This is a summary of the European public assessment report (EPAR) for Spinraza. 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 Spinraza.
For practical information about using Spinraza, patients should read the package leaflet or contact their doctor or pharmacist.
Spinraza : EPAR - Summary for the public (PDF/78.3 KB)
First published: 21/06/2017
Last updated: 11/01/2018
Spinraza : EPAR - Risk-management-plan summary (PDF/623.24 KB)
First published: 09/10/2019
|Agency product number||
|International non-proprietary name (INN) or common name||
|Therapeutic area (MeSH)||
Muscular Atrophy, Spinal
|Anatomical therapeutic chemical (ATC) code||
Biogen Netherlands B.V.
|Date of issue of marketing authorisation valid throughout the European Union||
23/08/2019 Spinraza - EMEA/H/C/004312 - PSUSA/00010595/201811
- 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.
Other nervous system drugs
Spinraza is indicated for the treatment of 5q Spinal Muscular Atrophy.