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Irish Medicines Database · HPRA register

Usgena 90 mg solution for injection in pre-filled syringe

Authorisation EU/1/25/1987/003-004 · Stada Arzneimittel AG

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Usgena 90 mg solution for injection in pre-filled syringe
Licence EU/1/25/1987/003-004 · Unknown
Licence holder
Stada Arzneimittel AG (all products →)
Active substance
Ustekinumab
Dosage form
Solution for injection in pre-filled syringe
Route of administration
Subcutaneous use
ATC code
L04AC05
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)

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.