Register of
Medicinal Products

Product class: Authorized package
Medicinal product class: For human use
Package code: 1818750
Name of medicinal product: ZOLGENSMA
Active substances:
Onasemnogene abeparvovec
Estonian, English, Latin
ATC code: M09AX09
Dosage form: solution for infusion
Route of administration: intravenous use
Strengh:  
Amount in package: 8.3ml 1TK
Legal status for supply*: Subject to medicinal prescription
Class of active substance:  
Additional information:  
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
Summary of product characteristics (SPC):
Package information leaflet (PIL): EST
Labelling:  
Last imported to Estonia: Never imported to Estonia
: 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 
Reference price:   
Under reference price:   
Reference price of daily dose:   
Entry/Changing date: April 10, 2023
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription

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