Ireland· IE-PA-EU/1/16/1152/016-028
Roteas 60 mg film-coated tablets
A edoxaban product containing edoxaban tosilate, registered in Ireland by Berlin-Chemie AG. The same ATC class is registered in 17 of our 19 countries.
Checked against HPRA (Ireland) on
Informational only — not a medical device.
Where it is registered
Edoxaban is registered in 17 of 19 countries.
Countries holding a registration under ATC B01AF03 (edoxaban), each read from that country’s own register.
- This record: Ireland, from HPRA (Ireland)
- 10 of them publish a price we can compare per daily dose
Edoxaban · ATC B01AF03
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 edoxaban costs, country by country.
Normalised to the WHO defined daily dose (60 mg), so markets compare like for like.
- 2 markets with a comparable price for this class
- Public list prices, converted to USD at the rate date shown
Edoxaban · price per daily dose (60 mg)
USD · FX 28 Sept 2026
- IT Italy$7.87
- CH Switzerland$6.81
The record
At a glance
HPRA (Ireland)- Active substance
- Edoxaban tosilate
- Manufacturer
- Berlin-Chemie AG
- Country
- Ireland (IE)
- ATC code
- B01AF03
- ATC class
- Edoxaban
- Defined daily dose
- 60 mg, O
- Reimbursed
- Not published by this register
- Source register
- HPRA (Ireland)
- Last checked
- September 28, 2026
Packs & prices · 1
- ie_pa_numberEU/1/16/1152/016-028
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Interactions
262 interactions on record for edoxaban.
Graded by severity as the source publishes them — 182 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
Edoxaban · interactions on record
262 records
- 182 severe
- 80 moderate
Most severe, free to view
- RolapitantA04AD14severe
- EliglustatA16AX10severe
- DicoumarolB01AA01severe
- WarfarinB01AA03severe
- 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
Edoxaban in 15 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- CzechiaDELIANDAKrka, d.d., Novo mesto, Novo mesto
- SwedenEdoflusio 60 mg Filmdragerad tablettSandoz A/S
- NetherlandsEdoxaban Cipla 60 mg, filmomhulde tablettenCipla Europe N.V.
- SwitzerlandEdoxaban NOBEL 60 mg, FilmtablettenNOBEL Pharma Schweiz AG
- SpainEDOXABAN ALMUS 60 MG COMPRIMIDOS RECUBIERTOS CON PELICULA EFGAlmus Farmaceutica S.A.U.
- FinlandEdoxaban AvansorAvansor Pharma Oy
- PolandDeliandaKrka, d.d., Novo mesto
- IcelandEdoxaban AccordAccord Healthcare B.V.
Authorised across Europe · EMA
The same active substance is authorised in 29 EEA countries. Names it is sold under:
- Austria · Edoflusio, Edoxaban !@ctavis
- Belgium · Edoxaban Hcs, Edoxaban Sandoz
- Bulgaria · Edoflusio, Делианда
- Czechia · Delianda, Edoxaban +pharma
- Germany · Edoxaban 1 A Pharma, Edoxaban 123 Acurae Pharma
- Denmark · Arelzamio, Dijuga
- Estonia · Delianda, Edoflusio
- Spain · Edoxabán Almus, Edoxabán Cinfa
- Finland · Edoxaban Avansor, Edoxaban Krka
- France · Oblonela
- United Kingdom (Northern Ireland) · Edoxaban, Edoxaban Accord
- Greece · Delianda, Edoxaban Pharmapath
- Croatia · Cagluen, Delianda
- Hungary · Cagluen, Delianda
- Iceland · Edoxaban Accord, Edoxaban Krka
- Italy · Edoxaban Dr. Reddy’s, Edoxaban Hcs
- Liechtenstein · Lixiana, Roteas
- Lithuania · Delianda, Edoflusio
- Luxembourg · Oblonela
- Latvia · Delianda, Edoflusio
- Malta · Arelzamio, Dijuga
- Netherlands · Edoxaban Cipla, Edoxaban G.L. Pharma
- Norway · Edoxaban Krka, Edoxaban Sandoz
- Poland · Delianda, Edoflusio
- Portugal · Edoxabano Bluepharma, Edoxabano Kern Pharma
- Romania · Cagluen, Delianda
- Sweden · Edoflusio, Edoxaban Avansor
- Slovenia · Delianda, Edoflusio
- Slovakia · Delianda, Edoxaban Accord
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 HPRA (Ireland). 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/bf20c93c-c0f1-4d01-a7fa-57a9f6acfd25 GET /v1/drugs/bf20c93c-c0f1-4d01-a7fa-57a9f6acfd25?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": "Film-coated tablet",
"routes": [
"Oral use"
],
"source": "hpra",
"atc_all": [
"B01AF",
"B01AF03"
],
"strength": null,
"pa_number": "EU/1/16/1152/016-028",
"substances": [
"Edoxaban tosilate"
],
"legal_basis": "Informed consent application (Article 10c of Directive No 2001/83/EC)",
"market_info": "Unknown",
"authorised_at": "20/04/2017",
"dispensing_status": "Product subject to prescription which may be renewed (B)",
"registration_status": "AU",
"supply_legal_status": "Supply through pharmacies only",
"interchangeable_code": null
}See everything about edoxaban.
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.