This is a summary of the European public assessment report (EPAR) for Revolade. It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is not intended to provide practical advice on how to use Revolade.
For practical information about using Revolade, patients should read the package leaflet or contact their doctor or pharmacist.
Revolade : EPAR - Summary for the public (PDF/85.98 KB)
First published: 29/04/2010
Last updated: 23/08/2017
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||
06/07/2018 Revolade - EMEA/H/C/001110 - PSUSA/00001205/201709
- 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) (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) 25-28 January 201629/01/2016
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 14-17 December 201518/12/2015