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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): Cometriq

cabozantinib, Thyroid Neoplasms
Date of authorisation: 21/03/2014, , Revision: 27, 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): Vitrakvi

larotrectinib sulfate, Abdominal Neoplasms
Date of authorisation: 19/09/2019, , , Revision: 8, 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): Hepcludex

Bulevirtide acetate, Hepatitis D, Chronic
Date of authorisation: 31/07/2020, , , , Revision: 9, 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): Blenrep

belantamab mafodotin, Multiple Myeloma
Date of authorisation: 25/08/2020, , , , Revision: 5, 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): 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): Nuvaxovid

SARS-CoV-2 recombinant spike protein, COVID-19 virus infection
Date of authorisation: 20/12/2021, , , Revision: 8, Authorised, Last updated: 27/03/2023
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Human medicine European public assessment report (EPAR): Symkevi

tezacaftor, ivacaftor, Cystic Fibrosis
Date of authorisation: 31/10/2018, , , Revision: 11, Authorised, Last updated: 24/03/2023
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Human medicine European public assessment report (EPAR): Opsumit

Macitentan, Hypertension, Pulmonary
Date of authorisation: 20/12/2013, , Revision: 22, Authorised, Last updated: 24/03/2023
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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): Enspryng

satralizumab, Neuromyelitis Optica
Date of authorisation: 24/06/2021, , Revision: 2, 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): Polivy

polatuzumab vedotin, Lymphoma, B-Cell
Date of authorisation: 16/01/2020, , , , Revision: 5, Authorised, Last updated: 22/03/2023
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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