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risdiplam

Evrysdi · ATC code M09AX10

Key facts
Active substance
risdiplam
ATC code
M09AX10
Authorisation
centrally authorised across the EU (EMA)
Dosage forms
Evrysdi 0.75 mg/mL powder for oral solution · Evrysdi 5 mg film-coated tablets
Marketing authorisation holder
Roche Registration GmbH
Information as of
2026-10-27

Key facts

Risdiplam (Evrysdi) is an oral medicine for 5q spinal muscular atrophy (SMA), available as an oral solution and as film-coated tablets.

What it is used for

  • 5q spinal muscular atrophy in patients with a clinical diagnosis of SMA Type 1, Type 2 or Type 3 or with one to four SMN2 copies

Dosing

  • Evrysdi oral solution, once daily by age and weight: < 2 months 0.15 mg/kg; 2 months to < 2 years 0.20 mg/kg; ≥2 years < 20 kg 0.25 mg/kg; ≥2 years ≥ 20 kg 5 mg
  • Evrysdi 5 mg film-coated tablet: 5 mg once daily for patients ≥ 2 years and ≥ 20 kg; swallow whole or disperse in water
  • Daily doses above 5 mg have not been studied
  • Take a missed dose if still within 6 hours; otherwise skip it
  • No dose adjustment in mild or moderate hepatic impairment; severe hepatic impairment not studied

Contraindications

  • Hypersensitivity to the active substance or any excipient

Important warnings

  • Embryo-foetal toxicity in animals: highly effective contraception until at least 1 month after the last dose in females and 4 months in males
  • Verify pregnancy status before starting
  • Possible effects on male fertility: no sperm donation during and for 4 months after treatment
  • Oral solution contains isomalt (not for hereditary fructose intolerance) and sodium benzoate

Side effects

  • Infantile-onset SMA: pyrexia (54.8%), rash (29.0%), diarrhoea (19.4%)
  • Later-onset SMA: pyrexia (21.7%), headache (20.0%), diarrhoea (16.7%), rash (16.7%)
  • These generally resolved despite ongoing treatment

Interactions

  • CYP3A inhibitors (e.g. itraconazole): no clinically relevant effect, no dose adjustment
  • Risdiplam is a weak CYP3A inhibitor; no dose adjustment needed for CYP3A substrates

Pregnancy and breastfeeding

  • Not recommended during pregnancy or in women of childbearing potential not using contraception
  • Breastfeeding is not recommended during treatment

Summary of the official product information, written with AI (Claude, Anthropic) on 2026-10-28. Every number was checked automatically against the original text. Not reviewed by a physician – the full official text is authoritative.

Full official text →

Common questions – ask Medelix

For patients

Package leaflet, verbatim

Package leaflet for patients →

Authorisation and brand names by country

Medicines with exactly this active-substance composition, as listed in the national registers – alphabetical and without ranking. Whether a product is currently available is not shown here.

EU – centrally authorised (all member states)

  • EvrysdiRoche Registration GmbH · EMEA/H/C/005145

Source: European Medicines Agency (EMA), product information

Turkey

  • EvrysdiROCHE MÜSTAHZARLARI SAN.A.Ş. · 1 register entry

Source: TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, as of 2026-10-16

Brand names in 3 more European countries
Iceland
Evrysdi
Liechtenstein
Evrysdi
Norway
Evrysdi

EMA – Article 57 product data (EU/EEA), 2026-10-28

Medelix receives no money from pharmaceutical companies. Brand names are listed alphabetically and without ranking.

Other substances in the same group

Another question about this substance?

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Sources

  1. European Medicines Agency. Evrysdi – EPAR, Product Information (OF THE TEXT Detailed information on this medicinal product i). 2026-10-27. https://www.ema.europa.eu/en/documents/product-information/evrysdi-epar-product-information_en.pdf
  2. TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, 2026-10-16. https://www.titck.gov.tr/dinamikmodul/85

Editorial: Medelix editorial team · last updated 2026-10-27 · How these pages are made · Report an error

Source: European Medicines Agency (EMA), product information. Not advertising, not a treatment recommendation. For questions about your own treatment, ask your doctor or pharmacist.