Ireland· IE-PA-EU/1/99/120/002
Ammonaps 500 mg Tablets
A sodium phenylbutyrate product containing sodium phenylbutyrate, registered in Ireland by Immedica Pharma AB. The same ATC class is registered in 14 of our 19 countries.
Checked against HPRA (Ireland) on
Informational only — not a medical device.
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
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
The record
At a glance
HPRA (Ireland)- Active substance
- Sodium phenylbutyrate
- Manufacturer
- Immedica Pharma AB
- 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_numberEU/1/99/120/002
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same medicine, other countries
Sodium phenylbutyrate in 8 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- United StatesBUPHENYLHorizon Therapeutics USA, Inc.
- CzechiaAMMONAPSImmedica Pharma AB, Stockholm
- United KingdomAmmonaps 500mg tabletsImmedica Pharma AB
- NorwayAmmonapsImmedica Pharma AB
- SwedenAmmonaps 500 mg TablettImmedica Pharma AB
- FinlandAmmonapsImmedica Pharma AB
- BelgiumAmmonaps 500 mgImmedica Pharma
- CanadaPHEBURANEMEDUNIK CANADA
Authorised across Europe · EMA
The same active substance is authorised in 3 EEA countries. Names it is sold under:
- Iceland · Ammonaps, Pheburane
- Liechtenstein · Ammonaps
- Norway · Ammonaps, Pheburane
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/00d9d027-1a97-48ff-afa7-790a1133f597 GET /v1/drugs/00d9d027-1a97-48ff-afa7-790a1133f597?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": "Tablet",
"routes": [
"Oral use"
],
"source": "hpra",
"atc_all": [
"A16AX03"
],
"strength": null,
"pa_number": "EU/1/99/120/002",
"substances": [
"Sodium phenylbutyrate"
],
"legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)",
"market_info": "Unknown",
"authorised_at": "08/12/1999",
"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.