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604 results

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(EPAR) filter Direct healthcare professional communication Remove Direct healthcare professional communication filter Withdrawn applications Remove Withdrawn applications filter

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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
List item

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
List item

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

mycophenolate mofetil, Graft Rejection
Date of authorisation: 21/02/2008, , Revision: 27, Authorised, Last updated: 26/09/2023
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Human medicine European public assessment report (EPAR): Abiraterone Accord (updated)

abiraterone acetate, Prostatic Neoplasms
Date of authorisation: 26/04/2021, , Revision: 1, Authorised, Last updated: 25/09/2023
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Human medicine European public assessment report (EPAR): Olanzapine Teva (updated)

olanzapine, Schizophrenia; Bipolar Disorder
Date of authorisation: 12/12/2007, , Revision: 30, 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): Lenalidomide Accord (updated)

lenalidomide, Multiple Myeloma
Date of authorisation: 20/09/2018, , Revision: 11, 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): 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): Levetiracetam Sun (updated)

levetiracetam, Epilepsy
Date of authorisation: 14/12/2011, , Revision: 19, 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): 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
List item

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): 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
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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
List item

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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604 results

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

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

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

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

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

Human medicine European public assessment report (EPAR): Abiraterone Accord (updated)

Human medicine European public assessment report (EPAR): Olanzapine Teva (updated)

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

Human medicine European public assessment report (EPAR): Lenalidomide Accord (updated)

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

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

Human medicine European public assessment report (EPAR): Levetiracetam Sun (updated)

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

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

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

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

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

Human medicine European public assessment report (EPAR): Chenodeoxycholic acid Leadiant (previously known as Chenodeoxycholic acid sigma-tau) (updated)

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

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

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

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

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

Human medicine European public assessment report (EPAR): Filgrastim Hexal (updated)

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