Poland· PL-100520239
Duvyzat
A givinostat product containing givinostatum, registered in Poland by Italfarmaco S.p.A.. The same ATC class is registered in 12 of our 19 countries.
Checked against URPL (Poland) on
Informational only — not a medical device.
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: Poland, from URPL (Poland)
- 8 of them publish a price we can compare per daily dose
Givinostat · ATC M09AX14
12 / 19 countries
- Belgiumprice
- Czechiaprice
- Denmark
- Finlandprice
- Icelandprice
- Ireland
- Netherlands
- Norwayprice
- Polandprice
- Spainprice
- United Kingdom
- United Statesprice
The record
At a glance
URPL (Poland)- Active substance
- Givinostatum
- Manufacturer
- Italfarmaco S.p.A.
- Country
- Poland (PL)
- ATC code
- M09AX14
- ATC class
- Givinostat
- Defined daily dose
- 0.106 g, O
- Reimbursed
- Not published by this register
- Source register
- URPL (Poland)
- Last checked
- September 27, 2026
Packs & prices · 1
- gtin08024790126513
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.
- BelgiumDuvyzat 8.86 mg/mlItalfarmaco
- CzechiaDUVYZATItalfarmaco S.p.A., Milano
- SpainDUVYZAT 8,86 MG/ML SUSPENSION ORALItalfarmaco S.P.A.
- FinlandDUVYZATITALFARMACO S.p.A.
- IrelandDuvyzat 8.86 mg/ml oral suspensionItalfarmaco S.p.A.
- IcelandDuvyzatItalfarmaco S.p.A.
- NetherlandsDuvyzat 8,86 mg/ml suspensie voor oraal gebruikItalfarmaco S.P.A.
- NorwayDuvyzatItalfarmaco S.p.A
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 URPL (Poland). 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/188e00c7-dc69-4511-be2f-10c5dafe28f8 GET /v1/drugs/188e00c7-dc69-4511-be2f-10c5dafe28f8?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": "Zawiesina doustna",
"source": "urpl",
"strength": "8,86 mg/ml",
"packaging": "Rpz ¦ EU/1/25/1930/001 ¦ 162543\n1 butelka 140 ml ¦ 1 strzykawka 10 ml doustna z podziałką\n¦ UR/Z/4b/224/25 - 08024790126513 ¦ UR/Z/4b/011/26 - 08024790126513 ¦ UR/Z/4b/060/26 - 08024790126513 ¦ UR/Z/4b/121/26 - 08024790126513 ¦ UR/Z/4b/151/26 - 08024790126513 ¦ UR/Z/4b/180/26 - 08024790126513 ¦ UR/Z/4b/243/26 - 08024790126513",
"substance": "Givinostati hydrochloridum monohydricum -",
"common_name": "Givinostatum",
"pl_product_id": "100520239",
"pozwolenie_nr": null,
"auth_procedure": "CEN",
"authorisation_validity": null
}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.