Belgium· BE-AMP-SAM251352-00

Carbaglu 200 mg

A carglumic acid product containing carglumic acid, registered in Belgium by Recordati Rare Diseases. The same ATC class is registered in 16 of our 19 countries.

ATC A16AA05

Checked against FAMHP / AFMPS (Belgium) on

Informational only — not a medical device.

SOURCE REGISTER · BEFAMHP / AFMPS (Belgium)normalisedCarbaglu 200 mgATCA16AA05REGISTER NO.BE-AMP-SAM251352-00PACKS LISTED3CHECKEDSeptember 26, 2026

Where it is registered

Carglumic acid is registered in 16 of 19 countries.

Countries holding a registration under ATC A16AA05 (carglumic acid), each read from that country’s own register.

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

Carglumic acid · ATC A16AA05

16 / 19 countries

  • Belgiumprice
  • Canada
  • Czechiaprice
  • Denmark
  • Finlandprice
  • Germany
  • Icelandprice
  • Ireland
  • Italyprice
  • 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 carglumic acid costs, country by country.

Normalised to the WHO defined daily dose (0.2 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

Carglumic acid · price per daily dose (0.2 g)

USD · FX 28 Sept 2026

  • IT Italy$92.77
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
Carglumic Acid
Manufacturer
Recordati Rare Diseases
Country
Belgium (BE)
ATC code
A16AA05
ATC class
Carglumic acid
Defined daily dose
0.2 g, O
Reimbursed
Not published by this register
Source register
FAMHP / AFMPS (Belgium)
Last checked
September 26, 2026

Packs & prices · 3

  • be_apb
    4202339
  • be_apb
    2339067
  • be_apb
    0783225

Regulatory notes

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

Same medicine, other countries

Carglumic acid in 17 other countries

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

All carglumic acid products

Authorised across Europe · EMA

The same active substance is authorised in 17 EEA countries. Names it is sold under:

  • Austria · Carglumsäure Waymade
  • Czechia · Carglumic Acid
  • Germany · Carglumsäure Waymade, Carglumsäure Zentiva
  • Denmark · Cargluminsyre
  • Spain · Ácido Carglúmico, Ácido Carglúmico Tillomed
  • Finland · Karglumiinihappo Waymade
  • France · Acide Carglumique Tillomed, Acide Carglumique Waymade
  • United Kingdom (Northern Ireland) · Carglumic Acid Waymade
  • Greece · Carglumic Acid, Carglumic Acid Tillomed
  • Iceland · Carbaglu, Ucedane
  • Italy · Acido Carglumico Waymade
  • Liechtenstein · Carbaglu, Ucedane
  • Netherlands · Carglumaatzuur Tillomed, Carglumaatzuur Waymade
  • Norway · Carbaglu, Kargluminsyre Waymade
  • Poland · Kwas Kargluminowy
  • Portugal · Ácido Carglúmico, Ácido Carglúmico Waymade
  • Sweden · Kargluminsyra Waymade

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/bc8688d6-4c46-47d3-9fc0-aa5ef36f1173
GET /v1/drugs/bc8688d6-4c46-47d3-9fc0-aa5ef36f1173?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": "Dispersible tablet",
  "source": "afmps",
  "status": "AUTHORIZED",
  "name_en": "Carbaglu 200 mg",
  "name_fr": "Carbaglu 200 mg",
  "name_nl": "Carbaglu 200 mg",
  "amp_code": "SAM251352-00",
  "strengths": [
    "200.0000",
    "200.0000",
    "200.0000"
  ],
  "pack_count": 3,
  "substances": [
    "Carglumic Acid",
    "Sodium Laurilsulfate",
    "Sodium Stearyl Fumarate"
  ],
  "medicine_type": "ALLOPATHIC",
  "atc_description": "Carglumic Acid",
  "authorisation_numbers": [
    "EU/1/02/246/003",
    "EU/1/02/246/002",
    "EU/1/02/246/001"
  ]
}

See everything about carglumic acid.

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.