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Human medicine European public assessment report (EPAR): Abecma
idecabtagene vicleucel, Multiple Myeloma; Neoplasms; Cancer; Neoplasms, Plasma Cell; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Infectious Mononucleosis; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases
Date of authorisation: 18/08/2021,,
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, Revision: 5, Authorised, Last updated: 21/12/2022
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Human medicine European public assessment report (EPAR): Adakveo (updated)
Crizanlizumab, Anemia, Sickle Cell
Date of authorisation: 28/10/2020,,
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, Revision: 3, Authorised, Last updated: 10/01/2023
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Human medicine European public assessment report (EPAR): Arepanrix
split influenza virus, inactivated, containing antigen*: A/California/7/2009 (H1N1)v like strain (X-179A)*propagated in eggs., Influenza, Human; Immunization; Disease Outbreaks
Date of authorisation: 23/03/2010,, Revision: 1, Withdrawn, Last updated: 25/10/2011
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Human medicine European public assessment report (EPAR): Ayvakyt
avapritinib, Gastrointestinal Stromal Tumors
Date of authorisation: 24/09/2020,,
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, Revision: 4, Authorised, Last updated: 18/05/2022
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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: 4, Authorised, Last updated: 12/10/2022
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Human medicine European public assessment report (EPAR): Caprelsa (updated)
Vandetanib, Thyroid Neoplasms
Date of authorisation: 16/02/2012,, Revision: 23, Authorised, Last updated: 01/02/2023
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Human medicine European public assessment report (EPAR): Carvykti (updated)
ciltacabtagene autoleucel, Multiple Myeloma
Date of authorisation: 25/05/2022,,
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, Revision: 1, Authorised, Last updated: 17/01/2023
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Human medicine European public assessment report (EPAR): Deltyba
Delamanid, Tuberculosis, Multidrug-Resistant
Date of authorisation: 27/04/2014,
Date of refusal: 25/07/2013,,
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, Revision: 22, Authorised, Last updated: 18/10/2022
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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,,
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, Revision: 6, Authorised, Last updated: 08/07/2022
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Human medicine European public assessment report (EPAR): Enhertu
trastuzumab deruxtecan, Breast Neoplasms
Date of authorisation: 18/01/2021,,
, Revision: 9, Authorised, Last updated: 17/11/2022
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Human medicine European public assessment report (EPAR): Gavreto
pralsetinib, Carcinoma, Non-Small-Cell Lung
Date of authorisation: 18/11/2021,,
, Revision: 3, Authorised, Last updated: 10/06/2022
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Human medicine European public assessment report (EPAR): Hepcludex
Bulevirtide acetate, Hepatitis D, Chronic
Date of authorisation: 31/07/2020,,
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, Revision: 8, Authorised, Last updated: 22/12/2022
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Human medicine European public assessment report (EPAR): Holoclar
ex vivo expanded autologous human corneal epithelial cells containing stem cells, Stem Cell Transplantation; Corneal Diseases
Date of authorisation: 17/02/2015,,
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, Revision: 8, Authorised, Last updated: 06/01/2022
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Human medicine European public assessment report (EPAR): Humenza
split influenza virus, inactivated, containing antigen*: A/California/7/2009 (H1N1)v like strain (X-179A)*propagated in eggs., Influenza, Human; Immunization; Disease Outbreaks
Date of authorisation: 08/06/2010,, Withdrawn, Last updated: 30/06/2011
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Human medicine European public assessment report (EPAR): Idefirix (updated)
Imlifidase, Desensitization, Immunologic; Kidney Transplantation
Date of authorisation: 25/08/2020,,
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, Revision: 3, Authorised, Last updated: 16/01/2023
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Human medicine European public assessment report (EPAR): Jemperli
dostarlimab, Endometrial Neoplasms
Date of authorisation: 21/04/2021,,
, Revision: 6, Authorised, Last updated: 19/12/2022
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Human medicine European public assessment report (EPAR): Kinpeygo
budesonide, micronised, Glomerulonephritis, IGA
Date of authorisation: 15/07/2022,,
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, Revision: 2, Authorised, Last updated: 23/11/2022
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Human medicine European public assessment report (EPAR): Koselugo (updated)
Selumetinib sulfate, Neurofibromatosis 1
Date of authorisation: 17/06/2021,,
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, Revision: 4, Authorised, Last updated: 16/01/2023
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Human medicine European public assessment report (EPAR): Lartruvo
Olaratumab, Sarcoma
Date of authorisation: 09/11/2016,,
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, Revision: 3, Withdrawn, Last updated: 02/09/2019
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Human medicine European public assessment report (EPAR): Libtayo
Cemiplimab, Carcinoma, Squamous Cell
Date of authorisation: 28/06/2019,,
, Revision: 13, Authorised, Last updated: 08/12/2022
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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: 10, Authorised, Last updated: 20/10/2022
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Human medicine European public assessment report (EPAR): Lumykras
sotorasib, Carcinoma, Non-Small-Cell Lung
Date of authorisation: 06/01/2022,,
, Revision: 1, Authorised, Last updated: 29/11/2022
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Human medicine European public assessment report (EPAR): Lunsumio
mosunetuzumab, Lymphoma, Follicular
Date of authorisation: 03/06/2022,,
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, Authorised, Last updated: 23/06/2022
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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: 3, Authorised, Last updated: 13/06/2022
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Human medicine European public assessment report (EPAR): Natpar (updated)
parathyroid hormone, Hypoparathyroidism
Date of authorisation: 24/04/2017,,
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, Revision: 13, Authorised, Last updated: 11/01/2023