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 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.
Revolade : EPAR - Medicine overview (PDF/84.14 KB) (updated)
First published: 29/04/2010
Last updated: 16/05/2019
Revolade : EPAR - Risk-management-plan summary (PDF/132.48 KB)
First published: 20/07/2018
Last updated: 20/07/2018
|Agency product number||
|International non-proprietary name (INN) or common name||
|Therapeutic area (MeSH)||
Purpura, Thrombocytopenic, Idiopathic
|Anatomical therapeutic chemical (ATC) code||
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.
Novartis Europharm Limited
|Date of issue of marketing authorisation valid throughout the European Union||
06/02/2019 Revolade - EMEA/H/C/001110 - II/0050
- Annex I - Summary of product characteristics
- Annex IIA - Manufacturing-authorisation holder responsible for batch release
- Annex IIB - Conditions of the marketing authorisation
- Annex IIIA - Labelling
- Annex IIIB - Package leaflet
Please note that the size of the above document can exceed 50 pages.
You are therefore advised to be selective about which sections or pages you wish to print.
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.
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 25-28 January 201629/01/2016
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 14-17 December 201518/12/2015