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Irish Medicines Database · HPRA register

Zaditen 1mg/5ml oral solution

Authorisation PA2206/004/001 · Alfasigma S.p.A

← All medicines
Zaditen 1mg/5ml oral solution
Licence PA2206/004/001 · Marketed
Licence holder
Alfasigma S.p.A (all products →)
Active substance
Ketotifen hydrogen fumarate
Dosage form
Oral solution
Route of administration
Oral use
ATC codes
R06AX, R06AX17
First authorised
30/11/1979
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.