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Human medicine European public assessment report (EPAR): Coagadex (updated)
Human coagulation factor X, Factor X Deficiency
Date of authorisation: 16/03/2016,
, 
, Revision: 9, Authorised, Last updated: 25/01/2023
under the supervision of a doctor experienced in the treatment … package leaflet or contact your doctor or pharmacist. How does Coagadex … effectiveness was based on the doctor’s and patient’s assessment … -
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Human medicine European public assessment report (EPAR): Praxbind (updated)
idarucizumab, Hemorrhage
Date of authorisation: 20/11/2015,, Revision: 11, Authorised, Last updated: 18/01/2023
a summary of the A set of documents describing the evaluation … leaflet or contact their doctor or pharmacist. What is Praxbind … has been included in the A document describing the properties … -
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Human medicine European public assessment report (EPAR): Takhzyro
lanadelumab, Angioedemas, Hereditary
Date of authorisation: 22/11/2018,
, , , Revision: 10, Authorised, Last updated: 13/12/2022
the two-weekly dose, the doctor can reduce the frequency … to once every 4 weeks. The doctor may decide that patients … started under supervision of a doctor experienced in managing hereditary … -
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Human medicine European public assessment report (EPAR): Jorveza
budesonide, Esophageal Diseases
Date of authorisation: 08/01/2018,, , Revision: 6, Authorised, Last updated: 06/12/2022
treatment should be started by a doctor experienced with diagnosing … and how severe it is. The doctor will decide how long the … package leaflet or contact your doctor or pharmacist. How does Jorveza … -
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Human medicine European public assessment report (EPAR): Zytiga
abiraterone acetate, Prostatic Neoplasms
Date of authorisation: 05/09/2011,, Revision: 26, Authorised, Last updated: 06/12/2022
a summary of the A set of documents describing the evaluation … leaflet or contact their doctor or pharmacist. What is Zytiga … and chemotherapy containing docetaxel have not worked or no longer … -
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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: 17, Authorised, Last updated: 29/11/2022
started and supervised by a doctor who is experienced in the … Before starting treatment, the doctor should use a genetic test … side effects develop, the doctor may decide to reduce the … -
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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: 30/11/2022
marketing-authorisation holder. Summary documents Zynteglo : EPAR - Medicine … in an approved centre by a doctor experienced in stem cell … package leaflet or contact your doctor or pharmacist. http://www.ema.europa.eu/how-to-find-us http://www.ema.europa.eu/contact https://www.ema.europa.eu/en/medicines/human/orphan-designations/eu3121091 Med icin al … -
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Human medicine European public assessment report (EPAR): Tegsedi
inotersen sodium, Amyloidosis
Date of authorisation: 06/07/2018,, , , Revision: 12, Authorised, Last updated: 08/11/2022
started and supervised by a doctor experienced in the treatment … package leaflet or contact your doctor or pharmacist. How does Tegsedi … also been included in the A document describing the properties … -
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Human medicine European public assessment report (EPAR): Cabometyx
cabozantinib (s)-malate, Carcinoma, Renal Cell; Carcinomas, Hepatocellular
Date of authorisation: 09/09/2016,, Revision: 15, Authorised, Last updated: 05/12/2022
treatment should be started by a doctor who has experience of using … package leaflet or contact your doctor or pharmacist. How does Cabometyx … treatment should be started by a doctor who has experience of using … -
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Human medicine European public assessment report (EPAR): Isentress
Raltegravir, HIV Infections
Date of authorisation: 19/12/2007,, Revision: 42, Authorised, Last updated: 20/10/2022
treatment should be started by a doctor who has experience in the … adults, as recommended by the doctor. Equivalent doses of these … package leaflet or contact your doctor or pharmacist. How does Isentress … -
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Human medicine European public assessment report (EPAR): Bylvay
Odevixibat, Cholestasis, Intrahepatic
Date of authorisation: 16/07/2021,, , 
, Revision: 2, Authorised, Last updated: 05/10/2022
started and supervised by a doctor who has experience in the … package leaflet or contact your doctor or pharmacist. How does Bylvay … have been included in the A document describing the properties … -
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Human medicine European public assessment report (EPAR): Harvoni
ledipasvir, Sofosbuvir, Hepatitis C, Chronic
Date of authorisation: 17/11/2014,, Revision: 26, Authorised, Last updated: 10/11/2022
started and monitored by a doctor experienced in the management … package leaflet or contact your doctor or pharmacist. How does Harvoni … -
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Human medicine European public assessment report (EPAR): Iclusig
ponatinib, Leukemia, Myeloid; Leukemia, Lymphoid
Date of authorisation: 01/07/2013,, , Revision: 24, Authorised, Last updated: 21/10/2022
treatment should be started by a doctor who is experienced in the … severe side effects, the doctor may decide to reduce subsequent … delay or stop treatment. The doctor should consider stopping … -
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Human medicine European public assessment report (EPAR): Vpriv
velaglucerase alfa, Gaucher Disease
Date of authorisation: 26/08/2010,, Revision: 19, Authorised, Last updated: 20/10/2022
should be supervised by a doctor experienced in managing Gaucher … the EPAR) or contact your doctor or pharmacist. List item … velaglucerase alfa This document is a summary of the European … -
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Human medicine European public assessment report (EPAR): Soliris
Eculizumab, Hemoglobinuria, Paroxysmal
Date of authorisation: 20/06/2007,, , Revision: 33, Authorised, Last updated: 14/11/2022
under the supervision of a doctor who has experience in the … infusion-related reactions, the doctor may slow down or stop the … -
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Human medicine European public assessment report (EPAR): Kalydeco
ivacaftor, Cystic Fibrosis
Date of authorisation: 23/07/2012,, Revision: 34, Authorised, Last updated: 21/10/2022
should only be prescribed by a doctor with experience in the treatment … package leaflet or contact your doctor or pharmacist. How does Kalydeco … should only be prescribed by a doctor with experience in the treatment … -
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Human medicine European public assessment report (EPAR): Hemlibra
Emicizumab, Hemophilia A
Date of authorisation: 23/02/2018,, , Revision: 12, Authorised, Last updated: 27/09/2022
treatment should be started by a doctor experienced in the treatment … package leaflet or contact your doctor or pharmacist. How does Hemlibra … -
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Human medicine European public assessment report (EPAR): Brineura
cerliponase alfa, Neuronal Ceroid-Lipofuscinoses
Date of authorisation: 30/05/2017,, , , , Revision: 6, Authorised, Last updated: 16/08/2022
a summary of the A set of documents describing the evaluation … leaflet or contact their doctor or pharmacist. What is Brineura … treatment. The rating was done by doctors who gave patients individual … -
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Human medicine European public assessment report (EPAR): Exviera
dasabuvir sodium, Hepatitis C, Chronic
Date of authorisation: 14/01/2015,, Revision: 25, Authorised, Last updated: 12/08/2022
leaflet or contact their doctor or pharmacist. Expand section … started and monitored by a doctor experienced in managing patients … the EPAR) or contact your doctor or pharmacist. List item … -
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Human medicine European public assessment report (EPAR): Maviret
glecaprevir, pibrentasvir, Hepatitis C, Chronic
Date of authorisation: 26/07/2017,, Revision: 17, Authorised, Last updated: 23/08/2022
started and monitored by a doctor experienced in the management … package leaflet or contact your doctor or pharmacist. How does Maviret … started and monitored by a doctor experienced in the management … -
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Human medicine European public assessment report (EPAR): Sovaldi
Sofosbuvir, Hepatitis C, Chronic
Date of authorisation: 16/01/2014,, Revision: 26, Authorised, Last updated: 22/08/2022
started and monitored by a doctor experienced in the management … package leaflet or contact your doctor or pharmacist. How does Sovaldi … -
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Human medicine European public assessment report (EPAR): Kanuma
sebelipase alfa, Lipid Metabolism, Inborn Errors
Date of authorisation: 28/08/2015,, , , Revision: 8, Authorised, Last updated: 21/06/2022
a summary of the A set of documents describing the evaluation … leaflet or contact their doctor or pharmacist. What is Kanuma … should be supervised by a doctor experienced in the treatment … -
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Human medicine European public assessment report (EPAR): Epclusa
Sofosbuvir, velpatasvir, Hepatitis C, Chronic
Date of authorisation: 06/07/2016,, Revision: 18, Authorised, Last updated: 06/07/2022
started and monitored by a doctor experienced in the management … package leaflet or contact your doctor or pharmacist. How does Epclusa … started and monitored by a doctor experienced in the management … -
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Human medicine European public assessment report (EPAR): Evrysdi
Risdiplam, Muscular Atrophy, Spinal
Date of authorisation: 26/03/2021,, , Revision: 2, Authorised, Last updated: 17/06/2022
Evrysdi must be started by a doctor experienced in treating SMA … package leaflet or contact your doctor or pharmacist. How does Evrysdi … Evrysdi must be started by a doctor experienced in treating SMA … -
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Human medicine European public assessment report (EPAR): Kisplyx
lenvatinib mesilate, Carcinoma, Renal Cell
Date of authorisation: 25/08/2016,, Revision: 17, Authorised, Last updated: 17/06/2022
started and supervised by a doctor who has experience in using … package leaflet or contact your doctor or pharmacist. How does … started and supervised by a doctor who has experience in using …