Basic Information
Spinraza
Regulatory Information
EMEA/H/C/004312
Authorised
May 30, 2017
April 21, 2017
18
February 27, 2025
Company Information
the netherlands
Prins Mauritslaan 13 1171 LP Badhoevedorp
Biogen Netherlands BV
Drug Classification
Orphan MedicineAccelerated Assessment
Active Substances Detail
EMA Resources
Detailed Information
Therapeutic Indication
### Therapeutic indication Spinraza is indicated for the treatment of 5q Spinal Muscular Atrophy.
Overview Summary
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.