Germany· DE-A57-d8409785899e1d3f
Ezetimib/Simvastatin Stada
A medicinal product containing simvastatin, ezetimibe, registered in Germany by Stadapharm Gmbh.
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
- Simvastatin, Ezetimibe
- Manufacturer
- Stadapharm Gmbh
- 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
Simvastatin, ezetimibe in 14 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- CzechiaEZETIMIBE/SIMVASTATIN TEVA CRTeva Pharmaceuticals CR, s.r.o., Praha
- SpainEZETIMIBA/SIMVASTATINA ALTER 10 MG/10 MG COMPRIMIDOS EFGLaboratorios Alter S.A.
- ItalyAMISITELAEBERLIFE FARMACEUTICI S.P.A.
- NetherlandsEzetimibe/Simvastatine Aurobindo 10/10 mg, tablettenAurobindo Pharma B.V.
- SwitzerlandEzetimib Simva Spirig HC
- United Statesezetimibe and simvastatinGlenmark Pharmaceuticals Inc., USA
- FranceEZETIMIBE/SIMVASTATINE ACCORD 10 mg/20 mg, compriméACCORD HEALTHCARE FRANCE
- United KingdomInegy 10mg/20mg tabletsMawdsley-Brooks & Company Ltd
Authorised across Europe · EMA
The same active substance is authorised in 21 EEA countries. Names it is sold under:
- Austria · Ezesim, Ezetimib/Simvastatin Accord
- Belgium · Ezetimib/Simvastatin Ab, Ezetimibe/Simvastatin Krka
- Cyprus · Ezetimibe/Simvastatin Accord, Inegy
- Czechia · Ezetimibe/Simvastatin Teva Cr, Glezisim
- Denmark · Ezetimib/Simvastatin Demo, Ezetimib/Simvastatin Hexal
- Spain · Ezetimiba/Simvastatina Alter, Ezetimiba/Simvastatina Aurovitas
- France · Ezetimibe/Simvastatine Accord, Ezetimibe/Simvastatine Almus
- United Kingdom (Northern Ireland) · Ezetimibe/Simvastatin Accord Healthcare, Ezetimibe/Simvastatin Ascend Laboratories
- Greece · Cildar Plus, Ezetimib/Simvastatin Mylan
- Croatia · Inegy, Vasitimb
- Hungary · Inegy
- Ireland · Ezetimibe/Simvastatin Clonmel, Ezetimibe/Simvastatin Krka
- Iceland · Ezetimib/Simvastatin Krka, Inegy
- Italy · Ezetimibe E Simvastatina Accord, Ezetimibe E Simvastatina Almus
- Luxembourg · Ezetimib/Simvastatin Ratiopharm®, Ezetimibe/Simvastatine Eg
- Netherlands · Ezetimibe/Simvastatin Aurobindo, Ezetimibe/Simvastatine Cf
- Norway · Ezetimib/Simvastatin Glenmark, Ezetimib/Simvastatin Krka
- Portugal · Inegy, Sinvastatina + Ezetimiba Alter
- Sweden · Ezetimib/Simvastatin Krka, Ezetimibe/Simvastatin Accord
- Slovenia · Inegy, Vasitimb
- Slovakia · Cornusan, Ezetimib/Simvastatín Teva B.V.
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/cc580454-d385-44aa-a78e-5c4dac381920 GET /v1/drugs/cc580454-d385-44aa-a78e-5c4dac381920?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": "Simvastatin, Ezetimibe",
"atc_from_source": null,
"authorisation_country": "Germany"
}See everything about simvastatin, ezetimibe.
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.