Source: European Medicines Agency (EU) Revision Year: 2024 Publisher: Roche Registration GmbH, Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Germany
Evrysdi 0.75 mg/mL powder for oral solution.
| Pharmaceutical Form |
|---|
|
Powder for oral solution. Light yellow, yellow, greyish yellow, greenish yellow, or light green powder. |
Each bottle contains 60 mg risdiplam in 2 g powder for oral solution.
Each mL of the constituted solution contains 0.75 mg risdiplam.
Excipients with known effects:
Each mL contains 0.38 mg of sodium benzoate (E211) and 2.97 mg of isomalt (E953).
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Risdiplam |
Risdiplam is a survival of motor neuron 2 (SMN2) pre-mRNA splicing modifier designed to treat SMA caused by mutations of the SMN1 gene in chromosome 5q that lead to SMN protein deficiency. Functional SMN protein deficiency is directly linked to the SMA pathophysiology which includes progressive loss of motor neurons and muscle weakness. Risdiplam treats SMA by increasing and sustaining functional SMN protein levels. |
| List of Excipients |
|---|
|
Mannitol (E421) |
Amber type III glass bottle with a tamper-evident child resistant screw cap.
Each carton contains; one bottle, 1 press-in bottle adaptor, two re-usable 1 mL, two re-usable 6 mL and one re-usable 12 mL graduated amber oral syringes.
Roche Registration GmbH, Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Germany
EU/1/21/1531/001
Date of first authorisation: 26 March 2021
| Drug | Countries | |
|---|---|---|
| EVRYSDI | Brazil, Ecuador, Estonia, Spain, Finland, Hong Kong, Croatia, Ireland, Israel, Japan, Lithuania, New Zealand, Poland, Romania, United Kingdom, United States |
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