Register of
Medicinal Products

Product class: Medicinal product with marketing authorization
Medicinal product class: Human medicine
Name of medicinal product: SPINRAZA
Active substances:
Nusinersen
Estonian, English, Latin
ATC code: M09AX07
Dosage form: solution for injection
Strength: 2,4mg 1ml
Legal status for supply*: Subject to medicinal prescription
Summary of product characteristics (SPC):
Package information leaflet (PIL): EST
Labelling:  
Indication: Spinraza is indicated for the treatment of 5q Spinal Muscular Atrophy.
Safety features: Yes
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 
Assessment report:   
Package code Name of medicinal product Dosage form Package Legal status Reimbursements Reference price Last imported PƤritolumaa Additional information
1746536  SPINRAZA  solution for injection  2,4mg 1ml 5ml 1TK  Prescription           
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription

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