Ireland· IE-PA-PA1347/108/002
Rosuvastatin/Ezetimibe KRKA 20 mg/10 mg Film-Coated Tablets
A rosuvastatin and ezetimibe product containing rosuvastatin calcium + ezetimibe, registered in Ireland by KRKA, d.d., Novo mesto. The same ATC class is registered in 9 of our 19 countries.
Checked against HPRA (Ireland) on
Informational only — not a medical device.
Where it is registered
Rosuvastatin and ezetimibe is registered in 9 of 19 countries.
Countries holding a registration under ATC C10BA06 (rosuvastatin and ezetimibe), each read from that country’s own register.
- This record: Ireland, from HPRA (Ireland)
- 7 of them publish a price we can compare per daily dose
Rosuvastatin and ezetimibe · ATC C10BA06
9 / 19 countries
- Belgiumprice
- Czechiaprice
- Finlandprice
- Ireland
- Italyprice
- Netherlands
- Norwayprice
- Polandprice
- Switzerlandprice
The record
At a glance
HPRA (Ireland)- Active substance
- Rosuvastatin calcium + Ezetimibe
- Manufacturer
- KRKA, d.d., Novo mesto
- Country
- Ireland (IE)
- ATC code
- C10BA06
- ATC class
- Rosuvastatin and ezetimibe
- Reimbursed
- Not published by this register
- Source register
- HPRA (Ireland)
- Last checked
- September 28, 2026
Packs & prices · 1
- ie_pa_numberPA1347/108/002
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same medicine, other countries
Rosuvastatin and ezetimibe in 10 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- CzechiaDELIPID PLUSEgis Pharmaceuticals PLC, Budapešť
- SpainALZIL PLUS 10 MG/10 MG COMPRIMIDOS RECUBIERTOS CON PELICULAFerrer Internacional S.A.
- ItalyAUROZEBAURORA BIOFARMA S.R.L.
- PolandCorosweraKrka, d.d., Novo mesto
- NetherlandsEklipo 10 mg/10 mg filmomhulde tablettenMedicair Bioscience Laboratories CY Limited
- SwitzerlandEzetimib Rosuvastatin axapharm
- FranceLIPOROSA 10 mg/10 mg, géluleDIFARMED (ESPAGNE)
- NorwayRostezeEQL Pharma AB
Authorised across Europe · EMA
The same active substance is authorised in 25 EEA countries. Names it is sold under:
- Austria · Arosuva Plus Ezetimib, Ezerosu
- Belgium · Cholecomb, Ezetimibe/Rosuvastatin Sandoz
- Bulgaria · Rosteza 10 Mg/10 Mg, Rosteza 20 Mg/10 Mg
- Cyprus · Celmantin Plus, Lipocomb
- Czechia · Delipid Plus, Refidoro
- Germany · Antilia, Ezehron Duo
- Estonia · Delipid Plus, Rosazimib
- Spain · Alzil Plus, Arrox Plus
- Finland · Rosuvastatin/Ezetimib Krka, Rosuvastatin/Ezetimibe Ratiopharm
- France · Liporosa, Quiloga
- Greece · Celmantin Plus, Co-Rosuvador
- Croatia · Arosen, Co-Roswera
- Hungary · Co-Xeter, Delipid Plus
- Italy · Aurozeb, Cholecomb
- Lithuania · Roselia, Sorvitimb
- Luxembourg · Cholecomb, Myrosor
- Latvia · Rosazimib, Rosulip
- Malta · Ezehron Duo, Lipocomb
- Netherlands · Ayadont, Cholecomb
- Norway · Rosteze, Rosuvastatin/Ezetimib Krka
- Poland · Coroswera, Ezehron Duo
- Portugal · Colroset, Lipocomb
- Romania · Co-Roswera, Lipocomb
- Slovenia · Refidoro, Rozor
- Slovakia · Lipocomb, Rosazimib
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/c5297db3-ef75-4fb4-bd86-4233cb532529 GET /v1/drugs/c5297db3-ef75-4fb4-bd86-4233cb532529?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": [
"C10BA06"
],
"strength": null,
"pa_number": "PA1347/108/002",
"substances": [
"Rosuvastatin calcium",
"Ezetimibe"
],
"legal_basis": "Fixed combination application (Article 10b of Directive No 2001/83/EC)",
"market_info": "Marketed",
"authorised_at": "06/01/2023",
"dispensing_status": "Product subject to prescription which may be renewed (B)",
"registration_status": "AU",
"supply_legal_status": "Supply through pharmacies only",
"interchangeable_code": "IC0111-061-009"
}See everything about rosuvastatin 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.