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)
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||
12/10/2022 Nplate - EMEA/H/C/000942 - N/0085
This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.
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.
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).