Netherlands· NL-debe85de1f5c
Rosuvastatine/Fenofibraat Viatris 10 mg/160 mg filmomhulde tabletten
A rosuvastatin und fenofibrat product containing fenofibraat + rosuvastatine calcium 0-water, registered in Netherlands by Viatris Healthcare B.V.. The same ATC class is registered in 3 of our 19 countries.
Checked against CBG-MEB (Netherlands) on
Informational only — not a medical device.
Where it is registered
Rosuvastatin und fenofibrat is registered in 3 of 19 countries.
Countries holding a registration under ATC C10BA09 (rosuvastatin und fenofibrat), each read from that country’s own register.
- This record: Netherlands, from CBG-MEB (Netherlands)
- 1 of them publish a price we can compare per daily dose
Rosuvastatin und fenofibrat · ATC C10BA09
3 / 19 countries
- Belgiumprice
- Denmark
- Netherlands
The record
At a glance
CBG-MEB (Netherlands)- Active substance
- FENOFIBRAAT + ROSUVASTATINE CALCIUM 0-WATER
- Manufacturer
- Viatris Healthcare B.V.
- Country
- Netherlands (NL)
- ATC code
- C10BA09
- ATC class
- Rosuvastatin und Fenofibrat
- Reimbursed
- Not published by this register
- Source register
- CBG-MEB (Netherlands)
- Last checked
- September 29, 2026
Packs & prices · 1
- cbg_meb_id133381
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same medicine, other countries
Rosuvastatin und fenofibrat in 1 other country
What each register calls a product with the same active substance — salts and hydrates count as the same.
Authorised across Europe · EMA
The same active substance is authorised in 6 EEA countries. Names it is sold under:
- Belgium · Rosufibric
- Denmark · Rosufenx
- Spain · Fenzil, Ixfenro
- Luxembourg · Rosufibric
- Portugal · Fenyrox, Ixfenro
- Slovakia · Ixfenro
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/08c9c831-1b61-4c12-b544-9903da3adc78 GET /v1/drugs/08c9c831-1b61-4c12-b544-9903da3adc78?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": "Filmomhulde tablet",
"route": "Oraal gebruik",
"soort": "RVG",
"source": "cbg_meb",
"smpc_url": "https://www.geneesmiddeleninformatiebank.nl/smpc/h133381_smpc_en.pdf",
"strength": null,
"atc_label": "Rosuvastatin and fenofibrate",
"detail_url": "https://www.geneesmiddeleninformatiebank.nl/nl/rvg133381",
"excipients": [
"CALCIUMWATERSTOFFOSFAAT 2-WATER (E 341)",
"CELLULOSE, MICROKRISTALLIJN (E 460(i))",
"CROSPOVIDON (E 1202)",
"HYPROMELLOSE 2910 (3 - 15 mPa.s) (E 464)",
"IJZEROXIDE GEEL (E 172)",
"LACTOSE 1-WATER",
"MACROGOL 4000",
"MANNITOL (D-) (E 421)",
"MAÏSZETMEEL, GEPREGELATINEERD",
"MEGLUMINE",
"NATRIUMLAURILSULFAAT",
"NATRIUMSTEARYLFUMARAAT",
"POVIDON K 30 (E 1201)",
"SELENIUMDIOXIDE",
"TITAANDIOXIDE (E 171)"
],
"substances": [
"FENOFIBRAAT",
"ROSUVASTATINE CALCIUM 0-WATER"
],
"leaflet_url": "https://www.geneesmiddeleninformatiebank.nl/bijsluiters/h133381_piluk.pdf",
"authorised_at": "2026/05/13",
"procedure_number": "NL/H/6131/001",
"dispensing_status": "Uitsluitend recept",
"registration_number": "133381",
"additional_monitoring": "N"
}See everything about rosuvastatin 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.