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Ireland· IE-PA-EU/1/14/945/007-008

IMBRUVICA 140 mg film-coated tablets

A ibrutinib product containing ibrutinib, registered in Ireland by Janssen-Cilag International NV.

ATC L01XE27

Checked against HPRA (Ireland) on

Informational only — not a medical device.

SOURCE REGISTER · IEHPRA (Ireland)normalisedIMBRUVICA 140 mg film-coated tabletsATCL01XE27REGISTER NO.IE-PA-EU/1/14/945/007…PACKS LISTED1CHECKEDSeptember 28, 2026

The record

At a glance

HPRA (Ireland)
Active substance
Ibrutinib
Manufacturer
Janssen-Cilag International NV
Country
Ireland (IE)
ATC code
L01XE27
ATC class
Ibrutinib
Reimbursed
Not published by this register
Source register
HPRA (Ireland)
Last checked
September 28, 2026

Packs & prices · 1

  • ie_pa_number
    EU/1/14/945/007-008

Regulatory notes

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

Interactions

370 interactions on record for ibrutinib.

Graded by severity as the source publishes them — 189 severe. Severity grades are free for everyone; mechanism and management come with Growth.

  • Severity for every pair — free, no plan needed
  • The source, licence and sync date on every record
  • Mechanism and what to do for each pair — Growth plan

Ibrutinib · interactions on record

370 records

  • 189 severe
  • 177 moderate
  • 4 minor

Most severe, free to view

  • AprepitantA04AD12severe
  • LinseedA06AC05severe
  • LonafarnibA16AX20severe
  • DicoumarolB01AA01severe
  • Interaction severity from DDInter 2.0 (Xiong G. et al., Nucleic Acids Res.), licensed CC BY-NC 4.0 — free for non-commercial use only; not covered by the Drug Database commercial licence.
Mechanism and what to do, in the interaction check
Source: DDInter 2.0 · synced 29 Sept 2026. Grades as the source publishes them.

Same medicine, other countries

Ibrutinib in 15 other countries

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

All ibrutinib products

Authorised across Europe · EMA

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

  • Iceland · Imbruvica
  • Liechtenstein · Imbruvica
  • Norway · Imbruvica

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/503e96c1-cc95-4ce7-8a95-c63a2c35f270
GET /v1/drugs/503e96c1-cc95-4ce7-8a95-c63a2c35f270?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": "Film-coated tablet",
  "routes": [
    "Oral use"
  ],
  "source": "hpra",
  "atc_all": [
    "L01XE27"
  ],
  "strength": null,
  "pa_number": "EU/1/14/945/007-008",
  "substances": [
    "Ibrutinib"
  ],
  "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)",
  "market_info": "Unknown",
  "authorised_at": null,
  "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 ibrutinib.

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.