Ireland· IE-PA-EU/1/15/1066/002-007
Ongentys 50 mg hard capsules
A other dopaminergic agents product containing opicapone, registered in Ireland by BIAL-Portela & Ca, S.A..
Checked against HPRA (Ireland) on
Informational only — not a medical device.
The record
At a glance
HPRA (Ireland)- Active substance
- Opicapone
- Manufacturer
- BIAL-Portela & Ca, S.A.
- Country
- Ireland (IE)
- ATC code
- N04BX
- ATC class
- Other dopaminergic agents
- Reimbursed
- Not published by this register
- Source register
- HPRA (Ireland)
- Last checked
- September 28, 2026
Packs & prices · 1
- ie_pa_numberEU/1/15/1066/002-007
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same medicine, other countries
Opicapone in 14 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- SpainONGENTYS 50 MG CAPSULAS DURASBial Portela & Ca S.A.
- CzechiaONGENTYSBIAL - Portela & Ca., SA, S. Mamede do Coronado
- FinlandOngentysAbacus Medicine A/S
- SwitzerlandOngentys 50 mg, gélulesBial SA
- BelgiumOngentys 50 mgBIAL - Portela & Cª
- United KingdomOngentys 50mg capsulesPharmaram Ltd
- PolandOngentysBIAL - Portela & Ca. SA
- IcelandOngentysBial - Portela & C. S.A.*
Authorised across Europe · EMA
The same active substance is authorised in 3 EEA countries. Names it is sold under:
- Iceland · Ongentys
- Liechtenstein · Ongentys
- Norway · Ongentys
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/e4562c54-9e0d-49a3-a232-d05b0c062bfe GET /v1/drugs/e4562c54-9e0d-49a3-a232-d05b0c062bfe?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": "Capsule, hard",
"routes": [
"Oral use"
],
"source": "hpra",
"atc_all": [
"N04BX"
],
"strength": null,
"pa_number": "EU/1/15/1066/002-007",
"substances": [
"Opicapone"
],
"legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)",
"market_info": "Unknown",
"authorised_at": "24/06/2016",
"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 opicapone.
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.