Revolade

RSS

eltrombopag

Authorised
This medicine is authorised for use in the European Union.

Overview

Revolade is a medicine that is used for the treatment of:

  • primary immune thrombocytopenia (ITP), a disease in which the patient’s immune system destroys platelets (components in the blood that help it to clot). Patients with ITP have low platelet counts in the blood (thrombocytopenia) and are at risk of bleeding. Revolade is used in patients from 1 year of age who have had the disease for at least 6 months and for whom treatment with medicines such as corticosteroids or immunoglobulins has not worked;

  • thrombocytopenia in adults with chronic (long-term) hepatitis C, a liver disease caused by the hepatitis C virus. Revolade is used when the thrombocytopenia is too severe to allow interferon-based therapy (type of treatment for hepatitis C );

  • acquired severe aplastic anaemia (a disease in which the bone marrow does not make enough blood cells or platelets). Revolade is used in adult patients whose disease is not controlled by immunosuppressive therapy (medicines that lower the body’s immune defences) and cannot receive haematopoietic stem cell transplantation (where the patient's bone marrow is replaced by stem cells from a donor to form new bone marrow).

Revolade contains the active substance eltrombopag.

This EPAR was last updated on 28/05/2019

Authorisation details

Product details
Name
Revolade
Agency product number
EMEA/H/C/001110
Active substance
Eltrombopag olamine
International non-proprietary name (INN) or common name
eltrombopag
Therapeutic area (MeSH)
Purpura, Thrombocytopenic, Idiopathic
Anatomical therapeutic chemical (ATC) code
B02BX05
OrphanOrphan

This medicine was designated an orphan medicine. This means that it was developed for use against a rare, life-threatening or chronically debilitating condition or, for economic reasons, it would be unlikely to have been developed without incentives. For more information, see Orphan designation.

Publication details
Marketing-authorisation holder
Novartis Europharm Limited
Revision
23
Date of issue of marketing authorisation valid throughout the European Union
11/03/2010
Contact address

Vista Building
Elm Park, Merrion Road
Dublin 4
Ireland

Product information

06/02/2019 Revolade - EMEA/H/C/001110 - II/0050

Contents

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Pharmacotherapeutic group

Antihaemorrhagics

Therapeutic indication

Revolade is indicated for chronic immune (idiopathic) thrombocytopenic purpura (ITP) patients aged 1 year and above who are refractory to other treatments (e.g. corticosteroids, immunoglobulins).

Revolade is indicated in adult patients with chronic hepatitis C virus (HCV) infection for the treatment of thrombocytopenia, where the degree of thrombocytopenia is the main factor preventing the initiation or limiting the ability to maintain optimal interferon-based therapy.

Revolade is indicated in adult patients with acquired severe aplastic anaemia (SAA) who were either refractory to prior immunosuppressive therapy or heavily pretreated and are unsuitable for haematopoietic stem cell transplantation.

Assessment history

Changes since initial authorisation of medicine

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