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Ireland· IE-PA-EU/1/16/1139/001

Ocaliva

A obeticholic acid product containing obeticholic acid, registered in Ireland by Advanz Pharma Limited. The same ATC class is registered in 7 of our 19 countries.

ATC A05AA04

Checked against HPRA (Ireland) on

Informational only — not a medical device.

SOURCE REGISTER · IEHPRA (Ireland)normalisedOcalivaATCA05AA04REGISTER NO.IE-PA-EU/1/16/1139/001PACKS LISTED1CHECKEDSeptember 28, 2026
Compare price across countriesPer daily dose · free accountAsk the assistant about obeticholic acidAnswers with sources · free accountCheck interactionsSeverity free · mechanism on Growth

Where it is registered

Obeticholic acid is registered in 7 of 19 countries.

Countries holding a registration under ATC A05AA04 (obeticholic acid), each read from that country’s own register.

  • This record: Ireland, from HPRA (Ireland)
  • 3 of them publish a price we can compare per daily dose
Search obeticholic acid products by name

Obeticholic acid · ATC A05AA04

7 / 19 countries

  • Belgiumprice
  • Canada
  • Denmark
  • Finlandprice
  • Ireland
  • Norwayprice
  • United Kingdom
Blue: a registration under this ATC code. The ringed marker is this record’s country. Markets marked price publish a price we can compare per daily dose.

The record

At a glance

HPRA (Ireland)
Active substance
Obeticholic acid
Manufacturer
Advanz Pharma Limited
Country
Ireland (IE)
ATC code
A05AA04
ATC class
Obeticholic acid
Defined daily dose
10 mg, O
Reimbursed
Not published by this register
Source register
HPRA (Ireland)
Last checked
September 28, 2026

Packs & prices · 1

  • ie_pa_number
    EU/1/16/1139/001

Regulatory notes

No shortage, Orange Book or US label notes for this record.

Interactions

49 interactions on record for obeticholic acid.

Graded by severity as the source publishes them — 2 severe. Severity grades are free for everyone; mechanism and management come with Growth.

  • Severity for every pair — free, no plan needed
  • The source, licence and sync date on every record
  • Mechanism and what to do for each pair — Growth plan
Check obeticholic acid against other medicinesHow interaction checks work

Obeticholic acid · interactions on record

49 records

  • 2 severe
  • 44 moderate
  • 3 minor

Most severe, free to view

  • GrazoprevirJ05AP11severe
  • TizanidineM03BX02severe
  • AlosetronA03AE01moderate
  • DicoumarolB01AA01moderate
  • Interaction severity from DDInter 2.0 (Xiong G. et al., Nucleic Acids Res.), licensed CC BY-NC 4.0 — free for non-commercial use only; not covered by the Drug Database commercial licence.
Mechanism and what to do, in the interaction check
Source: DDInter 2.0 · synced 29 Sept 2026. Grades as the source publishes them.

Same medicine, other countries

Obeticholic acid in 8 other countries

What each register calls a product with the same active substance — salts and hydrates count as the same.

All obeticholic acid products

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 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/0258c613-5e40-46f6-92f1-e84b30305c7b
GET /v1/drugs/0258c613-5e40-46f6-92f1-e84b30305c7b?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": [
    "A05AA",
    "A05AA04"
  ],
  "strength": null,
  "pa_number": "EU/1/16/1139/001",
  "substances": [
    "Obeticholic acid"
  ],
  "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)",
  "market_info": "Unknown",
  "authorised_at": null,
  "dispensing_status": "Product subject to prescription which may be renewed (B)",
  "registration_status": "AU",
  "supply_legal_status": "Supply through pharmacies only",
  "interchangeable_code": null
}
API referenceMCP serverPlans

See everything about obeticholic acid.

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.

Try it freeOpen in the console