This is a summary of the European public assessment report (EPAR) for Nplate. 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 Nplate.
For practical information about using Nplate, patients should read the package leaflet or contact their doctor or pharmacist.
Nplate : EPAR - Summary for the public (PDF/80.11 KB)
First published: 13/02/2009
Last updated: 01/06/2018
Nplate : EPAR - Risk-management-plan summary (PDF/247.02 KB) (new)
First published: 03/02/2021
|Agency product number||
|International non-proprietary name (INN) or common name||
|Therapeutic area (MeSH)||
Purpura, Thrombocytopenic, Idiopathic
|Anatomical therapeutic chemical (ATC) code||
Amgen Europe B.V.
|Date of issue of marketing authorisation valid throughout the European Union||
22/01/2021 Nplate - EMEA/H/C/000942 - II/0077
- 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.
Nplate is indicated for the treatment of primary immune thrombocytopenia (ITP) in adult patients who are refractory to other treatments (e.g. corticosteroids, immunoglobulins).
Nplate is indicated for the treatment of chronic primary immune thrombocytopenia (ITP) in paediatric patients one year of age and older who are refractory to other treatments (e.g. corticosteroids, immunoglobulins).