Iceland· IS-EU/1/02/246/001-003

Carbaglu

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

ATC A16AA05

Checked against Icelandic Medicines Agency (Iceland) on

Informational only — not a medical device.

SOURCE REGISTER · ISIcelandic Medicines Agency (Iceland)normalisedCarbagluATCA16AA05REGISTER NO.IS-EU/1/02/246/001-003PACKS LISTED2CHECKEDSeptember 29, 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: Iceland, from Icelandic Medicines Agency (Iceland)
  • 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

Icelandic Medicines Agency (Iceland)
Active substance
Carglumic acid
Manufacturer
Recordati Rare Diseases*
Country
Iceland (IS)
ATC code
A16AA05
ATC class
Carglumic acid
Defined daily dose
0.2 g, O
Reimbursed
Not published by this register
Source register
Icelandic Medicines Agency (Iceland)
Last checked
September 29, 2026

Packs & prices · 2

2 priced
  • ean
    014889
    60 stk x1 glas
    ISK 490995
  • ean
    024112
    5 stk x1 glas
    ISK 74604

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 16 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
  • 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 Icelandic Medicines Agency (Iceland). 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/00c74385-f3f7-455e-a2ec-c1db4f004819
GET /v1/drugs/00c74385-f3f7-455e-a2ec-c1db4f004819?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": "Dreifitafla",
  "source": "lyfjastofnun",
  "atc_raw": "A16AA05",
  "marketed": true,
  "strength": "200 mg",
  "ma_number": "EU/1/02/246/001-003",
  "substance": "Carglumic acid",
  "other_info": "Ávísun lyfsins er bundin við sérfræðinga í innkirtla- og efnaskiptasjúkdómum og sérfræðinga í taugasjúkdómum.",
  "legal_status": "(R Z) Sérfræðingsmerkt (og lyfseðilsskylt)",
  "ma_issued_serial": "37669"
}

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.