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Human medicine European public assessment report (EPAR): Calquence
Acalabrutinib, Leukemia, Lymphocytic, Chronic, B-Cell
Date of authorisation: 05/11/2020,, Revision: 7, Authorised, Last updated: 03/11/2023
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Human medicine European public assessment report (EPAR): Venclyxto
Venetoclax, Leukemia, Lymphocytic, Chronic, B-Cell
Date of authorisation: 04/12/2016,, Revision: 16, Authorised, Last updated: 31/10/2023
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Human medicine European public assessment report (EPAR): Comirnaty
Single-stranded, 5’-capped messenger RNA produced using a cell-free in vitro transcription from the corresponding DNA templates, encoding the viral spike (S) protein of SARS-CoV-2, COVID-19 virus infection
Date of authorisation: 21/12/2020,,
, Revision: 45, Authorised, Last updated: 31/10/2023
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Human medicine European public assessment report (EPAR): Minjuvi
Tafasitamab, Lymphoma, Large B-Cell, Diffuse
Date of authorisation: 26/08/2021,,
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, Revision: 4, Authorised, Last updated: 31/10/2023
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Human medicine European public assessment report (EPAR): Benlysta
belimumab, Lupus Erythematosus, Systemic
Date of authorisation: 13/07/2011,, Revision: 31, Authorised, Last updated: 31/10/2023
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Human medicine European public assessment report (EPAR): Yescarta
Axicabtagene ciloleucel, Lymphoma, Follicular; Lymphoma, Large B-Cell, Diffuse
Date of authorisation: 23/08/2018,,
, Revision: 12, Authorised, Last updated: 30/10/2023
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Human medicine European public assessment report (EPAR): Xofigo
radium (223Ra) dichloride, Prostatic Neoplasms
Date of authorisation: 13/11/2013,, Revision: 14, Authorised, Last updated: 30/10/2023
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Human medicine European public assessment report (EPAR): Tecvayli
Teclistamab, Multiple Myeloma
Date of authorisation: 23/08/2022,,
, Revision: 2, Authorised, Last updated: 30/10/2023
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Human medicine European public assessment report (EPAR): Raxone
idebenone, Optic Atrophy, Hereditary, Leber
Date of authorisation: 08/09/2015,,
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, Revision: 9, Authorised, Last updated: 30/10/2023
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Human medicine European public assessment report (EPAR): Adtralza
Tralokinumab, Dermatitis, Atopic
Date of authorisation: 17/06/2021,, Revision: 4, Authorised, Last updated: 30/10/2023
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Human medicine European public assessment report (EPAR): Lemtrada
alemtuzumab, Multiple Sclerosis
Date of authorisation: 12/09/2013,, Revision: 22, Authorised, Last updated: 30/10/2023
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Human medicine European public assessment report (EPAR): Pemetrexed Accord
pemetrexed disodium hemipentahydrate, Carcinoma, Non-Small-Cell Lung; Mesothelioma
Date of authorisation: 18/01/2016,, Revision: 10, Authorised, Last updated: 27/10/2023
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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,,
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, Revision: 16, Authorised, Last updated: 27/10/2023
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Human medicine European public assessment report (EPAR): Byfavo
remimazolam besilate, Conscious Sedation
Date of authorisation: 26/03/2021,, Revision: 6, Authorised, Last updated: 26/10/2023
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Human medicine European public assessment report (EPAR): Piqray
Alpelisib, Breast Neoplasms
Date of authorisation: 27/07/2020,, Revision: 10, Authorised, Last updated: 26/10/2023
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Human medicine European public assessment report (EPAR): Defitelio
defibrotide, Hepatic Veno-Occlusive Disease
Date of authorisation: 18/10/2013,,
, Revision: 15, Authorised, Last updated: 25/10/2023
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Human medicine European public assessment report (EPAR): Blenrep
belantamab mafodotin, Multiple Myeloma
Date of authorisation: 25/08/2020,,
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, Revision: 7, Authorised, Last updated: 25/10/2023
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Human medicine European public assessment report (EPAR): Actelsar HCT
Telmisartan, hydrochlorothiazide, Essential Hypertension
Date of authorisation: 13/03/2013,, Revision: 17, Authorised, Last updated: 24/10/2023
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Human medicine European public assessment report (EPAR): Telmisartan Actavis
Telmisartan, Hypertension
Date of authorisation: 29/09/2010,, Revision: 13, Authorised, Last updated: 24/10/2023
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Human medicine European public assessment report (EPAR): Heplisav B
hepatitis B surface antigen, Hepatitis B
Date of authorisation: 18/02/2021,, Revision: 5, Authorised, Last updated: 24/10/2023
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Human medicine European public assessment report (EPAR): Thiotepa Riemser
thiotepa, Hematopoietic Stem Cell Transplantation; Neoplasms
Date of authorisation: 26/03/2021,, Revision: 4, Authorised, Last updated: 23/10/2023
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Human medicine European public assessment report (EPAR): Revlimid
lenalidomide, Multiple Myeloma; Lymphoma, Mantle-Cell; Myelodysplastic Syndromes
Date of authorisation: 14/06/2007,, Revision: 51, Authorised, Last updated: 20/10/2023
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Human medicine European public assessment report (EPAR): Fintepla
Fenfluramine hydrochloride, Epilepsies, Myoclonic
Date of authorisation: 18/12/2020,,
, Revision: 7, Authorised, Last updated: 20/10/2023
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Human medicine European public assessment report (EPAR): Sunosi
solriamfetol hydrochloride, Narcolepsy; Sleep Apnea, Obstructive
Date of authorisation: 16/01/2020,, Revision: 8, Authorised, Last updated: 19/10/2023
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Human medicine European public assessment report (EPAR): Lytgobi
Futibatinib, Cholangiocarcinoma
Date of authorisation: 04/07/2023,,
, Revision: 1, Authorised, Last updated: 19/10/2023