Germany· DE-A57-481fe8a134609a57
Rosuamlo Apontis
A medicinal product containing amlodipine, rosuvastatin, registered in Germany by Adamed Pharma S.A..
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
- Amlodipine, Rosuvastatin
- Manufacturer
- Adamed Pharma S.A.
- 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
Amlodipine, rosuvastatin in 4 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- ItalyCOAREDAMSCHARPER S.P.A.
- SpainROSUVASTATINA/AMLODIPINO ARISTO 10 MG/10 MG CAPSULAS DURASAristo Pharma Gmbh
- FinlandRosudapinKRKA d.d. Novo mesto
- PolandRosuvastatin/Amlodipine TevaTeva B.V.
Authorised across Europe · EMA
The same active substance is authorised in 5 EEA countries. Names it is sold under:
- Bulgaria · Тинтарос Ам
- Spain · Rosuvastatina/Amlodipino Aristo
- Italy · Coaredam, Rosulod
- Poland · Rosuvastatin/Amlodipine Teva, Zahron Combi
- Portugal · Asutam
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/6e3c75aa-1fa5-4e7e-b00f-b555fd6771cc GET /v1/drugs/6e3c75aa-1fa5-4e7e-b00f-b555fd6771cc?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": "Amlodipine, Rosuvastatin",
"atc_from_source": null,
"authorisation_country": "Germany"
}See everything about amlodipine, 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.