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Ireland· IE-PA-EU/1/15/999/001-003

Zykadia 150 mg hard capsules

A other antineoplastic agents product containing ceritinib, registered in Ireland by Novartis Europharm Limited. The same ATC class is registered in 5 of our 19 countries.

ATC L01X

Checked against HPRA (Ireland) on

Informational only — not a medical device.

SOURCE REGISTER · IEHPRA (Ireland)normalisedZykadia 150 mg hard capsulesATCL01XREGISTER NO.IE-PA-EU/1/15/999/001…PACKS LISTED1CHECKEDSeptember 28, 2026

Where it is registered

Ceritinib is registered in 5 of 19 countries.

Countries holding a registration under ATC L01X (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

Ceritinib · ATC L01X

5 / 19 countries

  • Belgiumprice
  • Canada
  • Finlandprice
  • Ireland
  • Switzerlandprice
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
Ceritinib
Manufacturer
Novartis Europharm Limited
Country
Ireland (IE)
ATC code
L01X
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/1/15/999/001-003

Regulatory notes

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

Same medicine, other countries

Ceritinib in 15 other countries

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

All ceritinib products

Authorised across Europe · EMA

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

  • Iceland · Zykadia
  • Liechtenstein · Zykadia
  • Norway · Zykadia

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/d78c5970-6e49-4583-8d74-43097682e59b
GET /v1/drugs/d78c5970-6e49-4583-8d74-43097682e59b?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": [
    "L01X"
  ],
  "strength": null,
  "pa_number": "EU/1/15/999/001-003",
  "substances": [
    "Ceritinib"
  ],
  "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)",
  "market_info": "Unknown",
  "authorised_at": "06/05/2015",
  "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 ceritinib.

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.