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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): Ocaliva (updated)
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): 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): 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): Namuscla
Mexiletine hydrochloride, Myotonic Disorders
Date of authorisation: 18/12/2018,, Revision: 4, Authorised, Last updated: 13/12/2022
package leaflet or contact your doctor or pharmacist. How does Namuscla … educational material for doctors and a ‘patient alert card’ … also been included in the A document describing the properties … -
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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): Opsumit
Macitentan, Hypertension, Pulmonary
Date of authorisation: 20/12/2013,, Revision: 21, Authorised, Last updated: 22/12/2022
started and monitored by a doctor experienced in treating PAH … package leaflet or contact your doctor or pharmacist. How does Opsumit … also been included in the A document describing the properties … -
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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 … -
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Human medicine European public assessment report (EPAR): Scemblix
asciminib hydrochloride, Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Date of authorisation: 25/08/2022,, , Revision: 1, Authorised, Last updated: 15/12/2022
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): Pyrukynd
mitapivat sulfate, Genetic Diseases, Inborn; Anemia, Hemolytic
Date of authorisation: 09/11/2022,, , Authorised, Last updated: 05/12/2022
package leaflet or contact your doctor or pharmacist. How does Pyrukynd … have been included in the A document describing the properties … 9 November 2022. Summary documents Pyrukynd - EPAR - Medicine … -
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Human medicine European public assessment report (EPAR): Tavneos
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): Qarziba (previously Dinutuximab beta EUSA and Dinutuximab beta Apeiron)
dinutuximab beta, Neuroblastoma
Date of authorisation: 08/05/2017,, , , Revision: 12, Authorised, Last updated: 14/12/2022
leaflet or contact their doctor or pharmacist. Expand section … patient’s weight and height. The doctor may need to reduce or delay … Treatment must be supervised by a doctor experienced in the treatment … -
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Human medicine European public assessment report (EPAR): Nyxthracis (previously Obiltoxaximab SFL)
nyxthracis, Anthrax
Date of authorisation: 18/11/2020,, , , Revision: 3, Authorised, Last updated: 15/12/2022
package leaflet or contact your doctor or pharmacist. How does Obiltoxaximab … have been included in the A document describing the properties … EU on 18.11.2020. Summary documents Obiltoxaximab SFL : EPAR … -
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Human medicine European public assessment report (EPAR): Gazyvaro
Obinutuzumab, Leukemia, Lymphocytic, Chronic, B-Cell
Date of authorisation: 22/07/2014,, , Revision: 14, Authorised, Last updated: 14/12/2022
supervision of an experienced doctor. As serious side effects including … package leaflet or contact your doctor or pharmacist. How does Gazyvaro … -
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Human medicine European public assessment report (EPAR): Vyvgart
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): Onivyde pegylated liposomal (previously known as Onivyde)
irinotecan anhydrous free-base, Pancreatic Neoplasms
Date of authorisation: 14/10/2016,, Revision: 11, Authorised, Last updated: 13/12/2022
prescribed and given by a doctor who has experience in the … fluorouracil and leucovorin. The doctor may reduce the dose in patients … package leaflet or contact your doctor or pharmacist. How does Onivyde … -
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Human medicine European public assessment report (EPAR): Enjaymo
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): Prevymis
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): Vyxeos liposomal (previously known as Vyxeos)
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): Mylotarg
gemtuzumab ozogamicin, Leukemia, Myeloid, Acute
Date of authorisation: 19/04/2018,, , Revision: 11, Authorised, Last updated: 14/12/2022
package leaflet or contact your doctor or pharmacist. Mylotarg can … package leaflet or contact your doctor or pharmacist. Mylotarg … -
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Human medicine European public assessment report (EPAR): Abecma
idecabtagene vicleucel, Multiple Myeloma; Neoplasms; Cancer; Neoplasms, Plasma Cell; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Infectious Mononucleosis; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases
Date of authorisation: 18/08/2021,, , , Revision: 5, Authorised, Last updated: 21/12/2022
package leaflet or contact your doctor or pharmacist. How does Abecma … package leaflet or contact your doctor or pharmacist. Abecma … -
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Human medicine European public assessment report (EPAR): Nexavar
sorafenib, Carcinoma, Hepatocellular; Carcinoma, Renal Cell
Date of authorisation: 19/07/2006,, Revision: 32, Authorised, Last updated: 06/12/2022
Nexavar should be supervised by doctors who have experience of anticancer … the EPAR) or contact your doctor or pharmacist. List item … Nexavar should be supervised by doctors who have experience of anticancer … -
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Human medicine European public assessment report (EPAR): Waylivra
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
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 …