France· FR:69761794
OCALIVA 10 mg, comprimé
A medicinal product containing acide obéticholique, registered in France by ADVANZ PHARMA LIMITED.
Checked against Base de données publique des médicaments — BDPM (France) on
Informational only — not a medical device.
The record
At a glance
Base de données publique des médicaments — BDPM (France)- Active substance
- ACIDE OBÉTICHOLIQUE
- Manufacturer
- ADVANZ PHARMA LIMITED
- Country
- France (FR)
- ATC code
- —
- Reimbursed
- No
- Source register
- Base de données publique des médicaments — BDPM (France)
- Last checked
- September 12, 2026
Packs & prices · 1
- cip1334009300790651 flacon(s) polyéthylène haute densité (PEHD) avec fermeture de sécurité enfant de 30 comprimé(s)
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same medicine, other countries
Acide obéticholique in 8 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- BelgiumOcaliva 10 mgAdvanz Pharma
- SpainOCALIVA 10 MG COMPRIMIDOS RECUBIERTOS CON PELICULAAdvanz Pharma Limited
- FinlandOcalivaAdvanz Pharma Limited
- NorwayOcalivaAdvanz Pharma Limited
- SwedenOCALIVA 10 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 Base de données publique des médicaments — BDPM (France). 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/bdbc8a84-a60e-49c5-9b0c-ee982359642e GET /v1/drugs/bdbc8a84-a60e-49c5-9b0c-ee982359642e?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.
{
"cis": "69761794",
"date_amm": "2016-12-12",
"type_amm": "Procédure centralisée",
"numero_ue": "EU/1/16/1139",
"substance": "ACIDE OBÉTICHOLIQUE",
"statut_amm": "Autorisation retirée",
"statut_bdm": "Alerte",
"forme_pharmaceutique": "comprimé pelliculé",
"voies_administration": "orale",
"etat_commercialisation": "Non commercialisée",
"surveillance_renforcee": "Non"
}See everything about acide obéticholique.
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.