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Registers Irish medicines Tremfya 45 mg/0.45 mL solution for injection in pre-filled pen
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Tremfya 45 mg/0.45 mL solution for injection in pre-filled pen

Authorisation EU/1/17/1234/012 · Janssen-Cilag International NV

Source: Health Products Regulatory Authority (HPRA), open dataset, CC BY 4.0. Published 16 Sep 2026
Licence holder
Janssen-Cilag International NV (all products →)
Active substance
Guselkumab
Dosage form
Solution for injection
Route of administration
Subcutaneous use
ATC code
L04AC16
First authorised
10/11/2017
Prescription status
Product subject to prescription which may not be renewed (A)
Supply
Supply through pharmacies only
Legal basis
Full application (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.