Source: European Medicines Agency (EU) Revision Year: 2026 Publisher: Roche Registration GmbH, Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Germany
Evrysdi 5 mg film-coated tablets.
| Pharmaceutical Form |
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Film-coated tablet (tablet). Pale yellow film-coated tablet, round and curved, approximately 6.5 mm in diameter, with EVR debossed on one side. |
Each film-coated tablet contains 5 mg of risdiplam.
For the full list of excipients, see section 6.1.
| Active Ingredient |
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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 |
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Tablet core: Tartaric acid (E334) Film-coat: Polyvinyl alcohol |
Evrysdi film-coated tablets are available in aluminium/aluminium perforated unit-dose blisters containing 7 film-coated tablets. Pack size of 28 x 1 film-coated tablets (4 blisters of 7 x 1 tablets).
Roche Registration GmbH, Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Germany
EU/1/21/1531/002
Date of first authorisation: 26 March 2021
Date of latest renewal: 08 January 2026
| 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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