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Netherlands· NL-5fe6a7465575

Pravafenix 40 mg/160 mg harde capsules

A pravastatin und fenofibrat product containing fenofibraat + pravastatine natrium, registered in Netherlands by Laboratoires S.M.B. S.A.. The same ATC class is registered in 8 of our 19 countries.

ATC C10BA03

Checked against CBG-MEB (Netherlands) on

Informational only — not a medical device.

SOURCE REGISTER · NLCBG-MEB (Netherlands)normalisedPravafenix 40 mg/160 mg harde capsulesATCC10BA03REGISTER NO.NL-5fe6a7465575PACKS LISTED1CHECKEDSeptember 29, 2026
Compare price across countriesPer daily dose · free accountAsk the assistant about fenofibraat + pravastatine natriumAnswers with sources · free accountCheck interactionsSeverity free · mechanism on Growth

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: Netherlands, from CBG-MEB (Netherlands)
  • 5 of them publish a price we can compare per daily dose
Search pravastatin und fenofibrat products by name

Pravastatin und fenofibrat · ATC C10BA03

8 / 19 countries

  • Belgiumprice
  • Czechiaprice
  • Denmark
  • Finlandprice
  • Icelandprice
  • Ireland
  • Netherlands
  • Polandprice
Blue: a registration under this ATC code. The ringed marker is this record’s country. Markets marked price publish a price we can compare per daily dose.

The record

At a glance

CBG-MEB (Netherlands)
Active substance
FENOFIBRAAT + PRAVASTATINE NATRIUM
Manufacturer
Laboratoires S.M.B. S.A.
Country
Netherlands (NL)
ATC code
C10BA03
ATC class
Pravastatin und Fenofibrat
Reimbursed
Not published by this register
Source register
CBG-MEB (Netherlands)
Last checked
September 29, 2026

Packs & prices · 1

  • cbg_meb_id
    EU/1/11/697

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.

All pravastatin und fenofibrat products

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 CBG-MEB (Netherlands). 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/799a48a6-63d3-49a9-81cc-29e1c9144e73
GET /v1/drugs/799a48a6-63d3-49a9-81cc-29e1c9144e73?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",
  "route": "Oraal gebruik",
  "soort": null,
  "source": "cbg_meb",
  "smpc_url": "https://www.ema.europa.eu/en/documents/product-information/pravafenix-epar-product-information_nl.pdf",
  "strength": null,
  "atc_label": "Pravastatin and fenofibrate",
  "detail_url": "https://www.geneesmiddeleninformatiebank.nl/nl/cp106524",
  "excipients": [
    "ASCORBYLPALMITAAT (E 304)",
    "CELLULOSE, MICROKRISTALLIJN (E 460(i))",
    "GELATINE (E 441)",
    "GLYCEROLTRIACETAAT (E 1518)",
    "HYPROLOSE (E 463)",
    "IJZEROXIDE GEEL (E 172)",
    "IJZEROXIDE ZWART (E 172)",
    "INDIGOKARMIJN (E 132)",
    "LACTOSE 1-WATER",
    "LAUROYLMACROGOLGLYCERIDEN",
    "MACROGOL 20000",
    "MAGNESIUMSTEARAAT (E 470b)",
    "NATRIUMWATERSTOFCARBONAAT (E 500 (II))",
    "NATRIUMZETMEELGLYCOLAAT",
    "POVIDON K 30 (E 1201)",
    "TALK (E 553b)",
    "TITAANDIOXIDE (E 171)"
  ],
  "substances": [
    "FENOFIBRAAT",
    "PRAVASTATINE NATRIUM"
  ],
  "leaflet_url": null,
  "authorised_at": "2011/04/14",
  "procedure_number": "EMEA/H/C/001243",
  "dispensing_status": "Uitsluitend recept",
  "registration_number": "EU/1/11/697",
  "additional_monitoring": "N"
}
API referenceMCP serverPlans

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.

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