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Irish Medicines Database · HPRA register

Imaavy 185 mg/mL concentrate for solution for infusion

Authorisation EU/1/25/1989/001-002 · Janssen-Cilag International NV

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Imaavy 185 mg/mL concentrate for solution for infusion
Licence EU/1/25/1989/001-002 · Unknown
Licence holder
Janssen-Cilag International NV (all products →)
Active substance
Nipocalimab
Dosage form
Concentrate for solution for infusion
Route of administration
Intravenous use
ATC code
L04AL03
First authorised
28/11/2025
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)

Data: Health Products Regulatory Authority (HPRA) open dataset, licensed CC BY 4.0, published 16 Sep 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.