Medicine
Duvyzat 8.86 mg/mL oral suspension
Duvyzat 8.86 mg/mL oral suspension is a prescription medicine containing Givinostat for oral use, marketed by Italfarmaco, with its source record on the US FDA register. It is available on request for export supply from India to licensed hospitals, importers and physicians.
Availability
Export supply from India to licensed buyers
Typical lead time
On request
Counted from payment and complete documents
Shipping
Ambient
Do not freeze. Store at 20°C to 25°C (68°F to 77°F), excursions permitted to…
Key facts
- Active ingredient (INN)
- Givinostat
- Brand
- Duvyzat
- Strength
- 8.86 mg/mL
- Dosage form
- Oral suspension
- Route
- Oral
- Packs
- 1 bottle
- Marketing authorisation holder
- Italfarmaco
- Manufacturer
- Italfarmaco
- Origin register
- US FDA, United States
- Storage
- Do not freeze. Store at 20°C to 25°C (68°F to 77°F), excursions permitted to 15°C to 30°C (59°F to 86°F). Store upright.
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- M09AX14 Givinostat
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 21 March 2024
- Identifiers
- RxCUI 2678894, 2678900DailyMed set ID 1a28a3db-7880-4ac2-a2f2-2b4e362aafb6NDC 11797-110Application NDA217865
Record updated 12 November 2026
Documents available
Documents that can be provided with this medicine. Your regulator may ask for more, and the quote lists the full set.
No document list is recorded for this medicine yet. Tell us which documents your regulator needs (for example a CoA, COPP or GMP certificate) when you request a quote.
Packs
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 1 bottle in 1 carton / 140 mL in 1 bottle | 11797-110-02 | Italfarmaco | 21 March 2024 |
Status by register
Where this medicine is registered, from the source record and the regulator data we hold. Ask us about a country that is not listed.
Import route
Pick the destination country to see the legal import route, who applies and typical timelines, from our import guide for that country.
Import guides are available for 25 countries. Pick one to see its route summary.
BrazilColombiaEgyptEthiopiaGhanaIraqKazakhstanKenyaAll import guides
Clinical summary
Givinostat is a histone deacetylase inhibitor indicated for the treatment of Duchenne muscular dystrophy (DMD) in patients 6 years of age and older. It is available as oral suspension. MedsAcross supplies Givinostat for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
Read about GivinostatFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- DUVYZAT prescribing information (Italfarmaco) · U.S. National Library of Medicine, DailyMed
- Duvyzat: European public assessment report (EPAR) · European Medicines Agency
Need Duvyzat 8.86 mg/mL oral suspension for your hospital or patient?
Send one request with the destination country and quantity. We confirm availability, lead time and the documents your regulator needs.