Spain· ES:1151066003IP3
ONGENTYS 50 MG CAPSULAS DURAS
A medicinal product containing opicapona, registered in Spain by Bial Portela & Ca S.A..
Checked against AEMPS CIMA (Spain) on
Informational only — not a medical device.
The record
At a glance
AEMPS CIMA (Spain)- Active substance
- Opicapona
- Manufacturer
- Bial Portela & Ca S.A.
- Country
- Spain (ES)
- ATC code
- —
- Reimbursed
- Not published by this register
- Source register
- AEMPS CIMA (Spain)
- Last checked
- September 12, 2026
Packs & prices · 1
1 priced- cima_codigo76710430EUR 130.66
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same medicine, other countries
Opicapona in 14 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- CzechiaONGENTYSBIAL - Portela & Ca., SA, S. Mamede do Coronado
- FinlandOngentysBial Portela & C, S.A.
- SwitzerlandOngentys 50 mg, gélulesBial SA
- PolandOngentysBIAL - Portela & Ca. SA
- United KingdomOngentys 50mg capsulesBIAL Pharma UK Ltd
- BelgiumOngentys 50 mgBIAL - Portela & Cª
- United StatesONGENTYSAmneal Pharmaceuticals LLC
- FranceONGENTYS 50 mg, géluleBIAL - PORTELA & CA (PORTUGAL)
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 AEMPS CIMA (Spain). 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/f8625139-f596-4b8d-8d2a-129fed6aa168 GET /v1/drugs/f8625139-f596-4b8d-8d2a-129fed6aa168?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.
{
"cpresc": "Medicamento Sujeto A Prescripción Médica",
"estado": "{\"aut\":1741187047000}",
"nregistro": "1151066003IP3",
"substance": "Opicapona"
}See everything about opicapona.
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.