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Irish Medicines Database · HPRA register

Spinraza 28 mg solution for injection

Authorisation EU/1/17/1188/002 · Biogen Netherlands B.V.

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Spinraza 28 mg solution for injection
Licence EU/1/17/1188/002 · Unknown
Licence holder
Biogen Netherlands B.V. (all products →)
Active substance
Nusinersen sodium
Dosage form
Solution for injection
Route of administration
Intrathecal use
ATC code
M09AX07
First authorised
09/01/2026
Prescription status
Product subject to prescription which may not be renewed (A)
Supply
Supply through pharmacies only
Legal basis
Full application (Article 8(3) of Directive No 2001/83/EC)

Data: Health Products Regulatory Authority (HPRA) open dataset, licensed CC BY 4.0, published 16 Sep 2026. This listing is regulatory information, not medical advice — consult the package leaflet, SPC, or a healthcare professional. For the authoritative record see the HPRA register.