Belgium· BE-AMP-SAM443265-00
Pheburane 483 mg/g
A sodium phenylbutyrate product containing sodium phenylbutyrate, registered in Belgium by Eurocept International. The same ATC class is registered in 14 of our 19 countries.
Checked against FAMHP / AFMPS (Belgium) 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: Belgium, from FAMHP / AFMPS (Belgium)
- 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
FAMHP / AFMPS (Belgium)- Active substance
- Sodium Phenylbutyrate
- Manufacturer
- Eurocept International
- Country
- Belgium (BE)
- ATC code
- A16AX03
- ATC class
- Sodium phenylbutyrate
- Defined daily dose
- 20 g, O
- Reimbursed
- Not published by this register
- Source register
- FAMHP / AFMPS (Belgium)
- Last checked
- September 26, 2026
Packs & prices · 0
No packs listed by the register for this record.
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.
- FinlandPHEBURANEEurocept International BV
- NorwayPheburaneEurocept International B.V
- SwedenPHEBURANE 483 mg/g GranulatEurocept International B.V.
- United KingdomAmmonaps 500mg tabletsImmedica Pharma AB
- United StatesBuphenylHorizon Therapeutics USA, Inc.
- CzechiaAMMONAPSImmedica Pharma AB, Stockholm
- IrelandAmmonaps 500 mg TabletsImmedica Pharma AB
- 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 FAMHP / AFMPS (Belgium). 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/8290f398-6805-4e81-ae67-c5ceed6818dd GET /v1/drugs/8290f398-6805-4e81-ae67-c5ceed6818dd?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",
"source": "afmps",
"status": "AUTHORIZED",
"name_en": "Pheburane 483 mg/g",
"name_fr": "Pheburane 483 mg/g",
"name_nl": "Pheburane 483 mg/g",
"amp_code": "SAM443265-00",
"strengths": [
"483.0000"
],
"pack_count": 1,
"substances": [
"Sodium Phenylbutyrate"
],
"medicine_type": "ALLOPATHIC",
"atc_description": "Sodium Phenylbutyrate",
"authorisation_numbers": [
"EU/1/13/822/001"
]
}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.