Spinraza 12 mg raztopina za injiciranje
Nusinersen
General information
Drug nameSpinraza 12 mg raztopina za injiciranje
Medicine nameNusinersen
National drug code3005919
PMS ID—
SNOMED descriptive name code—
Legal statusZdravilo z dovoljenjem za promet
Drug groupChemical Medicinal Product
OriginatorYes
Orphan drugNo
Marketing authorization
Procedure typePotrditev podatkov za CP zdravila (modro okence)
No. and date of decision/certificate1024-38/2017-2, 29. 6. 2017
Authorization validity dateUntil further notice
Marketing end date—
Application type—
Authorization/certificate holderBiogen Netherlands B.V.
Drug safety monitoring
Additional safety monitoringNo
Precautionary measure/dispensing restrictions—
Pregnancy prevention programmeNo
Controlled access programme(s)No
ATC codes
Route of administration
Route of administration name
Intratekalna uporaba
Settlement data for compulsory health insurance billing
Substitute medicine
Preparation—
Valid from – to—
Clinical use data
Methods of use—
Indications—
Rounding factor—
DivisibleNo
Division for easier swallowingNo
Division for dosage adjustmentNo
Paediatric populationNo
Shortage actions
Substitute medicine in case of shortage - industrial medicine—
Substitute medicine in case of shortage - magistral or galenic medicine—
Prescribing restriction in case of drug shortageNo
Dispensing restriction in case of shortage or emergencyNo
Dispensing restriction for foreign prescriptions in case of shortage or emergencyNo
Export restrictionNo
Drug status
The medicinal product is present in wholesale distribution.
Last drug update date:9. 7. 2026