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Irish Medicines Database · HPRA register

Nilotinib Clonmel 150 mg hard capsules

Authorisation PA0126/393/002 · Clonmel Healthcare Ltd

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Nilotinib Clonmel 150 mg hard capsules
Licence PA0126/393/002 · Marketed
Licence holder
Clonmel Healthcare Ltd (all products →)
Active substance
Nilotinib hydrochloride dihydrate
Dosage form
Capsule, hard
Route of administration
Oral use
ATC code
L01EA03
First authorised
06/09/2024
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 16 Sep 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.