Spain· ES:1161139001
OCALIVA 5 MG COMPRIMIDOS RECUBIERTOS CON PELICULA
A medicinal product containing ácido obeticólico, registered in Spain by Advanz Pharma Limited.
Checked against AEMPS CIMA (Spain) on
Informational only — not a medical device.
The record
At a glance
AEMPS CIMA (Spain)- Active substance
- ácido obeticólico
- Manufacturer
- Advanz Pharma Limited
- Country
- Spain (ES)
- ATC code
- —
- Reimbursed
- Not published by this register
- Source register
- AEMPS CIMA (Spain)
- Last checked
- September 12, 2026
Packs & prices · 0
No packs listed by the register for this record.
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same medicine, other countries
Ácido obeticólico in 8 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- BelgiumOcaliva 5 mgAdvanz Pharma
- FinlandOcalivaAdvanz Pharma Limited
- FranceOCALIVA 5 mg, compriméADVANZ PHARMA LIMITED
- NorwayOcalivaAdvanz Pharma Limited
- SwedenOCALIVA 5 mg Filmdragerad tablettAdvanz Pharma Limited
- CanadaOCALIVAADVANZ PHARMA CANADA INC.
- United KingdomOcaliva 10mg tabletsAdvanz Pharma
- IrelandOcalivaAdvanz Pharma Limited
Authorised across Europe · EMA
The same active substance is authorised in 1 EEA country. Names it is sold under:
- United Kingdom (Northern Ireland) · Ocaliva
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/f6dcc8c5-421d-4e1e-9ff0-9ea56276e62a GET /v1/drugs/f6dcc8c5-421d-4e1e-9ff0-9ea56276e62a?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": "Diagnóstico Hospitalario",
"estado": "{\"aut\":1485852795000,\"rev\":1734079479000}",
"nregistro": "1161139001",
"substance": "ácido obeticólico"
}See everything about ácido obeticólico.
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.