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.
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_apb0129338
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.
- United KingdomChloral hydrate 1.25g/5ml oral solution BPSpecial Order
- Japan抱水クロラール久光製薬
- NorwayKloralhydrat SASykehusapotekene HF
- CanadaCHLORAL HYDRATE SYRUP ODANODAN LABORATORIES LTD
- GermanyChloralduratDesitin Arzneimittel Gmbh
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.