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Ireland· IE-PA-EU/1/13/822/001

PHEBURANE 483 mg/g granules

A sodium phenylbutyrate product containing sodium 4-phenylbutyrate, registered in Ireland by Eurocept International BV. The same ATC class is registered in 14 of our 19 countries.

ATC A16AX03

Checked against HPRA (Ireland) on

Informational only — not a medical device.

SOURCE REGISTER · IEHPRA (Ireland)normalisedPHEBURANE 483 mg/g granulesATCA16AX03REGISTER NO.IE-PA-EU/1/13/822/001PACKS LISTED1CHECKEDSeptember 28, 2026

Where it is registered

Sodium phenylbutyrate is registered in 14 of 19 countries.

Countries holding a registration under ATC A16AX03 (sodium phenylbutyrate), each read from that country’s own register.

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

Sodium phenylbutyrate · ATC A16AX03

14 / 19 countries

  • Belgiumprice
  • Canada
  • Czechiaprice
  • Denmark
  • Finlandprice
  • Icelandprice
  • Ireland
  • Japan
  • Netherlands
  • Norwayprice
  • Polandprice
  • Switzerlandprice
  • 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.

Price per daily dose

What a daily dose of sodium phenylbutyrate costs, country by country.

Normalised to the WHO defined daily dose (20 g), so markets compare like for like.

  • 1 market with a comparable price for this class
  • Public list prices, converted to USD at the rate date shown

Sodium phenylbutyrate · price per daily dose (20 g)

USD · FX 28 Sept 2026

  • CZ Czechia$0.46
Median listed price per WHO defined daily dose, in each market that publishes a price. Open the full comparison

The record

At a glance

HPRA (Ireland)
Active substance
Sodium 4-phenylbutyrate
Manufacturer
Eurocept International BV
Country
Ireland (IE)
ATC code
A16AX03
ATC class
Sodium phenylbutyrate
Defined daily dose
20 g, O
Reimbursed
Not published by this register
Source register
HPRA (Ireland)
Last checked
September 28, 2026

Packs & prices · 1

  • ie_pa_number
    EU/1/13/822/001

Regulatory notes

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

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/cbf56f34-64e2-40a9-aab1-feefd5efcdad
GET /v1/drugs/cbf56f34-64e2-40a9-aab1-feefd5efcdad?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": "Granules",
  "routes": [
    "Oral use"
  ],
  "source": "hpra",
  "atc_all": [
    "A16AX",
    "A16AX03"
  ],
  "strength": null,
  "pa_number": "EU/1/13/822/001",
  "substances": [
    "Sodium 4-phenylbutyrate"
  ],
  "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)",
  "market_info": "Unknown",
  "authorised_at": "31/07/2013",
  "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 sodium phenylbutyrate.

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.