Ireland· IE-PA-PA1347/108/003
Rosuvastatin/Ezetimibe Krka 40 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_numberPA1347/108/003
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same class
Other records under C10BA06
Rosuvastatin and ezetimibe, as other registers publish it.
- ItalyAUROZEBAURORA BIOFARMA S.R.L.
- ItalyAUROZEBAURORA BIOFARMA S.R.L.
- ItalyAUROZEBAURORA BIOFARMA S.R.L.
- ItalyAUROZEBAURORA BIOFARMA S.R.L.
- NetherlandsAyadont 10 mg/10 mg, harde capsulesEgis Pharmaceuticals Plc
- NetherlandsAyadont 20 mg/10 mg, harde capsulesEgis Pharmaceuticals Plc
- NetherlandsAyadont 40 mg/10 mg harde capsuleEgis Pharmaceuticals Plc
- NetherlandsAyadont 5 mg/10 mg, harde capsulesEgis Pharmaceuticals Plc
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/b251de55-206a-4a65-bfad-abc6406f67e7 GET /v1/drugs/b251de55-206a-4a65-bfad-abc6406f67e7?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": "PA1347/108/003",
"substances": [
"Rosuvastatin calcium",
"Ezetimibe"
],
"legal_basis": "Fixed combination application (Article 10b of Directive No 2001/83/EC)",
"market_info": "Marketed",
"authorised_at": "28/11/2025",
"dispensing_status": "Product subject to prescription which may be renewed (B)",
"registration_status": "AU",
"supply_legal_status": "Supply through pharmacies only",
"interchangeable_code": "IC0111-093-009"
}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.