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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.

ATC L01XX

Checked against HPRA (Ireland) on

Informational only — not a medical device.

SOURCE REGISTER · IEHPRA (Ireland)normalisedOdomzo 200 mg hard capsulesATCL01XXREGISTER NO.IE-PA-EU/1/15/1030/00…PACKS LISTED1CHECKEDSeptember 28, 2026

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
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

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_number
    EU/1/15/1030/001-002

Regulatory notes

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

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.