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.
Checked against HPRA (Ireland) on
Informational only — not a medical device.
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_numberEU/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.
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.
- CzechiaKISPLYXEisai GmbH, Frankfurt am Main
- NetherlandsKisplyx 10 mg, harde capsuleEisai GmbH
- FinlandIxedafinSTADA Arzneimittel AG
- SwedenKisplyx 10 mg Kapsel, hårdEisai GmbH
- BelgiumIxedafin 10 mgStada Arzneimittel
- SpainKISPLYX 10 MG CAPSULAS DURASEisai Gmbh
- United StatesLenvimaEisai Inc.
- SwitzerlandKisplyx
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.