Ireland· IE-PA-EU/1/20/1432/001
NUBEQA 300 mg film-coated tablets
A darolutamide product containing darolutamide, registered in Ireland by Bayer AG. The same ATC class is registered in 15 of our 19 countries.
Checked against HPRA (Ireland) on
Informational only — not a medical device.
Where it is registered
Darolutamide is registered in 15 of 19 countries.
Countries holding a registration under ATC L02BB06 (darolutamide), each read from that country’s own register.
- This record: Ireland, from HPRA (Ireland)
- 9 of them publish a price we can compare per daily dose
Darolutamide · ATC L02BB06
15 / 19 countries
- Belgiumprice
- Canada
- Czechiaprice
- Denmark
- Finlandprice
- Franceprice
- Icelandprice
- Ireland
- Japan
- Netherlands
- Norwayprice
- Polandprice
- Switzerlandprice
- United Kingdom
- United Statesprice
Price per daily dose
What a daily dose of darolutamide costs, country by country.
Normalised to the WHO defined daily dose (1.2 g), the median price runs from $0.86 in France to $129.97 in Switzerland — a ×151 gap.
- 2 markets with a comparable price for this class
- Public list prices, converted to USD at the rate date shown
Darolutamide · price per daily dose (1.2 g)
USD · FX 28 Sept 2026
- CH Switzerland$129.97
- FR France$0.86
The record
At a glance
HPRA (Ireland)- Active substance
- Darolutamide
- Manufacturer
- Bayer AG
- Country
- Ireland (IE)
- ATC code
- L02BB06
- ATC class
- Darolutamide
- Defined daily dose
- 1.2 g, O
- Reimbursed
- Not published by this register
- Source register
- HPRA (Ireland)
- Last checked
- September 28, 2026
Packs & prices · 1
- ie_pa_numberEU/1/20/1432/001
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Interactions
216 interactions on record for darolutamide.
Graded by severity as the source publishes them — 19 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
Darolutamide · interactions on record
216 records
- 19 severe
- 141 moderate
- 56 minor
Most severe, free to view
- EluxadolineA07DA06severe
- BerotralstatB06AC06severe
- RosuvastatinC10AA07severe
- DexamethasoneH02AB02severe
- 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
Darolutamide in 14 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- BelgiumNubeqa 300 mgBayer
- SwitzerlandNUBEQA 300 mg, FilmtablettenBayer (Schweiz) AG
- CzechiaNUBEQABayer AG, Leverkusen
- SpainNUBEQA 300 MG COMPRIMIDOS RECUBIERTOS CON PELICULABayer Ag
- FinlandNubeqaBayer AG
- FranceNUBEQA 300 mg, comprimé pelliculéBAYER AG (ALLEMAGNE)
- IcelandNubeqaBayer AG*
- NetherlandsNubeqa 300 mg, filmomhulde tablettenBayer AG
Authorised across Europe · EMA
The same active substance is authorised in 3 EEA countries. Names it is sold under:
- Iceland · Nubeqa
- Liechtenstein · Nubeqa
- Norway · Nubeqa
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/2755968e-587a-4fcc-a558-390af08646dd GET /v1/drugs/2755968e-587a-4fcc-a558-390af08646dd?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": [
"L02BB06"
],
"strength": null,
"pa_number": "EU/1/20/1432/001",
"substances": [
"Darolutamide"
],
"legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)",
"market_info": "Unknown",
"authorised_at": "27/03/2020",
"dispensing_status": "Product subject to prescription which may not be renewed (A)",
"registration_status": "AU",
"supply_legal_status": "Supply through pharmacies only",
"interchangeable_code": null
}See everything about darolutamide.
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.