Duvyzat
What Duvyzat is used for
Duvyzat is indicated for the treatment of Duchenne muscular dystrophy (DMD) in ambulant patients, aged 6 years and older, and with concomitant corticosteroid treatment.
Approved use, as published by the European Medicines Agency.
What the labels mean
- Orphan medicine: for a rare disease (affecting no more than 5 in 10,000 people in the EU).
- Conditional approval: approved on less complete data because the need is high; more data must follow.
Key facts
- Brand
- Duvyzat
- Active substance
- givinostat
- Disease area
- Muscular Dystrophy, Duchenne
- Medicine group
- Other drugs for disorders of the musculo-skeletal system
- ATC code
- M09AX14
- Marketing authorisation holder
- Italfarmaco S.p.A.
- Authorised in the EU since
- 2025
Official information
Specialist medicine: started and supervised by a specialist doctor or hospital. This page is a plain-language summary of public official information, not medical advice; follow your doctor and the official product information.
Common questions
What is Duvyzat used for?
Duvyzat is indicated for the treatment of Duchenne muscular dystrophy (DMD) in ambulant patients, aged 6 years and older, and with concomitant corticosteroid treatment.
What is the active substance in Duvyzat?
Duvyzat contains givinostat.
Who makes Duvyzat?
The EU marketing authorisation holder is Italfarmaco S.p.A..
Is Duvyzat an orphan medicine?
Yes. Duvyzat is designated an orphan medicine in the EU, for a rare disease (Muscular Dystrophy, Duchenne).
Source: European Medicines Agency medicines data (ema.europa.eu), reproduced with acknowledgement of the source. Page made 5 November 2026 by Satya Babu.
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