Paediatric investigation plans Remove Paediatric investigation plans filter Referrals Remove Referrals filter

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Human medicine European public assessment report (EPAR): Kirsty (previously Kixelle) (updated)

insulin aspart, Diabetes Mellitus
Date of authorisation: 05/02/2021, , , Revision: 3, Authorised, Last updated: 27/09/2023
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Human medicine European public assessment report (EPAR): Trepulmix (updated)

Treprostinil sodium, Hypertension, Pulmonary
Date of authorisation: 03/04/2020, , Revision: 4, Authorised, Last updated: 27/09/2023
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Human medicine European public assessment report (EPAR): Sovaldi (updated)

Sofosbuvir, Hepatitis C, Chronic
Date of authorisation: 16/01/2014, , Revision: 28, Authorised, Last updated: 27/09/2023
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Human medicine European public assessment report (EPAR): Harvoni (updated)

ledipasvir, Sofosbuvir, Hepatitis C, Chronic
Date of authorisation: 17/11/2014, , Revision: 28, Authorised, Last updated: 27/09/2023
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Human medicine European public assessment report (EPAR): Epclusa (updated)

Sofosbuvir, velpatasvir, Hepatitis C, Chronic
Date of authorisation: 06/07/2016, , Revision: 22, Authorised, Last updated: 27/09/2023
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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): 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): 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): 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): 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): 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): 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
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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): 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): 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
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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