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Irish Medicines Database · HPRA register

Amsalyo 75 mg powder for concentration for solution infusion

Authorisation PA1591/003/001 · Eurocept International BV

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Amsalyo 75 mg powder for concentration for solution infusion
Licence PA1591/003/001 · Not marketed
Licence holder
Eurocept International BV (all products →)
Active substance
Amsacrine
Dosage form
Powder for solution for infusion
Route of administration
Intravenous use
ATC code
L01XX01
First authorised
26/01/2024
Prescription status
Product subject to prescription which may not be renewed (A)
Supply
Supply through pharmacies only
Legal basis
Well-established use application (Article 10a 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.