Revolade

RSS

eltrombopag

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

Overview

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.

This EPAR was last updated on 20/07/2018

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
Orphan

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
21
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

06/07/2018 Revolade - EMEA/H/C/001110 - PSUSA/00001205/201709

Contents

  • 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.

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) (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).

Assessment history

Changes since initial authorisation of medicine

  • List item

    Revolade-H-C-PSUSA-00001205-201709 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation (PDF/70.77 KB)


    First published: 20/07/2018
    Last updated: 20/07/2018
    EMA/496004/2018

  • List item

    Revolade-H-C-1110-P46-028 : EPAR - Assessment Report (PDF/489.36 KB)

    Adopted

    First published: 26/04/2018
    Last updated: 26/04/2018
    EMA/125720/2018

  • List item

    Revolade-H-C-PSUSA-00001205-201609 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation (PDF/65.45 KB)


    First published: 23/08/2017
    Last updated: 23/08/2017
    EMA/481010/2017

  • List item

    Revolade-H-C-1110-X-0022-G : EPAR - Assessment Report - Extension (PDF/6.41 MB)

    Adopted

    First published: 20/04/2016
    Last updated: 20/04/2016
    EMA/CHMP/722220/2015

  • List item

    Revolade-H-C-1110-II-0023 : EPAR - Assessment Report - Variation (PDF/3.33 MB)

    Adopted

    First published: 07/04/2016
    Last updated: 07/04/2016
    EMA/CHMP/38474/2016

  • List item

    CHMP post-authorisation summary of positive opinion for Revolade (PDF/69.18 KB)

    Adopted

    First published: 18/12/2015
    Last updated: 18/12/2015
    EMA/CHMP/671604/2015

  • List item

    Revolade-H-C-1110-II-0020 : EPAR - Assessment Report - Variation (PDF/2.31 MB)

    Adopted

    First published: 05/11/2015
    Last updated: 05/11/2015
    EMA/CHMP/598426/2015

  • List item

    CHMP post-authorisation summary of positive opinion for Revolade (PDF/68.47 KB)

    Adopted

    First published: 24/07/2015
    Last updated: 24/07/2015
    EMA/CHMP/371721/2015

  • List item

    Revolade-H-C-1110-X-0012-G : EPAR - Assessment Report - Extension (PDF/2.2 MB)

    Adopted

    First published: 15/10/2013
    Last updated: 15/10/2013
    EMA/491212/2013

  • List item

    CHMP post-authorisation summary of positive opinion for Revolade (PDF/61.65 KB)

    Adopted

    First published: 26/07/2013
    Last updated: 26/07/2013
    EMA/CHMP/467044/2013

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