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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): Upstaza (updated)
Eladocagene exuparvovec, Amino Acid Metabolism, Inborn Errors
Date of authorisation: 18/07/2022,
, , 
, Authorised, Last updated: 10/08/2022
room under anaesthetic by a doctor who is experienced in brain … patient has a brain scan. The doctor will monitor recovery and … package leaflet or contact your doctor or pharmacist. How does Upstaza … -
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Human medicine European public assessment report (EPAR): Zejula (updated)
Niraparib (tosilate monohydrate), Fallopian Tube Neoplasms; Peritoneal Neoplasms; Ovarian Neoplasms
Date of authorisation: 16/11/2017,, , Revision: 18, Authorised, Last updated: 09/08/2022
patient benefits from it. The doctor may interrupt treatment or … started and supervised by a doctor who has experience in the … package leaflet or contact your doctor or pharmacist. How does Zejula … -
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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: 7, Authorised, Last updated: 27/07/2022
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): Cresemba (updated)
isavuconazole, Aspergillosis
Date of authorisation: 15/10/2015,, Revision: 14, Authorised, Last updated: 29/07/2022
a summary of the A set of documents describing the evaluation … leaflet or contact their doctor or pharmacist. What is Cresemba … has been included in the A document describing the properties … -
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Human medicine European public assessment report (EPAR): Cometriq (updated)
cabozantinib, Thyroid Neoplasms
Date of authorisation: 21/03/2014,, Revision: 25, Authorised, Last updated: 08/08/2022
a summary of the A set of documents describing the evaluation … leaflet or contact their doctor or pharmacist. What is Cometriq … should only be started by a doctor who has experience in using … -
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Human medicine European public assessment report (EPAR): Signifor (updated)
pasireotide, Acromegaly; Pituitary ACTH Hypersecretion
Date of authorisation: 24/04/2012,, Revision: 14, Authorised, Last updated: 09/08/2022
a summary of the A set of documents describing the evaluation … leaflet or contact their doctor or pharmacist. What is Signifor … leaflet or contact their doctor or pharmacist. What … -
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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): Sogroya (updated)
Somapacitan, Growth
Date of authorisation: 31/03/2021,, , Revision: 1, Authorised, Last updated: 01/08/2022
started and monitored by doctors who are qualified and experienced … package leaflet or contact your doctor or pharmacist. How does Sogroya … have been included in the A document describing the properties … -
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Human medicine European public assessment report (EPAR): Cablivi (updated)
Caplacizumab, Purpura, Thrombotic Thrombocytopenic
Date of authorisation: 30/08/2018,, , Revision: 6, Authorised, Last updated: 26/07/2022
started and supervised by doctors experienced in managing patients … package leaflet or contact your doctor or pharmacist. How does Cablivi … also been included in the A document describing the properties … -
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Human medicine European public assessment report (EPAR): Lutathera (updated)
lutetium (177Lu) oxodotreotide, Neuroendocrine Tumors
Date of authorisation: 26/09/2017,, Revision: 7, Authorised, Last updated: 14/07/2022
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): Kaftrio (updated)
ivacaftor, tezacaftor, elexacaftor, Cystic Fibrosis
Date of authorisation: 21/08/2020,, , Revision: 8, Authorised, Last updated: 09/08/2022
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): Kinpeygo (updated)
budesonide, Glomerulonephritis, IGA
Date of authorisation: 15/07/2022,, , 
, Authorised, Last updated: 18/07/2022
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): Strimvelis (updated)
autologous CD34+ enriched cell fraction that contains CD34+ cells transduced with retroviral vector that encodes for the human adenosine deaminase (ADA) cDNA sequence from human haematopoietic stem/progenitor (CD34+) cells, Severe Combined Immunodeficiency
Date of authorisation: 26/05/2016,, , Revision: 8, Authorised, Last updated: 01/08/2022
a summary of the A set of documents describing the evaluation … leaflet or contact their doctor or pharmacist. What is Strimvelis … specialist transplant centre by a doctor who has experience in the … -
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Human medicine European public assessment report (EPAR): Mylotarg (updated)
gemtuzumab ozogamicin, Leukemia, Myeloid, Acute
Date of authorisation: 19/04/2018,, , Revision: 10, Authorised, Last updated: 21/07/2022
package leaflet or contact your doctor or pharmacist. Mylotarg can … have been included in the A document describing the properties … on 19 April 2018. Summary documents Mylotarg : EPAR - Summary … -
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Human medicine European public assessment report (EPAR): Fintepla (updated)
Fenfluramine hydrochloride, Epilepsies, Myoclonic
Date of authorisation: 18/12/2020,, , Revision: 3, Authorised, Last updated: 26/07/2022
prevent misuse and to ensure doctors are informed about the need … started and supervised by a doctor experienced in the treatment … package leaflet or contact your doctor or pharmacist. How does Fintepla … -
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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: 6, Authorised, Last updated: 21/07/2022
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): Revestive (updated)
teduglutide, Malabsorption Syndromes
Date of authorisation: 30/08/2012,, , Revision: 20, Authorised, Last updated: 26/07/2022
a summary of the A set of documents describing the evaluation … leaflet or contact their doctor or pharmacist. What is Revestive … under the supervision of a doctor with experience in treating … -
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Human medicine European public assessment report (EPAR): Elzonris (updated)
tagraxofusp, Lymphoma
Date of authorisation: 07/01/2021,, , , Revision: 4, Authorised, Last updated: 29/07/2022
under the supervision of a doctor experienced in the use of … package leaflet or contact your doctor or pharmacist. How does Elzonris … also been included in the A document describing the properties … -
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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,, , , Revision: 6, Authorised, Last updated: 08/07/2022
started and monitored by a doctor experienced in managing multi-drug … package leaflet or contact your doctor or pharmacist. How does Pretomanid … -
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Human medicine European public assessment report (EPAR): Xermelo
telotristat etiprate, Carcinoid Tumor; Neuroendocrine Tumors
Date of authorisation: 17/09/2017,, Revision: 13, Authorised, Last updated: 01/07/2022
a summary of the A set of documents describing the evaluation … leaflet or contact their doctor or pharmacist. What is Xermelo … moderately reduced liver function. Doctors may consider stopping treatment … -
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Human medicine European public assessment report (EPAR): Yescarta (updated)
axicabtagene ciloleucel, Lymphoma, Follicular; Lymphoma, Large B-Cell, Diffuse
Date of authorisation: 23/08/2018,, , Revision: 8, Authorised, Last updated: 12/07/2022
package leaflet or contact your doctor or pharmacist. How does Yescarta … package leaflet or contact your doctor or pharmacist. How does … -
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Human medicine European public assessment report (EPAR): Xenpozyme (updated)
Olipudase alfa, Acid sphingomyelinase deficiency (ASMD) type A/B or type B
Date of authorisation: 24/06/2022,, , Authorised, Last updated: 27/07/2022
package leaflet or contact your doctor or pharmacist. How does Xenpozyme … also been included in the A document describing the properties … on 24 June 2022. Summary documents Xenpozyme : EPAR - Medicine … -
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Human medicine European public assessment report (EPAR): Filsuvez
dry extract from birch bark (DER 5-10 : 1), extraction solvent n-heptane 95% (w/w), Epidermolysis Bullosa Dystrophica; Epidermolysis Bullosa, Junctional
Date of authorisation: 21/06/2022,, Authorised, Last updated: 04/07/2022
package leaflet or contact your doctor, nurse or pharmacist. The … have been included in the A document describing the properties … on 21 June 2022. Summary documents Filsuvez : EPAR - Medicine … -
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Human medicine European public assessment report (EPAR): Rydapt
Midostaurin, Leukemia, Myeloid, Acute; Mastocytosis
Date of authorisation: 18/09/2017,, Revision: 8, Authorised, Last updated: 01/07/2022
leaflet or contact their doctor or pharmacist. Expand section … treatment should be started by a doctor experienced in the use of … severe side effects, the doctor may decide to reduce subsequent …