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Ireland· IE-PA-PA25342/003/001

Sigmopan 10 mg film-coated tablets

A butylscopolamine product containing hyoscine butylbromide, registered in Ireland by Ria Generics Limited. The same ATC class is registered in 11 of our 19 countries.

ATC A03BB01

Checked against HPRA (Ireland) on

Informational only — not a medical device.

SOURCE REGISTER · IEHPRA (Ireland)normalisedSigmopan 10 mg film-coated tabletsATCA03BB01REGISTER NO.IE-PA-PA25342/003/001PACKS LISTED1CHECKEDSeptember 28, 2026
Compare price across countriesPer daily dose · free accountAsk the assistant about hyoscine butylbromideAnswers with sources · free accountCheck interactionsSeverity free · mechanism on Growth

Where it is registered

Butylscopolamine is registered in 11 of 19 countries.

Countries holding a registration under ATC A03BB01 (butylscopolamine), each read from that country’s own register.

  • This record: Ireland, from HPRA (Ireland)
  • 6 of them publish a price we can compare per daily dose
Search butylscopolamine products by name

Butylscopolamine · ATC A03BB01

11 / 19 countries

  • Belgiumprice
  • Canada
  • Czechiaprice
  • Denmark
  • Finlandprice
  • Ireland
  • Japan
  • Netherlands
  • Norwayprice
  • Polandprice
  • Switzerlandprice
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

HPRA (Ireland)
Active substance
Hyoscine butylbromide
Manufacturer
Ria Generics Limited
Country
Ireland (IE)
ATC code
A03BB01
ATC class
Butylscopolamine
Defined daily dose
60 mg, O
Reimbursed
Not published by this register
Source register
HPRA (Ireland)
Last checked
September 28, 2026

Packs & prices · 1

  • ie_pa_number
    PA25342/003/001

Regulatory notes

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

Same medicine, other countries

Butylscopolamine in 10 other countries

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

All butylscopolamine products

Authorised across Europe · EMA

The same active substance is authorised in 27 EEA countries. Names it is sold under:

  • Austria · Buscapina, Buscopan
  • Belgium · Buscopan, Buscopan Forte
  • Bulgaria · Бусколизин, Бусколизин Форте
  • Cyprus · Avotrin, Buscopan
  • Czechia · Buscopan, Butylskopolaminium Bromid Kalceks
  • Germany · Buscopan, Buscopan Ampullen
  • Denmark · Bumacor
  • Estonia · Bysimin
  • Spain · Buscapina, Buscopresc
  • Finland · Bumacor, Buscopan
  • France · Buscopan, Scoburen
  • United Kingdom (Northern Ireland) · Almus Ibs Relief, Almus Stomach Cramp Relief
  • Greece · Avotrin, Buscopan
  • Croatia · Buscopan, Bysimin
  • Hungary · Buscopan, Buscopan Forte
  • Italy · Addofix, Buscopan
  • Luxembourg · Buscopan, Buscopan Forte
  • Latvia · Buscopan, Hyoscine Butylbromide Kalceks
  • Malta · Buscopan, Buscopan Ampoules
  • Netherlands · Buscopan, Scopolamine Butylbromide Kalceks
  • Norway · Bumacor, Buscopan
  • Poland · Aurogastro, Buscolysin
  • Portugal · Buscopan, Butilescopolamina Conforpam
  • Romania · Buscopan, Buscotil
  • Sweden · Bumacor, Buscopan
  • Slovenia · Buscopan
  • Slovakia · Buscopan, Scopolamine Butylbromide Kalceks

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 HPRA (Ireland). 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/660d2a20-9bc3-43ef-a323-3497ab0aa031
GET /v1/drugs/660d2a20-9bc3-43ef-a323-3497ab0aa031?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": "Film-coated tablet",
  "routes": [
    "Oral use"
  ],
  "source": "hpra",
  "atc_all": [
    "A03BB01"
  ],
  "strength": null,
  "pa_number": "PA25342/003/001",
  "substances": [
    "Hyoscine butylbromide"
  ],
  "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)",
  "market_info": "Not marketed",
  "authorised_at": "02/05/2025",
  "dispensing_status": "Product subject to prescription which may be renewed (B)",
  "registration_status": "AU",
  "supply_legal_status": "Supply through pharmacies only",
  "interchangeable_code": null
}
API referenceMCP serverPlans

See everything about butylscopolamine.

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.

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