Back to search

Ireland· IE-PA-EU/1/13/870/001-003

Orphacol 50 mg hard capsules

A cholic acid product containing cholic acid, registered in Ireland by Theravia. The same ATC class is registered in 11 of our 19 countries.

ATC A05AA03

Checked against HPRA (Ireland) on

Informational only — not a medical device.

SOURCE REGISTER · IEHPRA (Ireland)normalisedOrphacol 50 mg hard capsulesATCA05AA03REGISTER NO.IE-PA-EU/1/13/870/001…PACKS LISTED1CHECKEDSeptember 28, 2026

Where it is registered

Cholic acid is registered in 11 of 19 countries.

Countries holding a registration under ATC A05AA03 (cholic acid), each read from that country’s own register.

  • This record: Ireland, from HPRA (Ireland)
  • 6 of them publish a price we can compare per daily dose

Cholic acid · ATC A05AA03

11 / 19 countries

  • Belgiumprice
  • Czechiaprice
  • Denmark
  • Finlandprice
  • Icelandprice
  • Ireland
  • Japan
  • Netherlands
  • Polandprice
  • United Kingdom
  • United Statesprice
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
Cholic acid
Manufacturer
Theravia
Country
Ireland (IE)
ATC code
A05AA03
ATC class
Cholic acid
Defined daily dose
0.25 g, O
Reimbursed
Not published by this register
Source register
HPRA (Ireland)
Last checked
September 28, 2026

Packs & prices · 1

  • ie_pa_number
    EU/1/13/870/001-003

Regulatory notes

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

Interactions

12 interactions on record for cholic acid.

Graded by severity as the source publishes them — 12 moderate. 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

Cholic acid · interactions on record

12 records

  • 12 moderate

Most severe, free to view

  • SucralfateA02BX02moderate
  • ColestyramineC10AC01moderate
  • ColestipolC10AC02moderate
  • ColesevelamC10AC04moderate
  • 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

Cholic acid in 12 other countries

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

All cholic acid products

Authorised across Europe · EMA

The same active substance is authorised in 4 EEA countries. Names it is sold under:

  • United Kingdom (Northern Ireland) · Orphacol
  • Iceland · Orphacol
  • Liechtenstein · Orphacol
  • Norway · Orphacol

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/6a1c9d51-d8c2-4a77-9492-30f766f5b47d
GET /v1/drugs/6a1c9d51-d8c2-4a77-9492-30f766f5b47d?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": [
    "A05AA",
    "A05AA03"
  ],
  "strength": null,
  "pa_number": "EU/1/13/870/001-003",
  "substances": [
    "Cholic acid"
  ],
  "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)",
  "market_info": "Unknown",
  "authorised_at": "12/09/2013",
  "dispensing_status": "Product subject to prescription which may not be renewed (A)",
  "registration_status": "AU",
  "supply_legal_status": "Supply through pharmacies only",
  "interchangeable_code": null
}

See everything about cholic 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.