Nplate
romiplostim
Table of contents
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.
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List item
Nplate : EPAR - Summary for the public (PDF/80.11 KB)
First published: 13/02/2009
Last updated: 01/06/2018 -
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Nplate : EPAR - Risk-management-plan summary (PDF/247.02 KB) (new)
First published: 03/02/2021
Authorisation details
Product details | |
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Name |
Nplate
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Agency product number |
EMEA/H/C/000942
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Active substance |
romiplostim
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International non-proprietary name (INN) or common name |
romiplostim
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Therapeutic area (MeSH) |
Purpura, Thrombocytopenic, Idiopathic
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Anatomical therapeutic chemical (ATC) code |
B02BX04
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Publication details | |
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Marketing-authorisation holder |
Amgen Europe B.V.
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Revision |
24
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Date of issue of marketing authorisation valid throughout the European Union |
04/02/2009
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Contact address |
Product information
22/01/2021 Nplate - EMEA/H/C/000942 - II/0077
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
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
News
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Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 7-10 December 202011/12/2020
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10/11/2017
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18/12/2015