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.
Checked against HPRA (Ireland) on
Informational only — not a medical device.
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
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_numberEU/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.
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.
- CzechiaORPHACOLTHERAVIA, Neuilly-sur-Seine
- BelgiumKolbam 50 mgASK Pharmaceuticals
- FinlandKolbamRetrophin Europe Limited
- United KingdomKolbam 50mg capsulesRetrophin Inc
- FranceORPHACOL 50 mg, géluleTHERAVIA
- United StatesCHOLBAMMirum Pharmaceuticals Inc.
- IcelandOrphacolLaboratoires CTRS
- NetherlandsOrphacol 50 mg, harde capsulesLaboratoires CTRS
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.