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Ireland· IE-PA-PA23180/022/001

Buscopan Rx 10mg Coated Tablets

A butylscopolamine product containing hyoscine butylbromide, registered in Ireland by Opella Healthcare France SAS T/A Sanofi. 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)normalisedBuscopan Rx 10mg Coated TabletsATCA03BB01REGISTER NO.IE-PA-PA23180/022/001PACKS LISTED1CHECKEDSeptember 28, 2026

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

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
Opella Healthcare France SAS T/A Sanofi
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
    PA23180/022/001

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/40403f6a-1066-480f-8659-13f56589417e
GET /v1/drugs/40403f6a-1066-480f-8659-13f56589417e?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",
  "routes": [
    "Oral use"
  ],
  "source": "hpra",
  "atc_all": [
    "A03BB",
    "A03BB01"
  ],
  "strength": null,
  "pa_number": "PA23180/022/001",
  "substances": [
    "Hyoscine butylbromide"
  ],
  "legal_basis": "Informed consent application (Article 10c of Directive No 2001/83/EC)",
  "market_info": "Not marketed",
  "authorised_at": "02/12/2016",
  "dispensing_status": "Product subject to prescription which may be renewed (B)",
  "registration_status": "AU",
  "supply_legal_status": "Supply through pharmacies only",
  "interchangeable_code": null
}

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.