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729 results
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Human medicine European public assessment report (EPAR): Orkambi (updated)
Lumacaftor, ivacaftor, Cystic Fibrosis
Date of authorisation: 18/11/2015,
, Revision: 29, Authorised, Last updated: 25/07/2022
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Human medicine European public assessment report (EPAR): Trelegy Ellipta (updated)
fluticasone furoate, umeclidinium bromide, vilanterol trifenatate, Pulmonary Disease, Chronic Obstructive
Date of authorisation: 15/11/2017,, Revision: 9, Authorised, Last updated: 25/07/2022
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Human medicine European public assessment report (EPAR): Mayzent (updated)
Siponimod fumaric acid, Multiple Sclerosis, Relapsing-Remitting
Date of authorisation: 13/01/2020,, Revision: 8, Authorised, Last updated: 25/07/2022
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Human medicine European public assessment report (EPAR): Elebrato Ellipta (updated)
fluticasone furoate, umeclidinium bromide, vilanterol trifenatate, Pulmonary Disease, Chronic Obstructive
Date of authorisation: 15/11/2017,, Revision: 10, Authorised, Last updated: 25/07/2022
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Human medicine European public assessment report (EPAR): Emgality (updated)
Galcanezumab, Migraine Disorders
Date of authorisation: 14/11/2018,, Revision: 8, Authorised, Last updated: 22/07/2022
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Human medicine European public assessment report (EPAR): Spikevax (previously COVID-19 Vaccine Moderna) (updated)
CX-024414 (single-stranded, 5’-capped messenger RNA (mRNA) 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: 06/01/2021,
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, Revision: 26, Authorised, Last updated: 22/07/2022
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Human medicine European public assessment report (EPAR): Evrenzo (updated)
Roxadustat, Anemia; Kidney Failure, Chronic
Date of authorisation: 18/08/2021,, Revision: 1, Authorised, Last updated: 22/07/2022
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Human medicine European public assessment report (EPAR): Aybintio (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: 19/08/2020,, 
, Revision: 5, Authorised, Last updated: 21/07/2022
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Human medicine European public assessment report (EPAR): Onbevzi (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: 11/01/2021,, , Revision: 2, Authorised, Last updated: 21/07/2022
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Human medicine European public assessment report (EPAR): Mylotarg (updated)
gemtuzumab ozogamicin, Leukemia, Myeloid, Acute
Date of authorisation: 19/04/2018,, 
, Revision: 10, Authorised, Last updated: 21/07/2022
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Human medicine European public assessment report (EPAR): Kapruvia (updated)
difelikefalin, Pruritus
Date of authorisation: 25/04/2022,, Revision: 1, Authorised, Last updated: 21/07/2022
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Human medicine European public assessment report (EPAR): Zolgensma (updated)
onasemnogene abeparvovec, Muscular Atrophy, Spinal
Date of authorisation: 18/05/2020,, , , Revision: 6, Authorised, Last updated: 21/07/2022
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Human medicine European public assessment report (EPAR): Biktarvy (updated)
bictegravir, emtricitabine, tenofovir alafenamide, fumarate, HIV Infections
Date of authorisation: 21/06/2018,, Revision: 13, Authorised, Last updated: 20/07/2022
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Human medicine European public assessment report (EPAR): Roclanda (updated)
Latanoprost, Netarsudil mesilate, Glaucoma, Open-Angle; Ocular Hypertension
Date of authorisation: 07/01/2021,, Revision: 3, Authorised, Last updated: 20/07/2022
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Human medicine European public assessment report (EPAR): Lemtrada (updated)
alemtuzumab, Multiple Sclerosis
Date of authorisation: 12/09/2013,, Revision: 19, Authorised, Last updated: 19/07/2022
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Human medicine European public assessment report (EPAR): Kinpeygo (updated)
budesonide, Glomerulonephritis, IGA
Date of authorisation: 15/07/2022,, , , Authorised, Last updated: 18/07/2022
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Human medicine European public assessment report (EPAR): Mvasi
bevacizumab, Carcinoma, Renal Cell; Peritoneal Neoplasms; Ovarian Neoplasms; Breast Neoplasms; Carcinoma, Non-Small-Cell Lung; Fallopian Tube Neoplasms
Date of authorisation: 15/01/2018,, , Revision: 12, Authorised, Last updated: 14/07/2022
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Human medicine European public assessment report (EPAR): Copiktra
duvelisib, Leukemia, Lymphocytic, Chronic, B-Cell; Lymphoma, Follicular
Date of authorisation: 19/05/2021,, Revision: 2, Authorised, Last updated: 13/07/2022
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Human medicine European public assessment report (EPAR): Evoltra
clofarabine, Precursor Cell Lymphoblastic Leukemia-Lymphoma
Date of authorisation: 29/05/2006,, 
, Revision: 31, Authorised, Last updated: 13/07/2022
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Human medicine European public assessment report (EPAR): Veyvondi
vonicog alfa, von Willebrand Diseases
Date of authorisation: 31/08/2018,, Revision: 5, Authorised, Last updated: 13/07/2022
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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: 8, Authorised, Last updated: 12/07/2022
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Human medicine European public assessment report (EPAR): Trodelvy
Sacituzumab govitecan, Breast Neoplasms; Triple Negative Breast Neoplasms
Date of authorisation: 22/11/2021,, Revision: 1, Authorised, Last updated: 12/07/2022
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Human medicine European public assessment report (EPAR): Dovprela (previously Pretomanid FGK)
Pretomanid, Tuberculosis, Multidrug-Resistant
Date of authorisation: 31/07/2020,, , , Revision: 6, Authorised, Last updated: 08/07/2022
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Human medicine European public assessment report (EPAR): Spravato
esketamine hydrochloride, Depressive Disorder
Date of authorisation: 18/12/2019,, Revision: 5, Authorised, Last updated: 08/07/2022
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Human medicine European public assessment report (EPAR): Zynteglo
Autologous CD34+ cell enriched population that contains haematopoietic stem cells transduced with lentiviral vector encoding the βA-T87Q-globin gene, beta-Thalassemia
Date of authorisation: 29/05/2019,, , 
, , , Revision: 5, Withdrawn, Last updated: 08/07/2022