Nplate

RSS

romiplostim

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

Overview

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.

This EPAR was last updated on 17/10/2022

Authorisation details

Product details
Name
Nplate
Agency product number
EMEA/H/C/000942
Active substance
romiplostim
International non-proprietary name (INN) or common name
romiplostim
Therapeutic area (MeSH)
Purpura, Thrombocytopenic, Idiopathic
Anatomical therapeutic chemical (ATC) code
B02BX04
Publication details
Marketing-authorisation holder
Amgen Europe B.V.
Revision
26
Date of issue of marketing authorisation valid throughout the European Union
04/02/2009
Contact address

Minervum 7061
NL-4817 ZK Breda
The Netherlands

Product information

12/10/2022 Nplate - EMEA/H/C/000942 - N/0085

Other EU languages available icon 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:

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.

Pharmacotherapeutic group

Antihemorrhagics

Therapeutic indication

Adults:

Nplate is indicated for the treatment of primary immune thrombocytopenia  (ITP) in adult patients who are refractory to other treatments (e.g. corticosteroids, immunoglobulins).

Paediatrics:

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).

Assessment history

Changes since initial authorisation of medicine

Related content

How useful was this page?

Add your rating
Average
3 ratings