Ireland· IE-PA-EU/1/09/538/001
Afinitor 5 mg Tablet
A everolimus product containing everolimus, registered in Ireland by Novartis Europharm Limited. The same ATC class is registered in 3 of our 19 countries.
Checked against HPRA (Ireland) on
Informational only — not a medical device.
Where it is registered
Everolimus is registered in 3 of 19 countries.
Countries holding a registration under ATC L01XE10 (everolimus), each read from that country’s own register.
- This record: Ireland, from HPRA (Ireland)
- 2 of them publish a price we can compare per daily dose
Everolimus · ATC L01XE10
3 / 19 countries
- Ireland
- Polandprice
- Switzerlandprice
The record
At a glance
HPRA (Ireland)- Active substance
- Everolimus
- Manufacturer
- Novartis Europharm Limited
- Country
- Ireland (IE)
- ATC code
- L01XE10
- ATC class
- Everolimus
- Reimbursed
- Not published by this register
- Source register
- HPRA (Ireland)
- Last checked
- September 28, 2026
Packs & prices · 1
- ie_pa_numberEU/1/09/538/001
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Interactions
430 interactions on record for everolimus.
Graded by severity as the source publishes them — 165 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
Everolimus · interactions on record
430 records
- 165 severe
- 255 moderate
- 8 minor
Most severe, free to view
- AprepitantA04AD12severe
- NeomycinA07AA01severe
- StreptomycinA07AA04severe
- Polymyxin BA07AA05severe
2 more interactions with mechanism and management, from a commercially licensed source.
Sign in to check- 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
Everolimus in 16 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- CzechiaAFINITORNovartis Europharm Limited, Dublin
- NetherlandsAfinitor 5 mg, tablettenNovartis Europharm Limited
- United StatesAfinitorNovartis Pharmaceuticals Corporation
- SpainAFINITOR 5 MG COMPRIMIDOSNovartis Europharm Limited
- FinlandAfinitorNovartis Europharm Limited
- FranceAFINITOR 5 mg, comprimésNOVARTIS EUROPHARM (IRLANDE)
- United KingdomAfinitor 5mg tabletsNovartis Pharmaceuticals UK Ltd
- SwedenAfinitor 5 mg TablettNovartis Europharm Limited
Authorised across Europe · EMA
The same active substance is authorised in 30 EEA countries. Names it is sold under:
- Austria · Certican, Everolimus Ethypharm
- Belgium · Certican, Everolimus Eg
- Bulgaria · Еверолимус Крка, Еверолимус Майлан
- Cyprus · Certican, Everolimus Pharmazac
- Czechia · Certican, Everolimus Accord
- Germany · Certican, Everofin
- Denmark · Certican, Everolimus Krka
- Estonia · Certican, Everolimus Krka
- Spain · Certican, Everolimus Accord
- Finland · Aderolio, Certican
- France · Certican, Everolimus Arrow
- United Kingdom (Northern Ireland) · Aderolio, Aderolio 250 Mcg Tablets
- Greece · Certican, Everolimus Faran
- Croatia · Certican, Everolimus Krka
- Hungary · Certican, Everolimus Accord
- Iceland · Afinitor, Certican
- Italy · Certican, Everolimus Accord
- Liechtenstein · Afinitor, Votubia
- Lithuania · Certican, Everolimus Norameda
- Luxembourg · Certican, Everolimus Eg
- Latvia · Certican, Everolimus Norameda
- Malta · Certican, Everolimus Ascend
- Netherlands · Certican, Certican Dispers
- Norway · Afinitor, Certican
- Poland · Aderolio, Certican
- Portugal · Certican, Everolimus Ethypharm
- Romania · Certican, Everolimus Accord
- Sweden · Certican, Everolimus Avansor
- Slovenia · Certican, Everolimus Krka
- Slovakia · Certican, Everolimus Accord
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/e3f360e9-f98e-4358-9728-7339b8d8daad GET /v1/drugs/e3f360e9-f98e-4358-9728-7339b8d8daad?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": "Tablet",
"routes": [
"Oral use"
],
"source": "hpra",
"atc_all": [
"L01XE",
"L01XE10"
],
"strength": null,
"pa_number": "EU/1/09/538/001",
"substances": [
"Everolimus"
],
"legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)",
"market_info": "Unknown",
"authorised_at": "08/09/2009",
"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 everolimus.
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.