Ireland· IE-PA-EU/1/15/1030/001-002
Odomzo 200 mg hard capsules
A other antineoplastic agents product containing sonidegib, registered in Ireland by Sun Pharmaceutical Industries Europe B.V.. The same ATC class is registered in 5 of our 19 countries.
Checked against HPRA (Ireland) on
Informational only — not a medical device.
Where it is registered
Sonidegib is registered in 5 of 19 countries.
Countries holding a registration under ATC L01XX (other antineoplastic agents), each read from that country’s own register.
- This record: Ireland, from HPRA (Ireland)
- 3 of them publish a price we can compare per daily dose
Sonidegib · ATC L01XX
5 / 19 countries
- Denmark
- Finlandprice
- Ireland
- Polandprice
- United Statesprice
The record
At a glance
HPRA (Ireland)- Active substance
- Sonidegib
- Manufacturer
- Sun Pharmaceutical Industries Europe B.V.
- Country
- Ireland (IE)
- ATC code
- L01XX
- ATC class
- Other antineoplastic agents
- Reimbursed
- Not published by this register
- Source register
- HPRA (Ireland)
- Last checked
- September 28, 2026
Packs & prices · 1
- ie_pa_numberEU/1/15/1030/001-002
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same medicine, other countries
Sonidegib in 12 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- SwitzerlandOdomzo 200 mg, HartkapselnSun Pharma Switzerland Ltd
- CzechiaODOMZOSun Pharmaceutical Industries Europe B.V., Hoofddorp
- SpainODOMZO 200 MG CAPSULAS DURASSun Pharmaceutical Industries (Europe) B.V.
- FinlandOdomzoSun Pharmaceutical Industries Europe B.V.
- FranceODOMZO 200 mg, géluleSUN PHARMACEUTICAL INDUSTRIES EUROPE (PAYS BAS)
- IcelandOdomzoSun Pharmaceutical Industries Europe B.V.*
- NorwayOdomzoSun Pharmaceutical - Nederland
- PolandOdomzoSun Pharmaceutical Industries Europe B.V.
Authorised across Europe · EMA
The same active substance is authorised in 2 EEA countries. Names it is sold under:
- Iceland · Odomzo
- Norway · Odomzo
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/71562478-0cbd-418a-af8f-5b6220ef1c5a GET /v1/drugs/71562478-0cbd-418a-af8f-5b6220ef1c5a?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": "Capsule, hard",
"routes": [
"Oral use"
],
"source": "hpra",
"atc_all": [
"L01XX"
],
"strength": null,
"pa_number": "EU/1/15/1030/001-002",
"substances": [
"Sonidegib"
],
"legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)",
"market_info": "Unknown",
"authorised_at": "14/08/2015",
"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 sonidegib.
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.