Belgium· BE-AMP-SAM172916-00

Custodiol

A sonstige spüllösungen, kombinationen product containing mannitol, registered in Belgium by Dr. Kohler Chemie. The same ATC class is registered in 3 of our 19 countries.

ATC B05CX10

Checked against FAMHP / AFMPS (Belgium) on

Informational only — not a medical device.

SOURCE REGISTER · BEFAMHP / AFMPS (Belgium)normalisedCustodiolATCB05CX10REGISTER NO.BE-AMP-SAM172916-00PACKS LISTED1CHECKEDSeptember 26, 2026

Where it is registered

Sonstige spüllösungen, kombinationen is registered in 3 of 19 countries.

Countries holding a registration under ATC B05CX10 (sonstige spüllösungen, kombinationen), each read from that country’s own register.

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

Sonstige spüllösungen, kombinationen · ATC B05CX10

3 / 19 countries

  • Belgiumprice
  • Canada
  • Finlandprice
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
Mannitol
Manufacturer
Dr. Kohler Chemie
Country
Belgium (BE)
ATC code
B05CX10
ATC class
Sonstige Spüllösungen, Kombinationen
Reimbursed
Not published by this register
Source register
FAMHP / AFMPS (Belgium)
Last checked
September 26, 2026

Packs & prices · 1

  • be_apb
    1226042

Regulatory notes

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

Same medicine, other countries

Sonstige spüllösungen, kombinationen in 16 other countries

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

All sonstige spüllösungen, kombinationen products

Authorised across Europe · EMA

The same active substance is authorised in 30 EEA countries. Names it is sold under:

  • Austria · Mannit Fresenius
  • Bulgaria · Манитол Б. Браун, Манитол Бакстер
  • Cyprus · Mannitol Demo, Mannitol Βιοσερ
  • Czechia · Ardeaosmosol Ma, Manitol Viaflo Baxter
  • Germany · Aridol, Mannit-Lösung Serag
  • Denmark · Mannitol Fresenius Kabi, Osmohale
  • Estonia · Mannitol Fresenius
  • Spain · Manitol Mein, Osmofundina
  • Finland · Aridol, Mannitol Braun
  • France · Mannitol Aguettant, Mannitol B. Braun
  • United Kingdom (Northern Ireland) · Mannitol Baxter Healthcare, Osmohale
  • Greece · Mannitol Bradex, Mannitol Cooper
  • Croatia · Manitol Hztm
  • Hungary · Mannisol A, Mannisol B
  • Ireland · Mannitol Baxter Holding, Osmohale
  • Iceland · Bronchitol, Mannitol Viaflo Baxter
  • Italy · Mannitolo Bioindustria L.I.M, Mannitolo Bioindustria L.I.M.
  • Liechtenstein · Bronchitol
  • Lithuania · Mannitol Fresenius
  • Luxembourg · Mannitol Viaflo, Mannitol Viaflo Baxter
  • Latvia · Mannitol Fresenius
  • Malta · Mannitol Baxter Holding, Mannitol Monico
  • Netherlands · Mannitol Baxter, Osmohale
  • Norway · Aridol, Bronchitol
  • Poland · Mannitol Baxter, Mannitol Fresenius
  • Portugal · Manitol Braun, Manitol Labesfal
  • Romania · Manitol Infomed Fluids, Mannitol Vioser
  • Sweden · Aridol, Mannitol Fresenius Kabi
  • Slovenia · Manitol Hztm
  • Slovakia · Infusio Mannitoli, Mannitol Bieffe

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/55ee74d1-78c8-4aa2-9069-fe6347829a70
GET /v1/drugs/55ee74d1-78c8-4aa2-9069-fe6347829a70?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": "Solution for organ preservation",
  "source": "afmps",
  "status": "REVOKED",
  "name_en": "Custodiol",
  "name_fr": "Custodiol",
  "name_nl": "Custodiol",
  "amp_code": "SAM172916-00",
  "strengths": [
    "5.4600",
    "5.4600",
    "27.9200",
    "27.9200",
    "3.7700",
    "0.0022",
    "2.7900",
    "0.8100",
    "0.0022",
    "0.6700",
    "0.8700",
    "0.1800"
  ],
  "pack_count": 1,
  "substances": [
    "Mannitol",
    "Histidine",
    "Histidine Hydrochloride Monohydrate",
    "Calcium Chloride Dihydrate",
    "Magnesium Chloride Hexahydrate",
    "Potassium Chloride",
    "Sodium Chloride",
    "Potassium Hydrogen 2-Ketoglutarate",
    "Tryptophan (DL)"
  ],
  "medicine_type": "ALLOPATHIC",
  "atc_description": "Combinations",
  "authorisation_numbers": [
    "BE172916"
  ]
}

See everything about sonstige spüllösungen, kombinationen.

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.