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Ireland· IE-PA-EU/1/16/1128/002

Kisplyx 10 mg hard capsules

A lenvatinib product containing lenvatinib mesilate, registered in Ireland by Eisai GmbH.

ATC L01XE29

Checked against HPRA (Ireland) on

Informational only — not a medical device.

SOURCE REGISTER · IEHPRA (Ireland)normalisedKisplyx 10 mg hard capsulesATCL01XE29REGISTER NO.IE-PA-EU/1/16/1128/002PACKS LISTED1CHECKEDSeptember 28, 2026

The record

At a glance

HPRA (Ireland)
Active substance
Lenvatinib mesilate
Manufacturer
Eisai GmbH
Country
Ireland (IE)
ATC code
L01XE29
ATC class
Lenvatinib
Reimbursed
Not published by this register
Source register
HPRA (Ireland)
Last checked
September 28, 2026

Packs & prices · 1

  • ie_pa_number
    EU/1/16/1128/002

Regulatory notes

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

Interactions

315 interactions on record for lenvatinib.

Graded by severity as the source publishes them — 81 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

Lenvatinib · interactions on record

315 records

  • 81 severe
  • 230 moderate
  • 4 minor

Most severe, free to view

  • PapaverineA03AD01severe
  • CisaprideA03FA02severe
  • DolasetronA04AA04severe
  • QuinidineC01BA01severe
  • 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

Lenvatinib in 16 other countries

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

All lenvatinib products

Authorised across Europe · EMA

The same active substance is authorised in 28 EEA countries. Names it is sold under:

  • Austria · Lenvatinib Accord, Lenvatinib Rcc Sandoz
  • Belgium · Ixedafin, Lenvatinib Accord
  • Bulgaria · Ленватиниб Виатрис
  • Cyprus · Lenvatinib Remedica
  • Czechia · Lenvatinib Accord, Lenvatinib Sandoz
  • Germany · Lenvatinib Accord, Lenvatinib Hexal
  • Denmark · Lenvatinib Accord, Lenvatinib Sandoz
  • Estonia · Lenvatinib Remedica, Lenvatinib Sandoz
  • Spain · Lenvatinib Accord, Lenvatinib Sandoz
  • Finland · Ixedafin, Lenvatinib
  • France · Lenvatinib Accord, Lenvatinib Biogaran
  • United Kingdom (Northern Ireland) · Lenvatinib, Lenvatinib Thornton & Ross
  • Greece · Kynvalib, Lenvatinib Elpen
  • Croatia · Lenvatinib Remedica
  • Hungary · Lenvatinib Stada
  • Iceland · Kisplyx, Lenvima
  • Italy · Lenvatinib Accord, Lenvatinib Sandoz
  • Liechtenstein · Kisplyx, Lenvima
  • Lithuania · Lenvatinib Sandoz, Lenvatinib Stada
  • Luxembourg · Ixedafin, Lenvatinib Olpha
  • Latvia · Lenvatinib Sandoz, Lenvatinib Stada
  • Malta · Lenvatinib Remedica, Lenvatinib Stada
  • Netherlands · Lenvatinib 1a Pharma, Lenvatinib Accord
  • Norway · Kisplyx, Lenvatinib Accord
  • Portugal · Lenvatinib Accord, Lenvatinib Sandoz
  • Sweden · Lenvatinib Accord, Lenvatinib Avansor
  • Slovenia · 10 Mg, Lenvatinib Sandoz
  • Slovakia · Lenvatinib Pharmevid

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/1d4ad807-e6d0-4fcc-872f-ee99902e0179
GET /v1/drugs/1d4ad807-e6d0-4fcc-872f-ee99902e0179?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": null,
  "source": "hpra",
  "atc_all": [
    "L01XE",
    "L01XE29"
  ],
  "strength": null,
  "pa_number": "EU/1/16/1128/002",
  "substances": [
    "Lenvatinib mesilate"
  ],
  "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)",
  "market_info": "Unknown",
  "authorised_at": "25/08/2016",
  "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 lenvatinib.

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.