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Irish Medicines Database · HPRA register

Belnifrem 1.5 mg film-coated tablets

Authorisation PA23514/001/001 · Adamed Pharma S.A.

← All medicines
Belnifrem 1.5 mg film-coated tablets
Licence PA23514/001/001 · Not marketed
Licence holder
Adamed Pharma S.A. (all products →)
Active substance
Cytisinicline
Dosage form
Film-coated tablet
Route of administration
Oral use
ATC code
N07BA
First authorised
21/04/2023
Prescription status
Product subject to prescription which may be renewed (B)
Supply
Supply through pharmacies only
Legal basis
Generic application (Article 10(1) 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.