Belgium· BE-AMP-SAM030003-00

Sedemol

A medicinal product containing chloral hydrate, registered in Belgium by Melisana.

Checked against FAMHP / AFMPS (Belgium) on

Informational only — not a medical device.

SOURCE REGISTER · BEFAMHP / AFMPS (Belgium)normalisedSedemolATC—REGISTER NO.BE-AMP-SAM030003-00PACKS LISTED1CHECKEDSeptember 26, 2026

The record

At a glance

FAMHP / AFMPS (Belgium)
Active substance
Chloral Hydrate
Manufacturer
Melisana
Country
Belgium (BE)
ATC code
—
Reimbursed
Not published by this register
Source register
FAMHP / AFMPS (Belgium)
Last checked
September 26, 2026

Packs & prices · 1

  • be_apb
    0129338

Regulatory notes

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

Same medicine, other countries

Chloral hydrate in 5 other countries

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

All chloral hydrate products

Authorised across Europe · EMA

The same active substance is authorised in 2 EEA countries. Names it is sold under:

  • Germany · Chloraldurat
  • United Kingdom (Northern Ireland) · Chloral Hydrate, Chloral Hydrate Colonis Pharma

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/bdbe44dc-4d7a-405b-b74a-a9f8d78b3ff5
GET /v1/drugs/bdbe44dc-4d7a-405b-b74a-a9f8d78b3ff5?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": "Oromucosal/laryngopharyngeal solution",
  "source": "afmps",
  "status": "REVOKED",
  "name_en": "Sedemol",
  "name_fr": "Sedemol",
  "name_nl": "Sedemol",
  "amp_code": "SAM030003-00",
  "strengths": [
    "10.0000",
    "10.0000",
    "5.0000",
    "1.2500",
    "0.0700",
    "2.5000",
    "5.0000"
  ],
  "pack_count": 1,
  "substances": [
    "Chloral Hydrate",
    "Papaveris Fructus",
    "Phenol",
    "Sodium Fluoride",
    "Sodium Borate",
    "Althaea, Flower, Root"
  ],
  "medicine_type": "ALLOPATHIC",
  "atc_description": null,
  "authorisation_numbers": [
    "0616S 0470F011"
  ]
}

See everything about chloral hydrate.

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.