Belgium· BE-AMP-SAM487795-00

Ravicti 1.1 g/ml

A glycerol phenylbutyrate product containing glycerol phenylbutyrate, registered in Belgium by Immedica Pharma. The same ATC class is registered in 13 of our 19 countries.

ATC A16AX09

Checked against FAMHP / AFMPS (Belgium) on

Informational only — not a medical device.

SOURCE REGISTER · BEFAMHP / AFMPS (Belgium)normalisedRavicti 1.1 g/mlATCA16AX09REGISTER NO.BE-AMP-SAM487795-00PACKS LISTED2CHECKEDSeptember 26, 2026

Where it is registered

Glycerol phenylbutyrate is registered in 13 of 19 countries.

Countries holding a registration under ATC A16AX09 (glycerol phenylbutyrate), each read from that country’s own register.

  • This record: Belgium, from FAMHP / AFMPS (Belgium)
  • 7 of them publish a price we can compare per daily dose

Glycerol phenylbutyrate · ATC A16AX09

13 / 19 countries

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

The record

At a glance

FAMHP / AFMPS (Belgium)
Active substance
Glycerol Phenylbutyrate
Manufacturer
Immedica Pharma
Country
Belgium (BE)
ATC code
A16AX09
ATC class
Glycerol phenylbutyrate
Defined daily dose
15 g, O
Reimbursed
Not published by this register
Source register
FAMHP / AFMPS (Belgium)
Last checked
September 26, 2026

Packs & prices · 2

1 priced
  • be_apb
    7737604
  • be_apb
    4683322
    EUR 197.32

Regulatory notes

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

Interactions

244 interactions on record for glycerol phenylbutyrate.

Graded by severity as the source publishes them — 5 severe. 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

Glycerol phenylbutyrate · interactions on record

244 records

  • 5 severe
  • 235 moderate
  • 4 minor

Most severe, free to view

  • ProbenecidM04AB01severe
  • Valproic acidN03AG01severe
  • PantoprazoleA02BC02moderate
  • MetoclopramideA03FA01moderate
  • 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.
Mechanism and what to do, in the interaction check
Source: DDInter 2.0 · synced 29 Sept 2026. Grades as the source publishes them.

Same medicine, other countries

Glycerol phenylbutyrate in 12 other countries

What each register calls a product with the same active substance — salts and hydrates count as the same.

All glycerol phenylbutyrate products

Authorised across Europe · EMA

The same active substance is authorised in 3 EEA countries. Names it is sold under:

  • Iceland · Ravicti
  • Liechtenstein · Ravicti
  • Norway · Ravicti

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/41142f79-6321-40fd-9b65-4d4264b02bfa
GET /v1/drugs/41142f79-6321-40fd-9b65-4d4264b02bfa?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": "Oral liquid",
  "source": "afmps",
  "status": "AUTHORIZED",
  "name_en": "Ravicti 1.1 g/ml",
  "name_fr": "Ravicti 1.1 g/ml",
  "name_nl": "Ravicti 1.1 g/ml",
  "amp_code": "SAM487795-00",
  "strengths": [
    "1.1000"
  ],
  "pack_count": 4,
  "substances": [
    "Glycerol Phenylbutyrate"
  ],
  "medicine_type": "ALLOPATHIC",
  "atc_description": "Glycerol Phenylbutyrate",
  "authorisation_numbers": [
    "EU/1/15/1062/002",
    "EU/1/15/1062/001",
    "EU/1/15/1062/003",
    "EU/1/15/1062/004"
  ]
}

See everything about glycerol 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.