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Human medicine European public assessment report (EPAR): Kinpeygo
budesonide, micronised, Glomerulonephritis, IGA
Date of authorisation: 15/07/2022,
, 
, 
, Revision: 5, Authorised, Last updated: 21/08/2023
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: 27/06/2022treatment 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): Tevimbra (updated)
Tislelizumab, Esophageal Squamous Cell Carcinoma
Date of authorisation: 15/09/2023,, , Authorised, Last updated: 02/10/2023
started and supervised by a doctor experienced in treating cancer … the disease gets worse. The doctor may delay doses if certain … package leaflet or contact your doctor or pharmacist. How does Tevimbra … -
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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: 10, Authorised, Last updated: 22/09/2023
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): Hepcludex (updated)
Bulevirtide acetate, Hepatitis D, Chronic
Date of authorisation: 31/07/2020,, , Revision: 11, Authorised, Last updated: 28/09/2023
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): Scemblix (updated)
asciminib hydrochloride, Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Date of authorisation: 25/08/2022,, , Revision: 3, Authorised, Last updated: 22/09/2023
treatment must be started by a doctor who is experienced in the … by mouth twice a day. The doctor may interrupt treatment and … package leaflet or contact your doctor or pharmacist. How does Scemblix … -
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Human medicine European public assessment report (EPAR): Trepulmix (updated)
Treprostinil sodium, Hypertension, Pulmonary
Date of authorisation: 03/04/2020,, Revision: 4, Authorised, Last updated: 27/09/2023
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): Amglidia (updated)
glibenclamide, Diabetes Mellitus
Date of authorisation: 24/05/2018,, Revision: 7, Authorised, Last updated: 25/09/2023
package leaflet or contact your doctor or pharmacist. How does Amglidia … also been included in the A document describing the properties … EU on 24.05.2018. Summary documents Amglidia : EPAR - Medicine … -
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Human medicine European public assessment report (EPAR): Hyftor (updated)
Sirolimus, Angiofibroma; Tuberous Sclerosis
Date of authorisation: 15/05/2023,, Revision: 2, Authorised, Last updated: 25/09/2023
package leaflet or contact your doctor or pharmacist. How does Hyftor … package leaflet or contact your doctor or pharmacist. How does … -
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Human medicine European public assessment report (EPAR): SomaKit TOC (updated)
edotreotide, Neuroendocrine Tumors; Radionuclide Imaging
Date of authorisation: 08/12/2016,, Revision: 15, Authorised, Last updated: 29/09/2023
a summary of the A set of documents describing the evaluation … leaflet or contact their doctor or pharmacist. What is SomaKit … have been included in the A document describing the properties … -
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Human medicine European public assessment report (EPAR): Ledaga (updated)
Chlormethine, Mycosis Fungoides
Date of authorisation: 03/03/2017,, Revision: 9, Authorised, Last updated: 11/09/2023
a summary of the A set of documents describing the evaluation … leaflet or contact their doctor or pharmacist. What is Ledaga … Ledaga should be started by a doctor with appropriate experience … -
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Human medicine European public assessment report (EPAR): Vyndaqel (updated)
tafamidis, Amyloidosis
Date of authorisation: 16/11/2011,, , 
, Revision: 27, Authorised, Last updated: 22/09/2023
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): Talvey (updated)
talquetamab, Multiple Myeloma
Date of authorisation: 21/08/2023,, , , Authorised, Last updated: 21/09/2023
started and monitored by a doctor experienced in the management … cytokine release syndrome. Doctors should monitor patients for … the first 3 or 4 doses. The doctor may delay doses if certain … -
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Human medicine European public assessment report (EPAR): Pemazyre (updated)
pemigatinib, Cholangiocarcinoma
Date of authorisation: 26/03/2021,, , , Revision: 6, Authorised, Last updated: 12/09/2023
treatment must be started by a doctor experienced in diagnosis … package leaflet or contact your doctor or pharmacist. How does Pemazyre … have been included in the A document describing the properties … -
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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: 9, Authorised, Last updated: 19/09/2023
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): Mepsevii (updated)
vestronidase alfa, Mucopolysaccharidosis VII
Date of authorisation: 23/08/2018,, , , Revision: 7, Authorised, Last updated: 14/09/2023
package leaflet or contact your doctor or pharmacist. How does Mepsevii … have been included in the A document describing the properties … on 23 August 2018. Summary documents Mepsevii : EPAR - Medicine … -
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Human medicine European public assessment report (EPAR): Chenodeoxycholic acid Leadiant (previously known as Chenodeoxycholic acid sigma-tau) (updated)
Chenodeoxycholic acid, Xanthomatosis, Cerebrotendinous; Metabolism, Inborn Errors
Date of authorisation: 10/04/2017,, , , Revision: 6, Authorised, Last updated: 18/09/2023
a summary of the A set of documents describing the evaluation … leaflet or contact their doctor or pharmacist. What is Chenodeoxycholic … started and supervised by a doctor experienced in treating cerebrotendinous … -
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Human medicine European public assessment report (EPAR): Poteligeo (updated)
Mogamulizumab, Sezary Syndrome; Mycosis Fungoides
Date of authorisation: 22/11/2018,, Revision: 6, Authorised, Last updated: 06/09/2023
should be supervised by a doctor who has experience in the … treatment with Poteligeo. The doctor may interrupt or stop treatment … package leaflet or contact your doctor or pharmacist. How does Poteligeo … -
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Human medicine European public assessment report (EPAR): Voxzogo (updated)
Vosoritide, Achondroplasia
Date of authorisation: 26/08/2021,, , Revision: 3, Authorised, Last updated: 06/09/2023
package leaflet or contact your doctor or pharmacist. How does Voxzogo … package leaflet or contact your doctor or pharmacist. How does … -
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Human medicine European public assessment report (EPAR): Qinlock
ripretinib, Gastrointestinal Stromal Tumors
Date of authorisation: 18/11/2021,, , Revision: 5, Authorised, Last updated: 30/08/2023
Treatment should be started by a doctor experienced in the treatment … package leaflet or contact your doctor or pharmacist. How does Qinlock … have been included in the A document describing the properties … -
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Human medicine European public assessment report (EPAR): Ninlaro (updated)
ixazomib citrate, Multiple Myeloma
Date of authorisation: 21/11/2016,, , , Revision: 16, Authorised, Last updated: 05/09/2023
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): Roctavian (updated)
valoctocogene roxaparvovec,
Date of authorisation: 24/08/2022,, , , Revision: 3, Authorised, Last updated: 12/09/2023
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): Natpar (updated)
parathyroid hormone, Hypoparathyroidism
Date of authorisation: 24/04/2017,, , , Revision: 16, Authorised, Last updated: 08/09/2023
a summary of the A set of documents describing the evaluation … leaflet or contact their doctor or pharmacist. What is Natpar … also been included in the A document describing the properties … -
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Human medicine European public assessment report (EPAR): Fintepla
Fenfluramine hydrochloride, Epilepsies, Myoclonic
Date of authorisation: 18/12/2020,, , Revision: 6, Authorised, Last updated: 01/09/2023
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): Artesunate Amivas
artesunate, Malaria
Date of authorisation: 22/11/2021,, , Revision: 2, Authorised, Last updated: 23/08/2023
after consultation with a doctor experienced in the management … package leaflet or contact your doctor or pharmacist. How does Artesunate … have been included in the A document describing the properties …