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129 results
Medicine type
Conditional approval Remove Conditional approval filter
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Human medicine European public assessment report (EPAR): Retsevmo
Selpercatinib, Carcinoma, Non-Small-Cell Lung; Thyroid Neoplasms
Date of authorisation: 11/02/2021,,
, Revision: 3, Authorised, Last updated: 14/03/2022
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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: 5, Authorised, Last updated: 23/02/2022
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Human medicine European public assessment report (EPAR): Translarna
Ataluren, Muscular Dystrophy, Duchenne
Date of authorisation: 31/07/2014,,
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, Revision: 21, Authorised, Last updated: 10/02/2022
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Human medicine European public assessment report (EPAR): Vitrakvi
larotrectinib sulfate, Abdominal Neoplasms
Date of authorisation: 19/09/2019,,
, Revision: 5, Authorised, Last updated: 09/02/2022
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Human medicine European public assessment report (EPAR): Rybrevant
amivantamab, Carcinoma, Non-Small-Cell Lung
Date of authorisation: 09/12/2021,,
, Authorised, Last updated: 04/02/2022
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Human medicine European public assessment report (EPAR): Libtayo
Cemiplimab, Carcinoma, Squamous Cell
Date of authorisation: 28/06/2019,,
, Revision: 11, Authorised, Last updated: 04/02/2022
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Human medicine European public assessment report (EPAR): Caprelsa
Vandetanib, Thyroid Neoplasms
Date of authorisation: 16/02/2012,,
, Revision: 21, Authorised, Last updated: 28/01/2022
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Human medicine European public assessment report (EPAR): Ocaliva
Obeticholic acid, Liver Cirrhosis, Biliary
Date of authorisation: 12/12/2016,,
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, Revision: 12, Authorised, Last updated: 21/01/2022
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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,,
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, Revision: 5, Authorised, Last updated: 20/01/2022
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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): Natpar
parathyroid hormone, Hypoparathyroidism
Date of authorisation: 24/04/2017,,
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, Revision: 11, Authorised, Last updated: 04/01/2022
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Human medicine European public assessment report (EPAR): Crysvita
Burosumab, Hypophosphatemia, Familial; Hypophosphatemic Rickets, X-Linked Dominant
Date of authorisation: 19/02/2018,,
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, Revision: 9, Authorised, Last updated: 10/12/2021
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Human medicine European public assessment report (EPAR): Zolgensma
onasemnogene abeparvovec, Muscular Atrophy, Spinal
Date of authorisation: 18/05/2020,,
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, Revision: 4, Authorised, Last updated: 06/12/2021
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Human medicine European public assessment report (EPAR): Sirturo
bedaquiline fumarate, Tuberculosis, Multidrug-Resistant
Date of authorisation: 05/03/2014,,
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, Revision: 20, Authorised, Last updated: 23/11/2021
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Human medicine European public assessment report (EPAR): Koselugo
Selumetinib sulfate, Neurofibromatosis 1
Date of authorisation: 17/06/2021,,
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, Revision: 1, Authorised, Last updated: 10/11/2021
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Human medicine European public assessment report (EPAR): Waylivra
Volanesorsen sodium, Hyperlipoproteinemia Type I
Date of authorisation: 03/05/2019,,
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, Revision: 4, Authorised, Last updated: 29/10/2021
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Human medicine European public assessment report (EPAR): Tecartus
Autologous peripheral blood T cells CD4 and CD8 selected and CD3 and CD28 activated transduced with retroviral vector expressing anti-CD19 CD28/CD3-zeta chimeric antigen receptor and cultured, Lymphoma, Mantle-Cell
Date of authorisation: 14/12/2020,,
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, Revision: 1, Authorised, Last updated: 15/10/2021
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Human medicine European public assessment report (EPAR): Idefirix
Imlifidase, Desensitization, Immunologic; Kidney Transplantation
Date of authorisation: 25/08/2020,,
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, Revision: 1, Authorised, Last updated: 31/08/2021
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Human medicine European public assessment report (EPAR): Adakveo
Crizanlizumab, Anemia, Sickle Cell
Date of authorisation: 28/10/2020,,
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, Revision: 2, Authorised, Last updated: 30/08/2021
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Human medicine European public assessment report (EPAR): Pandemic influenza vaccine H5N1 AstraZeneca (previously Pandemic influenza vaccine H5N1 Medimmune)
reassortant influenza virus (live attenuated) of the following strain: A/Vietnam/1203/2004 (H5N1) strain, Influenza, Human
Date of authorisation: 20/05/2016,,
, Revision: 8, Authorised, Last updated: 08/07/2021
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Human medicine European public assessment report (EPAR): Zalmoxis
Allogeneic T cells genetically modified with a retroviral vector encoding for a truncated form of the human low affinity nerve growth factor receptor (ΔLNGFR) and the herpes simplex I virus thymidine kinase (HSV-TK Mut2), Hematopoietic Stem Cell Transplantation; Graft vs Host Disease
Date of authorisation: 18/08/2016,, Revision: 1, Withdrawn, Last updated: 14/02/2020
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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): 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): 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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Summary of opinion: Retsevmo
selpercatinib, opinion date: 22/04/2022, Positive, Last updated: 22/04/2022