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 23/11/2018

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
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
Amgen Europe B.V.
Revision
20
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

04/06/2018 Nplate - EMEA/H/C/000942 - IG/0946

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

Nplate is indicated for adult chronic-immune (idiopathic)-thrombocytopenic-purpura (ITP) patients who are refractory to other treatments (e.g. corticosteroids, immunoglobulins).

Assessment history

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