Belgium· BE-AMP-SAM222555-00

Ammonaps 500 mg

A sodium phenylbutyrate product containing sodium phenylbutyrate, registered in Belgium by Immedica Pharma. The same ATC class is registered in 14 of our 19 countries.

ATC A16AX03

Checked against FAMHP / AFMPS (Belgium) on

Informational only — not a medical device.

SOURCE REGISTER · BEFAMHP / AFMPS (Belgium)normalisedAmmonaps 500 mgATCA16AX03REGISTER NO.BE-AMP-SAM222555-00PACKS LISTED1CHECKEDSeptember 26, 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: 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
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

FAMHP / AFMPS (Belgium)
Active substance
Sodium Phenylbutyrate
Manufacturer
Immedica Pharma
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 · 1

  • be_apb
    3551546

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.

All sodium phenylbutyrate products

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/83b236b1-b88c-4111-aa78-852056fc5a3c
GET /v1/drugs/83b236b1-b88c-4111-aa78-852056fc5a3c?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",
  "source": "afmps",
  "status": "AUTHORIZED",
  "name_en": "Ammonaps 500 mg",
  "name_fr": "Ammonaps 500 mg",
  "name_nl": "Ammonaps 500 mg",
  "amp_code": "SAM222555-00",
  "strengths": [
    "500.0000"
  ],
  "pack_count": 2,
  "substances": [
    "Sodium Phenylbutyrate"
  ],
  "medicine_type": "ALLOPATHIC",
  "atc_description": "Sodium Phenylbutyrate",
  "authorisation_numbers": [
    "EU/1/99/120/001",
    "EU/1/99/120/002"
  ]
}

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.