Germany· DE-A57-50e526350c0ece60
Rosuzet
A medicinal product containing ezetimibe, rosuvastatin, registered in Germany by Aristo Pharma Gmbh (Art 57).
Checked against EMA Article 57 (European Union) on
Informational only — not a medical device.
The record
At a glance
EMA Article 57 (European Union)- Active substance
- Ezetimibe, Rosuvastatin
- Manufacturer
- Aristo Pharma Gmbh (Art 57)
- Country
- Germany (DE)
- ATC code
- —
- Reimbursed
- Not published by this register
- Source register
- EMA Article 57 (European Union)
- Last checked
- September 30, 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
Ezetimibe, rosuvastatin in 10 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- CzechiaDELIPID PLUSEgis Pharmaceuticals PLC, Budapešť
- SpainALZIL PLUS 10 MG/10 MG COMPRIMIDOS RECUBIERTOS CON PELICULAFerrer Internacional S.A.
- ItalyAUROZEBAURORA BIOFARMA S.R.L.
- PolandCorosweraKrka, d.d., Novo mesto
- NetherlandsEklipo 10 mg/10 mg filmomhulde tablettenMedicair Bioscience Laboratories CY Limited
- SwitzerlandEzetimib Rosuvastatin axapharm
- FranceLIPOROSA 10 mg/10 mg, géluleDIFARMED (ESPAGNE)
- NorwayRostezeEQL Pharma AB
Authorised across Europe · EMA
The same active substance is authorised in 25 EEA countries. Names it is sold under:
- Austria · Arosuva Plus Ezetimib, Ezerosu
- Belgium · Cholecomb, Ezetimibe/Rosuvastatin Sandoz
- Bulgaria · Rosteza 10 Mg/10 Mg, Rosteza 20 Mg/10 Mg
- Cyprus · Celmantin Plus, Lipocomb
- Czechia · Delipid Plus, Refidoro
- Estonia · Delipid Plus, Rosazimib
- Spain · Alzil Plus, Arrox Plus
- Finland · Rosuvastatin/Ezetimib Krka, Rosuvastatin/Ezetimibe Ratiopharm
- France · Liporosa, Quiloga
- Greece · Celmantin Plus, Co-Rosuvador
- Croatia · Arosen, Co-Roswera
- Hungary · Co-Xeter, Delipid Plus
- Ireland · Lipocomb, Rosuvastatin/Ezetimibe Krka
- Italy · Aurozeb, Cholecomb
- Lithuania · Roselia, Sorvitimb
- Luxembourg · Cholecomb, Myrosor
- Latvia · Rosazimib, Rosulip
- Malta · Ezehron Duo, Lipocomb
- Netherlands · Ayadont, Cholecomb
- Norway · Rosteze, Rosuvastatin/Ezetimib Krka
- Poland · Coroswera, Ezehron Duo
- Portugal · Colroset, Lipocomb
- Romania · Co-Roswera, Lipocomb
- Slovenia · Refidoro, Rozor
- Slovakia · Lipocomb, Rosazimib
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 EMA Article 57 (European Union). 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/ec19b83b-24df-4f78-8527-45e74f210fc6 GET /v1/drugs/ec19b83b-24df-4f78-8527-45e74f210fc6?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.
{
"pzn": null,
"route": "Oral Use",
"source": "ema_art57_de",
"ma_number": null,
"substance": "Ezetimibe, Rosuvastatin",
"atc_from_source": null,
"authorisation_country": "Germany"
}See everything about ezetimibe, rosuvastatin.
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.