Sweden· SE-20091222000019
Pravafenix 40 mg/160 mg Kapsel, hård
A medicinal product containing pravastatin sodium + fenofibrate, registered in Sweden by Laboratoires SMB S.A..
Checked against Swedish Medical Products Agency (Sweden) on
Informational only — not a medical device.
The record
At a glance
Swedish Medical Products Agency (Sweden)- Active substance
- Pravastatin Sodium + Fenofibrate
- Manufacturer
- Laboratoires SMB S.A.
- Country
- Sweden (SE)
- ATC code
- —
- Reimbursed
- Not published by this register
- Source register
- Swedish Medical Products Agency (Sweden)
- Last checked
- October 1, 2026
Packs & prices · 1
- se_varunummer20091222000019
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same medicine, other countries
Pravastatin sodium + fenofibrate 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.
- IrelandPravafenix 40 mg/160 mg hard capsulesLaboratoires SMB S.A.
- IcelandPravafenixLaboratoires SMB S.A.*
- NetherlandsPravafenix 40 mg/160 mg harde capsulesLaboratoires S.M.B. S.A.
- PolandPravafenixLaboratoires 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 Swedish Medical Products Agency (Sweden). 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/fa123312-2da7-4303-9ba9-1c1da369754d GET /v1/drugs/fa123312-2da7-4303-9ba9-1c1da369754d?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.
{
"source": "lakemedelsverket",
"doc_types": [
"EMA",
"EPAR"
],
"se_npl_id": "20091222000019",
"product_page": "https://www.lakemedelsverket.se/sv/sok-lakemedelsfakta/lakemedel?id=20091222000019",
"product_doc_link": "https://www.ema.europa.eu/en/medicines/human/EPAR/pravafenix"
}See everything about pravastatin sodium + fenofibrate.
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.