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Registers Irish medicines Fubelv 25 mg solution for injection in pre-filled syringe
Medicines register · Ireland

Fubelv 25 mg solution for injection in pre-filled syringe

Authorisation EU/1/26/2023/001-003 · Biocon Biologics Ireland Limited

Source: Health Products Regulatory Authority (HPRA), open dataset, CC BY 4.0. Published 16 Sep 2026
Licence holder
Biocon Biologics Ireland Limited (all products →)
Active substance
Etanercept
Dosage form
Solution for injection in pre-filled syringe
Route of administration
Subcutaneous use
ATC code
L04AB01
First authorised
23/04/2026
Prescription status
Product subject to prescription which may not be renewed (A)
Supply
Supply through pharmacies only
Legal basis
Generic, hybrid or similar biological application (Article 10 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.