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Netherlands· NL-12f9e2dd00e7

Duvyzat 8,86 mg/ml suspensie voor oraal gebruik

A givinostat product containing givinostathydrochloride 1-water, registered in Netherlands by Italfarmaco S.P.A.. The same ATC class is registered in 12 of our 19 countries.

ATC M09AX14

Checked against CBG-MEB (Netherlands) on

Informational only — not a medical device.

SOURCE REGISTER · NLCBG-MEB (Netherlands)normalisedDuvyzat 8,86 mg/ml suspensie voor ora…ATCM09AX14REGISTER NO.NL-12f9e2dd00e7PACKS LISTED1CHECKEDSeptember 29, 2026
Compare price across countriesPer daily dose · free accountAsk the assistant about givinostathydrochloride 1-waterAnswers with sources · free accountCheck interactionsSeverity free · mechanism on Growth

Where it is registered

Givinostat is registered in 12 of 19 countries.

Countries holding a registration under ATC M09AX14 (givinostat), each read from that country’s own register.

  • This record: Netherlands, from CBG-MEB (Netherlands)
  • 8 of them publish a price we can compare per daily dose
Search givinostat products by name

Givinostat · ATC M09AX14

12 / 19 countries

  • Belgiumprice
  • Czechiaprice
  • Denmark
  • Finlandprice
  • Icelandprice
  • Ireland
  • Netherlands
  • Norwayprice
  • Polandprice
  • Spainprice
  • United Kingdom
  • United Statesprice
Blue: a registration under this ATC code. The ringed marker is this record’s country. Markets marked price publish a price we can compare per daily dose.

The record

At a glance

CBG-MEB (Netherlands)
Active substance
GIVINOSTATHYDROCHLORIDE 1-WATER
Manufacturer
Italfarmaco S.P.A.
Country
Netherlands (NL)
ATC code
M09AX14
ATC class
Givinostat
Defined daily dose
0.106 g, O
Reimbursed
Not published by this register
Source register
CBG-MEB (Netherlands)
Last checked
September 29, 2026

Packs & prices · 1

  • cbg_meb_id
    EU/1/25/1930

Regulatory notes

No shortage, Orange Book or US label notes for this record.

Same medicine, other countries

Givinostat in 11 other countries

What each register calls a product with the same active substance — salts and hydrates count as the same.

All givinostat products

Authorised across Europe · EMA

The same active substance is authorised in 3 EEA countries. Names it is sold under:

  • Iceland · Duvyzat
  • Liechtenstein · Duvyzat
  • Norway · Duvyzat

Source: European Medicines Agency, Article 57 product data.

Sourced from a public register and reproduced with attribution. Drug Database is not affiliated with, endorsed by, or a partner of CBG-MEB (Netherlands). This is an informational data service and not a medical device — verify against the official source of record before any clinical decision.

For developers

The same record over the API, and the raw payload
GET /v1/drugs/7f520f2d-f06d-47a8-85af-30da6cb947bf
GET /v1/drugs/7f520f2d-f06d-47a8-85af-30da6cb947bf?format=fhir

Every response carries last_synced_at, so freshness is a field rather than a promise. Below is exactly what the ingestion wrote, before any presentation — the same JSON the API returns under payload.

{
  "form": "Suspensie voor oraal gebruik",
  "route": "Oraal gebruik",
  "soort": null,
  "source": "cbg_meb",
  "smpc_url": "https://www.ema.europa.eu/en/documents/product-information/duvyzat-epar-product-information_nl.pdf",
  "strength": null,
  "atc_label": "Givinostat",
  "detail_url": "https://www.geneesmiddeleninformatiebank.nl/nl/cp131847",
  "excipients": [
    "GLYCEROL (E 422)",
    "NATRIUMBENZOAAT (E 211)",
    "NATRIUMHYDROXIDE (E 524)",
    "PERZIKSMAAKSTOF",
    "POLYSORBAAT 20 (E 432)",
    "PROPYLEENGLYCOL (E 1520)",
    "PROPYLEENGLYCOL (E 1520)",
    "ROOMSMAAKSTOF",
    "SACCHAROIDE NATRIUM X-WATER (E 954)",
    "SORBITOL, VLOEIBAAR, NIET-KRISTALLISEERBAAR (E 420)",
    "TRAGACANT (E 413)",
    "WATER, GEZUIVERD",
    "WIJNSTEENZUUR, (L (+) Vorm) (E 334)"
  ],
  "substances": [
    "GIVINOSTATHYDROCHLORIDE 1-WATER"
  ],
  "leaflet_url": null,
  "authorised_at": "2025/06/06",
  "procedure_number": "EMEA/H/C/006079",
  "dispensing_status": "Uitsluitend recept",
  "registration_number": "EU/1/25/1930",
  "additional_monitoring": "Y"
}
API referenceMCP serverPlans

See everything about givinostat.

This page is the registration. A free account adds the label text as the regulator wrote it, what it costs per daily dose across the markets that publish a price, a feed of what changes in the registers, and an assistant that answers with its sources. Interaction severity is free; mechanism and management are on the Growth plan. No card, nothing to install.

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