Table of contents
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||
This medicine had an accelerated assessment. This means that it is a medicine of major interest for public health, so its timeframe for review was 150 evaluation days rather than 210. For more information, see Accelerated assessment.
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.
Biogen Netherlands B.V.
|Date of issue of marketing authorisation valid throughout the European Union||
Prins Mauritslaan 13
31/01/2022 Spinraza - EMEA/H/C/004312 - R/0025
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.
Other nervous system drugs
Spinraza is indicated for the treatment of 5q Spinal Muscular Atrophy.