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Human medicine European public assessment report (EPAR): Kinpeygo (updated)
budesonide, micronised, Glomerulonephritis, IGA
Date of authorisation: 15/07/2022,
, 
, 
, Revision: 2, Authorised, Last updated: 23/11/2022
necessary by the treating doctor. When stopping treatment … discretion of the treating doctor. For more information about … package leaflet or contact your doctor or pharmacist. How does Kinpeygo … -
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Human medicine European public assessment report (EPAR): Votubia
everolimus, Tuberous Sclerosis
Date of authorisation: 02/09/2011,, Revision: 30, Authorised, Last updated: 27/06/2022
treatment should be started by a doctor experienced in treating tuberous … patient’s age, but the doctor will adjust the dose based … experience severe side effects the doctor may need to reduce the dose … -
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Human medicine European public assessment report (EPAR): Livtencity (updated)
Maribavir, Cytomegalovirus Infections
Date of authorisation: 09/11/2022,, , Authorised, Last updated: 24/11/2022
Treatment should be started by a doctor experienced in managing patients … package leaflet or contact your doctor or pharmacist. How does Livtencity … treatment chosen by their doctor. What are the risks associated … -
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Human medicine European public assessment report (EPAR): Tavneos (updated)
Avacopan, Microscopic Polyangiitis; Wegener Granulomatosis
Date of authorisation: 11/01/2022,, , Revision: 1, Authorised, Last updated: 25/11/2022
twice daily with meals. The doctor may have to interrupt or … package leaflet or contact your doctor or pharmacist. How does Tavneos … guidance presented in the Documents providing officially approved … -
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Human medicine European public assessment report (EPAR): Prevymis (updated)
Letermovir, Cytomegalovirus Infections
Date of authorisation: 08/01/2018,, Revision: 13, Authorised, Last updated: 24/11/2022
treatment should be started by a doctor experienced in managing patients … haematopoietic stem cell transplant. Doctors should consider official … package leaflet or contact your doctor or pharmacist. How does Prevymis … -
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Human medicine European public assessment report (EPAR): Vyvgart (updated)
Efgartigimod alfa, Myasthenia Gravis
Date of authorisation: 10/08/2022,, , Revision: 2, Authorised, Last updated: 22/11/2022
treatment should be initiated by doctors with experience in the management … over cycles of 4 weeks. The doctor will decide on how many cycles … package leaflet or contact your doctor or pharmacist. How does Vyvgart … -
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Human medicine European public assessment report (EPAR): Enjaymo (updated)
sutimlimab, Hemolysis; Anemia, Hemolytic, Autoimmune
Date of authorisation: 15/11/2022,, , Authorised, Last updated: 17/11/2022
should be supervised by a doctor with experience in the management … tolerated during this period, the doctor may consider home infusion … package leaflet or contact your doctor or pharmacist. How does Enjaymo … -
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Human medicine European public assessment report (EPAR): Vyxeos liposomal (previously known as Vyxeos) (updated)
daunorubicin hydrochloride, cytarabine, Leukemia, Myeloid, Acute
Date of authorisation: 23/08/2018,, Revision: 8, Authorised, Last updated: 10/11/2022
works well enough and the doctor considers further courses … each further course. The doctor may delay doses or stop treatment … started and supervised by a doctor experienced in using cancer … -
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Human medicine European public assessment report (EPAR): Zolgensma (updated)
onasemnogene abeparvovec, Muscular Atrophy, Spinal
Date of authorisation: 18/05/2020,, , , Revision: 8, Authorised, Last updated: 14/11/2022
under the supervision of a doctor experienced in managing spinal … package leaflet or contact your doctor or pharmacist. How does Zolgensma … under the supervision of a doctor experienced in managing spinal … -
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Human medicine European public assessment report (EPAR): Waylivra (updated)
Volanesorsen sodium, Hyperlipoproteinemia Type I
Date of authorisation: 03/05/2019,, , , Revision: 6, Authorised, Last updated: 08/11/2022
should be supervised by a doctor who has experience in treating … package leaflet or contact your doctor or pharmacist. How does Waylivra … also been included in the A document describing the properties … -
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Human medicine European public assessment report (EPAR): Tegsedi (updated)
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): Lutathera
lutetium (177Lu) oxodotreotide, Neuroendocrine Tumors
Date of authorisation: 26/09/2017,, Revision: 8, Authorised, Last updated: 25/10/2022
a summary of the A set of documents describing the evaluation … leaflet or contact their doctor or pharmacist. What is Lutathera … until told to do so by the doctor. Before starting treatment … -
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Human medicine European public assessment report (EPAR): Scenesse (updated)
afamelanotide, Protoporphyria, Erythropoietic
Date of authorisation: 22/12/2014,, , 
, Revision: 9, Authorised, Last updated: 04/11/2022
a summary of the A set of documents describing the evaluation … leaflet or contact their doctor or pharmacist. What is Scenesse … prescribed by specialist doctors in recognised centres for … -
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Human medicine European public assessment report (EPAR): Imcivree (updated)
Setmelanotide, Obesity
Date of authorisation: 16/07/2021,, , Revision: 5, Authorised, Last updated: 22/11/2022
prescribed and supervised by a doctor with expertise in treating … have been included in the A document describing the properties … on 16 July 2021. Summary documents Imcivree : EPAR - Medicine … -
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Human medicine European public assessment report (EPAR): Vyndaqel (updated)
tafamidis, Amyloidosis
Date of authorisation: 16/11/2011,, , , Revision: 22, Authorised, Last updated: 11/11/2022
a summary of the A set of documents describing the evaluation … started and supervised by a doctor knowledgeable in the management … educational material to all doctors expected to prescribe Vyndaqel … -
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Human medicine European public assessment report (EPAR): Lamzede
velmanase alfa, alpha-Mannosidosis
Date of authorisation: 23/03/2018,, , , Revision: 5, Authorised, Last updated: 27/10/2022
should be supervised by a doctor experienced in treating alpha-mannosidosis … package leaflet or contact your doctor or pharmacist. How does Lamzede … have been included in the A document describing the properties … -
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Human medicine European public assessment report (EPAR): Ravicti
glycerol phenylbutyrate, Urea Cycle Disorders, Inborn
Date of authorisation: 26/11/2015,, Revision: 15, Authorised, Last updated: 20/10/2022
should be prescribed by a doctor who has experience in treating … package leaflet or contact your doctor or pharmacist. How does Ravicti … also been included in the A document describing the properties … -
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Human medicine European public assessment report (EPAR): Kaftrio (updated)
ivacaftor, tezacaftor, elexacaftor, Cystic Fibrosis
Date of authorisation: 21/08/2020,, , Revision: 10, Authorised, Last updated: 09/11/2022
ivacaftor work in the body The doctor may need to adjust the dose … package leaflet or contact your doctor or pharmacist. How does Kaftrio … ivacaftor work in the body The doctor may need to adjust the dose … -
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Human medicine European public assessment report (EPAR): Roctavian (updated)
valoctocogene roxaparvovec,
Date of authorisation: 24/08/2022,, , , Revision: 1, Authorised, Last updated: 09/11/2022
started under supervision of a doctor experienced in the treatment … package leaflet or contact your doctor or pharmacist. How does Roctavian … also been included in the A document describing the properties … -
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Human medicine European public assessment report (EPAR): Crysvita (updated)
Burosumab, Hypophosphatemia, Familial; Hypophosphatemic Rickets, X-Linked Dominant; Osteomalacia
Date of authorisation: 19/02/2018,, , Revision: 10, Authorised, Last updated: 08/11/2022
treatment should be started by a doctor experienced in the management … package leaflet or contact your doctor or pharmacist. How does Crysvita … treatment should be started by a doctor experienced in the management … -
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Human medicine European public assessment report (EPAR): Takhzyro
lanadelumab, Angioedemas, Hereditary
Date of authorisation: 22/11/2018,, , , Revision: 9, Authorised, Last updated: 17/10/2022
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): 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): 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,, , , Revision: 2, Authorised, Last updated: 18/10/2022
qualified treatment centre by a doctor with experience in the treatment … package leaflet or contact your doctor or pharmacist. How does Tecartus … also been included in the A document describing the properties … -
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Human medicine European public assessment report (EPAR): Raxone
idebenone, Optic Atrophy, Hereditary, Leber
Date of authorisation: 08/09/2015,, , , Revision: 8, Authorised, Last updated: 27/10/2022
a summary of the A set of documents describing the evaluation … leaflet or contact their doctor or pharmacist. What is Raxone … started and supervised by a doctor with experience in LHON … -
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Human medicine European public assessment report (EPAR): Hetlioz
tasimelteon, Sleep Disorders, Circadian Rhythm
Date of authorisation: 03/07/2015,, Revision: 9, Authorised, Last updated: 11/10/2022
a summary of the A set of documents describing the evaluation … leaflet or contact their doctor or pharmacist. What is Hetlioz … has been included in the A document describing the properties …