Ireland· IE-PA-EU/1/25/1930/001
Duvyzat 8.86 mg/ml oral suspension
A givinostat product containing givinostat hydrochloride monohydrate, registered in Ireland by Italfarmaco S.p.A.. The same ATC class is registered in 12 of our 19 countries.
Checked against HPRA (Ireland) 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: Ireland, from HPRA (Ireland)
- 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
HPRA (Ireland)- Active substance
- Givinostat hydrochloride monohydrate
- Manufacturer
- Italfarmaco S.p.A.
- Country
- Ireland (IE)
- ATC code
- M09AX14
- ATC class
- Givinostat
- Defined daily dose
- 0.106 g, O
- Reimbursed
- Not published by this register
- Source register
- HPRA (Ireland)
- Last checked
- September 28, 2026
Packs & prices · 1
- ie_pa_numberEU/1/25/1930/001
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.
- IcelandDuvyzatItalfarmaco S.p.A.
- NetherlandsDuvyzat 8,86 mg/ml suspensie voor oraal gebruikItalfarmaco S.P.A.
- NorwayDuvyzatItalfarmaco S.p.A
- PolandDuvyzatItalfarmaco 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 HPRA (Ireland). 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/980e0c07-6927-407c-bb0f-8a239a255f36 GET /v1/drugs/980e0c07-6927-407c-bb0f-8a239a255f36?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": "Oral suspension",
"routes": [
"Oral use"
],
"source": "hpra",
"atc_all": [
"M09AX14"
],
"strength": null,
"pa_number": "EU/1/25/1930/001",
"substances": [
"Givinostat hydrochloride monohydrate"
],
"legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)",
"market_info": "Unknown",
"authorised_at": "06/06/2025",
"dispensing_status": "Product subject to prescription which may not be renewed (A)",
"registration_status": "AU",
"supply_legal_status": "Supply through pharmacies only",
"interchangeable_code": 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.