Ireland· IE-PA-EU/1/11/679/001-006
Pravafenix 40 mg/160 mg hard capsules
A pravastatin und fenofibrat product containing fenofibrate + pravastatin sodium, registered in Ireland by Laboratoires SMB S.A.. The same ATC class is registered in 8 of our 19 countries.
Checked against HPRA (Ireland) on
Informational only — not a medical device.
Where it is registered
Pravastatin und fenofibrat is registered in 8 of 19 countries.
Countries holding a registration under ATC C10BA03 (pravastatin und fenofibrat), each read from that country’s own register.
- This record: Ireland, from HPRA (Ireland)
- 5 of them publish a price we can compare per daily dose
Pravastatin und fenofibrat · ATC C10BA03
8 / 19 countries
- Belgiumprice
- Czechiaprice
- Denmark
- Finlandprice
- Icelandprice
- Ireland
- Netherlands
- Polandprice
The record
At a glance
HPRA (Ireland)- Active substance
- Fenofibrate + Pravastatin sodium
- Manufacturer
- Laboratoires SMB S.A.
- Country
- Ireland (IE)
- ATC code
- C10BA03
- ATC class
- Pravastatin und Fenofibrat
- Reimbursed
- Not published by this register
- Source register
- HPRA (Ireland)
- Last checked
- September 28, 2026
Packs & prices · 1
- ie_pa_numberEU/1/11/679/001-006
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same medicine, other countries
Pravastatin und fenofibrat in 7 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- CzechiaPRAVAFENIXLaboratoires S.M.B. S.A., Brusel
- SpainPRAVAFENIX 40 mg/160 mg CAPSULAS DURASLaboratoires S.M.B. S.A.
- FinlandPravafenixLaboratoires SMB S.A.
- IcelandPravafenixLaboratoires SMB S.A.*
- NetherlandsPravafenix 40 mg/160 mg harde capsulesLaboratoires S.M.B. S.A.
- PolandPravafenixLaboratoires SMB s.a.
- SwedenPravafenix 40 mg/160 mg Kapsel, hårdLaboratoires SMB S.A.
Authorised across Europe · EMA
The same active substance is authorised in 4 EEA countries. Names it is sold under:
- Spain · Pravastatina/Fenofibrato Cinfa
- Iceland · Pravafenix
- Liechtenstein · Pravafenix
- Norway · Pravafenix
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/cb8ced25-7605-40df-b5d8-fbf2244c93b4 GET /v1/drugs/cb8ced25-7605-40df-b5d8-fbf2244c93b4?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": [
"Oral use"
],
"source": "hpra",
"atc_all": [
"C10BA",
"C10BA03"
],
"strength": null,
"pa_number": "EU/1/11/679/001-006",
"substances": [
"Fenofibrate",
"Pravastatin sodium"
],
"legal_basis": "Fixed combination application (Article 10b of Directive No 2001/83/EC)",
"market_info": "Unknown",
"authorised_at": "14/04/2011",
"dispensing_status": "Product subject to prescription which may be renewed (B)",
"registration_status": "AU",
"supply_legal_status": "Supply through pharmacies only",
"interchangeable_code": null
}See everything about pravastatin und fenofibrat.
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.