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Irish Medicines Database · HPRA register

Leflunomide Zentiva 100 mg film-coated tablets

Authorisation EU/1/09/604/10 · Zentiva k.s.

← All medicines
Leflunomide Zentiva 100 mg film-coated tablets
Licence EU/1/09/604/10 · Unknown
Licence holder
Zentiva k.s. (all products →)
Active substance
Leflunomide
Dosage form
Film-coated tablet
Route of administration
Oral use
ATC codes
L04AA, L04AA13
Prescription status
Product subject to prescription which may not be renewed (A)
Supply
Supply through pharmacies only
Legal basis
Informed consent application (Article 10c 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.