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Irish Medicines Database · HPRA register

Aniva 25 mg film-coated tablets

Authorisation PA22871/023/002 · Azure Pharmaceuticals Ltd.

← All medicines
Aniva 25 mg film-coated tablets
Licence PA22871/023/002 · Not marketed
Licence holder
Azure Pharmaceuticals Ltd. (all products →)
Active substance
Amitriptyline hydrochloride
Dosage form
Film-coated tablet
Route of administration
Oral use
ATC code
N06AA09
First authorised
28/02/2025
Prescription status
Product subject to prescription which may not be renewed (A)
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.