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Registers Irish medicines Saphnelo 120 mg solution for injection in pre-filled pen
Medicines register · Ireland

Saphnelo 120 mg solution for injection in pre-filled pen

Authorisation EU/1/21/1623/003-005 · AstraZeneca AB

Source: Health Products Regulatory Authority (HPRA), open dataset, CC BY 4.0. Published 16 Sep 2026
Licence holder
AstraZeneca AB (all products →)
Active substance
Anifrolumab
Dosage form
Solution for injection in pre-filled pen
Route of administration
Subcutaneous use
ATC code
L04AG11
First authorised
12/12/2025
Prescription status
Product subject to prescription which may not be renewed (A)
Supply
Supply through pharmacies only
Legal basis
Known active substance (Article 8(3) 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.