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Irish Medicines Database · HPRA register

Zaditen 0.25 mg/ml, eye drops, solution

Authorisation PA1107/010/001 · Laboratoires Thea

← All medicines

Zaditen 0.25 mg/ml, eye drops, solution

Licence PA1107/010/001 · Marketed

Licence holder: Laboratoires Thea (all products →)
Active substance: KETOTIFEN FUMARATE
Dosage form: Eye drops, solution
Route of administration: Not Currently Available
ATC codes: S01GX, S01GX08
First authorised: 24/11/2000
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.