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Irish Medicines Database · HPRA register

Salofalk 1.5g prolonged-release granules

Authorisation PA0573/003/007 · Dr. Falk Pharma GmbH

← All medicines
Salofalk 1.5g prolonged-release granules
Licence PA0573/003/007 · Marketed
Licence holder
Dr. Falk Pharma GmbH (all products →)
Active substance
Mesalazine
Dosage form
Prolonged-release granules
Route of administration
Oral use
ATC codes
A07EC, A07EC02
First authorised
23/08/2013
Prescription status
Product subject to prescription which may be renewed (B)
Supply
Supply through pharmacies only
Legal basis
Full application (Article 8(3) 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.