Belgium· BE-AMP-SAM145293-00

Spasmomen 20 mg

A otilonium bromide product containing otilonium bromide, registered in Belgium by Menarini Benelux. The same ATC class is registered in 2 of our 19 countries.

ATC A03AB06

Checked against FAMHP / AFMPS (Belgium) on

Informational only — not a medical device.

SOURCE REGISTER · BEFAMHP / AFMPS (Belgium)normalisedSpasmomen 20 mgATCA03AB06REGISTER NO.BE-AMP-SAM145293-00PACKS LISTED0CHECKEDSeptember 26, 2026

Where it is registered

Otilonium bromide is registered in 2 of 19 countries.

Countries holding a registration under ATC A03AB06 (otilonium bromide), 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

Otilonium bromide · ATC A03AB06

2 / 19 countries

  • Belgiumprice
  • Czechiaprice
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
Otilonium Bromide
Manufacturer
Menarini Benelux
Country
Belgium (BE)
ATC code
A03AB06
ATC class
Otilonium bromide
Reimbursed
Not published by this register
Source register
FAMHP / AFMPS (Belgium)
Last checked
September 26, 2026

Packs & prices · 0

No packs listed by the register for this record.

Regulatory notes

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

Same medicine, other countries

Otilonium bromide in 2 other countries

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

All otilonium bromide products

Authorised across Europe · EMA

The same active substance is authorised in 14 EEA countries. Names it is sold under:

  • Bulgaria · Спазмомен
  • Cyprus · Doralin
  • Czechia · Spasmomen
  • Spain · Otilonio Cinfa, Otilonio Qualigen
  • Greece · Doralin, Otilax
  • Croatia · Spasmomen
  • Hungary · Otilonium Supremex, Spasmomen
  • Italy · Obimal, Spasmomen
  • Lithuania · Spasmomen
  • Luxembourg · Spasmomen
  • Latvia · Spasmomen
  • Malta · Spasmomen
  • Portugal · Spasmomen
  • Romania · Spasmomen

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/8061bcf3-3c4b-4810-8516-f7435d05e52d
GET /v1/drugs/8061bcf3-3c4b-4810-8516-f7435d05e52d?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": "Coated tablet",
  "source": "afmps",
  "status": "REVOKED",
  "name_en": "Spasmomen 20 mg",
  "name_fr": "Spasmomen 20 mg",
  "name_nl": "Spasmomen 20 mg",
  "amp_code": "SAM145293-00",
  "strengths": [
    "20.0000",
    "20.0000"
  ],
  "pack_count": 2,
  "substances": [
    "Otilonium Bromide"
  ],
  "medicine_type": "ALLOPATHIC",
  "atc_description": "Otilonium Bromide",
  "authorisation_numbers": [
    "BE145293"
  ]
}

See everything about otilonium bromide.

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.