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Irish Medicines Database · HPRA register

Arthrotec 50 modified-release tablets

Authorisation PPA0465/114/001 · PCO Manufacturing Ltd.

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Arthrotec 50 modified-release tablets
Licence PPA0465/114/001 · Unknown
Licence holder
PCO Manufacturing Ltd. (all products →)
Active substances
Misoprostol, Diclofenac sodium
Dosage form
Modified-release tablet
Route of administration
Oral use
ATC codes
M01AB, M01AB55
First authorised
31/03/2004
Prescription status
Product subject to prescription which may not be renewed (A)
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 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.