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Human medicine European public assessment report (EPAR): Zynteglo
Autologous CD34+ cell enriched population that contains hematopoietic stem cells transduced with lentiglobin BB305 lentiviral vector encoding the beta-A-T87Q-globin gene, beta-Thalassemia
Date of authorisation: 29/05/2019,
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, Revision: 3, Authorised, Last updated: 28/01/2021
be a theoretical risk of cancer caused by unintended changes … including the potential risks of cancer and bleeding, and how it … -
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Human medicine European public assessment report (EPAR): Darzalex
Daratumumab, Multiple Myeloma
Date of authorisation: 20/05/2016,, , , Revision: 15, Authorised, Last updated: 26/01/2021
daratumumab Overview Darzalex is a cancer medicine used to treat adults … with multiple myeloma (a cancer of the bone marrow). In patients … back after treatment with cancer medicines (including medicines … -
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Human medicine European public assessment report (EPAR): Viekirax
Ombitasvir, paritaprevir, ritonavir, Hepatitis C, Chronic
Date of authorisation: 14/01/2015,, , Revision: 21, Authorised, Last updated: 20/10/2020
patients who have had liver cancer to evaluate the risk of liver … evaluate the risk of liver cancer returning after treatment … medicines who have had liver cancer could be at risk of their … -
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Human medicine European public assessment report (EPAR): Tagrisso
osimertinib mesilate, Carcinoma, Non-Small-Cell Lung
Date of authorisation: 01/02/2016,, , Revision: 12, Authorised, Last updated: 16/10/2020
medicine for treating a lung cancer called non-small cell lung cancer (NSCLC) when the cancer is advanced or has spread … medicine for treating a lung cancer called non-small cell lung cancer (NSCLC) when the cancer is advanced or has spread … -
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Human medicine European public assessment report (EPAR): Hemlibra
Emicizumab, Hemophilia A
Date of authorisation: 23/02/2018,, , Revision: 7, Authorised, Last updated: 22/12/2020
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Human medicine European public assessment report (EPAR): Sovaldi
Sofosbuvir, Hepatitis C, Chronic
Date of authorisation: 16/01/2014,, , Revision: 21, Authorised, Last updated: 14/08/2020
patients who have had liver cancer to evaluate the risk of the cancer returning after treatment … medicines who have had liver cancer could be at risk of their cancer returning early. Recommendations … -
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Human medicine European public assessment report (EPAR): Ofev
nintedanib, Idiopathic Pulmonary Fibrosis
Date of authorisation: 14/01/2015,, Revision: 17, Authorised, Last updated: 25/01/2021
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Human medicine European public assessment report (EPAR): Tegsedi
inotersen sodium, Amyloidosis
Date of authorisation: 05/07/2018,, , , Revision: 6, Authorised, Last updated: 16/10/2020
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Human medicine European public assessment report (EPAR): Verkazia
ciclosporin, Conjunctivitis, Keratitis
Date of authorisation: 06/07/2018,, , Revision: 4, Authorised, Last updated: 10/07/2020
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Human medicine European public assessment report (EPAR): Kisplyx
lenvatinib mesilate, Carcinoma, Renal Cell
Date of authorisation: 25/08/2016,, , Revision: 12, Authorised, Last updated: 14/01/2021
it used for? Kisplyx is a cancer medicine used to treat adults … carcinoma (a type of kidney cancer) who have been previously … previously treated with a type of cancer medicine called a ‘vascular … -
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Human medicine European public assessment report (EPAR): Lenvima
lenvatinib mesilate, Thyroid Neoplasms
Date of authorisation: 28/05/2015,, , Revision: 14, Authorised, Last updated: 15/01/2021
lenvatinib Overview Lenvima is a cancer medicine used on its own … thyroid carcinoma, a type of cancer originating from the follicular … Lenvima is used when the cancer has progressed or spread … -
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Human medicine European public assessment report (EPAR): Maviret (updated)
glecaprevir, pibrentasvir, Hepatitis C, Chronic
Date of authorisation: 26/07/2017,, , Revision: 11, Authorised, Last updated: 03/03/2021
previously have had liver cancer to evaluate the risk of liver … evaluate the risk of liver cancer returning after treatment … Maviret and who have had liver cancer could be at risk of their … -
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Human medicine European public assessment report (EPAR): Vosevi
Sofosbuvir, velpatasvir, voxilaprevi, Hepatitis C, Chronic
Date of authorisation: 26/07/2017,, , Revision: 9, Authorised, Last updated: 08/06/2020
previously have had liver cancer to evaluate the risk of liver … evaluate the risk of liver cancer returning after treatment … Vosevi who have had liver cancer could be at risk of their … -
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Human medicine European public assessment report (EPAR): Epclusa
Sofosbuvir, velpatasvir, Hepatitis C, Chronic
Date of authorisation: 06/07/2016,, , Revision: 13, Authorised, Last updated: 11/12/2020
evaluate the recurrence of liver cancer in patients treated with … evaluate the recurrence of liver cancer in patients treated with … -
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Human medicine European public assessment report (EPAR): Zytiga
abiraterone acetate, Prostatic Neoplasms
Date of authorisation: 05/09/2011,, Revision: 23, Authorised, Last updated: 21/12/2020
a medicine used to treat cancer of the prostate (a gland … system) in adult men when the cancer is metastatic (has spread … following situations: when the cancer is newly diagnosed, high … -
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Human medicine European public assessment report (EPAR): Harvoni
ledipasvir, Sofosbuvir, Hepatitis C, Chronic
Date of authorisation: 17/11/2014,, , Revision: 21, Authorised, Last updated: 29/07/2020
previously have had liver cancer to evaluate the risk of liver … evaluate the risk of liver cancer returning after treatment … medicines who have had liver cancer could be at risk of their … -
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Human medicine European public assessment report (EPAR): Isentress
Raltegravir, HIV Infections
Date of authorisation: 19/12/2007,, Revision: 37, Authorised, Last updated: 16/11/2020
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Human medicine European public assessment report (EPAR): Kyprolis
carfilzomib, Multiple Myeloma
Date of authorisation: 19/11/2015,, , Revision: 18, Authorised, Last updated: 28/01/2021
Kyprolis is a cancer medicine used together with … treat multiple myeloma (a cancer of the bone marrow). It is … previous treatment for their cancer. Kyprolis contains the active … -
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Human medicine European public assessment report (EPAR): Iclusig
ponatinib, Leukemia, Myeloid, Leukemia, Lymphoid
Date of authorisation: 01/07/2013,, , , Revision: 20, Authorised, Last updated: 29/10/2019
Iclusig is a cancer medicine that contains the … following types of leukaemia (cancer of the white blood cells … with CML), which are other cancer medicines of the same class … -
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Human medicine European public assessment report (EPAR): Cabometyx
cabozantinib (s)-malate, Carcinoma, Renal Cell
Date of authorisation: 09/09/2016,, , Revision: 9, Authorised, Last updated: 11/11/2020
Cabometyx is a cancer medicine used to treat adults … cell carcinoma (a kidney cancer). It is used in patients who … previously treated with a type of cancer medicine called ‘vascular … -
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Human medicine European public assessment report (EPAR): Sylvant
siltuximab, Giant Lymph Node Hyperplasia
Date of authorisation: 22/05/2014,, , Revision: 10, Authorised, Last updated: 08/10/2019
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Human medicine European public assessment report (EPAR): Exviera
dasabuvir sodium, Hepatitis C, Chronic
Date of authorisation: 14/01/2015,, , Revision: 18, Authorised, Last updated: 13/10/2020
previously have had liver cancer to evaluate the risk of liver … evaluate the risk of liver cancer returning after treatment … medicines who have had liver cancer could be at risk of their … -
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Human medicine European public assessment report (EPAR): Jorveza
budesonide, Esophageal Diseases
Date of authorisation: 08/01/2018,, , Revision: 2, Authorised, Last updated: 04/06/2020
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Human medicine European public assessment report (EPAR): Soliris
Eculizumab, Hemoglobinuria, Paroxysmal
Date of authorisation: 20/06/2007,, , Revision: 29, Authorised, Last updated: 01/07/2020
treat certain types of cancer, infections, a rare genetic … -
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Human medicine European public assessment report (EPAR): Brineura
cerliponase alfa, Neuronal Ceroid-Lipofuscinoses
Date of authorisation: 30/05/2017,, , , 
, Revision: 4, Authorised, Last updated: 12/06/2020