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Irish Medicines Database · HPRA register

Asacolon 800 mg Gastro-resistant Tablets

Authorisation PPA1463/264/001 · IMED Healthcare Ltd.,

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Asacolon 800 mg Gastro-resistant Tablets
Licence PPA1463/264/001 · Unknown
Licence holder
IMED Healthcare Ltd., (all products →)
Active substance
Mesalazine
Dosage form
Gastro-resistant tablet
Route of administration
Oral use
ATC code
A07EC02
First authorised
21/08/2026
Prescription status
Product subject to prescription which may be renewed (B)
Supply
Supply through pharmacies only
Legal basis
Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC

Data: Health Products Regulatory Authority (HPRA) open dataset, licensed CC BY 4.0, published 16 Sep 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.