Medicine guide

Duvyzat

Prescription status not stated
Muscles, joints and bones

Active substance: Givinostat
Used in: Muscles, joints and bones
Made by: Italfarmaco S.p.A.
Source: Official label

Quoted from the official source. Not yet reviewed by Mediclarum — the leaflet in your pack is authoritative.

What it is 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.

From the official label · 2026-09-30 · European Medicines Agency

How it works

From the US prescribing label for the same active substance (DUVYZAT). It describes the substance, not this exact product.

DUVYZAT is a histone deacetylase inhibitor.
The precise mechanism by which DUVYZAT exerts its effect in patients with DMD is unknown.

Peak level after2–3 h

Half-life6 h

Mostly cleared after≈ 30 hfive half-lives — our arithmetic

The shape is a standard model drawn from the two times above, not a measurement. How fast a medicine acts and wears off also depends on the dose, the form and the person.

How the body breaks it down

In vitro studies with human enzymatic preparations together with animal metabolism showed that givinostat is extensively metabolized forming several metabolites.

Quoted from the prescribing label, sections “Mechanism of Action” and “Pharmacokinetics”. DailyMed · 2024-11-21

Same active substance, strength and form in other countries

Matched on active substance, strength and kind of form only. This is not a statement that the products are equivalent or interchangeable: other ingredients, release and approved uses can differ — ask a pharmacist before swapping.

Medicine passport: one printable page to show a pharmacist abroad

United StatesNo exact match for this strength and form

Every strength and form (1)

SpainNo exact match for this strength and form

Every strength and form (1)

NetherlandsNo exact match for this strength and form

Every strength and form (1)

Details

Made by	Italfarmaco S.p.A.
Active substance	Givinostat
Used in	Muscles, joints and bones
Classification	M09AX14 · Muscles, joints and bones
Orphan medicine	Yes — designated for a rare disease, according to the register
Additional monitoring ▼	Yes — under additional monitoring (black triangle). Report suspected side effects.
Authorised on	2025-06-06
Last updated by the regulator	2026-07-03
EMA product number	EMEA/H/C/006079

Source: European Medicines Agency — medicine data · 2026-09-30 · not reviewed by a clinician

Source: European Medicines Agency (EMA). Product information as published by EMA. Reuse terms: EMA legal notice (reproduction authorised).

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