Spinraza

RSS

nusinersen

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

Overview

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.

This EPAR was last updated on 07/09/2018

Authorisation details

Product details
Name
Spinraza
Agency product number
EMEA/H/C/004312
Active substance
nusinersen sodium
International non-proprietary name (INN) or common name
nusinersen
Therapeutic area (MeSH)
Muscular Atrophy, Spinal
Anatomical therapeutic chemical (ATC) code
M09
Additional monitoring

This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring.

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
Biogen Idec Ltd
Revision
4
Date of issue of marketing authorisation valid throughout the European Union
29/05/2017
Contact address
Innovation House
70 Norden Road
Berkshire
Maidenhead
SL6 4AY
United Kigndom

Product information

30/08/2018 Spinraza - EMEA/H/C/004312 - II/0004

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

Other nervous system drugs

Therapeutic indication

Spinraza is indicated for the treatment of 5q Spinal Muscular Atrophy.

Assessment history

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