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Human medicine European public assessment report (EPAR): Brineura (updated)
cerliponase alfa, Neuronal Ceroid-Lipofuscinoses
Date of authorisation: 30/05/2017,
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, 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 (updated)
dasabuvir sodium, Hepatitis C, Chronic
Date of authorisation: 14/01/2015,, Revision: 25, Authorised, Last updated: 12/08/2022
a summary of the A set of documents describing the evaluation … leaflet or contact their doctor or pharmacist. What is Exviera … started and monitored by a doctor experienced in managing patients … -
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Human medicine European public assessment report (EPAR): Tegsedi (updated)
inotersen sodium, Amyloidosis
Date of authorisation: 06/07/2018,, , , Revision: 11, Authorised, Last updated: 28/07/2022
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): Kalydeco (updated)
ivacaftor, Cystic Fibrosis
Date of authorisation: 23/07/2012,, Revision: 33, Authorised, Last updated: 10/08/2022
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): 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 … also been included in the A document describing the properties … -
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Human medicine European public assessment report (EPAR): Maviret
glecaprevir, pibrentasvir, Hepatitis C, Chronic
Date of authorisation: 26/07/2017,, Revision: 16, Authorised, Last updated: 20/06/2022
started and monitored by a doctor experienced in the management … package leaflet or contact your doctor or pharmacist. How does Maviret … also 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: 25, 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 Harvoni … also been included in the A document describing the properties … -
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Human medicine European public assessment report (EPAR): Sovaldi
Sofosbuvir, Hepatitis C, Chronic
Date of authorisation: 16/01/2014,, Revision: 25, 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 Sovaldi … also been included in the A document describing the properties … -
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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): 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): 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
PDF/4.81 MB) (PDF/4.81 MB) Documents providing officially approved … requirements'. Product information documents contain: A document describing the properties … in an approved centre by a doctor experienced in stem cell … -
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Human medicine European public assessment report (EPAR): Bylvay
Odevixibat, Cholestasis, Intrahepatic
Date of authorisation: 16/07/2021,, , , Revision: 1, Authorised, Last updated: 31/05/2022
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): Darzalex
Daratumumab, Multiple Myeloma
Date of authorisation: 20/05/2016,, , Revision: 19, Authorised, Last updated: 11/07/2022
infusion-related reactions, the doctor may slow down the infusion … package leaflet or contact your doctor or pharmacist. How does Darzalex … -
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Human medicine European public assessment report (EPAR): Zytiga
abiraterone acetate, Prostatic Neoplasms
Date of authorisation: 05/09/2011,, Revision: 24, Authorised, Last updated: 13/05/2022
leaflet or contact their doctor or pharmacist. Expand section … and chemotherapy containing docetaxel have not worked or no longer … treatment and chemotherapy with docetaxel, the main measure of effectiveness … -
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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 … -
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Human medicine European public assessment report (EPAR): Kyprolis
carfilzomib, Multiple Myeloma
Date of authorisation: 19/11/2015,, , Revision: 20, Authorised, Last updated: 15/06/2022
treatment must be supervised by a doctor experienced in the treatment … package leaflet or contact your doctor or pharmacist. How does Kyprolis … treatment must be supervised by a doctor experienced 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: 11, Authorised, Last updated: 10/05/2022
treatment should be started by a doctor experienced in the treatment … package leaflet or contact your doctor or pharmacist. How does Hemlibra … patients. Materials will include Documents providing officially approved … -
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Human medicine European public assessment report (EPAR): Vidaza
azacitidine, Myelodysplastic Syndromes
Date of authorisation: 17/12/2008,, Revision: 25, Authorised, Last updated: 14/06/2022
under the supervision of a doctor experienced in the use of … the EPAR) or contact your doctor or pharmacist. List item … -
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Human medicine European public assessment report (EPAR): Iclusig
ponatinib, Leukemia, Myeloid; Leukemia, Lymphoid
Date of authorisation: 01/07/2013,, , Revision: 23, Authorised, Last updated: 11/05/2022
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): Cabometyx
cabozantinib (s)-malate, Carcinoma, Renal Cell; Carcinomas, Hepatocellular
Date of authorisation: 09/09/2016,, Revision: 14, Authorised, Last updated: 09/06/2022
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): Oxervate
Recombinant human nerve growth factor, Keratitis
Date of authorisation: 06/07/2017,, , , Revision: 1, Authorised, Last updated: 04/04/2022
a summary of the A set of documents describing the evaluation … leaflet or contact their doctor or pharmacist. What is Oxervate … have been included in the A document describing the properties … -
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Human medicine European public assessment report (EPAR): Ofev
nintedanib, Idiopathic Pulmonary Fibrosis
Date of authorisation: 14/01/2015,, Revision: 22, Authorised, Last updated: 26/04/2022
treatment should be started by a doctor experienced in the diagnosis … package leaflet or contact your doctor or pharmacist. How does Ofev … -
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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: 15, Authorised, Last updated: 07/04/2022
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): Spinraza
nusinersen sodium, Muscular Atrophy, Spinal
Date of authorisation: 30/05/2017,, , Revision: 13, Authorised, Last updated: 02/02/2022
a summary of the A set of documents describing the evaluation … leaflet or contact their doctor or pharmacist. What is Spinraza … treatment should be started by a doctor with experience in the treatment … -
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Human medicine European public assessment report (EPAR): Takhzyro
lanadelumab, Angioedemas, Hereditary
Date of authorisation: 22/11/2018,, , , Revision: 7, Authorised, Last updated: 19/01/2022
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 …