Register of
Medicinal Products

Product class: Authorized package
Medicinal product class: For human use
Package code: 1746536
Name of medicinal product: SPINRAZA
Active substances:
Nusinersen
Estonian, English, Latin
ATC code: M09AX07
Dosage form: solution for injection
Route of administration: intrathecal use
Strengh: 2,4mg 1ml
Amount in package: 5ml 1TK
Legal status for supply*: Subject to medicinal prescription
Class of active substance:  
Additional information:  
Indication: Spinraza is indicated for the treatment of 5q Spinal Muscular Atrophy.
Safety features: Yes
Summary of product characteristics (SPC):
Package information leaflet (PIL): EST
Labelling:  
Last imported to Estonia: Never imported to Estonia
Marketing authorization holder: Biogen Netherlands B.V. 
Marketing authorization number: EU/1/17/1188 
Marketing authorization issued on: May 30, 2017 
Marketing authorization expires on: Unlimited 
Marketing authorization procedure type: Centralised 
Reference price:   
Under reference price:   
Reference price of daily dose:   
Entry/Changing date: March 1, 2022
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription

You can download Acrobat Reader fromhere