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Human medicine European public assessment report (EPAR): Ninlaro
ixazomib citrate, Multiple Myeloma
Date of authorisation: 21/11/2016,
, 
, 
, Revision: 15, Authorised, Last updated: 01/02/2023
a summary of the A set of documents describing the evaluation … leaflet or contact their doctor or pharmacist. What is Ninlaro … started and monitored by a doctor experienced in the management … -
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Human medicine European public assessment report (EPAR): Zejula
Niraparib (tosilate monohydrate), Fallopian Tube Neoplasms; Peritoneal Neoplasms; Ovarian Neoplasms
Date of authorisation: 16/11/2017,, , Revision: 19, Authorised, Last updated: 13/02/2023
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): Trepulmix
Treprostinil sodium, Hypertension, Pulmonary
Date of authorisation: 03/04/2020,, Revision: 3, Authorised, Last updated: 23/01/2023
package leaflet or contact your doctor or pharmacist. How does Trepulmix … have been included in the A document describing the properties … on 3 April 2020. Summary documents Trepulmix : EPAR - Medicine … -
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Human medicine European public assessment report (EPAR): Alofisel
darvadstrocel, Rectal Fistula
Date of authorisation: 23/03/2018,, , Revision: 9, Authorised, Last updated: 12/01/2023
a summary of the A set of documents describing the evaluation … leaflet or contact their doctor or pharmacist. What is Alofisel … given only by specialist doctors experienced in the diagnosis … -
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Human medicine European public assessment report (EPAR): Natpar
parathyroid hormone, Hypoparathyroidism
Date of authorisation: 24/04/2017,, , , Revision: 14, Authorised, Last updated: 22/02/2023
leaflet or contact their doctor or pharmacist. Expand section … the EPAR) or contact your doctor or pharmacist. List item … professionals can 1 This document was updated in October 2022 … -
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Human medicine European public assessment report (EPAR): Defitelio
defibrotide, Hepatic Veno-Occlusive Disease
Date of authorisation: 18/10/2013,, , 
, Revision: 14, Authorised, Last updated: 09/02/2023
prescribed and given by a doctor experienced in the management … package leaflet or contact your doctor or pharmacist. How does Defitelio … have been included in the A document describing the properties … -
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Human medicine European public assessment report (EPAR): Idefirix
Imlifidase, Desensitization, Immunologic; Kidney Transplantation
Date of authorisation: 25/08/2020,, , , Revision: 3, Authorised, Last updated: 16/01/2023
prescribed and supervised by a doctor experienced in the use of … package leaflet or contact your doctor or pharmacist. How does Idefirix … also been included in the A document describing the properties … -
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Human medicine European public assessment report (EPAR): Orphacol
cholic acid, Digestive System Diseases; Metabolism, Inborn Errors
Date of authorisation: 12/09/2013,
Date of refusal: 25/05/2012,, , , Revision: 12, Authorised, Last updated: 16/01/2023
a summary of the A set of documents describing the evaluation … leaflet or contact their doctor or pharmacist. What is Orphacol … started and supervised by a doctor specialised in liver disease … -
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Human medicine European public assessment report (EPAR): Amvuttra
vutrisiran sodium, Amyloid Neuropathies, Familial
Date of authorisation: 15/09/2022,, , Revision: 1, Authorised, Last updated: 10/01/2023
started and supervised by a doctor experienced in the treatment … stage 3 polyneuropathy, the doctor may continue treatment if … package leaflet or contact your doctor or pharmacist. How does Amvuttra … -
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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 (brexucabtagene autoleucel), Lymphoma, Mantle-Cell
Date of authorisation: 14/12/2020,, , , Revision: 4, Authorised, Last updated: 30/01/2023
given to patients by trained doctors in specialist hospitals … package leaflet or contact your doctor or pharmacist. How does Tecartus … given to patients by trained doctors in specialist hospitals … -
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Human medicine European public assessment report (EPAR): Adakveo
Crizanlizumab, Anemia, Sickle Cell
Date of authorisation: 28/10/2020,, , , Revision: 3, Authorised, Last updated: 10/01/2023
Treatment should be started by a doctor experienced in treating sickle … package leaflet or contact your doctor or pharmacist. How does Adakveo … have been included in the A document describing the properties … -
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Human medicine European public assessment report (EPAR): Koselugo
Selumetinib sulfate, Neurofibromatosis 1
Date of authorisation: 17/06/2021,, , , Revision: 4, Authorised, Last updated: 16/01/2023
Treatment should be started by a doctor experienced in the diagnosis … treatment with Koselugo, the doctor will check how well the patient’s … effects are tolerable. The doctor may reduce the dose or stop … -
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Human medicine European public assessment report (EPAR): Yescarta
axicabtagene ciloleucel, Lymphoma, Follicular; Lymphoma, Large B-Cell, Diffuse
Date of authorisation: 23/08/2018,, , Revision: 11, Authorised, Last updated: 30/01/2023
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): Kaftrio
ivacaftor, tezacaftor, elexacaftor, Cystic Fibrosis
Date of authorisation: 21/08/2020,, , Revision: 11, Authorised, Last updated: 16/01/2023
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): Cresemba
isavuconazole, Aspergillosis
Date of authorisation: 15/10/2015,, Revision: 15, Authorised, Last updated: 17/01/2023
leaflet or contact their doctor or pharmacist. Expand section … the EPAR) or contact your doctor or pharmacist. List item … leaflet or contact their doctor or pharmacist. What … -
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Human medicine European public assessment report (EPAR): Hepcludex
Bulevirtide acetate, Hepatitis D, Chronic
Date of authorisation: 31/07/2020,, , , Revision: 8, Authorised, Last updated: 22/12/2022
should be started only by a doctor experienced in the management … package leaflet or contact your doctor or pharmacist. How does Hepcludex … have been included in the A document describing the properties … -
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Human medicine European public assessment report (EPAR): Amglidia
glibenclamide, Diabetes Mellitus
Date of authorisation: 24/05/2018,, Revision: 5, Authorised, Last updated: 16/02/2023
package leaflet or contact your doctor or pharmacist. How does Amglidia … prescribing the medicine, the doctor will also specify the strength … Amglidia as advised by the doctor. Parents and carers should … -
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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: 15, Authorised, Last updated: 12/12/2022
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): Trecondi
Treosulfan, Hematopoietic Stem Cell Transplantation
Date of authorisation: 20/06/2019,, Revision: 3, Authorised, Last updated: 25/01/2023
Trecondi must be supervised by a doctor experienced in conditioning … package leaflet or contact your doctor or pharmacist. How does Trecondi … -
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Human medicine European public assessment report (EPAR): Ngenla
somatrogon, Growth and Development
Date of authorisation: 14/02/2022,, , Revision: 4, Authorised, Last updated: 06/12/2022
started and monitored by a doctor experienced in the management … each week, adjusted by the doctor if necessary. For patients … package leaflet or contact your doctor or pharmacist. How does Ngenla … -
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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): 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): Ocaliva
Obeticholic acid, Liver Cirrhosis, Biliary
Date of authorisation: 12/12/2016,, , , Revision: 15, Authorised, Last updated: 04/01/2023
package leaflet or contact your doctor or pharmacist. How does Ocaliva … have been included in the A document describing the properties … 12 December 2016. Summary documents Ocaliva : EPAR - Summary … -
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Human medicine European public assessment report (EPAR): Carvykti
ciltacabtagene autoleucel, Multiple Myeloma
Date of authorisation: 25/05/2022,, , , Revision: 1, Authorised, Last updated: 17/01/2023
patients only by trained doctors in specialist hospitals … package leaflet or contact your doctor or pharmacist. How does Carvykti … patients only by trained doctors in specialist hospitals … -
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Human medicine European public assessment report (EPAR): Livmarli
Maralixibat chloride, Alagille Syndrome
Date of authorisation: 09/12/2022,, , , Authorised, Last updated: 14/12/2022
started and supervised by a doctor experienced in treating liver … with a low dose which the doctor will increase after one week … improvement after 3 months the doctor should consider an alternative …