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Medicine European public assessment reports (EPAR) Remove European public assessment reports (EPAR) filter Referrals Remove Referrals filter Withdrawn applications Remove Withdrawn applications filter Summaries of opinion Remove Summaries of opinion filter

Medicine type Accelerated assessment Remove Accelerated assessment filter Conditional approval Remove Conditional approval filter Biosimilar Remove Biosimilar filter

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

trastuzumab, Stomach Neoplasms; Breast Neoplasms
Date of authorisation: 15/11/2017, , Revision: 14, Authorised, Last updated: 20/09/2022
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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: 16, Authorised, Last updated: 19/09/2022
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Human medicine European public assessment report (EPAR): Nepexto (updated)

etanercept, Arthritis, Rheumatoid; Arthritis, Juvenile Rheumatoid; Arthritis, Psoriatic; Spondylarthropathies; Spondylitis, Ankylosing; Psoriasis
Date of authorisation: 20/05/2020, , , Revision: 7, Authorised, Last updated: 19/09/2022
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Human medicine European public assessment report (EPAR): Vpriv (updated)

velaglucerase alfa, Gaucher Disease
Date of authorisation: 26/08/2010, , Revision: 18, Authorised, Last updated: 16/09/2022
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Human medicine European public assessment report (EPAR): Soliris (updated)

Eculizumab, Hemoglobinuria, Paroxysmal
Date of authorisation: 20/06/2007, , , Revision: 32, Authorised, Last updated: 10/09/2022
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Human medicine European public assessment report (EPAR): Takhzyro (updated)

lanadelumab, Angioedemas, Hereditary
Date of authorisation: 22/11/2018, , , , Revision: 8, Authorised, Last updated: 09/09/2022
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Human medicine European public assessment report (EPAR): Erelzi (updated)

etanercept, Arthritis, Psoriatic; Psoriasis; Arthritis, Juvenile Rheumatoid; Arthritis, Rheumatoid; Spondylitis, Ankylosing
Date of authorisation: 23/06/2017, , , Revision: 12, Authorised, Last updated: 09/09/2022
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Human medicine European public assessment report (EPAR): Zolgensma

onasemnogene abeparvovec, Muscular Atrophy, Spinal
Date of authorisation: 18/05/2020, , , , Revision: 7, Authorised, Last updated: 06/09/2022
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Human medicine European public assessment report (EPAR): Waylivra

Volanesorsen sodium, Hyperlipoproteinemia Type I
Date of authorisation: 03/05/2019, , , , Revision: 5, Authorised, Last updated: 06/09/2022
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Human medicine European public assessment report (EPAR): Inhixa

enoxaparin sodium, Venous Thromboembolism
Date of authorisation: 15/09/2016, , Revision: 22, Authorised, Last updated: 06/09/2022
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Human medicine European public assessment report (EPAR): Truxima

rituximab, Lymphoma, Non-Hodgkin; Arthritis, Rheumatoid; Wegener Granulomatosis; Leukemia, Lymphocytic, Chronic, B-Cell; Microscopic Polyangiitis
Date of authorisation: 17/02/2017, , Revision: 17, Authorised, Last updated: 05/09/2022
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Human medicine European public assessment report (EPAR): Blitzima

rituximab, Lymphoma, Non-Hodgkin; Leukemia, Lymphocytic, Chronic, B-Cell
Date of authorisation: 13/07/2017, , Revision: 16, Authorised, Last updated: 01/09/2022
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Human medicine European public assessment report (EPAR): Jemperli

dostarlimab, Endometrial Neoplasms
Date of authorisation: 21/04/2021, , , Revision: 4, Authorised, Last updated: 01/09/2022
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Human medicine European public assessment report (EPAR): Riximyo

rituximab, Lymphoma, Non-Hodgkin; Arthritis, Rheumatoid; Microscopic Polyangiitis; Wegener Granulomatosis
Date of authorisation: 15/06/2017, , Revision: 11, Authorised, Last updated: 31/08/2022
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Human medicine European public assessment report (EPAR): Rixathon

rituximab, Lymphoma, Non-Hodgkin; Arthritis, Rheumatoid; Leukemia, Lymphocytic, Chronic, B-Cell; Wegener Granulomatosis; Microscopic Polyangiitis; Pemphigus
Date of authorisation: 15/06/2017, , Revision: 9, Authorised, Last updated: 31/08/2022
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Human medicine European public assessment report (EPAR): Hepcludex

Bulevirtide acetate, Hepatitis D, Chronic
Date of authorisation: 31/07/2020, , , , Revision: 7, Authorised, Last updated: 29/08/2022
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Human medicine European public assessment report (EPAR): Abevmy

bevacizumab, Colorectal Neoplasms; Breast Neoplasms; Ovarian Neoplasms; Fallopian Tube Neoplasms; Peritoneal Neoplasms; Carcinoma, Non-Small-Cell Lung; Carcinoma, Renal Cell; Uterine Cervical Neoplasms
Date of authorisation: 21/04/2021, , , Revision: 4, Authorised, Last updated: 25/08/2022
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Human medicine European public assessment report (EPAR): Koselugo

Selumetinib sulfate, Neurofibromatosis 1
Date of authorisation: 17/06/2021, , , , Revision: 3, Authorised, Last updated: 25/08/2022
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Human medicine European public assessment report (EPAR): Maviret

glecaprevir, pibrentasvir, Hepatitis C, Chronic
Date of authorisation: 26/07/2017, , Revision: 17, Authorised, Last updated: 23/08/2022
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Human medicine European public assessment report (EPAR): Sovaldi

Sofosbuvir, Hepatitis C, Chronic
Date of authorisation: 16/01/2014, , Revision: 26, Authorised, Last updated: 22/08/2022
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Human medicine European public assessment report (EPAR): Brineura

cerliponase alfa, Neuronal Ceroid-Lipofuscinoses
Date of authorisation: 30/05/2017, , , , , Revision: 6, Authorised, Last updated: 16/08/2022
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Human medicine European public assessment report (EPAR): Exviera

dasabuvir sodium, Hepatitis C, Chronic
Date of authorisation: 14/01/2015, , Revision: 25, Authorised, Last updated: 12/08/2022
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Human medicine European public assessment report (EPAR): Grasustek

pegfilgrastim, Neutropenia
Date of authorisation: 20/06/2019, , , Revision: 3, Authorised, Last updated: 10/08/2022
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Human medicine European public assessment report (EPAR): Kalydeco

ivacaftor, Cystic Fibrosis
Date of authorisation: 23/07/2012, , Revision: 33, Authorised, Last updated: 10/08/2022
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Human medicine European public assessment report (EPAR): Imraldi

adalimumab, Spondylitis, Ankylosing; Arthritis, Rheumatoid; Uveitis; Colitis, Ulcerative; Psoriasis; Arthritis, Psoriatic; Crohn Disease; Hidradenitis Suppurativa; Arthritis
Date of authorisation: 24/08/2017, , Revision: 18, Authorised, Last updated: 09/08/2022