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Zaditen 1 mg Tablets
Licence PA2206/004/002 · Marketed
- Licence holder
- Alfasigma S.p.A (all products →)
- Active substance
- KETOTIFEN FUMARATE
- Dosage form
- Tablet
- Route of administration
- Oral use
- ATC codes
- R06AX, R06AX17
- First authorised
- 19/12/1979
- 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.