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Belgium· BE-AMP-SAM665208-00

Rosufibric 20 mg - 160 mg

A rosuvastatin und fenofibrat product containing rosuvastatin calcium, registered in Belgium by Laboratoires S.M.B.. The same ATC class is registered in 3 of our 19 countries.

ATC C10BA09

Checked against FAMHP / AFMPS (Belgium) on

Informational only — not a medical device.

SOURCE REGISTER · BEFAMHP / AFMPS (Belgium)normalisedRosufibric 20 mg - 160 mgATCC10BA09REGISTER NO.BE-AMP-SAM665208-00PACKS LISTED0CHECKEDSeptember 26, 2026

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: Belgium, from FAMHP / AFMPS (Belgium)
  • 1 of them publish a price we can compare per daily dose

Rosuvastatin und fenofibrat · ATC C10BA09

3 / 19 countries

  • Belgiumprice
  • Denmark
  • Netherlands
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

FAMHP / AFMPS (Belgium)
Active substance
Rosuvastatin Calcium
Manufacturer
Laboratoires S.M.B.
Country
Belgium (BE)
ATC code
C10BA09
ATC class
Rosuvastatin und Fenofibrat
Reimbursed
Not published by this register
Source register
FAMHP / AFMPS (Belgium)
Last checked
September 26, 2026

Packs & prices · 0

No packs listed by the register for this record.

Regulatory notes

No shortage, Orange Book or US label notes for this record.

Same medicine, other countries

Rosuvastatin und fenofibrat in 17 other countries

What each register calls a product with the same active substance — salts and hydrates count as the same.

All rosuvastatin und fenofibrat products

Authorised across Europe · EMA

The same active substance is authorised in 29 EEA countries. Names it is sold under:

  • Austria · Arosuva, Crestor
  • Bulgaria · Rossta, Rosuvastatin Viatris
  • Cyprus · Artepro, Celmantin
  • Czechia · Corvapro Neo, Mertenil
  • Germany · Crestor, Rosuvador
  • Denmark · Celmantin, Crestor
  • Estonia · Crestor, Rosucard
  • Spain · Abemax, Alcotina
  • Finland · Crestor, Rosuvastatin Actavis
  • France · Crestor, Rosuvastatine Almus
  • United Kingdom (Northern Ireland) · Crestor, Enebium
  • Greece · Celmantin, Crestilen
  • Croatia · Corvapro, Corvapro Neo
  • Hungary · Delipid, Ropuido
  • Ireland · Crestor, Rosuva
  • Iceland · Platorel, Rosuvastatin Actavis
  • Italy · Borghes, Colcardiol
  • Lithuania · Crestor, Rosuvacard
  • Luxembourg · Crestor, Rosuvastatin Micro Labs
  • Latvia · Crestor, Rosuvacard
  • Malta · Celmantin, Corvapro Neo
  • Netherlands · Crestor, Provisacor
  • Norway · Crestor, Rosuvastatin Glenmark
  • Poland · Aporoza, Crosuvo
  • Portugal · Crestor, Crestor 10mg Ip
  • Romania · Crestor, Rosi
  • Sweden · Crestor, Rosuvastatin Glenmark
  • Slovenia · Celmantin, Coupet
  • Slovakia · Provacor, Rosucard

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 FAMHP / AFMPS (Belgium). 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/b53a074d-593e-4766-a761-f61acb47cfd5
GET /v1/drugs/b53a074d-593e-4766-a761-f61acb47cfd5?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",
  "source": "afmps",
  "status": "AUTHORIZED",
  "name_en": "Rosufibric 20 mg - 160 mg",
  "name_fr": "Rosufibric 20 mg - 160 mg",
  "name_nl": "Rosufibric 20 mg - 160 mg",
  "amp_code": "SAM665208-00",
  "strengths": [
    "21.0000",
    "21.0000",
    "20.0000",
    "20.0000",
    "160.0000",
    "160.0000",
    "111.9000",
    "18.0000"
  ],
  "pack_count": 1,
  "substances": [
    "Rosuvastatin Calcium",
    "Rosuvastatin",
    "Fenofibrate",
    "Lactose Monohydrate",
    "Sodium Starch Glycolate (Type A)"
  ],
  "medicine_type": "ALLOPATHIC",
  "atc_description": "Rosuvastatin and Fenofibrate",
  "authorisation_numbers": [
    "BE665208"
  ]
}

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.