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Medicine European public assessment reports (EPAR) Remove European public assessment reports (EPAR) filter Orphan designations Remove Orphan designations filter Referrals Remove Referrals filter

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Human medicine European public assessment report (EPAR): Anagrelide Mylan (updated)

Anagrelide hydrochloride, Thrombocythemia, Essential
Date of authorisation: 15/02/2018, , Revision: 8, Authorised, Last updated: 11/05/2023
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Human medicine European public assessment report (EPAR): Vegzelma (updated)

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: 17/08/2022, , , Revision: 3, Authorised, Last updated: 10/05/2023
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Human medicine European public assessment report (EPAR): Deferasirox Accord (updated)

deferasirox, Iron Overload; beta-Thalassemia
Date of authorisation: 09/01/2020, , Revision: 4, Authorised, Last updated: 08/05/2023
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Human medicine European public assessment report (EPAR): Pioglitazone Teva (updated)

pioglitazone hydrochloride, Diabetes Mellitus, Type 2
Date of authorisation: 26/03/2012, , Revision: 12, Withdrawn, Last updated: 04/05/2023
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Human medicine European public assessment report (EPAR): Tegsedi

inotersen sodium, Amyloidosis
Date of authorisation: 06/07/2018, , , Revision: 14, Authorised, Last updated: 02/05/2023
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Human medicine European public assessment report (EPAR): Ocaliva

Obeticholic acid, Liver Cirrhosis, Biliary
Date of authorisation: 12/12/2016, , , , Revision: 16, Authorised, Last updated: 02/05/2023
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Human medicine European public assessment report (EPAR): Zynlonta

loncastuximab tesirine, Lymphoma, Large B-Cell, Diffuse; Lymphoma, B-Cell
Date of authorisation: 20/12/2022, , , Revision: 2, Authorised, Last updated: 02/05/2023
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Human medicine European public assessment report (EPAR): Fingolimod Mylan

fingolimod hydrochloride , Multiple Sclerosis, Relapsing-Remitting
Date of authorisation: 18/08/2021, , Revision: 4, Authorised, Last updated: 02/05/2023
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Human medicine European public assessment report (EPAR): Kalydeco

ivacaftor, Cystic Fibrosis
Date of authorisation: 23/07/2012, , Revision: 35, Authorised, Last updated: 28/04/2023
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Human medicine European public assessment report (EPAR): Cinacalcet Mylan

cinacalcet hydrochloride, Hyperparathyroidism, Secondary; Hypercalcemia
Date of authorisation: 19/11/2015, , Revision: 15, Authorised, Last updated: 26/04/2023
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Human medicine European public assessment report (EPAR): Ambrisentan Mylan

ambrisentan, Hypertension, Pulmonary
Date of authorisation: 20/06/2019, , Revision: 4, Authorised, Last updated: 26/04/2023
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Human medicine European public assessment report (EPAR): Nemdatine

memantine, Alzheimer Disease
Date of authorisation: 22/04/2013,
Date of refusal: 22/02/2013, , Revision: 12, Authorised, Last updated: 25/04/2023
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Human medicine European public assessment report (EPAR): Verkazia

ciclosporin, Conjunctivitis; Keratitis
Date of authorisation: 06/07/2018, , , Revision: 7, Authorised, Last updated: 25/04/2023
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Human medicine European public assessment report (EPAR): Translarna

Ataluren, Muscular Dystrophy, Duchenne
Date of authorisation: 31/07/2014, , , , Revision: 22, Authorised, Last updated: 25/04/2023
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Human medicine European public assessment report (EPAR): Epclusa

Sofosbuvir, velpatasvir, Hepatitis C, Chronic
Date of authorisation: 06/07/2016, , Revision: 20, Authorised, Last updated: 21/04/2023
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Human medicine European public assessment report (EPAR): Lamivudine Teva Pharma B.V.

lamivudine, HIV Infections
Date of authorisation: 10/12/2009, , Revision: 19, Authorised, Last updated: 21/04/2023
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Human medicine European public assessment report (EPAR): Eptifibatide Accord

eptifibatide, Myocardial Infarction
Date of authorisation: 11/01/2016, , Revision: 6, Authorised, Last updated: 21/04/2023
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Human medicine European public assessment report (EPAR): Lunsumio

mosunetuzumab, Lymphoma, Follicular
Date of authorisation: 03/06/2022, , , , Revision: 1, Authorised, Last updated: 20/04/2023
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Human medicine European public assessment report (EPAR): Inpremzia

insulin human (rDNA), Diabetes Mellitus
Date of authorisation: 25/04/2022, , , Withdrawn, Last updated: 20/04/2023
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Human medicine European public assessment report (EPAR): Pelgraz

pegfilgrastim, Neutropenia
Date of authorisation: 21/09/2018, , , Revision: 9, Authorised, Last updated: 20/04/2023
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Human medicine European public assessment report (EPAR): Zoledronic acid Mylan

zoledronic acid, Fractures, Bone
Date of authorisation: 23/08/2012, , Revision: 14, Authorised, Last updated: 20/04/2023
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Human medicine European public assessment report (EPAR): Entecavir Mylan

entecavir monohydrate, Hepatitis B
Date of authorisation: 18/09/2017, , Revision: 6, Authorised, Last updated: 19/04/2023
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Human medicine European public assessment report (EPAR): Alymsys

bevacizumab, Colorectal Neoplasms; Breast Neoplasms; Ovarian Neoplasms; Peritoneal Neoplasms; Carcinoma, Non-Small-Cell Lung; Carcinoma, Renal Cell; Uterine Cervical Neoplasms
Date of authorisation: 26/03/2021, , , Revision: 5, Authorised, Last updated: 18/04/2023
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Human medicine European public assessment report (EPAR): Lorviqua

Lorlatinib, Carcinoma, Non-Small-Cell Lung
Date of authorisation: 06/05/2019, , , Revision: 11, Authorised, Last updated: 18/04/2023
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Human medicine European public assessment report (EPAR): Soliris

Eculizumab, Hemoglobinuria, Paroxysmal
Date of authorisation: 20/06/2007, , , Revision: 34, Authorised, Last updated: 18/04/2023