Belgium· BE-AMP-SAM126113-00

Dormonoct 1 mg

A loprazolam product containing loprazolam mesilate, registered in Belgium by Teofarma. The same ATC class is registered in 3 of our 19 countries.

ATC N05CD11

Checked against FAMHP / AFMPS (Belgium) on

Informational only — not a medical device.

SOURCE REGISTER · BEFAMHP / AFMPS (Belgium)normalisedDormonoct 1 mgATCN05CD11REGISTER NO.BE-AMP-SAM126113-00PACKS LISTED1CHECKEDSeptember 26, 2026

Where it is registered

Loprazolam is registered in 3 of 19 countries.

Countries holding a registration under ATC N05CD11 (loprazolam), 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

Loprazolam · ATC N05CD11

3 / 19 countries

  • Belgiumprice
  • Spainprice
  • United Kingdom
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 loprazolam costs, country by country.

Normalised to the WHO defined daily dose (1 mg), 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

Loprazolam · price per daily dose (1 mg)

USD · FX 28 Sept 2026

  • ES Spain$0.13
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
Loprazolam Mesilate
Manufacturer
Teofarma
Country
Belgium (BE)
ATC code
N05CD11
ATC class
Loprazolam
Defined daily dose
1 mg, O
Reimbursed
Not published by this register
Source register
FAMHP / AFMPS (Belgium)
Last checked
September 26, 2026

Packs & prices · 1

  • be_apb
    0888982

Regulatory notes

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

Same medicine, other countries

Loprazolam in 3 other countries

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

All loprazolam products

Authorised across Europe · EMA

The same active substance is authorised in 5 EEA countries. Names it is sold under:

  • Spain · Somnovit
  • France · Havlane
  • United Kingdom (Northern Ireland) · Loprazolam Focus Pharmaceuticals, Loprazolam Zentiva Pharma Uk
  • Luxembourg · Dormonoct
  • Portugal · Dormonoct

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/92695c58-a91f-43d0-b264-8ab25e8fae0e
GET /v1/drugs/92695c58-a91f-43d0-b264-8ab25e8fae0e?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": "Tablet",
  "source": "afmps",
  "status": "AUTHORIZED",
  "name_en": "Dormonoct 1 mg",
  "name_fr": "Dormonoct 1 mg",
  "name_nl": "Dormonoct 1 mg",
  "amp_code": "SAM126113-00",
  "strengths": [
    "1.0000",
    "1.0000",
    "120.0000"
  ],
  "pack_count": 2,
  "substances": [
    "Loprazolam Mesilate",
    "Loprazolam",
    "Lactose Monohydrate"
  ],
  "medicine_type": "ALLOPATHIC",
  "atc_description": "Loprazolam",
  "authorisation_numbers": [
    "BE126113"
  ]
}

See everything about loprazolam.

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.