Ireland· IE-PA-PA1347/067/001
Ezetimibe/Simvastatin Krka 10 mg/10 mg tablets
A simvastatin and ezetimibe product containing ezetimibe + simvastatin, registered in Ireland by KRKA, d.d., Novo mesto. The same ATC class is registered in 13 of our 19 countries.
Checked against HPRA (Ireland) on
Informational only — not a medical device.
Where it is registered
Simvastatin and ezetimibe is registered in 13 of 19 countries.
Countries holding a registration under ATC C10BA02 (simvastatin and ezetimibe), each read from that country’s own register.
- This record: Ireland, from HPRA (Ireland)
- 9 of them publish a price we can compare per daily dose
Simvastatin and ezetimibe · ATC C10BA02
13 / 19 countries
- Belgiumprice
- Czechiaprice
- Denmark
- Finlandprice
- Icelandprice
- Ireland
- Italyprice
- Netherlands
- Norwayprice
- Polandprice
- Switzerlandprice
- United Kingdom
- United Statesprice
The record
At a glance
HPRA (Ireland)- Active substance
- Ezetimibe + Simvastatin
- Manufacturer
- KRKA, d.d., Novo mesto
- Country
- Ireland (IE)
- ATC code
- C10BA02
- ATC class
- Simvastatin and ezetimibe
- Reimbursed
- Not published by this register
- Source register
- HPRA (Ireland)
- Last checked
- September 28, 2026
Packs & prices · 1
- ie_pa_numberPA1347/067/001
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Interactions
14 interactions on record for simvastatin and ezetimibe.
Mechanism, severity and management for each pair, from a commercially licensed source — included 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
Simvastatin and ezetimibe · interactions on record
14 records
14 more interactions with mechanism and management, from a commercially licensed source.
Sign in to checkSame medicine, other countries
Simvastatin and ezetimibe in 14 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- CzechiaEZETIMIBE/SIMVASTATIN TEVA CRTeva Pharmaceuticals CR, s.r.o., Praha
- SpainEZETIMIBA/SIMVASTATINA ALTER 10 MG/10 MG COMPRIMIDOS EFGLaboratorios Alter S.A.
- ItalyAMISITELAEBERLIFE FARMACEUTICI S.P.A.
- NetherlandsEzetimibe/Simvastatine Aurobindo 10/10 mg, tablettenAurobindo Pharma B.V.
- SwitzerlandEzetimib Simva Spirig HC
- United Statesezetimibe and simvastatinGlenmark Pharmaceuticals Inc., USA
- FranceEZETIMIBE/SIMVASTATINE ACCORD 10 mg/20 mg, compriméACCORD HEALTHCARE FRANCE
- United KingdomInegy 10mg/20mg tabletsMawdsley-Brooks & Company Ltd
Authorised across Europe · EMA
The same active substance is authorised in 21 EEA countries. Names it is sold under:
- Austria · Ezesim, Ezetimib/Simvastatin Accord
- Belgium · Ezetimib/Simvastatin Ab, Ezetimibe/Simvastatin Krka
- Cyprus · Ezetimibe/Simvastatin Accord, Inegy
- Czechia · Ezetimibe/Simvastatin Teva Cr, Glezisim
- Germany · Ezesimin, Ezetimib Simvastatin Zentiva
- Denmark · Ezetimib/Simvastatin Demo, Ezetimib/Simvastatin Hexal
- Spain · Ezetimiba/Simvastatina Alter, Ezetimiba/Simvastatina Aurovitas
- France · Ezetimibe/Simvastatine Accord, Ezetimibe/Simvastatine Almus
- United Kingdom (Northern Ireland) · Ezetimibe/Simvastatin Accord Healthcare, Ezetimibe/Simvastatin Ascend Laboratories
- Greece · Cildar Plus, Ezetimib/Simvastatin Mylan
- Croatia · Inegy, Vasitimb
- Hungary · Inegy
- Iceland · Ezetimib/Simvastatin Krka, Inegy
- Italy · Ezetimibe E Simvastatina Accord, Ezetimibe E Simvastatina Almus
- Luxembourg · Ezetimib/Simvastatin Ratiopharm®, Ezetimibe/Simvastatine Eg
- Netherlands · Ezetimibe/Simvastatin Aurobindo, Ezetimibe/Simvastatine Cf
- Norway · Ezetimib/Simvastatin Glenmark, Ezetimib/Simvastatin Krka
- Portugal · Inegy, Sinvastatina + Ezetimiba Alter
- Sweden · Ezetimib/Simvastatin Krka, Ezetimibe/Simvastatin Accord
- Slovenia · Inegy, Vasitimb
- Slovakia · Cornusan, Ezetimib/Simvastatín Teva B.V.
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/c7075fe5-a156-4adc-ae5b-27c30c5f0648 GET /v1/drugs/c7075fe5-a156-4adc-ae5b-27c30c5f0648?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": [
"C10BA",
"C10BA02"
],
"strength": null,
"pa_number": "PA1347/067/001",
"substances": [
"Ezetimibe",
"Simvastatin"
],
"legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)",
"market_info": "Not marketed",
"authorised_at": "01/03/2017",
"dispensing_status": "Product subject to prescription which may be renewed (B)",
"registration_status": "AU",
"supply_legal_status": "Supply through pharmacies only",
"interchangeable_code": "IC0034-017-002"
}See everything about simvastatin and ezetimibe.
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.