Ireland· IE-PA-PA0126/411/001
Enzalutamide Clonmel 160 mg film-coated tablets
A ql02bb04 product containing enzalutamide, registered in Ireland by Clonmel Healthcare Ltd.
Checked against HPRA (Ireland) on
Informational only — not a medical device.
The record
At a glance
HPRA (Ireland)- Active substance
- Enzalutamide
- Manufacturer
- Clonmel Healthcare Ltd
- Country
- Ireland (IE)
- ATC code
- QL02BB04
- ATC class
- QL02BB04
- Reimbursed
- Not published by this register
- Source register
- HPRA (Ireland)
- Last checked
- September 28, 2026
Packs & prices · 1
- ie_pa_numberPA0126/411/001
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same medicine, other countries
Enzalutamide in 15 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- CzechiaENZALUTAMID SANDOZ S.R.O.Sandoz s.r.o., Praha
- NetherlandsEnzalutamide 1A Pharma 160 mg, filmomhulde tabletten1A Pharma GmbH
- SwedenEnzalutamide Accordpharma 160 mg Filmdragerad tablettAccord Healthcare S.L.U.
- BelgiumEnzalutamide Accordpharma 160 mgAccord Healthcare
- PolandEnzalutamide AccordpharmaAccord Healthcare S.L.U.
- IcelandEnzalutamide AccordpharmaAccord Healthcare S.L.U.
- SpainENZALUTAMIDA STADA 160 MG COMPRIMIDOS RECUBIERTOS CON PELICULALaboratorio Stada S.L.
- SwitzerlandEnzalutamid Sandoz 160 mg, FilmtablettenSandoz Pharmaceuticals AG
Authorised across Europe · EMA
The same active substance is authorised in 30 EEA countries. Names it is sold under:
- Austria · Englabloc, Enzalutamid 1a Pharma
- Belgium · Enzalutamide Accord, Enzalutamide Eg
- Bulgaria · Ензалутамид Sdz, Ензалутамид Сандоз
- Cyprus · Enzalutamide Accord, Enzalutamide Ebewe
- Czechia · Enzalutamid Sandoz S.R.O., Enzalutamid Stada
- Germany · Enzalutamid Accord, Enzalutamid Al
- Denmark · Enzalutamide "sandoz", Enzalutamide Hexal
- Estonia · Enzalutamide Accord, Enzalutamide Norameda
- Spain · Enzalutamida Accord, Enzalutamida Sandoz
- Finland · Enzalutamide 1a Farma, Enzalutamide Adalvo
- France · Enzalutamide Accord, Enzalutamide Biogaran
- United Kingdom (Northern Ireland) · Enzalutamide Accord Healthcare, Enzalutamide Genus Pharmaceuticals
- Greece · Enzalutamide Accord, Enzalutamide Anabiosis
- Croatia · Enzalutamid Accord, Enzalutamid Pharmascience
- Hungary · Enzalutamid 1 A Pharma, Enzalutamid Sandoz
- Iceland · Enzalutamide Accordpharma, Enzalutamide Hexal
- Italy · Enzalutamide Accord, Enzalutamide Eg
- Liechtenstein · Enzalutamide Accordpharma, Enzalutamide Viatris
- Lithuania · Enzalutamide Accord, Enzalutamide Hexal
- Luxembourg · Enzalutamide Eg
- Latvia · Enzalutamide Accord, Enzalutamide Hexal
- Malta · Enzalutamid Pharos, Enzalutamide
- Netherlands · Enzalutamide 1a Pharma, Enzalutamide Anabiosis
- Norway · Enzalutamide Accord, Enzalutamide Accordpharma
- Poland · Enzalutamid Sandoz, Enzalutamide
- Portugal · Enzalutamida Stada, Enzalutamida Stada 40 Mg Comprimidos Revestidos Por Película
- Romania · Enzalutamidă Accord, Enzalutamida Rhei
- Sweden · Enzalutamid Sun Pharma, Enzalutamide Hexal
- Slovenia · Enzalutamid Sandoz, Enzalutamid Sandoz Gmbh
- Slovakia · Englabloc, Enzalutamid Sandoz
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/fdaeaf63-5f10-4ed1-bd6b-95332cb5cb4c GET /v1/drugs/fdaeaf63-5f10-4ed1-bd6b-95332cb5cb4c?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": [
"QL02BB04"
],
"strength": null,
"pa_number": "PA0126/411/001",
"substances": [
"Enzalutamide"
],
"legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)",
"market_info": "Not marketed",
"authorised_at": "24/10/2025",
"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 enzalutamide.
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.