Register of
Medicinal Products

Product class: Medicinal product with marketing authorization
Medicinal product class: Human medicine
Name of medicinal product: ZOLGENSMA
Active substances:
Onasemnogene abeparvovec
Estonian, English, Latin
ATC code: M09AX09
Dosage form: solution for infusion
Strength:  
Legal status for supply*: Subject to medicinal prescription
Summary of product characteristics (SPC):
Package information leaflet (PIL): EST
Labelling:  
Indication: Zolgensma is indicated for the treatment of: - patients with 5q spinal muscular atrophy (SMA) with a bi-allelic mutation in the SMN1 gene and a clinical diagnosis of SMA Type 1, or - patients with 5q SMA with a bi-allelic mutation in the SMN1 gene and up to 3 copies of the SMN2 gene
Safety features: Yes
: This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Patients and healthcare professionals are asked to report any suspected adverse reactions to State Agency of Medicines.State Agency of Medicines
Marketing authorization holder: Novartis Europharm Limited 
Marketing authorization number: EU/1/20/1443 
Marketing authorization issued on: May 18, 2020 
Marketing authorization expires on: May 17, 2027 
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
1818749  ZOLGENSMA  solution for infusion  5.5ml 1TK  Prescription           
1818750  ZOLGENSMA  solution for infusion  8.3ml 1TK  Prescription           
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription

You can download Acrobat Reader fromhere