Register of
Medicinal Products

Product class: Medicinal product with marketing authorization
Medicinal product class: Human medicine
Name of medicinal product: EVRYSDI
Active substances:
Estonian, English, Latin
ATC code: M09AX10
Dosage form: powder for oral solution
Strength: 0,75mg 1ml
Legal status for supply*: Subject to medicinal prescription
Summary of product characteristics (SPC):
Package information leaflet (PIL): EST
Indication: Evrysdi is indicated for the treatment of 5q spinal muscular atrophy (SMA) in patients 2 months of age and older, with a clinical diagnosis of SMA Type 1, Type 2 or Type 3 or with one to four SMN2 copies.
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: Roche Registration GmbH 
Marketing authorization number: EU/1/21/1531 
Marketing authorization issued on: March 26, 2021 
Marketing authorization expires on: March 29, 2026 
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
1845446  EVRYSDI  powder for oral solution  0,75mg 1ml 80ml 1TK  Prescription  100%    31.03.2024     
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription

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