Germany· DE-A57-77e0c9d619cd3c6a
Dronedaron Beta
A dronedarone product containing dronedarone, registered in Germany by Betapharm Arzneimittel Gmbh. The same ATC class is registered in 17 of our 19 countries.
Checked against EMA Article 57 (European Union) on
Informational only — not a medical device.
Where it is registered
Dronedarone is registered in 17 of 19 countries.
Countries holding a registration under ATC C01BD07 (dronedarone), each read from that country’s own register.
- This record: Germany, from EMA Article 57 (European Union)
- 10 of them publish a price we can compare per daily dose
Dronedarone · ATC C01BD07
17 / 19 countries
- Belgiumprice
- Canada
- Czechiaprice
- Denmark
- Finlandprice
- Germany
- Icelandprice
- Ireland
- Italyprice
- Netherlands
- Norwayprice
- Polandprice
- Spainprice
- Sweden
- Switzerlandprice
- United Kingdom
- United Statesprice
Price per daily dose
What a daily dose of dronedarone costs, country by country.
Normalised to the WHO defined daily dose (0.8 g), so markets compare like for like.
- 3 markets with a comparable price for this class
- Public list prices, converted to USD at the rate date shown
Dronedarone · price per daily dose (0.8 g)
USD · FX 28 Sept 2026
- CH Switzerland$2.33
- ES Spain$2.15
- IT Italy$1.77
The record
At a glance
EMA Article 57 (European Union)- Active substance
- Dronedarone
- Manufacturer
- Betapharm Arzneimittel Gmbh
- Country
- Germany (DE)
- ATC code
- C01BD07
- ATC class
- Dronedarone
- Defined daily dose
- 0.8 g, O
- 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.
Interactions
446 interactions on record for dronedarone.
Graded by severity as the source publishes them — 176 severe. Severity grades are free for everyone; mechanism and management come with Growth.
- Severity for every pair — free, no plan needed
- The source, licence and sync date on every record
- Mechanism and what to do for each pair — Growth plan
Dronedarone · interactions on record
446 records
- 176 severe
- 176 moderate
- 10 minor
Most severe, free to view
- PapaverineA03AD01severe
- CisaprideA03FA02severe
- OndansetronA04AA01severe
- GranisetronA04AA02severe
84 more interactions with mechanism and management, from a commercially licensed source.
Sign in to check- Interaction severity from DDInter 2.0 (Xiong G. et al., Nucleic Acids Res.), licensed CC BY-NC 4.0 — free for non-commercial use only; not covered by the Drug Database commercial licence.
Same medicine, other countries
Dronedarone in 16 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- United KingdomDronedarone 400mg tabletsMilpharm Ltd
- SpainDRONEDARONA ARISTO 400 MG COMPRIMIDOS RECUBIERTOS CON PELICULA EFGAristo Pharma Gmbh
- SwedenDronedaron Aristo 400 mg Filmdragerad tablettAristo Pharma GmbH
- CzechiaMULTAQSanofi Winthrop Industrie, Gentilly
- IcelandDronedarone STADASTADA Arzneimittel AG
- ItalyDRONEDARONE ARISTOARISTO PHARMA GMBH
- NorwayDronedaron AristoAristo Pharma GmbH
- United StatesMultaqCardinal Health 107, LLC
Authorised across Europe · EMA
The same active substance is authorised in 12 EEA countries. Names it is sold under:
- Denmark · Dronedaron Aristo, Dronedarone Stada
- Spain · Dronedarona Aristo, Dronedarona Aurovitas
- Finland · Dronedarone Stada
- United Kingdom (Northern Ireland) · Dronedarone Aristo, Dronedarone Milpharm
- Croatia · Dronedaron Pliva
- Hungary · Dronedaron Aristo, Dronedaron Ratiopharm
- Iceland · Dronedarone Stada, Dronedarone Teva
- Italy · Dronedarone Aristo, Dronedarone Aurobindo
- Liechtenstein · Multaq
- Norway · Dronedaron Aristo, Dronedarone Teva
- Portugal · Dronedarona Generis
- Sweden · Dronedaron Aristo, Dronedarone Stada
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/1ab26070-f99e-4d9a-ac82-46b61a4b8086 GET /v1/drugs/1ab26070-f99e-4d9a-ac82-46b61a4b8086?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": "Dronedarone",
"atc_from_source": null,
"authorisation_country": "Germany"
}See everything about dronedarone.
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.