Table of contents
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 for whom treatment with medicines such as corticosteroids or immunoglobulins has not worked. In children and adolescents, the medicine is used when they have had the disease for at least 6 months;
- 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 (a 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/149.57 KB)
First published: 29/04/2010
Last updated: 04/11/2022
Revolade : EPAR - Risk Management Plan (PDF/1.09 MB) (updated)
First published: 20/07/2018
Last updated: 16/05/2023
|Agency product number||
|International non-proprietary name (INN) or common name||
|Therapeutic area (MeSH)||
Purpura, Thrombocytopenic, Idiopathic
|Anatomical therapeutic chemical (ATC) code||
Novartis Europharm Limited
|Date of issue of marketing authorisation valid throughout the European Union||
14/10/2022 Revolade - EMEA/H/C/001110 - II/0068
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Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.
Other systemic hemostatics
Revolade is indicated for the treatment of adult patients with primary immune thrombocytopenia (ITP) who are refractory to other treatments (e.g. corticosteroids, immunoglobulins) (see sections 4.2 and 5.1).
Revolade is indicated for the treatment of paediatric patients aged 1 year and above with primary immune thrombocytopenia (ITP) lasting 6 months or longer from diagnosis and who are refractory to other treatments (e.g. corticosteroids, immunoglobulins) (see sections 4.2 and 5.1).
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 (see sections 4.4 and 5.1).
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 (see section 5.1).
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 12-15 September 202216/09/2022
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 14-17 October 201918/10/2019
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