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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): 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): Ceplene
Histamine dihydrochloride, Leukemia, Myeloid, Acute
Date of authorisation: 07/10/2008,
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, Revision: 12, Authorised, Last updated: 19/04/2023
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Human medicine European public assessment report (EPAR): Soliris
Eculizumab, Hemoglobinuria, Paroxysmal
Date of authorisation: 20/06/2007,
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, Revision: 34, Authorised, Last updated: 18/04/2023
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Human medicine European public assessment report (EPAR): Exviera
dasabuvir sodium, Hepatitis C, Chronic
Date of authorisation: 14/01/2015,, Revision: 26, Authorised, Last updated: 13/04/2023
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Human medicine European public assessment report (EPAR): Dimethyl fumarate Neuraxpharm
dimethyl fumarate, Multiple Sclerosis, Relapsing-Remitting
Date of authorisation: 13/05/2022,, Revision: 4, Authorised, Last updated: 13/04/2023
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Human medicine European public assessment report (EPAR): Granpidam
sildenafil citrate, Hypertension, Pulmonary
Date of authorisation: 14/11/2016,, Revision: 8, Authorised, Last updated: 11/04/2023
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Human medicine European public assessment report (EPAR): Cabometyx
cabozantinib (s)-malate, Carcinoma, Renal Cell; Carcinomas, Hepatocellular
Date of authorisation: 09/09/2016,, Revision: 16, Authorised, Last updated: 05/04/2023
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Human medicine European public assessment report (EPAR): Upstaza
Eladocagene exuparvovec, Amino Acid Metabolism, Inborn Errors
Date of authorisation: 18/07/2022,, , , Revision: 4, Authorised, Last updated: 05/04/2023
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Human medicine European public assessment report (EPAR): Dapagliflozin Viatris
dapagliflozin, Diabetes Mellitus, Type 2; Heart Failure, Systolic; Heart Failure; Renal Insufficiency, Chronic
Date of authorisation: 24/03/2023,, Authorised, Last updated: 04/04/2023
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Human medicine European public assessment report (EPAR): Qarziba (previously Dinutuximab beta EUSA and Dinutuximab beta Apeiron)
Dinutuximab beta, Neuroblastoma
Date of authorisation: 08/05/2017,, , , Revision: 14, Authorised, Last updated: 31/03/2023
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Human medicine European public assessment report (EPAR): Capecitabine Medac
capecitabine, Colorectal Neoplasms
Date of authorisation: 19/11/2012,, Revision: 13, Authorised, Last updated: 31/03/2023
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Human medicine European public assessment report (EPAR): Dasatinib Accord
dasatinib, Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Date of authorisation: 24/03/2022,, Revision: 1, Withdrawn, Last updated: 30/03/2023
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Human medicine European public assessment report (EPAR): Dasatinib Accordpharma
dasatinib, Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Date of authorisation: 24/03/2022,, Revision: 1, Withdrawn, Last updated: 30/03/2023
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Human medicine European public assessment report (EPAR): Azacitidine Accord
azacitidine, Myelodysplastic Syndromes; Leukemia, Myelomonocytic, Chronic; Leukemia, Myeloid, Acute
Date of authorisation: 13/02/2020,, Revision: 6, Authorised, Last updated: 29/03/2023
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Human medicine European public assessment report (EPAR): Imvanex
modified vaccinia Ankara - Bavarian Nordic (MVA-BN) virus, Smallpox Vaccine; Monkeypox virus
Date of authorisation: 31/07/2013,, , Revision: 25, Authorised, Last updated: 29/03/2023
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Human medicine European public assessment report (EPAR): Memantine Mylan
memantine hydrochloride, Alzheimer Disease
Date of authorisation: 21/04/2013,, Revision: 10, Authorised, Last updated: 29/03/2023
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Human medicine European public assessment report (EPAR): Arsenic trioxide Mylan
Arsenic trioxide, Leukemia, Promyelocytic, Acute
Date of authorisation: 01/04/2020,, Revision: 4, Authorised, Last updated: 29/03/2023
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Human medicine European public assessment report (EPAR): Deferasirox Mylan
deferasirox, Iron Overload; beta-Thalassemia
Date of authorisation: 26/09/2019,, Revision: 9, Authorised, Last updated: 28/03/2023
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Human medicine European public assessment report (EPAR): Levetiracetam Accord
levetiracetam, Epilepsy
Date of authorisation: 03/10/2011,, Revision: 15, Authorised, Last updated: 24/03/2023
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Human medicine European public assessment report (EPAR): Zokinvy
Lonafarnib, Progeria; Laminopathies
Date of authorisation: 18/07/2022,, , , Revision: 1, Authorised, Last updated: 24/03/2023
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Human medicine European public assessment report (EPAR): Miglustat Dipharma
miglustat, Gaucher Disease
Date of authorisation: 18/02/2019,, Revision: 5, Authorised, Last updated: 24/03/2023
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Human medicine European public assessment report (EPAR): Darzalex
Daratumumab, Multiple Myeloma
Date of authorisation: 20/05/2016,, , Revision: 20, Authorised, Last updated: 22/03/2023