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Irish Medicines Database · HPRA register

Buscopan Rx 10mg Coated Tablets

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

← All medicines
Buscopan Rx 10mg Coated Tablets
Licence PA23180/022/001 · Not marketed
Licence holder
Opella Healthcare France SAS T/A Sanofi (all products →)
Active substance
Hyoscine butylbromide
Dosage form
Coated tablet
Route of administration
Oral use
ATC codes
A03BB, A03BB01
First authorised
02/12/2016
Prescription status
Product subject to prescription which may be renewed (B)
Supply
Supply through pharmacies only
Legal basis
Informed consent application (Article 10c of Directive No 2001/83/EC)

Data: Health Products Regulatory Authority (HPRA) open dataset, licensed CC BY 4.0, published 04 Jul 2026. This listing is regulatory information, not medical advice — consult the package leaflet, SPC, or a healthcare professional. For the authoritative record see the HPRA register.