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Irish Medicines Database · HPRA register

Amikacin 125 mg/ml Solution for injection/infusion

Authorisation PA1122/034/001 · Noridem Enterprises Limited

← All medicines

Amikacin 125 mg/ml Solution for injection/infusion

Licence PA1122/034/001 · Not marketed

Licence holder: Noridem Enterprises Limited (all products →)
Active substance: AMIKACIN SULFATE
Dosage form: Solution for injection/infusion
Routes of administration: Intramuscular use, Intravenous use
ATC code: J01GB06
First authorised: 24/05/2024
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 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.