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Registers Irish medicines Acvybra 60 mg solution for injection in pre-filled syringe
Medicines register · Ireland

Acvybra 60 mg solution for injection in pre-filled syringe

Authorisation EU/1/25/1983/001 · Reddy Holding GmbH

Source: Health Products Regulatory Authority (HPRA), open dataset, CC BY 4.0. Published 16 Sep 2026
Licence holder
Reddy Holding GmbH (all products →)
Active substance
Denosumab
Dosage form
Solution for injection in pre-filled syringe
Route of administration
Subcutaneous use
ATC code
M05BX04
First authorised
17/11/2025
Prescription status
Product subject to prescription which may not be renewed (A)
Supply
Supply through pharmacies only
Legal basis
Similar biological application (Article 10(4) of Directive No 2001/83/EC)

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.